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

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 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.

AI/ML Overview

The BioMonitor Implantable Cardiac Monitor is designed to continuously monitor a patient's subcutaneous ECG and automatically record arrhythmias. The 510(k) summary provides details about its performance and the testing conducted to establish substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state formal acceptance criteria with specific performance thresholds (e.g., "sensitivity must be >X%"). Instead, it focuses on demonstrating technological equivalence to predicate devices and verifying various functional and safety aspects. The "Summary of Testing" section lists the types of testing performed and concludes that "No safety or effectiveness issues were identified." The device performance is implicitly established by showing that its technical characteristics are comparable to cleared predicate devices.

However, based on the context of an arrhythmia detector and the technical characteristics provided, we can infer some implied performance areas.

Performance Characteristic (Implied Acceptance Area)	Reported Device Performance (as demonstrated by testing and comparison to predicates)
Arrhythmia Detection (General)	Automatically records arrhythmias (bradyarrhythmia, asystole, high ventricular rate).
QRS Detection	Functional via combination signal from 3 vectors. Analysis of clinical data to support QRS detection was performed. Implied to be comparable to predicate devices which also perform QRS detection.
Asystole Triggering	Triggers for asystole at 40s/episode (30s prior auto activation, 10s post auto activation). Functionality confirmed.
Brady/Rate Drop Triggering	Triggers for brady/rate drop at 40s/episode (30s prior auto activation, 10s post auto activation). Functionality confirmed. Similar to predicate devices that have low rate triggers.
High Ventricular Rate (VT-FVT) Triggering	Triggers for VT-FVT at 40s/episode (30s prior auto activation, 10s post auto activation). Functionality confirmed. Similar to predicate devices that have high rate triggers.
ECG Recording / Storage	Stores up to 13.3 minutes of auto-activated ECG recordings and 22.5 minutes of patient-triggered ECG recordings. Functionality confirmed and comparable to predicate devices in terms of pre/post event storage capabilities.
Patient Activation	Allows patient activation for 7.5 min per event (7 min prior to activation, 0.5 min following activation). Functionality confirmed and comparable to predicate devices.
Auto Activation Triggers	Has auto activation triggers. Functionality confirmed and comparable to predicate devices.
Manual (Patient) Activation Trigger	Has manual (patient) activation trigger. Functionality confirmed and comparable to predicate devices.
Programmable High Rate Count	Has programmable high rate count. Functionality confirmed and comparable to predicate devices.
Functional Performance	Functional testing performed (details not specified, but concluded no safety/effectiveness issues).
Mechanical Performance	Mechanical testing performed (details not specified, but concluded no safety/effectiveness issues).
Biocompatibility	Biocompatibility testing performed (details not specified, but concluded no safety/effectiveness issues).
Electrical Safety / EMC	Electrical Safety / EMC testing performed (details not specified, but concluded no safety/effectiveness issues).
Packaging, Sterilization & Shelf Life	Packaging, Sterilization, and Shelf life testing performed (details not specified, but concluded no safety/effectiveness issues).

2. Sample Size for Test Set and Data Provenance:

The document mentions "Analysis of clinical data to support QRS detection" but does not specify the sample size used for this analysis, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective nature). The other validation tests listed (Functional, Mechanical, Biocompatibility, Electrical Safety/EMC, Packaging, Sterilization, Shelf life) are typically bench or lab tests and do not involve "patient data" test sets in the same manner as clinical performance evaluation.

3. Number of Experts and Qualifications for Ground Truth for Test Set:

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for any clinical data analysis mentioned (e.g., QRS detection).

4. Adjudication Method for Test Set:

No information is provided regarding any adjudication method for a test set. This type of detail would typically be found in a clinical study report, which is not present in this 510(k) summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated, nor does it provide an effect size for such a study. The BioMonitor is presented as a standalone automated arrhythmia detector.

6. Standalone (Algorithm Only) Performance:

Yes, the information provided primarily describes the standalone performance of the BioMonitor algorithm. The device "automatically record the occurrence of arrhythmias" and the "Analysis of clinical data to support QRS detection" would inherently evaluate the algorithm's performance without human intervention in the detection process. The summary table comparing "Technical Data" to predicate devices focuses on the device's inherent capabilities (e.g., trigger types, storage, sampling rate), all indicative of standalone algorithmic function.

7. Type of Ground Truth Used:

The type of ground truth used for the "Analysis of clinical data to support QRS detection" is not explicitly stated. For arrhythmia detection studies, ground truth is typically established by:

Expert Consensus: Independent review of ECGs by multiple cardiologists/electrophysiologists.
Adjudicated ECGs: Often involving multiple experts reviewing and agreeing on arrhythmia events.
Simulated Arrhythmias: In some functional testing, precisely controlled simulated signals might be used.

Given the context of "clinical data," it is most likely that expert consensus or adjudicated ECGs served as the ground truth, but this is not confirmed in the document.

8. Sample Size for Training Set:

The document does not provide any information about a training set or its sample size. This type of information is typically related to machine learning model development, which is not detailed in this 510(k) summary focused on hardware and basic algorithmic functionality comparison.

9. How Ground Truth for Training Set Was Established:

Since no information regarding a training set is provided, there is no information on how its ground truth was established.

Summary

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510(k) Summary for BioMonitor Implantable Cardiac Monitor

Date Prepared	June 5, 2014
Sponsor	BIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035 .Establishment Registration 1028232
Manufacturer	BIOTRONIK SE & Co. KGWoermannkehre 1,12359 Berlin, Germany011-49-30-689-05-1210Establishment Registration 9610139
Contact Person	Jon BrumbaughVP, Regulatory Affairs and CompliancePhone (888) 345-0374Fax (800) 913-6993jon.brumbaugh@biotronik.com
Device Information	Trade Name	BioMonitor
	Common Name	Implantable Cardiac Monitor
	Classification Name	Arrhythmia detector and alarm (includingST-segment measurement and alarm)
	Classification	Class II (21 CFR 870.1025)

General Description:

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)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 min22.5 min for patient triggeredevents13.3 min for auto-activatedeventsLongest/oldest/newest	49.5 min22.5 min for patienttriggered events27 min for auto-activatedevents3 most recent episodes	48 min3 most recentepisodes
Patient Activation	7.5 min per event7 min prior to activation0.5 min following activation	7.5 min per event6.5 min prior to activation1 min for auto-activatedevents	1- 4 min prior toactivation10-60s postactivation
AsystoleBrady/rate dropVT-FVT	40 s/episode30 s prior auto activation10 s post auto activation	1 min/episode30 s prior auto activationLast 30 s of episode	10 - 60 s prioractivation10- 60s postactivation
AT/AF	N/A	1 min/episode30 s prior auto activationLast 30 s of episode	10 - 60 s prioractivation10- 60s postactivation
Vector Mapping Required	No	Yes	Yes
Sampling Rate	128 Hz	256 Hz	128 Hz
Auto Activation Triggers	Yes	Yes	Yes
Manual (Patient) ActivationTrigger	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 dailytransmissions	CareLink	TranstelephonicMonitoring (TTM)
QRS Detection	Combination signal from 3vectors	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 (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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

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

Image /page/4/Picture/6 description: The image shows the text "Sincerely yours," followed by a logo. The logo appears to be the letters FDA, but they are heavily crossed out with black lines. The logo is in a rectangular box.

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'

Page 1 of 1

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.