(351 days)
No
The summary describes a data collection, storage, and transmission platform with basic analysis and communication features. There is no mention of AI, ML, or any algorithms that would perform complex analysis, interpretation, or prediction based on the collected data. The device is explicitly stated as "not interpretive".
No.
The device is a remote monitoring software solution for collecting and storing biometric data, and it explicitly states that it is not interpretive, nor is it intended for diagnosis or as a replacement for the oversight of healthcare professionals.
No
The "Intended Use / Indications for Use" section explicitly states that "It is not interpretive, nor is it intended for diagnosis or as a replacement for the oversight of healthcare professionals." Its primary function is to collect, store, and transmit biometric data for review.
Yes
The device is described as a "software platform" and a "remote monitoring software solution." While it interacts with external hardware devices (glucometer, weight scale, etc.) and uses existing telecommunications infrastructure (cellphones, computers), the core regulated component described is the software itself for data collection, storage, transmission, and display. The performance studies mentioned are focused on software verification and validation.
Based on the provided information, the CHM Device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the CHM Device collects and stores biometric data from physiological measurement devices (like glucometers, weight scales, etc.) and transmits this data. It does not involve the analysis of biological samples (blood, urine, tissue, etc.).
- The device is not interpretive and not intended for diagnosis. IVDs are typically used to provide information that aids in diagnosis or monitoring of a disease or condition by analyzing biological samples. The CHM Device explicitly states it is not interpretive and not intended for diagnosis.
- The focus is on remote monitoring of physiological data. The primary function is to collect, store, and transmit data from external devices that measure physiological parameters.
The CHM Device falls under the category of a remote patient monitoring software solution, which is a different type of medical device than an IVD. The predicate devices listed (Alcatel-Lucent Telehealth Manager and Vignet Telehealth Monitoring System) also support this classification as they are remote monitoring systems, not IVDs.
N/A
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 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.
Product codes
DRG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use, Clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K060504, K080283, K070371, K080538
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
^
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.
3
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
4
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'