Your Software. Medical Device

Transcription

1 March 18, Your Software can be a Medical Device Software Compliance Expert US Food & Drug Administration Why am I here today? To tell you how I think about determining if a software product is a medical device I am in the Medical Device Software Business 2 1

2 March 18, What about Health IT? There is an increasing interest in "Electronic Health Record (EHR) Systems and Health IT CDRH has established an EHR System Working Group Issues and questions should be referred to Donna-Bea Tillman, Director ODE 3 Any product can become a medical device A magnet An IP phone A palm pilot An RFID chip All it takes is an intended use that meets the legal definition of a device 4 2

3 March 18, Good intended use definition Before you start deciding you have to have a good intended use definition To get this done you need to define what it does and why it is of value The idea here is to describe the functionality and output of the software and how it will be used to diagnose, treat or cure patients. To put it another way how can this product help the practitioner practice medicine. 5 It is really a 2 part question What does it do? (engineering view) And how can I use that? (clinical view) 6 3

4 March 18, Examples of what Displays data Displays medical device data Stores Data Stores Medical Device data Transmit Data Transmits medical device data 7 More What Displays images Displays medical images Stores images Stores medical images Transmits images Transmits medical images 8 4

5 March 18, More what Calculates doses Creates radiation treatment plans Checks for drug interactions Checks for allergies Calculates treatment timing Controls treatment timing 9 K INTENDED USE: is a data acquisition program for use with the DIAS (Dynatech ImmunoAssay System formerly MR7000 System) System. Time Management Software communicates commands to microtiter dispensing and diluting equipment 10 5

6 March 18, The TMS Is a Microsoft Windows (v3.1) based software for an IBM PC AT or compatible with a CPU of 386SX or greater personal computer (PC) using MSDOS (Microsoft Disk Operating System) 3.1 or later. The TMS manages critical timings presented by in vitro diagnostic laboratory assay processes so as to prevent scheduling problems (resource contention) between ELISA washer, dispenser, incubator, and reader. The TMS will perform final result calculation using curve fitting, threshold matrix (cutoff), ratio matrix, and differential matrix. The TMS is similar in function to the software which controls the MR7000, cleared via K Examples of Use Output can be used to formulate treatment plans Output can be used to recommend additional analysis and test Output can be used to diagnose the presence of tumors Output can be used as an aid in the diagnosis of Alzheimer s Output can be used to calculate insulin dose 12 6

7 March 18, More Use Output directly controls infusion rate Output directly controls radiation treatment Output provides medical guidance to practitioners Output t provides computer aided d decision i making to the practitioners 13 What is John s algorithm? Does your product meet and existing device classification? 21 CFR 860 to 21 CFR 892 Is your product an accessory to a classified medical device? Does your product meet the legal definition of a medical device? Is your device exempted by regulation? 21 CFR Exemptions for device establishments How should your device classified? Class I, II or III 510(k), PMA 14 7

8 March 18, How do you think about the classification model? From Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Proposed Rules The level of FDA oversight of software should depend primarily on the risk to the patient should the software fail to perform in accordance with its specifications 15 Software Device Safari Let s search the CDRH public data base and see what kinds of software devices already exist? rh/cfdocs/cfpmn/pmn.cfm What is the history here? 16 8

9 March 18, What information can we find in the public 510(k) database? Software 431 listings Record 319 listings Computer 225 listings Network 43 listings Calculator 20 listings Internet 1 listing Health IT 0 listings 17 Pro Code NZH Sec Remote Medication Management System. A remote medication management system is a device composed of clinical and communications software, a medication delivery unit, and medication packaging. The system is intended to store the patient's prescribed medications in a delivery unit, to permit a health care professional to remotely schedule the patient's prescribed medications, to notify the patient when the prescribed medications are due to be taken, to release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command, and to record a history of the event for the health care professional. The system is intended for use as an aid to health care professionals in managing therapeutic regimens for patients in the home or clinic. 18 9

10 March 18, Calculator Drug Dose Regulation Description Predictive pulmonary-function value calculator Product Code NDC Submission Type510(k) [7 to date} Regulation Number Device Class 2 GMP Exempt? No 19 Medical computers and software Code LNX Unclassified Reason Pre-Amendment Submission Type 510(k) [10 to date} Device Class Unclassified GMP Exempt? No 20 10

11 March 18, Electronic Medical Record Pro Code LNX medical computers and software 510(k) Number K XXX HEALTH CARE SYSTEMS ELECTRONIC MEDICAL RECORD 21 Pro Code NSX Software, transmission and storage, patient data Alarming software that captures patient data from patient monitoring devices and transmits the data to the patient electronic medical record, where the data is stored. Not Classified Reason Enforcement Discretion Submission Type Enforcement Discretion Device Class Not Classified GMP Exempt? No 22 11

