(208 days)
The MyHealthPoint Telehealth Manager is an accessory software that wirelessly collects, records and transmits biometric data (including glucose, blood pressure, weight, body composition, activity, body temperature, ECG and pulse oximeter readings) from a variety of supported home-monitoring devices as well as supporting manual uploading of data. The MyHealthPoint application uses the same data repository platform that is already cleared, MyGlucoHealth Software System (K081703).
MyHealthPoint TeleHealth Manager is intended to be used by patients in non-clinical settings (e.g. home) to collect, record and transmit their biometric data to a remote secure server. Stored data is accessible by healthcare professionals and caregivers for analysis, messaging and intervention using standard digital communication technologies and protocols. Patients may also view the data to assist in self-management of their specific health condition. The MyHealthPoint Telehealth Manager is intended to be used in combination with a variety of external vital sign devices.
The MyHealthPoint Telehealth Manager is intended to be used by patients identified by their healthcare organization that would benefit from remote monitoring. It is not intended as a replacement of the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. It does not measure, interpret or make any decisions on the data that it conveys.
The MyHealthPoint Telehealth Manager is a software platform accessible via PC or mobile smart phone that collects member's biometric data such as activity, blood pressure, blood glucose, ECG, body temperature, body composition/weight and pulse oximetry, and has the ability to send medication reminders. The MyHealthPoint TeleHealth Manager can be used by patients during their daily lives to collect biometric readings from various personal health monitors from a variety of manufacturers to assist in maintaining wellness regimens and the clinical monitoring of patients with chronic disease. The system can be accessed by members, clinicians and caregivers for analysis and intervention using standard digital communication technologies and protocols. The MyHealthPoint Telehealth Manager is intended for use in remote monitoring of patient biometrics and supports messaging between member's, clinicians and caregivers. In addition to monitoring, MyHealthPoint TeleHealth Manager supports reminders, alerts, and online graphical reports to help patients and their healthcare professionals better understand and manage their conditions.
The provided document is a 510(k) premarket notification for the MyHealthPoint TeleHealth Manager, a software platform. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for an AI algorithm.
Here's a breakdown of the requested information based on the provided text, with explicit notes where information is not available or not applicable to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Specifications | Product meets product performance and functional specifications. | "Verification testing that product meets product performance and functional specifications." (Implies successful completion, but no specific quantitative metrics are provided.) |
| Data Integrity | Biometric data from personal home-use devices are captured (wirelessly or manually), transmitted, and stored properly to maintain data integrity (e.g., no loss of data or corruption). | "Verification that biometric data submitted by personal home-use devices are captured (wirelessly or manually), transmitted and stored properly to maintain data integrity (e.g. no loss of data or corruption)" (Implies successful completion, but no specific quantitative metrics, such as error rates or data loss percentages, are provided.) |
| Instructional Utility | Adequate instructional utility of the User Manual. | "User performance testing to demonstrate adequate instructional utility of the User Manual." (Implies successful completion, but no specific metrics, such as completion rates or error rates by users, are provided.) |
| Safety | No new issues of safety identified after extensive testing. | "After extensive bench testing to performance requirements and criteria established in accordance with application of EN14971 risk analysis, no new issues of safety, performance, technology or intended use were identified." (Broad statement, no specific safety metrics or thresholds.) |
| Performance (General) | No new issues of performance identified after extensive testing. | "After extensive bench testing to performance requirements and criteria established in accordance with application of EN14971 risk analysis, no new issues of safety, performance, technology or intended use were identified." (Broad statement, no specific performance metrics or thresholds for the software's functional capabilities.) |
| Substantial Equivalence | Device is substantially equivalent to identified predicate devices. | "Therefore the MyHealthPoint TeleHealth Manager is concluded to be substantially equivalent to the identified predicates." (This is the primary conclusion of the 510(k) submission, based on comparisons of intended use, technological characteristics, and features, rather than specific performance metrics against pre-defined thresholds for a novel algorithm.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The submission describes "extensive bench testing" and "user performance testing" but does not provide any details on the number of cases, data points, or users involved in these tests.
- Data Provenance: Not specified. The document does not mention the country of origin of any data, nor whether it was retrospective or prospective. Given the nature of a 510(k) for a software platform emphasizing substantial equivalence and verification of data transfer/storage, the focus is on functional testing rather than clinical data from a patient population.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Specified. The submission does not detail any expert-derived ground truth or clinical interpretations. The "performance" assessment focuses on the software's ability to capture, transmit, and store data correctly, and the usability of the manual. It's a technical verification, not a clinical validation requiring expert ground truth.
