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 and pediatric 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, and parameters such as ECG, heart rate, body weight, temperature, respiration rate, blood pressure, and SpO2.

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

Device Description

Arrhythmia Detector and Alarm; Patient Physiological Monitor (with arrhythmia detection)

The predicate device's ECG Unit is a small, ambulatory cardiac monitor that records and transmits ECG data. The subject device's ECG Unit is also a small, ambulatory cardiac monitor that records and transmits ECG data.

Both products, the predicate and subject devices, provide a data hub function that connects to commercially available devices such as weight scales, blood pressure monitors, pulse oximeters, ECG Units and other plug-in devices.

For both devices, the predicate and subject devices, data is transmitted to an external device or server, depending model. If not a server, this device sends the data to a remote computer server that allows healthcare professionals to access and review the data.

AI/ML Overview

This document is a 510(k) summary for the BodyGuardian Remote Monitoring System (K192732). It focuses on demonstrating substantial equivalence to a predicate device (BodyGuardian Remote Monitoring System, K151188) rather than providing detailed acceptance criteria and performance data from a new clinical study.

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is explicitly stated as not present (e.g., clinical testing was not performed):

Key Takeaway: The submission relies on non-clinical testing and comparison to a predicate device, asserting that the technology is not new and therefore a clinical study was not necessary. This means many of your requested details about acceptance criteria directly tied to a clinical performance study are not available in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity for arrhythmia detection) because no clinical study was conducted for this submission. The "acceptance criteria" discussed are implicitly related to demonstrating substantial equivalence through non-clinical means.

The non-clinical "performance testing" mentioned includes:

EMC and electrical safety testing
Electrical and mechanical safety testing
System safety testing
Software verification and validation
Performance testing (general statement, no specific metrics provided)
Predicate device comparison tests
Usability Testing
Biocompatibility for patient contact materials

The document states, "We conclude that the results of testing show the Preventice BG RMS to be substantially equivalent to the predicate device." This implies the performance observed during these non-clinical tests met the unstated internal acceptance criteria for substantial equivalence.

2. Sample size used for the test set and data provenance:

Test Set Sample Size: Not applicable for clinical performance, as "a clinical study was not considered necessary."
Data Provenance: Not applicable for clinical performance. The non-clinical tests would have been performed in a lab setting by the manufacturer.

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

Not applicable as no clinical study with a test set requiring expert ground truth establishment for arrhythmia detection was performed.

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

Not applicable for the same reason as above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC or comparative effectiveness study involving human readers and AI assistance was conducted or described. The device's primary function is described as detecting and monitoring, rather than assisting human readers in interpreting images or patterns.

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

The document implies the device has an algorithmic component for "detects and monitors cardiac arrhythmias." However, no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) for this algorithm are provided, nor is a dedicated "standalone study" described in the context of clinical performance. The focus is on the device as a whole system.

7. The type of ground truth used:

For the non-clinical "performance testing," the ground truth would typically be established based on engineering specifications, known signal inputs, and reference standards for electrical, mechanical, and software verification. For biocompatibility, it would be based on ISO standards. For usability, it would involve direct observation and user feedback against defined usability goals. No clinical ground truth (e.g., expert consensus, pathology, outcome data) for arrhythmia diagnosis is mentioned.

8. The sample size for the training set:

Not applicable, as no mention of a training set for an AI/ML algorithm (in the context of clinical performance) is made. The device is referred to using existing technology ("This technology is not new").

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

Not applicable for the same reason as above.

Summary of what the document does state regarding validation:

The validation for this 510(k) submission primarily relies on:

Bench Testing: EMC, electrical/mechanical safety, system safety, software V&V, general performance testing, and predicate device comparison tests.
Biocompatibility: Testing to ensure patient contact materials are safe.
Quality Assurance Measures: FMEA, Design FMEAs, Performance Requirements Testing (including Final System Verification and Validation Testing), ISO 60601 Testing.
Usability Testing: Performed, including a pediatric usability study to show "no new hazards or risk associated with pediatric use."
Comparison to Predicate Device (BodyGuardian Remote Monitoring System, K151188): The core argument for substantial equivalence is that the new device has "the same technological characteristics" and "the same intended uses" as the predicate device. "There are no fundamental differences between their technological characteristics."
Waiver of Clinical Testing: Explicitly states, "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."

