Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
Patients who experience transient symptoms that may suggest a cardiac arrhythmia
The device has not been tested for and it is not intended for pediatric use

Device 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 bradyarrhythmia, asystole, or high ventricular rate. The device memory can store up to 13.3 min of ECG recordings from automatically detected arrhythmias and up to 22.5 min of ECG recordings from patienttriggered episodes. When a patient experiences symptoms, the ECG recordings can be manually triggered by placing a magnet over the BioMonitor. The BioMonitor is intended to aid in the diagnosis of cardiac arrhythmias in patients that may otherwise qo undetected.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the BioMonitor, an implantable cardiac monitor with AF detection. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The main performance metrics reported are for Atrial Fibrillation (AF) detection. The text does not explicitly state pre-defined acceptance criteria values (e.g., "Sensitivity must be > 90%"). Instead, it presents the results of the clinical study as the device's performance.

Performance Metric	Reported Device Performance (Mean ± SD)
AF Episode Sensitivity	94% ± 14.7%
AF Episode Positive Predictive Value (PPV)	73.7% ± 40.3%

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 50 participants. Of these, 27 showed at least one true AF episode.
Data Provenance: Single-center, prospective, nonrandomized study. The text does not specify the country of origin, but given the manufacturer is BIOTRONIK SE & Co. KG (Germany) and the sponsor is BIOTRONIK, Inc. (USA), it's likely a study conducted in either the US or Europe, or both. The data is prospective as participants were equipped with both devices and monitored.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not explicitly stated. The text mentions "expert-annotated, external Holter ECG recorder." It implies an expert (or team of experts) reviewed the Holter data, but the exact number isn't provided.
Qualifications of Experts: Not explicitly stated. The term "expert" implies a qualified medical professional, likely a cardiologist or electrophysiologist, experienced in interpreting ECGs and diagnosing cardiac arrhythmias.

4. Adjudication Method for the Test Set

The text states that the ground truth was established by "expert-annotated, external Holter ECG recorder." It does not provide details on an adjudication method (e.g., 2+1, 3+1, none) among multiple experts, suggesting either a single expert annotation or a process that doesn't involve explicit adjudication steps among several.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned as being performed to compare human readers with and without AI assistance. The study described focuses on the standalone performance of the BioMonitor against an expert-annotated Holter ECG as the gold standard.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was done. The clinical study aimed to "evaluate BioMonitor AF detection performance... in comparison with the gold standard, expert-annotated, external Holter ECG recorder." This demonstrates the algorithm's performance without direct human intervention in the detection process based on the BioMonitor's automated output.

7. The Type of Ground Truth Used

The ground truth used was expert consensus / expert annotation based on an external Holter ECG recorder. The text explicitly states: "The ability of BioMonitor to detect episodes of AF was quantified in comparison with the gold standard, expert-annotated, external Holter ECG recorder."

8. The Sample Size for the Training Set

The document does not provide information about the sample size used for the training set for the BioMonitor's AF detection algorithm. The clinical study described is a validation study, assessing the performance of the already developed device.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. It only details the validation study and its ground truth establishment.

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

March 19, 2015

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

Re: K143503

Trade/Device Name: Biomonitor 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: January 9, 2015 Received: January 12, 2015

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 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,

Bram D. Zuckerman -S

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): K143503

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 ●
The device has not been tested for and it is not intended for pediatric use

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)

Page 1 of 1

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BioMonitor Implantable Cardiac Monitor with AF Detection Traditional 510(k) Premarket Notification

1 510(K) SUMMARY

Date 510(k) Summary Prepared:	March 9, 2015
Name and Address of Sponsor:	BIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035
Establishment Registration Number:	1028232
Name and Address of Manufacturer:	BIOTRONIK SE & Co. KG (reg. no. 9610139)Woermannkehre 1,12359 Berlin, Germany011-49-30-689-05-1210Sterigenics Germany GmbHKasteler Straße 45D- 65203 Wiesbaden, Germany
Contact Person(s) and Phone Number:	Jon BrumbaughVP, Regulatory Affairs and CompliancePhone (888) 345-0374Fax (800) 913-6993jon.brumbaugh@biotronik.com
Device Name:
Trade Name:	BioMonitor
Common Name:	Implantable Cardiac Monitor
Classification Name:	Arrhythmia detector and alarm (including ST-segmentmeasurement and alarm).
Classification:	Class II (21 CFR 870.1025)
Product Code:	MXD

