· 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

BIOMONITOR III and BIOMONITOR IIIm are programmable, subcutaneous insertable cardiac monitors able to record subcutaneous ECGs (sECGs) and other physiological parameters.

The BIOMONITOR III and BIOMONITOR IIIm are designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial fibrillation (AF), bradyarrhythmia, asystole, sudden rate drop, or high ventricular rate. In addition, the BIOMONITOR III and BIOMONITOR IIIm can be activated by the patient using the Remote Assistant III to record cardiac rhythm during symptomatic episodes. BIOMONITOR III and BIOMONITOR IIIm may be used with the current legally marketed BIOTRONIK Home Monitoring® technology, which is an automatic, wireless, remote monitoring system for management of patients with implantable cardiac monitors.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the BIOMONITOR III and BIOMONITOR IIIm, based on the provided document:

This document primarily describes the substantial equivalence of the BIOMONITOR III and BIOMONITOR IIIm to a predicate device (BIOMONITOR III, K190548) for FDA clearance. The information provided is characteristic of a 510(k) submission, where the focus is often on demonstrating that a new device is as safe and effective as an already legally marketed device, rather than proving performance against novel acceptance criteria with a new clinical study.

The key study mentioned is the "AF Detect study" for the BIOMONITOR IIIm.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) for the updated BIOMONITOR III and BIOMONITOR IIIm. The "AF Detect study" is described as demonstrating "substantial equivalence" and "further improvement of the performance in terms of reduction of false AF snapshots," but specific metrics or thresholds for this improvement are not provided in the summary.

Therefore, a table of quantitative acceptance criteria and reported performance cannot be fully constructed from the provided text. The document focuses on the sameness of the device's fundamental function compared to the predicate.

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

Test Set Sample Size: Not explicitly stated for the "AF Detect study." The document only mentions "utilizing real-world clinical data."
Data Provenance: "real-world clinical data." The country of origin and whether it was retrospective or prospective is not specified in the provided text.

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

This information is not provided in the document. Ground truth establishment methods, including the number and qualifications of experts, are not detailed for the "AF Detect study."

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study described: The document does not mention an MRMC study. The study described focuses on the device's detection algorithm, not on human reader performance with or without AI assistance.
Effect size: Not applicable, as no MRMC study was described.

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

Yes, the "AF Detect study" appears to be a standalone performance evaluation of the AF detection algorithm. It aims to demonstrate the performance of the algorithm in the BIOMONITOR IIIm, specifically the extended AF detection algorithm with an additional parameter for ectopy rejection. The comparison is made to the predicate BIOMONITOR III's AF detection algorithm, implying an algorithm-to-algorithm comparison.

7. The type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The type of ground truth used for the "AF Detect study" is not explicitly stated in the provided document. It refers to "real-world clinical data," but the method by which AF events within this data were definitively identified (e.g., expert consensus of ECGs, other diagnostic tests) is not described.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. The description of the BIOMONITOR IIIm's AF algorithm states it has been "extended with an additional parameter to identify and reject specific patterns associated with ectopy rhythms," which implies some form of development or training, but details regarding a training set are absent.

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

This information is not provided in the document, as no training set details were given.

Summary

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April 23, 2020

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

Re: K200444

Trade/Device Name: BIOMONITOR III, BIOMONITOR IIIm 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: February 21, 2020 Received: February 24, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Jennifer Shih Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200444

Device Name BIOMONITOR III BIOMONITOR IIIm

Indications for Use (Describe)

The BIOMONITOR III/BIOMONITOR IIIm is indicated to detect the following cardiac arrhythmias:

· atrial fibrillation
bradycardia
· sudden rate drop
· high ventricular rate (HVR)
· asystole

The BIOMONITOR III/BIOMONITOR IIIm is indicated for use in:

· 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the word "BIOTRONIK" in large, bold, dark blue letters, with a smaller, light blue circle containing the letters "BIO" to the left. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, light blue font.

510(k) Summary

BIOMONITOR III and BIOMONITOR IIIm, Implantable Cardiac Monitors

Traditional 510(k) Premarket Notification

Submission Information 1.
Date prepared February 19, 2020
Contact Jon Brumbaugh VP, Requlatory Affairs and Compliance BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 Phone (888) 345-0374 jon.brumbaugh@biotronik.com
Manufacturer BIOTRONIK SE & Co. KG Woermannkehre 1, 12359 Berlin, Germany Registration number 9610139

Subject Devices 2.

