The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. Not for use with patients requiring attended, In-hospital monitoring for life threatening arrhythmias.

The Preventice BodyGuardian Remote Monitoring System is intended for use with adult patients in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters. The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.

Device Description

AI/ML Overview

Here’s an analysis of the provided information regarding the BodyGuardian Remote Monitoring System, focusing on acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The provided document does not explicitly state quantitative acceptance criteria or device performance in the typical format of sensitivity, specificity, accuracy, etc., for arrhythmia detection. Instead, it relies on a comparison to predicate devices and results of non-clinical bench testing.

Therefore, the "acceptance criteria" can be inferred as demonstration of substantial equivalence to predicate devices through various non-clinical tests, ensuring safety and effectiveness.

Acceptance Criteria (Inferred)	Reported Device Performance
Functional Equivalence to Predicate Devices: The device should perform an equivalent function as the predicate devices in detecting and monitoring cardiac arrhythmias and transmitting health parameters.	The BodyGuardian System is stated to have the "same technological characteristics as the predicate devices in that all devices are intended to detect, transmit, and report digital data using similar computerized technology." It also has the "same intended uses as the predicate devices in that all devices are intended for ambulatory monitoring."
Electrical and Mechanical Safety Testing: The device must meet established safety standards.	EMC and electrical safety testing, electrical and mechanical safety testing, and system safety testing were conducted.
Software Verification and Validation: The software components must be verified and validated.	Software verification and validation were performed.
Performance Testing: The device's overall performance must be acceptable.	Performance testing was conducted.
Predicate Device Comparison Tests: Direct comparison testing against predicate devices.	Predicate device comparison tests were conducted.
Usability Testing: The device must be user-friendly and safe for its intended users.	Usability Testing was conducted.
Wireless Transmission Data Quality and Coexistence: The wireless communication must be reliable and not interfere with other devices.	Wireless transmission data quality and wireless coexistence testing were conducted.
Biocompatibility for Patient Contact Materials: Materials in contact with the patient must be biocompatible.	Biocompatibility testing for patient contact materials (Makrolon Versaflex) was performed.
Quality Assurance Measures: Development process must follow quality standards (e.g., FMEA).	Failure Mode Effects Analysis/Hazard Analysis (FMEA) and Design FMEAs for mechanical and RF designs were applied. Performance Requirements Testing including Final System Verification and Validation Testing, ISO 60601 Testing, 3rd Edition were completed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Clinical Testing: This technology is not new, therefore a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing."

Therefore, there was no clinical test set (and thus no sample size, data provenance) used to demonstrate the device's performance for arrhythmia detection in this submission. The evaluation was based solely on non-clinical (bench) testing and comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical test set was used to establish ground truth for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set was used.

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

Not applicable. No clinical studies, including MRMC studies, were performed or required for this submission. The device is a "Remote Monitoring System" that collects and transmits data; it "does not provide any diagnosis." There is no mention of AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not describe a standalone performance study for an algorithm related to arrhythmia detection. The device is described as a system that "detects and monitors cardiac arrhythmias" and collects data from "ECG sensors," but the validation focuses on the system's overall function and equivalence to predicates, not the independent performance of an arrhythmia detection algorithm against ground truth. Since it states the device "does not provide any diagnosis," it suggests the detection is a flag for healthcare professionals to review, rather than a diagnostic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no clinical data or ground truth was established for performance evaluation in this submission. The ground truth for the non-clinical testing would have been defined by the test protocols (e.g., simulated signals for electrical safety, known material properties for biocompatibility).

8. The sample size for the training set

Not applicable, as no clinical data or machine learning models requiring a training set are described in this submission.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 17, 2015

Preventice Charlie Rector Director of RA/QA 2765 Commerce Drive NW, #220 Rochester, Minnesota 55901

Re: K151188

Trade/Device Name: BodyGuardian Remote Monitoring System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: DSI Dated: August 19, 2015 Received: August 20, 2015

Dear Charlie Rector:

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

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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 of medical devicerelated 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 contact the Division of Industry and Consumer Education 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 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,

Mitchell Stein

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

510(k) Number (if known) Page 1 of 1 K151188

Device Name

BodyGuardian Remote Monitoring System

Indications for Use (Describe)

The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. Not for use with pattended, In-hospital monitoring for life threatening arrhythmias.