4. Adjudication Method for the Test Set
- Not Applicable / Not Specified. No adjudication method is mentioned as there's no indication of a diagnostic or interpretive task requiring expert consensus for ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not done. The device is a data management and communication system, not an AI algorithm performing diagnostic interpretations that would typically be evaluated in an MRMC study. The document states it "does not measure, interpret or make any decisions on the data that it conveys."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Partially Applicable / Not Explicitly Described as "Standalone Study". The "Verification testing that product meets product performance and functional specifications" and "Verification that biometric data submitted by personal home-use devices are captured (wirelessly or manually), transmitted and stored properly" essentially describe standalone testing of the software's core functionalities (data handling, transmission, storage). However, it's not structured as a typical "standalone algorithm performance study" for an AI diagnostic device, as the MyHealthPoint TeleHealth Manager itself is not an AI diagnostic algorithm.
7. Type of Ground Truth Used
- Functional/Technical Verification. The "ground truth" for the tests described would be based on expected software behavior and data integrity rather than clinical outcomes, pathology, or expert consensus on a medical diagnosis. For example, for data integrity, the ground truth would be that the transmitted data perfectly matches the source data. For functional specifications, the ground truth would be the defined expected behavior of the software.
8. Sample Size for the Training Set
- Not Applicable / Not Specified. The MyHealthPoint TeleHealth Manager is described as a software platform for data collection and display, not a machine learning or AI algorithm that requires a training set. There is no mention of an algorithm being trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Specified. As there is no mention of a training set or an AI algorithm requiring training, the establishment of ground truth for such a set is not discussed.
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APR 1 4 2014
Image /page/0/Picture/1 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E", "h", and "S" arranged horizontally. The "h" is inside of a black circle. Below the letters is the text "Entra Health Systems".
December 26, 2013
| Entra Health Systems LLC | |
|---|---|
| 3111 Camino del Rio North | |
| Suite 101 | |
| San Diego, CA 92108 | |
| Main 877 458 2646 | |
| Fax 619 584 4504 | |
| K132930 |
(in accordance with 21 CFR 807.92)
| A. Submitter: | Entra Health Systems |
|---|---|
| B. Address: | 3111 Camino Del Rio NorthSuite 101San Diego CA 92108 |
| C. Corporate Contact: | Richard Strobridge, CEOEntra Health Systems |
| D. Telephone: | Ph: 877-458-2646Fax: 619-584-4504 |
| E. Submission Contact: | Emily Davis, Project ManagerEntra Health Systems3111 Camino Del Rio NorthSuite 101San Diego CA 92108Ph: 877-458-2646edavis@entrahealthsystems.com |
| F. Trade Name: | MyHealthPoint TeleHealth Manager |
| G. Predicate Device(s): | - Vignet TeleHealth Manager, K113446- Honeywell Genesis DM Monitor, K101242- Verizon Wireless Converged Health Management Device, K122458 |
| H. Common Name: | Telemedicine System |
- I. Classification:
| RegulationNumber | ProductCode | Classification Name | DeviceClass |
|---|---|---|---|
| 870.2910 | DRG | Radiofrequency Physiological SignalTransmitter and Receiver | II |
| Medical device product codes also supported by MyHealthPoint Telehealth Manager bymeans of separate medical devices | |||
| 862.2100 | JQP | Calculator/Data Processing Module | I |
| 870.1130 | DXN | Noninvasive Blood Pressure Measurement | II |
| 870.2700 | DQA | Oximeter | II |
| 880.2910 | FLL | Thermometer, Electronic, Clinical | II |
| 870.2340 | DPS | Elecrocardiograph | II |
| 870.2360 | DRX | Electrocardiograph electrode | II |
| 890.5060 | NXB | Medication Reminder | I |
| 880.2700 | FRI | Patient Weight Scale | I |
| 880.6310 | OUG | Medical device data system | I |
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- J. Device Description
The MyHealthPoint Telehealth Manager is a software platform accessible via PC or mobile smart phone that collects member's biometric data such as activity, blood pressure, blood glucose, ECG, body temperature, body composition/weight and pulse oximetry, and has the ability to send medication reminders. The MyHealthPoint TeleHealth Manager can be used by patients during their daily lives to collect biometric readings from various personal health monitors from a variety of manufacturers to assist in maintaining wellness regimens and the clinical monitoring of patients with chronic disease. The system can be accessed by members, clinicians and caregivers for analysis and intervention using standard digital communication technologies and protocols. The MyHealthPoint Telehealth Manager is intended for use in remote monitoring of patient biometrics and supports messaging between member's, clinicians and caregivers. In addition to monitoring, MyHealthPoint TeleHealth Manager supports reminders, alerts, and online graphical reports to help patients and their healthcare professionals better understand and manage their conditions.
