BIOMONITOR

K132960 · Biotronik, Inc. · MXD · Jun 6, 2014 · Cardiovascular

Device Facts

• Record ID: K132960
• Device Name: BIOMONITOR
• Applicant: Biotronik, Inc.
• Product Code: MXD · Cardiovascular
• Decision Date: Jun 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The BioMonitor is indicated for: - Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias . - Patients who experience transient symptoms that may suggest a cardiac arrhythmia .

Device Story

BioMonitor is a small, leadless, implantable cardiac monitor; uses three electrodes on device body to continuously monitor subcutaneous ECG. Automatically detects and records arrhythmias (asystole, bradyarrhythmia, high ventricular rate). Stores up to 13.3 minutes of auto-detected ECG and 22.5 minutes of patient-triggered ECG. Patient triggers recording by placing magnet over device during symptomatic events. Used in clinical/home settings; operated by patient (triggering) and physician (reviewing). Data transmitted via Home Monitoring system. Output allows physicians to correlate patient symptoms with ECG findings, facilitating diagnosis and management of cardiac arrhythmias.

Clinical Evidence

Clinical data analysis performed to support QRS detection performance. No other clinical study results provided. Bench testing included functional, mechanical, biocompatibility, electrical safety/EMC, packaging, and sterilization/shelf-life validation.

Technological Characteristics

Leadless implantable device; 53.3 x 42.7 x 7.1 mm; 12.5 cc volume; 26 g weight. Uses 3-electrode configuration for subcutaneous ECG sensing. Sampling rate 128 Hz. Connectivity via Home Monitoring daily transmissions. 48-month longevity. Class II device (21 CFR 870.1025).

Indications for Use

Indicated for patients with clinical syndromes/situations at increased risk of cardiac arrhythmias or patients experiencing transient symptoms suggestive of cardiac arrhythmia.

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

• Medtronic Reveal XT Model 9529 (K071641)
• St. Jude Medical Confirm DM 2100 (K081365)

Submission Summary (Full Text)

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# 510(k) Summary for BioMonitor Implantable Cardiac Monitor

| Date Prepared | June 5, 2014 | | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--|
| Sponsor | BIOTRONIK, Inc.<br>6024 Jean Road<br>Lake Oswego, OR 97035 .<br>Establishment Registration 1028232 | | |
| Manufacturer | BIOTRONIK SE & Co. KG<br>Woermannkehre 1,<br>12359 Berlin, Germany<br>011-49-30-689-05-1210<br>Establishment Registration 9610139 | | |
| Contact Person | Jon Brumbaugh<br>VP, Regulatory Affairs and Compliance<br>Phone [phone]<br>Fax [phone]<br>[e-mail] | | |
| Device Information | Trade Name | BioMonitor | |
| | Common Name | Implantable Cardiac Monitor | |
| | Classification Name | Arrhythmia detector and alarm (including<br>ST-segment measurement and alarm) | |
| | Classification | Class II (21 CFR 870.1025) | |

#### General Description:

The BioMonitor is a small, leadless, implantable device that uses three electrodes on the body of the device to continuously monitor the patient's subcutaneous ECG. The BioMonitor is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as bradvarrhythmia. asvstole, or high ventricular rate. The device memory can store up to 13.3 minutes of ECG recordings from automatically detected arrhythmias and up to 22.5 minutes of ECG recordings from patient-triggered episodes. When a patient experiences symptoms, the ECG recordings can be manually triggered by placing a magnet over the BioMonitor.

MXD

#### Predicate Devices:

- . Medtronic Reveal XT Model 9529 (K071641, cleared November 21, 2007)
Product Code

- St. Jude Medical Confirm DM 2100 (K081365, cleared August 15, 2008) .
#### Indication for Use:

The BioMonitor is indicated for:

- Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias .
- Patients who experience transient symptoms that may suggest a cardiac arrhythmia .

