(91 days)
The Peerbridge Corns System family of products is intended to capture and transmit events and continuous external electrocardiogram (ECG) information for 24 hours and up to 7 days (long term monitoring). The Peerbridge CorTM System continuous external electrocardiogram (ECG) recorder with a patient-activated events button. It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient. symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety. The reported ECG metrics supports 2-channel ECG analysis on a beat-by-beat basis. heart rate measurement and rhythm analysis by FDA cleared algorithms. The report generated does not contain diagnostic interpretation; the report is provided for review by intended users to render a diagnosis based on their clinical judgment and experience.
The Peerbridge Cor™ System is a family of products comprised of two models, the Peerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). The system is an ambulatory wearable ECG monitoring system designed to record and provide patient's electrocardiogram (ECG) data to the clinician.
The Peerbridge System consists of five components: (1) Wearable ECG Sensor with Bluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld Transmitter Device, (4) Data Upload Fixture and Software that allow ECG data to be uploaded from the Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-based Backend Data Management Module. The Wearable ECG sensor attaches to the patient's chest and records the patient's ECG continuously. This device can collect two (2) channels of ECG data continuously for up to seven (7) days. In addition, patients can report symptomatic events by pressing the Event Button on the Wearable ECG Sensor or by using the mobile application on the Handheld Transmitter when a symptom is experienced. The device generates ECG reports to be displayed on the clinician's interface.
The Peerbridge System Cor XT and Cor Event have identical functionalities and components while differing in post-data acquisition clinical workflow. These configurations are presented in Table 1 with their respective tests. Through the two configurations, the system supports three tests based on medical necessity determined by the prescribing clinician.
The provided text describes the Peerbridge Cor™ System and its FDA 510(k) premarket notification. However, it does not contain specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test sets, details about ground truth establishment (number of experts, qualifications, adjudication method), or information about MRMC studies, standalone performance, or training set details.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (iRhythm Technologies, Inc. ZIO® SkyRunner) based on shared intended use, similar technological characteristics, and non-clinical bench testing.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that nonclinical bench testing was "performed and passed" but does not report specific quantitative acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity for ECG analysis). It doesn't mention any clinical performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document explicitly states: "Clinical testing is not provided in support of this premarket notification." Therefore, there is no test set in the clinical performance sense described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. Since no clinical testing was performed for this premarket notification, there was no test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. As no clinical testing was performed, no adjudication method was used for a clinical test set.
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
- Cannot be provided. The document does not mention any MRMC studies or AI assistance for human readers. The device provides "ECG analysis by FDA cleared algorithms" and "The report generated does not contain diagnostic interpretation; the report is provided for review by intended users to render a diagnosis based on their clinical judgment and experience." This suggests the device's algorithms analyze ECG data, but it doesn't describe an AI-assisted human reading workflow.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially Answered. The document mentions "ECG analysis by FDA cleared algorithms" and that the system "supports 2-channel ECG analysis on a beat-by-beat basis, heart rate measurement and rhythm analysis by FDA cleared algorithms." While this implies the algorithms perform standalone analysis, specific performance metrics for this standalone functionality are not provided in the document. The general statement is that "nonclinical testing demonstrate that the device meets its performance requirements."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. As no clinical testing was performed, there isn't a described ground truth type for a clinical test set. For the "FDA cleared algorithms" that perform ECG analysis, the nature of their ground truth for development or validation is not detailed.
8. The sample size for the training set
- Cannot be provided. The document does not provide details about the training set for the device's algorithms.
9. How the ground truth for the training set was established
- Cannot be provided. The document does not provide details about the training set or its ground truth establishment.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. In the center of the circle is a stylized image of three human profiles facing to the right, one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2017
Peerbridge Health Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW Buffalo, Minnesota 55313
Re: K171936
Trade/Device Name: Peerbridge Cor™ System Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH Dated: September 19, 2017 Received: September 20, 2017
Dear Mark Job:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
{1}------------------------------------------------
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 (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 Industry and Consumer Education (DICE) 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. 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 Industry and Consumer Education (DICE) 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,
M. A. Wilhelm
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K171936
Device Name Peerbridge CorTM System
Indications for Use (Describe)
The Peerbridge Corns System family of products is intended to capture and transmit events and continuous external electrocardiogram (ECG) information for 24 hours and up to 7 days (long term monitoring). The Peerbridge CorTM System continuous external electrocardiogram (ECG) recorder with a patient-activated events button. It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient. symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety. The reported ECG metrics supports 2-channel ECG analysis on a beat-by-beat basis. heart rate measurement and rhythm analysis by FDA cleared algorithms. The report generated does not contain diagnostic interpretation; the report is provided for review by intended users to render a diagnosis based on their clinical judgment and experience.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Notification K 171936
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Peerbridge Health Inc. 1440 Broadway, 23rd Floor New York, NY 10018 USA Phone: 925-260-2096
Contact Person:
Anna Libman Regulatory Consultant to Peerbridge Health, Inc. Director, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA
Date Prepared: May 15, 2017
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
Peerbridge Cor™ System
Generic/Common Name:
Medical magnetic tape recorder
Classification:
Class II, 21 CFR§870.2800, Recorder, Magnetic Tape, Medical
Product Code:
DSH, Medical magnetic tape recorder
PREDICATE DEVICE(S) [807.92(a)(3)]
- . Primary Predicate: iRhythm Technologies, Inc. ZIO® SkyRunner Electrocardiogram Monitoring Services (K143513) ("SkyRunner")
- Reference Devices: .