The supported cleared, home-monitoring devices currently marketed with the MyHealthPoint TeleHealth Manager for wireless collection of data and physiological information is in the table below and the systems Architecture is explained on page 3.
| No. | Vital Signs/Product Code | Measurement | Vital Signs EquipmentManufacturers/Models (510k) | Connection Type toMyHealthPoint |
|---|---|---|---|---|
| 1 | Glucose | Blood glucose (mg/dl ormmol/L) | Entra Health Systems,MGH-BT1, K081703 | Bluetooth throughMobile App, USB orMDDS Device |
| 2 | Weight | Weight Scale ((lbs. orKgs.)/Body Composition | AnD, UC-321PBT | Bluetooth throughMDDS Device |
| Omron, HBF-206IT | Bluetooth throughMDDS Device | |||
| Fora Weight Scale, W310b | Bluetooth throughMDDS Device | |||
| Withings Wi-Fi Scale, WS-50 | Wifi through HomeRouter | |||
| 3 | PulseOximetry | Pulse Rate and OxygenSaturation | Nonin, 95608T (K09336) | Bluetooth throughMDDS Device |
| 4 | BloodPressure | Blood pressure (Systolic(mmHg), Diastolic (mmHg)) | AnD,UA-767BTB (K043217) | Bluetooth throughMDDS Device |
| Omron BP Monitor, BP792IT(K131742) | Bluetooth throughMDDS Device | |||
| Fora BP Monitor, P20b (K092106) | Bluetooth throughMDDS Device | |||
| 5 | Pedometer | Steps, Calories, Sleep | Fitbit, Flexx, Zip, One, Force | Bluetooth throughMDDS Device andUSB |
| BodyMedia, Link, Core | Bluetooth throughMDDS Device andUSB | |||
| 6 | ECG | Heart Rate, Respiration | Zephyr , Bioharness 3.1 9607.0090(K113045) | Bluetooth throughMDDS Device |
| 7 | Thermometer | Body Temperature (Celsius orFahrenheit) | For a, IR20b (K090395) | Bluetooth throughMDDS Device |
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| 8 | Transfer ofData | Medical Device Data System | Qualcomm 2Net,65-KA123 | Receives Bluetoothand sends Cellular |
|---|---|---|---|---|
| 9 | MedicationReminder | Member has the optional abilityto add medications or productsthey are using with a remindersent by SMS or email. | Entra Health Systems | Softwarecomponent only. |
MyHealthPoint TeleHealth System Architecture
Image /page/2/Figure/4 description: The image shows a diagram of a health monitoring system. The system includes wireless devices such as a weight scale, glucose monitor, and blood pressure monitor. These devices connect to interface devices like smartphones, tablets, and computers, which then transmit data to a central data server called the 'MyHealthPoint Platform'. The platform provides APIs for third-party apps and hospital systems, and the data is displayed on mobile devices and clinician portals.
K. Intended Use
The MyHealthPoint Telehealth Manager is an accessory software that wirelessly, collects, records and transmits biometric data (including glucose, blood pressure, weight, body composition, activity, body temperature, ECG and pulse oximeter readings) from a variety of supported home-monitoring devices as well as supporting manual uploading of data. The MyHealthPoint application uses the same data repository platform that is already cleared. MyGlucoHealth Software System (K081703).
MyHealthPoint TeleHealth Manager is intended to be used by patients in non-clinical settings (e.g. home) to collect, record and transmit their biometric data to a remote secure server. Stored data is accessible by healthcare professionals and caregivers for analysis, messaging and intervention using standard digital communication technologies and protocols. Patients may also view the data to assist in self-management of their specific health condition. The MyHealthPoint Telehealth Manager is intended to be used in combination with a variety of external vital sign devices.
The MyHealthPoint Telehealth Manager is intended to be used by patients identified by their healthcare organization that would benefit from remote monitoring. It is not intended as a replacement of the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. It does not measure, interpret or make any decisions on the data that it conveys.