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#### Technological Characteristics and Substantial Equivalence:

The substantial equivalence claim between the subject and the predicate device is supported by the information included in the premarket notification. This includes the following information:

- . Description of the subject and predicate devices
- Intended use of the subject and predicate devices .
- . Performance of the subject and predicate devices
- Technological characteristics of the subject and predicate devices .
- Validation testing .

| Technical Data | BioMonitor | Reveal XT | Confirm DM 2100 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| FDA Clearance | Subject | K071641 | K081365 |
| Dimensions (mm)<br>Length x Width x Height | 53.3 x 42.7 x 7.1 | 19 x 62 x 8 | 18.5 x 56.3 x 8 |
| Volume | 12.5 cc | 9 cc | 6.5 cc |
| Weight | 26 g | 15 g | 12 g |
| Longevity | 48 months | 36 months | 36 months |
| Subcutaneous ECG Recording | Yes | Yes | Yes |
| Pre and Post Event Storage | Yes | Yes | Yes |
| SEGM Storage | 35.8 min<br>22.5 min for patient triggered<br>events<br>13.3 min for auto-activated<br>events<br>Longest/oldest/newest | 49.5 min<br>22.5 min for patient<br>triggered events<br>27 min for auto-activated<br>events<br>3 most recent episodes | 48 min<br>3 most recent<br>episodes |
| Patient Activation | 7.5 min per event<br>7 min prior to activation<br>0.5 min following activation | 7.5 min per event<br>6.5 min prior to activation<br>1 min for auto-activated<br>events | 1- 4 min prior to<br>activation<br>10-60s post<br>activation |
| Asystole<br>Brady/rate drop<br>VT-FVT | 40 s/episode<br>30 s prior auto activation<br>10 s post auto activation | 1 min/episode<br>30 s prior auto activation<br>Last 30 s of episode | 10 - 60 s prior<br>activation<br>10- 60s post<br>activation |
| AT/AF | N/A | 1 min/episode<br>30 s prior auto activation<br>Last 30 s of episode | 10 - 60 s prior<br>activation<br>10- 60s post<br>activation |
| Vector Mapping Required | No | Yes | Yes |
| Sampling Rate | 128 Hz | 256 Hz | 128 Hz |
| Auto Activation Triggers | Yes | Yes | Yes |
| Manual (Patient) Activation<br>Trigger | Yes | Yes | Yes |
| High Rate Trigger | Yes | Yes | Yes |
| Programmable High Rate Count | Yes | Yes | Yes |
| Low Rate Trigger | Yes | Yes | Yes |

#### Table 1: BioMonitor Compared to Predicate Devices

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| Technical Data | BioMonitor | Reveal XT | Confirm DM 2100 |
|-------------------|----------------------------------------|----------------------|-------------------------------------|
| FDA Clearance | Subject | K071641 | K081365 |
| Asystole Trigger | Yes | Yes | Yes |
| Remote Monitoring | Home Monitoring daily<br>transmissions | CareLink | Transtelephonic<br>Monitoring (TTM) |
| QRS Detection | Combination signal from 3<br>vectors | One vector detection | One vector detection |

#### Summary of Testing:

The substantial equivalence claim between the subject and the predicate device is supported by the information included in this premarket notification. This includes the following:

- Comparison of attributes and specifications of the subject and predicate devices .
- Subject device risk analysis .
- . Subject device validation testing which includes the following testing:
- Functional ö
- Mechanical 0
- Biocompatibility o
- Electrical Safety / EMC 0
- Packaging 0
- Sterilization and Shelf life o
- . Analysis of clinical data to support QRS detection

#### Conclusion:

.

BIOTRONIK considers the BioMonitor implantable cardiac monitor to be substantially equivalent to legally marketed predicate devices through the data and information presented. No safety or effectiveness issues were identified.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 Now Hampshire Avenue Document Control Center WO66-GHO9 Silver Spring, MD 20993-0002

Image /page/3/Picture/3 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

June 6, 2014

Biotronik, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035 US

Re: K132960 Trade/Device Name: BioMonitor ICM Regulation Number: 21 CFR 870,1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II

Product Code: MXD Dated: May 30, 2014 Received: June 2, 2014

Dear Jon Brumbaugh:

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

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Page 2 - Jon Brumbaugh

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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.

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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: K132960

#### Device Name: BioMonitor Indications for Use:

The BioMonitor is indicated for:

- Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias .
- Patients who experience transient symptoms that may suggest a cardiac arrhythmia .

> Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Date
2014.06.06
09:32:04 -04'00'

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