(351 days)
The CHM Device is a remote monitoring software solution intended to collect and store biometric data from physiological measurement devices intended for use in the home. The CHM Device also allows for the automated transmission of the biometric data to a remote secure server via existing mobile telecommunications and/or Internet infrastructure.
The stored biometric data is accessible by clinicians for analysis and intervention. Patients can also review the stored biometric data and receive educational content from clinicians.
The CHM Device can be used as a standalone device or in conjunction with supported patient monitoring devices, such as a glucometer, weight scale, pulse oximeter, and blood pressure monitor.
The CHM Device is not intended for use in surgical rooms, intensive care units, intermediate or stepdown units or emergency vehicles. It is not interpretive, nor is it intended for diagnosis or as a replacement for the oversight of healthcare professionals. It does not provide real-time or emergency monitoring.
The CHM Device is a software platform for the collection and display of biometric data, primarily from externally supported patient monitoring devices, both to the clinician. The CHM Device may also be used as a standalone device. The CHM Device uses existing Internet and telecommunications architecture (cellphones and computers) for the automated transmission of medical data to a remote server from where it can be viewed remotely by clinicians and patients for the purposes of storage and basic analysis. The CHM Device also provides educational and motivational functionalities allowing the clinician to send tasks, recommendations, surveys, and educational and motivational messages to patients.
The Verizon Wireless Converged Health Management Device (K122458) is a software solution for remote monitoring, not an AI/ML diagnostic tool. Therefore, many of the typical acceptance criteria and study components requested for AI/ML devices, such as performance metrics (e.g., sensitivity, specificity), ground truth establishment by experts, and MRMC studies, are not applicable.
The submission focuses on software verification and validation, demonstrating that the device functions as intended and safely transmits data.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Software Functionality: The CHM Device performs appropriately per defined specifications. | Software verification and validation testing, including usability validation, was performed successfully, demonstrating that the CHM Device performs appropriately per defined specifications. |
| Input Requirements: The CHM Device meets all input requirements. | Software verification and validation testing... demonstrating that the CHM Device... meets all input requirements. |
| Intended Use: The CHM Device fulfills the device's intended use. | Software verification and validation testing... demonstrating that the CHM Device... fulfills the device's intended use. |
| Safety Mitigations: The CHM Device correctly incorporates all required safety mitigations. | Software verification and validation testing... demonstrating that the CHM Device... correctly incorporates all required safety mitigations. |
2. Sample size used for the test set and the data provenance
Not applicable for this type of software device. The "test set" would primarily involve internal software testing and validation rather than a clinical dataset of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is its adherence to software specifications and functional requirements, which are typically established by software engineers and quality assurance personnel, not medical experts.
4. Adjudication method for the test set
Not applicable. Software testing for functionality does not typically involve an adjudication method by medical experts in the way an AI diagnostic tool would.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This device is a data collection and transmission platform, not an interpretive or diagnostic AI. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the software verification and validation described is a standalone assessment of the algorithmic/software performance. It focuses on the device's ability to collect, store, and transmit data accurately and according to specifications, independent of human interpretation of that data.
7. The type of ground truth used
The ground truth used for this device's performance validation is its defined software specifications and functional requirements. The testing confirmed that the software behaved as designed and intended.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. As this device is not an AI/ML algorithm requiring training data, this question is not relevant.
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510(k) Summary
Verizon Wireless Converged Health Management Device (K122458)
Submitter's Name. Address, Telephone Number, Contact Person and Date Prepared
Cellco Partnership d/b/a Verizon Wireless One Verizon Way Basking Ridge, NJ 07920 Phone: (202) 515-2454 Facsimile: (202) 289-6781
JUL 3 0 2013
Contact Person: Lolita Forbes, Assistant General Counsel - Mobile Health lolita.forbes@verizon.com
Date Prepared: July 3, 2013
Name of Device and Name/Address of Sponsor
Verizon Wireless Converged Health Management Device
Cellco Partnership d/b/a Verizon Wireless One Verizon Way Basking Ridge, NJ 07920
Common or Usual Name: Telemedicine System
Classification Name:
Radiofrequency Physiological Signal Transmitter and Receiver (21 CFR 870.2910; DRG)
Predicate Devices:
Alcatel-Lucent Telehealth Manager (K092635) Vignet Telehealth Monitoring System (K113446)
Intended Use / Indications for Use
The CHM Device is a remote monitoring software solution intended to collect and store biometric data from physiological measurement devices intended for use in the home. The CHM Device also allows for the automated transmission of the biometric data to a remote secure server via existing mobile telecommunications and/or Internet infrastructure.