- L. Predicate Devices
The MyHealthPoint Management System is substantially equivalent to the following FDA cleared predicate devices:
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Predicate #1
510(k) Number: Trade Name: Manufacturer: Classification Name:
Common/Usual Name: Regulation Number: Product Codes: Subsequent Product Codes: Classification:
K113446 Vignet TeleHealth Manager Vignet Inc. Radiofrequency Physiological Signal Transmitter and Receiver Telemedicine System 870.2910 DRG DXN, NBW, FRW Class II
Predicate #2
K101242 510(k) Number: Trade Name: Genesis DM Monitor Manufacturer: Honeywell HomMed, LLC Radiofrequency Physiological Signal Transmitter Classification Name: and Receiver Common/Usual Name: Patient Vital Signs Monitor 870.2910 Regulation Number: Product Codes: DRG Subsequent Product Codes: DXN, DQA, FRI, NBW, BZH, FLL, GJS, DPS, NXB Classification: Class II
Predicate #3
| 510(k) Number: | K122458 |
|---|---|
| Trade Name: | Verizon Wireless Converged Health Management(CHM) Device |
| Manufacturer: | Verizon Wireless |
| Classification Name: | Radiofrequency Physiological Signal Transmitterand Receiver |
| Common/Usual Name: | Telemedicine System |
| Regulation Number: | 870.2910 |
| Product Codes: | DRG |
| Subsequent Product Codes: | DXN, NBW, FRW |
| Classification: | Class II |
Entra Health systems has determined that the MyHealthPoint TeleHealth Manager is substantially equivalent to the performance of the three mention predicate devices. The differences between these systems are incidental and not significant. The devices use a similar technological characteristics and principles. Substantial Equivalence section in this submission (Tab 11) explains more on the similarities and equivalence.
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M. Technological Characteristics
The MyHealthPoint TeleHealth Manager is a software platform for the collection and display of biometric data, from primarily supported patient monitoring devices, to the patient, caregiver and clinician. It is used with in combination with a variety of FDA cleared external bio-metric measuring devices included in the table that follows. Technological characteristics of our device compared to each predicate is shown on the following tables and in the Substantial Equivalence (Tab 11).
M1.DEVICES
| Vital Signs/Product Code | Measurement ofSubmitted Device(MyHealthPoint) | Vital Signs EquipmentManufacturers/Models(510k) | Predicate #1Vignet Inc. | Predicate #2HoneywellHomMed | Predicate #3VerizonWireless |
|---|---|---|---|---|---|
| Glucose(NBW) | Blood glucose(mg/dl or mmol/L) | Entra Health Systems,MGH-BT1, K081703AnD, UC-321PBT | SubstantiallyEquivalent | SubstantiallyEquivalent | SubstantiallyEquivalent |
| Weight (FRI) | Weight Scale (lbs.or Kgs.)/Body Composition | Omron, HBF-206ITFora Weight Scale,W310bWithings Wi-Fi Scale,WS-50 | SubstantiallyEquivalent | SubstantiallyEquivalent | SubstantiallyEquivalent |
| PulseOximetry(DQA) | Pulse Rate andOxygen Saturation | Nonin, 9560BT, K09336 | SubstantiallyEquivalent | SubstantiallyEquivalent | SubstantiallyEquivalent |
| BloodPressure(DXN) | Blood pressure((Systolic (mmHg),Diastolic (mmHg)) | AnD, UA-767PBT,K043217Omron BP Monitor,BP792IT, K131742Fora BP Monitor, P20b,K092106 | SubstantiallyEquivalent | SubstantiallyEquivalent | SubstantiallyEquivalent |
| Pedometer(Activity) | Steps, Calories,Sleep | Fitbit, Flexx, Zip, One,ForceBodyMedia, Link, Core | SubstantiallyEquivalent | Does not trackactivity. | Does not trackactivity. |
| ECG (DSI,DRX,DPS) | Heart Rate,Respiration | Zephyr , Bioharness 3.19607.0090, K113045 | Does not haveECG | SubstantiallyEquivalent | Does not haveECG |
| Thermometer(FLL) | Body Temperature(Celsius orFahrenheit) | For a, IR20b, K090395 | SubstantiallyEquivalent | SubstantiallyEquivalent | SubstantiallyEquivalent |
| Transfer ofData (OUG) | Medical Device DataSystem | Qualcomm 2Net,65-KA123 | SubstantiallyEquivalent | SubstantiallyEquivalent | SubstantiallyEquivalent |
| MedicationReminder(NXB) | Member has theoptional ability toadd medications orproducts they areusing with areminder sent by | Built intoMyHealthPoint by EntraHealth Systems. | Does not havemedicationreminder. | SubstantiallyEquivalent | Does not havemedicationreminder. |
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M2.FEATURES
| Feature | Submitted Device(My Health Point) | Predicate #1Vignet Inc. | Predicate #2HoneywellHomMed | Predicate #3Verizon Wireless |
|---|---|---|---|---|
| Intended Use | Home use, wirelesscollection of data;Remote data access | SubstantiallyEquivalent | SubstantiallyEquivalent | Substantially Equivalent |
| Indication forUse (Ref: Tab 4) | Remote healthmanagement | SubstantiallyEquivalent | SubstantiallyEquivalent | Substantially Equivalent |
