(91 days)
No
The summary explicitly states that the ECG analysis is performed by "FDA cleared algorithms," and there is no mention of AI, ML, or any related concepts in the device description or performance studies.
No
The device is used for capturing and transmitting ECG information for monitoring and diagnostic purposes, not for treating a condition.
No.
The "Intended Use / Indications for Use" section explicitly states, "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 indicates that the device provides data for a clinician to interpret, rather than making a diagnosis itself.
No
The device description explicitly lists multiple hardware components: Wearable ECG Sensor, Adhesive Electrode, dedicated Handheld Transmitter Device, and Data Upload Fixture.
Based on the provided text, the Peerbridge Corns System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Peerbridge System Function: The Peerbridge System is an external electrocardiogram (ECG) monitoring system. It records electrical activity of the heart directly from the patient's chest using electrodes. It does not analyze samples taken from the body.
- Intended Use: The intended use is to capture and transmit ECG information for review by a clinician to aid in diagnosis based on their clinical judgment. This is a physiological measurement, not an in vitro test.
Therefore, the Peerbridge Corns System falls under the category of a medical device for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Peerbridge CorTM 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.
Product codes
DSH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's chest
Indicated Patient Age Range
adult patients 18 years or older
Intended User / Care Setting
Not Found
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)
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.
Clinical Testing Summary:
Clinical testing is not provided in support of this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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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 Holter | |
| Monitoring | Test 3: Patient Activated Event with |
| Surveillance |
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.