Trade Name BIOMONITOR III and BIOMONITOR IIIm
Common Name Implantable Cardiac Monitor
Classification Name Recorder, Event, Implantable Cardiac (With Arrhythmia Detection)
Classification Class II (21 CFR 870.1025)
Product Code MXD

3. Predicate Device

BIOTRONIK BIOMONITOR III, K190548, cleared July 5, 2019

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Image /page/4/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the letters "BIO" inside of a circle that is divided into quadrants. To the right of the circle is the word "BIOTRONIK" in large, bold, blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller font.

4. Device Descriptions

BIOMONITOR III and BIOMONITOR IIIm are programmable, subcutaneous insertable cardiac monitors able to record subcutaneous ECGs (sECGs) and other physiological parameters.

5. Indications for Use

The indications for use for the BIOMONITOR III and BIOMONITOR IIIm are identical to the predicate device.

The BIOMONITOR III/BIOMONITOR IIIm are indicated to detect the following cardiac arrhythmias:

. atrial fibrillation
bradycardia
sudden rate drop
. high ventricular rate (HVR)
. asystole

The BIOMONITOR III/BIOMONITOR IIIm 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 6.

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 subiect 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

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Image /page/5/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of a circular emblem with the letters "BIO" inside, followed by the word "BIOTRONIK" in bold, dark blue letters. Below the word "BIOTRONIK" is the tagline "excellence for life" in a smaller, lighter blue font.

Technical Data	Predicate BIOMONITOR III	Updated BIOMONITOR III and BIOMONITOR IIIm
FDA Clearance	K190548, Predicate	Subjects of this 510(k)
Indications	Patients with clinical syndromes or situations at increasedrisk of cardiac arrhythmiasPatients who experience transient symptoms that maysuggest a cardiac arrhythmiaThe device has not been tested for and it is not intended forpediatric use
Principle of Operation	The BIOMONITOR III/BIOMONITOR IIIm sensessubcutaneous electrocardiograms (SECG) using twointegrated electrodes and has the capability of detecting anumber of arrhythmias. Like the predicate device,BIOMONITOR III/BIOMONITOR IIIm sends recorded SECGand statistics to the Home Monitoring Service Center.
Dimensions (mm)	47.5 x 8.3 x 4.3 (can)
Length x Width x Height	77.5 x 8.6 x 4.6 w/ lead
Volume	1.9 cc
Weight	4.0 g
AT/AF	40 s/episode30 s prior auto activation10 s post auto activation
MR Conditional	Yes

Table 1. Comparison of Updated BIOMONITOR III, BIOMONITOR IIIm and Predicate, BIOMONITOR III

7. Non-Clinical Performance Data

The following performance data are provided in support of the substantial equivalence determination:

7.1 AF Detect Study:

The basic AF detection algorithm in BIOMONITOR IIIm remains unchanged compared to the predicate BIOMONITOR III. In the BIOMONITOR IIIm device, the AF detection algorithm has been extended with an additional parameter to identify and reject specific patterns associated with ectopy rhythms. An AF Detect study was conducted and the results of the study demonstrate the substantial equivalence of BIOMONITOR IIIm and BIOMONITOR III utilizing real-world clinical data while the additional ectopy rejection parameter resulted in further improvement of the performance in terms of reduction of false AF snapshots.

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Image /page/6/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the letters "BIO" stacked on top of each other inside of a circle that is divided into quadrants. To the right of the circle is the word "BIOTRONIK" in large, bold, dark blue letters, and below that is the phrase "excellence for life" in smaller, light blue letters.

7.2 Validation and Verification Testing:

The BIOMONITOR III and BIOMONITOR IIIm have undergone thorough validation and verification testing to ensure final device functionality. The following categories of tests were performed and passed:

Software Testing
Electromagnetic Compatibility Testing ●
. Mechanical Testing
. Electrical Testing

7.3 1.5T and 3.0T MRI Testing:

BIOTRONIK conducted validation testing according to the Joint Working Group's International Technical Specification for ISO/TS 10974: 2018.

Clinical Performance Data 8.

No clinical performance data was submitted or relied upon in support of the substantial equivalence determination.

9. Conclusion

BIOTRONIK concludes that the Updated BIOMONITOR III and BIOMONITOR IIIm are substantially equivalent to BIOTRONIK's predicate BIOMONITOR III. The subject BIOMONITOR III and BIOMONITOR IIIm devices and the predicate BIOMONITOR III device use the same principles of operation, have similar device features, and there are no new issues of safety or effectiveness. The BIOMONITOR III and BIOMONITOR IIIm devices keep the core software features and functionality as the predicate BIOMONITOR III with only a minor update to the AF Detection Algorithm for BIOMONITOR IIIm. The hardware design is similarly adapted from the predicate with the only significant difference being that the updated BIOMONITOR III and BIOMONITOR IIIm have an updated electronic module. These aspects of equivalence are confirmed by testing provided within the application.

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.