12 March 18, Transmitter and receivers, physiological signal, radio frequency Product Code DRG Submission Type 510(k) Regulation Number [80 to date] Device Class2 GMP Exempt? No 23 Remote Patient Monitoring System K Trade Name: Intel"' Health Guide PHS6000 Classification Name: Transmitters and Receivers. Physiological Signal, Radiofrequency (21 CFR , Product Code DRG) Substantial Equivalence is claimed to the following devices: 1. Philips Medical Systems' M3810A TeleMonitoring System with M3812B TeleStation (K023749) 2. Health Hero Network's Health Buddy'~ Appliance (K063612) 3. WEBVMC. LLC's RemoteNurse TM Patient Monitoring system (K041308) 24 12

13 March 18, PHS6000 Is a communication tool that allows caregivers to remotely access vital sign measurements of patients t at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys. 25 Medical Computers and software for ophthalmic use Product Code LQB Submission Type Contact ODE [2 to date] Device Class 3 GMP Exempt? No 26 13

14 March 18, Monitor, st segment with alarm Product Code MLD Submission Type 510(k) Regulation Number [13 to date] Device Class 2 GMP Exempt? No 27 System network and communication physiological monitors Product Code MSX Submission Type510(k) Regulation Number [54 to date] Device Class 2 GMP Exempt? No 28 14

15 March 18, Monitor, physiological, patient (without arrhythmia detection or alarms) Product Code MWI Submission Type 510(k) Regulation Number [109 to date] Device Class 2 GMP Exempt? No 29 Monitor, bed patient Product Code KMI Submission Type 510(k) Exempt Regulation Number [24 old] Device Class 1 GMP Exempt? No 30 15

16 March 18, Device recorder, magnetic tape Product Code DSH Submission Type510(k) Regulation Number [140 to date] Device Class 2 GMP Exempt? No A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers

17 March 18, K has the same intended d use as the previously marketed telemetry t system, which is for use by medical professionals with Nihon Kohden telemetry transmitters and central stations to provide cardiac and vital signs monitoring for multiple patients. The device can receive the patient's ECG, respiration, SPO2, and noninvasive blood pressure data (NIBP value is only displayed on the central monitor) from a transmitter and send it to Nihon Kohden Central monitor within the medical facility. The device is designed as a component of a central monitor network to be used in the ICU, CCU, HCU, recovery room, operating room and general ward. The device will receive and transmit physiological data from telemetry transmitters/receivers and generate an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected. 33 K The is intended to collect and transmit physiological information, such as weight, via standard telephone lines or the internet to local or remote computer systems for use by the patient or a healthcare professional. Technological Characteristics Medic4AlI's VMS-01 telemedicine system (VMS-01) is a wireless telephonic/internet-based physiologic monitoring system, designed for care of patients requiring periodic monitoring. It is designed for interactive, remote, physiological data measurement, transmission, processing, storage and display of data. Additionally, the system allows optional verbal and video conferencing between a care giver and a patient through common telephone lines or the internet and optional hardware

18 March 18, K PREDICATE DEVICES Health Buddy with Device Connectivity (#K042273, #K040086) Health Buddy with Buddylink (#K993128) CareMatix Weilness System (#K040966) Viterion 100 TeleHealth Monitor (#K030419) 35 INDICATION FOR USE STATEMENT is indicated for use in non-clinical settings to collect and transmit historical data to healthcare professionals to help support effective management of their patients. is an accessory device, intended to be a communication tool to enable healthcare providers to receive historical patient information. The product is used in conjunction with Health Hero Network's Online Service, a communication tool to enable health care providers to educate, motivate, and receive patient information. is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional

19 March 18, Device Description is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional (s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuffs, patient weight scales and peak flow meters). The Health Buddy appliance retrieves data from a specific medical device and stores it for transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEWi (forced expiratory volume) measurements. The Health Buddy device has data ports that allow it to download readings from identified attached devices, activated only upon appropriate patient enrollment. is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to a Data Center via a toll-free number to send patient responses from the previous day and to retrieve the current day's dialogue. The screen displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient information is sent to the patient's health care provider. 37 K collects, processes, and records data directly from medical monitors which themselves are attached to the patients in the operating room environment

20 March 18, 21 CFR Pro Code NXQ [1 510(k)} A medication reminder is a device intended for medical purposes to provide alerts to patients or healthcare providers for pre-determined medication dosing schedules. The device may incorporate wireless communication. 39 K CFR Pro Code NVI BioPlex 2200 Medical Decision Support Software (MDSS). used in conjunction with the ANA Screen is an optional laboratory tool that associates patient antibody results with predefined MDSS profiles that have been correlated with the following systemic autoimmune diseases: Systemic Lupus Erythematosus (SL ), Mixed Connective [issue Disease (MC'I D). Sjdgrens Sy ndrome (SS), Scieroderma (Systemic Sclerosis) and Polymyositis

21 March 18, How Do You Regulate a Product Without Any Physical Representation? 41 21