BodyGuardian Remote Monitoring System

K151188 · Preventice · DSI · Sep 17, 2015 · Cardiovascular

Device Facts

• Record ID: K151188
• Device Name: BodyGuardian Remote Monitoring System
• Applicant: Preventice
• Product Code: DSI · Cardiovascular
• Decision Date: Sep 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Indications for Use

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 Story

BodyGuardian Remote Monitoring System is an ambulatory cardiac monitor; collects health parameters via external plug-in devices (ECG sensors, weight scales, blood pressure meters, pulse oximeters). Device acts as a data hub; transmits collected data to an external device, which relays information to a remote computer server. Healthcare professionals access and review data via the server. System facilitates remote monitoring and evaluation of patient health parameters; does not provide automated diagnosis. Used in clinical and non-clinical settings; operated by healthcare professionals for patient monitoring. Benefits include remote access to physiological data for improved patient management.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including EMC, electrical safety, system safety, software verification/validation, performance testing, and wireless transmission/coexistence testing.

Technological Characteristics

Ambulatory cardiac monitor; data hub functionality for external sensors. Materials: Makrolon, Versaflex. Connectivity: Wireless data transmission to external device/remote server. Software: Verification and validation performed. Standards: ISO 60601 (3rd Edition).

Indications for Use

Indicated for adult patients in clinical and non-clinical settings for the detection and monitoring of cardiac arrhythmias. Not for use with patients requiring attended, in-hospital monitoring for life-threatening arrhythmias.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• eMotion Faros ECG Mobile
• BodyGuardian Remote Monitoring System

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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#### ທ 510(k) Summary

| 510(k) Summary (As required by section 21 CFR 807.92(c)) | |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Preventice<br>2765 Commerce Drive NW, Suite 220, Rochester, MN 55901 |
| Contact Person: | Charles Rector<br>Director, RA/QA<br>Telephone: [phone]<br>Email: [e-mail] |
| Date Prepared: | March 01, 2015 |
| Trade Name: | BodyGuardian Remote Monitoring System |
| Common/Usual Name: | Remote Monitoring System |
| Classification: | 21 CFR 870.1025<br>Patient Physiological Monitor (with arrhythmia detection) |
| Product Code: | DSI |
| Manufacturer: | Preventice<br>2765 Commerce Drive NW, Suite 220, Rochester, MN 55901 |
| Establishment Registration: | 3009883402 |
| Predicate Devices: | eMotion Faros ECG Mobile &<br>BodyGuardian Remote Monitoring System |
| Device Description: | Arrhythmia Detector and Alarm;<br>Patient Physiological Monitor (with arrhythmia detection)<br>The BodyGuardian System detects and monitors cardiac<br>arrhythmias in ambulatory patients, when prescribed by a<br>physician or other qualified healthcare professional. Not for use<br>with patients requiring attended, In-hospital monitoring for life<br>threatening arrhythmias. |
| Intended Use | The Preventice BodyGuardian Remote Monitoring System is<br>intended for use with adult patients in clinical and non-clinical<br>settings to collect and transmit health parameters to healthcare<br>professionals for monitoring and evaluation. Health parameters<br>are collected from a variety of commercially available, external<br>plug in devices such as ECG sensors, Weight Scales, Blood Pressure<br>Meters and Pulse Oximeters. The Preventice BodyGuardian<br>Remote Monitoring System does not provide any diagnosis |
| 510(k) Summary | (As required by section 21 CFR 807.92(c)) |
| Comparison of<br>Technological<br>Characteristics: | The predicate devices and the BodyGuardian System are small,<br>ambulatory cardiac monitors that record and transmit health<br>monitors. They provide a data hub function that connects to<br>commercially available devices such as weight scales, blood<br>pressure monitors, pulse oximeters and other plug-in devices.<br>Data is transmitted to an external device which, in turn, sends the<br>data to a remote computer server that allows healthcare<br>professionals to access and review the data. There are no<br>fundamental differences between their technological<br>characteristics. |
| Non-Clinical Testing: | The following bench testing was conducted on the Preventice BG<br>RMS:<br>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 wireless<br>coexistence testing The following testing has been performed to support substantial<br>equivalence (see table 9): Biocompatibility for patient contact materials: Makrolon Versaflex See Appendix Q for specifications.<br>The following quality assurance measures were applied during<br>development 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 System<br>Verification and Validation Testing, ISO 60601 Testing, 3rd<br>Edition. |
| Clinical Testing: | This technology is not new, therefore a clinical study was not<br>considered necessary prior to release. Additionally, there was no<br>clinical testing required to support the medical device as the<br>indications for use is equivalent to the predicate device. The<br>substantial equivalence of the device is supported by the non-<br>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 BG<br>RMS to be substantially equivalent to the predicate devices. |
| | The Preventice BG RMS has the same technological characteristics<br>as the predicate devices in that all devices are intended to detect,<br>transmit, and report digital data using similar computerized<br>technology. The Preventice BG RMS has the same intended uses<br>as the predicate devices in that all devices are intended for<br>ambulatory monitoring. |
| | It has been shown in this 510(k) submission that the differences<br>between the Preventice BG RMS and the predicates do not raise<br>any questions regarding safety and effectiveness. The Preventice<br>BG RMS, as designed and manufactured, is substantially<br>equivalent to, and as safe and effective as, the referenced<br>predicate devices. |

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