The stored biometric data is accessible by clinicians for analysis and intervention. Patients can also review the stored biometric data and receive educational content from clinicians.
The CHM Device can be used as a standalone device or in conjunction with supported patient monitoring devices, such as a glucometer, weight scale, pulse oximeter, and blood pressure monitor.
Page 1 of 2
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The CHM Device is not intended for use in surgical rooms, intensive care units, intermediate or stepdown units or emergency vehicles. It is not interpretive, nor is it intended for diagnosis or as a replacement for the oversight of healthcare professionals. It does not provide real-time or emergency monitoring.
Technological Characteristics
The CHM Device is a software platform for the collection and display of biometric data, primarily from externally supported patient monitoring devices, both to the clinician. The CHM Device may also be used as a standalone device. The CHM Device uses existing Internet and telecommunications architecture (cellphones and computers) for the automated transmission of medical data to a remote server from where it can be viewed remotely by clinicians and patients for the purposes of storage and basic analysis. The CHM Device also provides educational and motivational functionalities allowing the clinician to send tasks, recommendations, surveys, and educational and motivational messages to patients.
The Verizon Wireless Converged Health Management Device may be used in conjunction with the following externally supported patient monitoring devices:
- . Ideal Life Inc., Blood Pressure Cuff (K060504)
- Ideal Life Inc., Glucose Monitor Model GMM0001 (K080283) .
- Ideal Life SpO2 Pulse Oximeter (K070371) .
- Ideal Life Weight Scale (Class I. 510(k)-exempt) .
- Ideal Life Communication Gateway Ideal Life Pod ILP (K080538) .
Performance Data
The Verizon Converged Health Management Device is a software application. Software verification and validation testing, including usability validation, was performed successfully, demonstrating that the CHM Device performs appropriately per defined specifications, meets all input requirements, fulfills the device's intended use, and correctly incorporates all required safety mitigations.
Substantial Equivalence
The CHM Device has the same intended use and similar indications for use as its predicate devices. The CHM Device also has similar technological characteristics as its predicate devices. Software verification and validation testing demonstrate that the CHM Device performs as intended and that the differences between the CHM Device and its predicate devices do not raise new questions of safety or effectiveness.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
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July 30, 2013
Cello Partnership D/B/A Verizon Wireless C/O Ms. Lolita Forbes Assistant General Counsel - Mobile Health 1300 I St NW, Suite 400 W Washington, DC 20005
Re: KI22458
Trade/Device Name: Verizon Wireless Converged Health Management System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG Dated: 06/04/2013 Received: 06/04/2013
Dear Ms. Forbes:
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 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.
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Page 2 - Ms. Lolita Forbes
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 number (800) 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
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.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
Sincerely yours.
Owen P. Faris -S
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 Statement
510(k) Number (if known): K122458
Device Name: Verizon Wireless Converged Health Management (CHM) Device
The CHM Device is a remote monitoring software solution intended to collect and store biometric data from physiological measurement devices intended for use in the home. The CHM Device also allows for the automated transmission of the biometric data to a remote secure server via existing mobile telecommunications and/or Internet infrastructure.
The stored biometric data is accessible by clinicians for analysis and intervention. Patients can also review the stored biometric data and receive educational and motivational content from clinicians.
The CHM Device can be used as a standalone device or in conjunction with supported patient monitoring devices, such as a glucometer, weight scale, pulse oximeter, and blood pressure monitor.
The CHM Device is not intended for use in surgical rooms, intensive care units, intermediate or stepdown units or emergency vehicles. It is not interpretive, nor is it intended for diagnosis or as a replacement for the oversight of heathcare professionals. It does not provide real-time or emergency monitoring.
Prescription Use X (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)
Digitally signed by Owen
P. Farls -S
Date: 2013.07.30 10:18:20
-04'00'
§ 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).