General Description / Intended Use:

Predicate Devices:

BIOTRONIK BioMonitor without AF Detection (K132960, cleared June 6, 2014) .
Medtronic Reveal XT Model 9529 (K071641, cleared November 21, 2007)
St. Jude Medical Confirm DM 2100 (K081365, cleared August 15, 2008)

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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 ●
. The device has not been tested for and it is not intended for pediatric use

Technological Characteristics and Substantial Equivalence:

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 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

Table 1: Comparison of BioMonitor with AF Detection and the Predicates

Technical Data	BioMonitor w/AF	BioMonitor	Reveal XT	Confirm DM 2100
FDA Clearance	Subject of this 510(k)	K132960	K071641	K081365
Dimensions (mm)Length x Width xHeight	53.3 x 42.7 x 7.1	53.3 x 42.7 x 7.1	19 x 62 x 8	18.5 x 56.3 x 8
Volume	12.5 cc	12.5 cc	9 cc	6.5 cc
Weight	26 g	26 g	15 g	12 g
AT/AF	40 seconds/episode30 seconds beforetrigger, 10 secondsafter trigger	N/A	1 min/episode30 s prior autoactivationLast 30 s of episode	10 – 60 s prioractivation10– 60s postactivation
MR Conditional	Yes	No	Yes	Yes

Performance Data:

The following performance data were provided in support of the substantial equivalence determination.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" in a separate submission. The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Atrial Fibrillation Feature Testing

AF Feature validation testing was completed by a functional software test to confirm that the BioMonitor

detects atrial fibrillation. The device must detect the following episodes and store them in the Holter memory:

•All AF sequences exceeding the programmed confirmation time and the stability limit of adjacent QRS intervals appear as an entry in the Holter memory.

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•Episodes which did not exceed the programmed stability limit or confirmation time do not appear in the Holter memory.

•AF detections or terminations are inhibited during the presence of noise resulting in:

•Complete inhibition of AF detection

·Shortening of AF episode due to noise in the beginning of the episode
•Prolonging of AF episode due to noise in the end of the episode.

MR Conditional Testing

BIOTRONIK conducted validation testing according to the Joint Working Group's International Technical Specification for ISO/TS 10974: 2012 (E). The following tests were performed:

·Gradient Induced Heating

·Vibration

·Static Malfunction

•Gradient Radiated Malfunction

•Vibration Malfunction

Clinical Study

In order to evaluate BioMonitor AF detection performance, clinical data was collected in a single-center, prospective, nonrandomized study. The ability of BioMonitor to detect episodes of AF was quantified in comparison with the gold standard, expert-annotated, external Holter ECG recorder. Fifty (50) participants with suspected paroxysmal or persistent atrial fibrillation who had been implanted with a BioMonitor were additionally equipped with an external Holter ECG recorder. Of these 50 participants, 27 showed at least one true AF episode during the two-day Holter period. A total of 131 AF episodes were annotated for 2132.9 hours of Holter ECG data.

False positive AF episodes (i.e. non-AF periods falsely detected as AF by BioMonitor), resulting in positive predictive values less than 100%, were predominately associated with episodes of ectopic beats.

False negative AF episodes (i.e. true AF episodes undetected by BioMonitor), resulting in sensitivity values less than 100%, were mainly attributed to R-R interval variability that did not exceed the BioMonitor-programmed limit of 12.5% for a sufficient fraction of intervals. All of these FN patients had AF documented by the BioMonitor in another episode and were thus identified as AF positive patients. Table 1 summarizes the mean episode sensitivity and a mean episode PPV.

Sensitivity (%) ± SD	PPV (%) ± SD
94 ± 14.7	73.7 ± 40.3

Table 1: Mean BioMonitor AF Detection Performance Statistics

List of Applied Standards

The BioMonitor was tested in accordance with the following standards:

ANSI/AAMI PC69: 2007 ●
ASTM F2119-07 (2013)
EN 45502-1: 1998 ●

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EN 45502-2-1: 2003 ●
. IEC 60601-2-33
ISO/TS 10974: 2012 ●
ISO 14708-1
ISO 14971: 2007

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.

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.