{4}------------------------------------------------
DEVICE DESCRIPTION [807.92(a)(4)]
The Peerbridge Cor™ System is a family of products comprised of two models, the Peerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). The system is an ambulatory wearable ECG monitoring system designed to record and provide patient's electrocardiogram (ECG) data to the clinician.
The Peerbridge System consists of five components: (1) Wearable ECG Sensor with Bluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld Transmitter Device, (4) Data Upload Fixture and Software that allow ECG data to be uploaded from the Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-based Backend Data Management Module. The Wearable ECG sensor attaches to the patient's chest and records the patient's ECG continuously. This device can collect two (2) channels of ECG data continuously for up to seven (7) days. In addition, patients can report symptomatic events by pressing the Event Button on the Wearable ECG Sensor or by using the mobile application on the Handheld Transmitter when a symptom is experienced. The device generates ECG reports to be displayed on the clinician's interface.
The Peerbridge System Cor XT and Cor Event have identical functionalities and components while differing in post-data acquisition clinical workflow. These configurations are presented in Table 1 with their respective tests. Through the two configurations, the system supports three tests based on medical necessity determined by the prescribing clinician.
| Peerbridge Cor XT | Peerbridge Cor Event |
|---|---|
| Test 1: 24 hours of Holter monitoring | Test 1: 24 hours of Holter monitoring |
| Test 2: Up to 7 days of HolterMonitoring | Test 3: Patient Activated Event withSurveillance |
Table 1- Peerbridge System Family Configurations
To initiate a test, the clinician uses the Peerbridge Portal to enter the patient's profile and select the appropriate test (Test 1, Test 2, or Test 3).
INDICATIONS FOR USE [807.92(a)(5)]
The Peerbridge Cor™ System family of products is intended to capture and transmit symptomatic events and continuous external electrocardiogram (ECG) information for 24 hours and up to 7 days (long term monitoring). The Peerbridge Cor™ System contains a continuous external electrocardiogram (ECG) recorder with a patient-activated events button. It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, presyncope, fatigue, or anxiety. The reported ECG metrics supports 2-channel ECG analysis on a beat-by-beat basis, heart rate measurement and rhythm analysis by FDA cleared algorithms. The report generated does not contain diagnostic interpretation; the report is provided for review by intended users to render a diagnosis based on their clinical judgment and experience.
{5}------------------------------------------------
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]
The Peerbridge System and the SkyRunner predicate device both capture, record, transmit, and analyze symptomatic events and continuous ECG recordings over an extended period in adult patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety. The Peerbridge System and the SkyRunner provide a report of the analyzed ECG data for the clinician to interpret. The reports for both systems are generated by FDA-cleared algorithms. Similar to the SkyRunner, the ECG data report is displayed in the clinician interface. Overall, the Peerbridge System is similar to the predicate device in terms of technological and safety characteristics and differences in technological characteristics have been analyzed and tested to ensure that there are no different questions of safety or effectiveness.
SUBSTANTIAL EQUIVALENCE
The Peerbridge System is substantially equivalent to the SkyRunner. The two devices have the same intended use and similar technological characteristics. Differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness. Thus, the Peerbridge System is substantially equivalent to the predicate device.
PERFORMANCE DATA [807.92(b)]
All necessary non-clinical testing was conducted on the Peerbridge System to support a determination of substantial equivalence to the predicate device.
[807.92(b)(1)| Nonclinical Testing Summary:
The nonclinical, bench testing included the following tests that were performed and passed:
- . Software unit, integration, and system level testing
- Biocompatibility
- Electrical Safety and Electromagnetic Compatibility testing
- Defibrillation Safety testing ●
- ECG Wearable Sensor functional testing ●
- Wearability testing
- Summative human factors and usability testing ●
The collective results of the nonclinical testing demonstrate that the device meets its performance requirements and does not raise different questions of safety or effectiveness for measuring ECG or presenting information to the clinician when compared to the predicate device.
[807.92(b)(2)] Clinical Testing Summary:
Clinical testing is not provided in support of this premarket notification.
{6}------------------------------------------------
510(k) SUMMARY
CONCLUSIONS [807.92(b)(3)]
In summary, the Peerbridge System and the SkyRunner have the same intended use and similar technological characteristics. Differences in the technological characteristics have been evaluated and supported with appropriate testing. Therefore, differences in technological characteristics do not raise different questions of safety or effectiveness.
SUMMARY
The Peerbridge Cor™ System is substantially equivalent to the predicate device.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).