BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT

K121197 · Preventice, Inc. · DSI · Aug 10, 2012 · Cardiovascular

Device Facts

• Record ID: K121197
• Device Name: BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
• Applicant: Preventice, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Aug 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The BodyGuardian System detects and monitors non-lethal cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. The BodyGuardian System continuously records, stores and periodically transmits the following physiological data to a remote computer server for up to 30 days at a time: • ECG • Heart rate (including HR variability and HR reliability) • Respiration rate • Activity

Device Story

Ambulatory cardiac monitoring system; collects ECG, heart rate, respiration rate, and activity data. Components include BodyGuardian Control Unit, SnapStrip, Connect, and software applications (PatientCare, Web/iPad portals). Device records/stores data locally, transmits to remote Preventice server for professional review. Used in ambulatory settings; operated by patient (wearable) and healthcare professionals (data review). Enables remote monitoring for up to 30 days; facilitates clinical decision-making regarding cardiac health through continuous physiological data access.

Clinical Evidence

Bench testing only. Testing included EMC and electrical safety, ECG performance, activity level measurement validation, respiration rate measurement validation, software verification and validation, and biocompatibility testing.

Technological Characteristics

Ambulatory cardiac monitor; measures ECG, heart rate, respiration, and activity. Connectivity via external broadcast to remote server. Software-based data management. Biocompatible materials used. No specific ASTM/ISO standards cited in summary.

Indications for Use

Indicated for ambulatory patients requiring detection and monitoring of non-lethal cardiac arrhythmias, as prescribed by a physician or qualified healthcare professional.

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

• AVIVO Mobile Patient Management System (k083287)

Submission Summary (Full Text)

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Pg lofz

k121197

AUG 1 0 2012

#### 8 510(k) Summary

| Submitter: | Preventice, Inc.<br>2765 Commerce Drive NW<br>Suite 220<br>Rochester, MN 55901 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Drew Palin, M.D.<br>Medical Innovation Officer<br>[e-mail]<br>Mobile: [phone]<br>Office : 507-322-3712<br>FAX: [phone]<br><br>Preventice<br>2765 Commerce Drive NW<br>Suite 220<br>Rochester. MN 55901 |
| Date Prepared: | April 18, 2012 |
| Trade Names: | BodyGuardian System [Preventice BodyGuardian Device<br>(BodyGuardian Control Unit and BodyGuardian SnapStrip), Preventice<br>BodyGuardian Connect, BodyGuardian Application, Preventice<br>PatientCare, PatientCare Portal for the Web, and PatientCare for iPad |
| Classification: | 21 CFR 870.1025<br>• Patient Physiological Monitor (with arrhythmia detection)<br>• Arrhythmia Detector and Alarm |
| Product Codes: | MHX, DSI |
| Predicate Device: | AVIVO Mobile Patient Management System (k083287) |
| Device Description: | The BodyGuardian System is an ambulatory cardiac monitoring system<br>prescribed by healthcare providers. It monitors and records a patient's<br>electrocardiographic (ECG) data, heart rate, respiration rate and activity<br>level. The complete system consists of components that collect data,<br>send the data to a remote Preventice computer server, store the data in<br>secure databases, and present the data for review by healthcare<br>professionals. |

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pg 20f2

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# 510(k) Summary (Continued)

| Intended Use: | The BodyGuardian System detects and monitors non-lethal cardiac<br>arrhythmias in ambulatory patients, when prescribed by a physician or other<br>qualified healthcare professional. The BodyGuardian System continuously<br>records, stores and periodically transmits the following physiological data to<br>a remote computer server for up to 30 days at a time:<br>• ECG<br>• Heart rate (including HR variability and HR reliability)<br>• Respiration rate<br>• Activity |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of<br>Technological<br>Characteristics: | Both the predicate system and the BodyGuardian System are small,<br>ambulatory cardiac monitors that measure ECG, heart rate, respiration rate<br>and activity levels. Both transmit their data to an external device which, in<br>turn, broadcasts the data to a remote computer server that allows healthcare<br>professionals to access and review the data. There are no fundamental<br>differences between their technological characteristics. |
| Non-Clinical<br>Testing: | The following bench testing was conducted on the BodyGuardian System:<br>• EMC and electrical safety testing<br>• ECG performance testing<br>• Activity level measurement validation<br>• Respiration rate measurement validation<br>• Software verification and validation<br>• Biocompatibility testing |
| Clinical Testing | Not applicable. |
| Conclusion: | We conclude that the results of testing show the BodyGuardian System to be<br>substantially equivalent to the predicate device. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

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

AUG 10 2012

Preventice, Inc c/o Drew Palin, M.D. Medical Innovation Officer 2765 Commerce Drive NW, Suite 220 Rochester, MN 55901

Re: K121197

Trade Name: Preventice BodyGuardian System Regulatory Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: II (two) Product Code: DSI Dated: August 2, 2012 Received: August 3, 2012

### Dear Mr. Palin:

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.

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## Page 2 - Mr. Drew Palin

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 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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#### 7 Indications for Use Statement

510(k) Number (if known):

Device Name: BodyGuardian System

Indications for Use:

The BodyGuardian System detects and monitors non-lethal cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. The BodyGuardian System continuously records, stores and periodically transmits the following physiological data to a remote computer server for up to 30 days at a time:

- . ECG
- . Heart rate (including HR variability and HR reliability)
- Respiration rate ●
- Activity .

Over-The-Counter Use Prescription Use X . AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Concurrence of CDRH, Office of Device Evaluation (ODE)

on of Cardiovascular Devices

510(k) Number K121197