Summary

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March 26, 2020

Preventice Technologies, Inc. Charles Rector VP of Quality, Regulatory & Logistics 3052 Hwy52 N, Building 003-2 Rochester, Minnesota 55901

Re: K192732

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: February 20, 2020 Received: February 24, 2020

Dear Charles 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer Shih Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192732

Device Name BodyGuardian Remote Monitoring System

Indications for Use (Describe)

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)

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510(k) Summary (As required by section 21 CFR 807.92(c))
Submitter:	Preventice Technologies, Inc.3605 Hwy 52N, Building 003-2Rochester, MN 55122
Contact Person:	Charles RectorVice-President, Quality/RegulatoryTelephone: 763-225-4977Email: crector@preventice.com
	Preventice Technologies, Inc.3605 Hwy 52N, Building 003-2Rochester, MN 55122
Date Prepared:	September 25, 2019
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:	Preventice Technologies, Inc.3605 Hwy 52N, Building 003-2Rochester, MN 55122
Establishment Registration:	3009883402
Predicate Device:	BodyGuardian Remote Monitoring System, K151188
Device Description:	Arrhythmia Detector and Alarm;Patient Physiological Monitor (with arrhythmia detection)
510(k) Summary (As required by section 21 CFR 807.92(c))
Intended Use	The BodyGuardian System detects and monitors cardiacarrhythmias in ambulatory patients, when prescribed by a physicianor other qualified healthcare professional. Not for use with patientsrequiring attended, in-hospital monitoring for life threateningarrhythmias.The Preventice BodyGuardian Remote Monitoring System isintended for use with adult and pediatric patients in clinical andnon-clinical settings to collect and transmit health parameters tohealthcare professionals for monitoring and evaluation. Healthparameters are collected from a variety of commercially available,external plug in devices such as ECG sensors, weight scales, bloodpressure meters and pulse oximeters, and parameters such as ECG,heart rate, body weight, temperature, respiration rate, bloodpressure, and SpO2.The Preventice BodyGuardian Remote Monitoring System does notprovide any diagnosis.
Comparison ofTechnologicalCharacteristics:	The predicate device's ECG Unit is a small, ambulatory cardiacmonitor that records and transmits ECG data. The subject device'sECG Unit is also a small, ambulatory cardiac monitor that recordsand transmits ECG data.Both products, the predicate and subject devices, provide a data hub function that connects to commercially available devices such as weight scales, blood pressure monitors, pulse oximeters, ECGUnits and other plug-in devices.For both devices, the predicate and subject devices, data is transmitted to an external device or server, depending model. If not a server, this device sends the data to a remote computer server that allows healthcare professionals to access and review the data.There are no fundamental differences between their technological characteristics.
510(k) Summary (As required by section 21 CFR 807.92(c))
Non-Clinical Testing:	The following bench testing was conducted on the PreventiceBG RMS: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 The following testing has been performed to supportsubstantial equivalence:Biocompatibility for patient contact materials. The following quality assurance measures were applied during development of this device:Failure Mode Effects Analysis/Hazard Analysis (FMEA) Design FMEAs for mechanical and RF designs Performance Requirements Testing including Final System Verification and Validation Testing, ISO 60601 Testing, Edition 3.1.
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.

510(k) Summary

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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 device.
	The Preventice BG RMS has the same technological characteristicsas the predicate device in that all devices are intended to detect,transmit, and report digital data using similar computerizedtechnology. The Preventice BG RMS has the same intended uses asthe predicate device in that all devices are intended for ambulatorymonitoring. A pediatric usability study has shown no new hazardsor risk associated with pediatric use.
	It has been shown in this 510(k) submission that the differencesbetween the Preventice BG RMS and the predicate do not raise anyquestions regarding safety and effectiveness. The Preventice BGRMS, as designed and manufactured, is substantially equivalent to,and as safe and effective as, the referenced predicate device.

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.