(49 days)
No
The summary describes a remote monitoring software for collecting and transmitting biometric data, with basic analysis and communication features. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on data collection, storage, transmission, and basic display/communication.
No
The CHM Device is a remote monitoring software solution for collecting and storing biometric data and allowing access to clinicians; it explicitly states it is not intended for diagnosis or as a replacement for healthcare professionals.
No
The document explicitly states: "It is not interpretive, nor is it intended for diagnosis or as a replacement for the oversight of healthcare professionals."
Yes
The device description explicitly states it is a "software platform" and utilizes existing hardware (cell phones and computers) for data transmission and display. While it interacts with external physiological measurement devices, the core regulated component described is the software itself.
Based on the provided text, the CHM Device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. These tests are performed in vitro (in a test tube or other artificial environment) and provide information for diagnosis, monitoring, or screening.
- CHM Device Function: The CHM Device is described as a software solution that collects and stores biometric data from physiological measurement devices (like glucometers, weight scales, pulse oximeters, and blood pressure monitors). It transmits this data and allows clinicians and patients to view it.
- Lack of In Vitro Testing: The description explicitly states that the CHM Device collects data from devices that measure physiological parameters in the home. It does not perform any tests on biological samples in vitro.
- Intended Use: The intended use is for remote monitoring, data collection, storage, and transmission, as well as providing educational and motivational content. It is explicitly stated that it is not interpretive, nor is it intended for diagnosis.
In summary, the CHM Device is a remote patient monitoring software platform that handles data from other medical devices. It does not perform any diagnostic tests on biological samples, which is the defining characteristic of an IVD.
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 an 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 step-down 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.
Product codes
DRG
Device Description
The CHM is a software platform for the collection and display of biometric data, primarily from externally supported patient monitoring devices, both to the patient and to the clinician. The CHM Device may also be used as a standalone device. The CHM Device uses existing Internet and telecommunications architecture (cell phones and computers) for the automated transmission of medical data to a remote secure 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 motivationalities 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
Used in the home. Clinicians can access stored biometric data for analysis and intervention. Patients can review data and receive educational/motivational content.
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)
As part of its software verification and validation activities, regression and usability testing was performed to ensure that the changes to the software have not introduced new faults and that a change to one part of the software does not affect other parts of the software. Additional verification and verification activities were performed to ensure that the biometric data was transferred accurately from the Telcare and Genesis Health glucometers server infrastructure into the CHM platform. All verification and validation activities, as required by the risk analysis, were performed and the results demonstrated that the predetermined acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K060504, K080283, K070371, K080538, K110571, K121224
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FEB 1 4 2014
K134004 Page 1 of 3
510(k) SUMMARY
Verizon Wireless Converged Health Management Device
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Verizon Wireless One Verizon Way Basking Ridge, NJ 07920 Phone: 202-515-2454 Facsimile: 202-289-6781
Contact Person: Lolita Forbes, Assistant General Counsel - Mobile Health
December 27, 2013 Date Prepared:
Name of Device and Name/Address of Sponsor
Verizon Wireless Converged Health Management Device
Verizon Wireless One Verizon Way Basking Ridge, NJ 07920
Common or Usual Name: Telemedicine System
Classification Name: Radiofrequency Physiological Signal Transmitter and Receiver
Predicate Devices:
The Verizon Wireless Converged Health Management Device is a modification to K122458 Verizon Wireless Converged Health Management Device.
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K134004 Page 2 of 3
Intended 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 an 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 step-down 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 is a software platform for the collection and display of biometric data, primarily from externally supported patient monitoring devices, both to the patient and to the clinician. The CHM Device may also be used as a standalone device. The CHM Device uses existing Internet and telecommunications architecture (cell phones and computers) for the automated transmission of medical data to a remote secure 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 motivationalities 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 Inc. SpO2 Pulse Oximeter (K070371)
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K134004 Page 3 of 3
- Ideal Life Inc., Weight Scale (Class I, 510(k) Exempt) .
- Ideal Life Inc. Communication Gateway Ideal Life Pod ILP (K080538) .
- . Telecare Inc., Blood Glucose Monitoring System (K110571)
- . Genesis Health Technologies, Blood Glucose Monitoring System (K121224)
Performance Data
As part of its software verification and validation activities, regression and usability testing was performed to ensure that the changes to the software have not introduced new faults and that a change to one part of the software does not affect other parts of the software. Additional verification and verification activities were performed to ensure that the biometric data was transferred accurately from the Telcare and Genesis Health glucometers server infrastructure into the CHM platform. All verification and validation activities, as required by the risk analysis, were performed and the results demonstrated that the predetermined acceptance criteria were met.
Substantial Equivalence
The Verizon Wireless Converged Health Management Device has the same intended Use and indications for use and its predicate, Verizon Wireless Converged Health Management Device (K122458). It also has identical technological characteristics as the predicate device. Software verification and validation testing demonstrate that the Verizon Wireless Converged Health Management Device performs as intended and that the differences between the Verizon Wireless Converged Health Management Device and its predicate do not raise new questions of safety or effectivenesss.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-002
February 14, 2014
Cellco Partnership D/b/a Verizon Wireless Ms. Lolita Forbes Assistance General Counsel One Verizon Way Basking Ridge, NJ 07920 US
Re: K134004
Trade/Device Name: Verizon Wireless Converged Health Management Device Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: December 27, 2013 Received: December 27, 2013
Dear Ms. Lolita 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.
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
4
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor 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 yours,
Owen-Paris-S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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K134004 Page 1 of 1
Indications for Use Statement
510(k) Number (if known):
Device Name: Verizon Wireless Converged Health Management System
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 an 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 step-down 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use_ (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Digitally signed by
Owen Faris -S
Date: 2014.02.14
11:51:21-05'00'