The Preventice BodyGuardian Remote Monitoring System is intended for use with adult patients in clinical and non-

clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation.

Health parameters are collected from a variety of commercially available, external plug in devices such as ECG sensors.

Weight Scales, Blood Pressure Meters and Pulse Oximeters.

The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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ທ 510(k) Summary

510(k) Summary (As required by section 21 CFR 807.92(c))
Submitter:	Preventice2765 Commerce Drive NW, Suite 220, Rochester, MN 55901
Contact Person:	Charles RectorDirector, RA/QATelephone: 952/564-1465Email: crector@preventice.com
Date Prepared:	March 01, 2015
Trade Name:	BodyGuardian Remote Monitoring System
Common/Usual Name:	Remote Monitoring System
Classification:	21 CFR 870.1025Patient Physiological Monitor (with arrhythmia detection)
Product Code:	DSI
Manufacturer:	Preventice2765 Commerce Drive NW, Suite 220, Rochester, MN 55901
Establishment Registration:	3009883402
Predicate Devices:	eMotion Faros ECG Mobile &BodyGuardian Remote Monitoring System
Device Description:	Arrhythmia Detector and Alarm;Patient Physiological Monitor (with arrhythmia detection)The BodyGuardian System detects and monitors cardiacarrhythmias in ambulatory patients, when prescribed by aphysician or other qualified healthcare professional. Not for usewith patients requiring attended, In-hospital monitoring for lifethreatening arrhythmias.
Intended Use	The Preventice BodyGuardian Remote Monitoring System isintended for use with adult patients in clinical and non-clinicalsettings to collect and transmit health parameters to healthcareprofessionals for monitoring and evaluation. Health parametersare collected from a variety of commercially available, externalplug in devices such as ECG sensors, Weight Scales, Blood PressureMeters and Pulse Oximeters. The Preventice BodyGuardianRemote Monitoring System does not provide any diagnosis
510(k) Summary	(As required by section 21 CFR 807.92(c))
Comparison ofTechnologicalCharacteristics:	The predicate devices and the BodyGuardian System are small,ambulatory cardiac monitors that record and transmit healthmonitors. They provide a data hub function that connects tocommercially available devices such as weight scales, bloodpressure monitors, pulse oximeters and other plug-in devices.Data is transmitted to an external device which, in turn, sends thedata to a remote computer server that allows healthcareprofessionals to access and review the data. There are nofundamental differences between their technologicalcharacteristics.
Non-Clinical Testing:	The following bench testing was conducted on the Preventice BGRMS:EMC and electrical safety testing Electrical and mechanical safety testing System safety testing Software verification and validation Performance testing Predicate device comparison tests Usability Testing Wireless transmission data quality and wirelesscoexistence testing The following testing has been performed to support substantialequivalence (see table 9): Biocompatibility for patient contact materials: Makrolon Versaflex See Appendix Q for specifications.The following quality assurance measures were applied duringdevelopment of this device (appendices D, F, G): Failure Mode Effects Analysis/Hazard Analysis (FMEA) Design FMEAs for mechanical and RF designs. Performance Requirements Testing including Final SystemVerification and Validation Testing, ISO 60601 Testing, 3rdEdition.
Clinical Testing:	This technology is not new, therefore a clinical study was notconsidered necessary prior to release. Additionally, there was noclinical testing required to support the medical device as theindications for use is equivalent to the predicate device. Thesubstantial equivalence of the device is supported by the non-clinical testing.
510(k) Summary (As required by section 21 CFR 807.92(c))
Conclusion:	We conclude that the results of testing show the Preventice BGRMS to be substantially equivalent to the predicate devices.
	The Preventice BG RMS has the same technological characteristicsas the predicate devices in that all devices are intended to detect,transmit, and report digital data using similar computerizedtechnology. The Preventice BG RMS has the same intended usesas the predicate devices in that all devices are intended forambulatory monitoring.
	It has been shown in this 510(k) submission that the differencesbetween the Preventice BG RMS and the predicates do not raiseany questions regarding safety and effectiveness. The PreventiceBG RMS, as designed and manufactured, is substantiallyequivalent to, and as safe and effective as, the referencedpredicate devices.

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Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.