| Systemdescription | Software, wireless,reporting and charts,messaging, targets andalerts | SubstantiallyEquivalent | SubstantiallyEquivalent | Substantially Equivalent |
| Feature | Submitted Device(MyHealthPoint) | Predicate #1Vignet Inc. | Predicate #2HoneywellHomMed | Predicate #3Verizon Wireless |
| Data Collectionsoftware | Proprietary Software | SubstantiallyEquivalent | SubstantiallyEquivalent | Substantially Equivalent |
| Types of homeuse devicesinterfaced | FDA cleared homedevices: Glucose, Bloodpressure, weight/bodycomposition, pulseoximeter, thermometer,ECG, activity, medicationreminder | SubstantiallyEquivalent | SubstantiallyEquivalent | Substantially Equivalent |
| Data Capturemethod(connectivity) | Wireless, cellular, serverto server, client toserver. | SubstantiallyEquivalent | SubstantiallyEquivalent | Substantially Equivalent |
| Power source | Smart device battery,plug for MDDS | SubstantiallyEquivalent | SubstantiallyEquivalent | Substantially Equivalent |
| Display | Computer, smart phone | SubstantiallyEquivalent | SubstantiallyEquivalent | Substantially Equivalent |
| Messaging | Secure messages, SMSmessaging, motivational,reminders, on linegraphical reports andcharts, personalprogress indicators | SubstantiallyEquivalent | SubstantiallyEquivalent | Substantially Equivalent |
| Configuration ofpersonalwellness regimen | Configures patient alertsettings set by clinician.Messaging. | SubstantiallyEquivalent | SubstantiallyEquivalent | Substantially Equivalent |
N. Performance (non-clinical) data
The MyHealthPoint TeleHealth Manager is a software application, therefore no electrical safety or electromagnetic testing was required. After extensive bench testing to performance requirements and criteria established in accordance with application of EN14971 risk analysis,
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no new issues of safety, performance, technology or intended use were identified. Testing conducted to demonstrate software validation and substantial equivalence included:
- . Verification testing that product meets product performance and functional specifications.
- . Verification that biometric data submitted by personal home-use devices are captured (wirelessly or manually), transmitted and stored properly to maintain data integrity (e.g. no loss of data or corruption)
- User performance testing to demonstrate adequate instructional utility of the User . Manual.
Therefore the MyHealthPoint TeleHealth Manager is concluded to be substantially equivalent to the identified predicates.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2014
Entra Health Systems Richard Strobridge 3111 Camino Del Rio North Suite 101 San Diego, CA 92108 US
Re: K132930
Trade/Device Name: MyHealthPoint TeleHealth Manager Regulation Number: 21 CFR 870.2910 Regulation Name: Telemedicine System Regulatory Class: Class II Product Code: DRG, JQP, DXN, DQA, FLL, DPS, DRX, NXB, FRI, OUG Dated: March 15, 2014 Received: March 21, 2014
Dear Richard Strobridge:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
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Page 2 - Richard Strobridge
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree free number 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: MyHealthPoint Telehealth Manager
Indications for Use
The MyHealthPoint Telehealth Manager is an accessory software that wirelessly collects, records and transmits biometric data (including glucose, blood pressure, weight, body composition, activity, body temperature, ECG and pulse oximeter readings) from a variety of supported home-monitoring devices as well as supporting manual uploading of data. The MyHealthPoint application uses the same data repository platform that is already cleared, MyGlucoHealth Software System (K081703).
MyHealthPoint TeleHealth Manager is intended to be used by patients in non-clinical settings (e.g. home) to collect, record and transmit their biometric data to a remote secure server. Stored data is accessible by healthcare professionals and caregivers for analysis, messaging and intervention using standard digital communication technologies and protocols. Patients may also view the data to assist in self-management of their specific health condition. The MyHealthPoint Telehealth Manager is intended to be used in combination with a variety of external vital sign devices.
The MyHealthPoint Telehealth Manager is intended to be used by patients identified by their healthcare organization that would benefit from remote monitoring. It is not intended as a replacement of the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. It does not measure, interpret or make any decisions on the data that it conveys.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Page _ 1_ of l
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).