The BIOMONITOR III is 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 can be activated by the patient to record cardiac rhythm during symptomatic episodes. BIOMONITOR III 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. The BIOMONITOR III is smaller than the predicate BioMonitor 2 while maintaining the same clinical functionality.

AI/ML Overview

This 510(k) summary does not contain the detailed clinical study information typically found in a clinical trial report. It states that "No clinical performance data was submitted or relied upon in support of the substantial equivalence determination." Instead, it focuses on demonstrating substantial equivalence to a predicate device (BIOTRONIK BioMonitor 2, K152995) through non-clinical performance data and technological characteristics.

Therefore, many of the requested details regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, and ground truth for training sets cannot be extracted from this document because a clinical study of that nature was not provided.

However, based on the non-clinical data, we can infer some "acceptance criteria" through the validation testing described.

Here's a summary of the available information:

1. A table of acceptance criteria and the reported device performance

Since no clinical performance data for specific arrhythmias are provided, the "acceptance criteria" are implied through the successful completion of the non-clinical tests demonstrating equivalence and safety.

Acceptance Criteria (Implied from Non-Clinical Tests)	Reported Device Performance
No safety issues related to incision tool, insertion tool, or implant.	Successfully demonstrated no safety issues.
Equivalent QRS detection performance to the predicate device.	Demonstrated equivalent QRS detection performance between BIOMONITOR III and the predicate device over the implantation period.
User interfaces are safe and effective for intended users, uses, and environments (Usability/Human Factors).	Found to be safe and effective, conforming to IEC 62366-1.
Final device functionality (Validation and Verification Testing).	Thorough validation and verification testing performed and passed for: Particulate Matter Validation, Mechanical Verification and Validation, Electrical Verification and Validation, Biocompatibility, Sterilization Validation.
MRI compatibility at 1.5T and 3.0T.	Validation testing conducted according to ISO/TS 10974: 2018.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided as a formal clinical study with a test set was not submitted. The "preclinical study" mentioned in section 7.1 would have involved a sample size (e.g., number of animals or in vitro samples), but these details are not specified in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable/not provided as no clinical study with expert-adjudicated ground truth was submitted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/not provided as no clinical study with expert adjudication was submitted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done/not submitted. The device is an implantable monitor, and the focus is on its automated detection capabilities as substantially equivalent to a predicate device, not on human reader improvement with AI assistance.

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

While not explicitly called a "standalone study", the document states that the device automatically records arrhythmias and that its "detection algorithms of BIOMONITOR III being unchanged from the predicate device." The validation testing (e.g., QRS detection performance) inherently evaluates the algorithm's performance in detecting these events without human intervention during the detection process. The statement that "BIOMONITOR III has the same part-rigid part-flexible design and the same overall shape as the predicate device (BioMonitor 2)" and that "BIOMONITOR III implant hardware-platform has been miniaturized with respect to BioMonitor 2" further suggests the focus is on hardware changes while maintaining the proven algoritihms of the previous device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "equivalent QRS detection performance" in the preclinical study, the ground truth would typically be established by a reference standard (e.g., human expert interpretation of ECGs, or another validated detection method) against which the device's QRS detection is compared. However, the exact nature of this ground truth is not detailed in this summary.

8. The sample size for the training set

This information is not applicable/not provided. The document states that the "detection algorithms of BIOMONITOR III being unchanged from the predicate device," implying that new training was not required for the algorithms themselves, or if training was done, it was for the predicate device and not detailed here.

9. How the ground truth for the training set was established

This information is not applicable/not provided for the reasons mentioned in point 8.

Summary

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July 5, 2019

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

Re: K190548

Trade/Device Name: BIOMONITOR III, Remote Assistant III 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: June 4, 2019 Received: June 6, 2019

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

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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 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 mediation-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 Nicole Goodsell External Heart Rhythm and Rate Team Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices 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) K190548

Device Name BIOMONITOR III

Indications for Use (Describe)

The BIOMONITOR III 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.

Type of Use (Select one or both, as applicable)
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/1 description: The image shows the logo for BIOTRONIK. The logo consists of the letters "BIO" inside of a circle to the left of the word "BIOTRONIK" in large, bold, dark blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter blue font.

510(k) Summary BIOMONITOR III, Implantable Cardiac Monitor Traditional 510(k) Premarket Notification

1. Submission Information

Date prepared March 1, 2019

Contact Jon Brumbaugh VP, Regulatory 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

2. Subject Device

Trade Name BIOMONITOR III
Common Name Implantable Cardiac Monitor

Classification Name Recorder, Event, Implantable Cardiac (With Arrhythmia Detection)

Classification Class II (21 CFR 870.1025)
Product Code MXD

Predicate Device 3.

BIOTRONIK BioMonitor 2, K152995, cleared April 11, 2016

BIOTRONIK. Inc 6024 lean Road ke Oswego, OR 97035 800-547-039. elephone 800-291-0470 www.biotr onik.com

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Image /page/4/Picture/1 description: The image contains the logo for BIOTRONIK. The logo consists of the word "BIOTRONIK" in large, bold, dark blue letters. To the left of the word is a circular emblem with the letters "BIO" inside. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter blue font.

Device Description 4.

BIOMONITOR III is a programmable, subcutaneous insertable monitor able to record subcutaneous ECGs (sECGs) and other physiological parameters.

5. Indications for Use

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

The BIOMONITOR III 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 followinq 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
o Validation testing

BIOTRONIK. Inc. 6024 Jean Road Lake Oswego, OR 97035 800-547-0394 Telephone 800-291-0470 www.biotronik.com

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Technical Data	BioMonitor 2	BIOMONITOR III
FDA Clearance	K152995, Predicate	Subject 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 senses subcutaneous electrocardiograms(SECG) using two integrated electrodes and has the capability ofdetecting a number of arrhythmias. Like the predicate device,BIOMONITOR III sends recorded SECG and statistics to the HomeMonitoring Service Center.
Dimensions (mm)	53.4 x 15 x 6 (can)	47.5 x 8.3 x 4.3 (can)
Length x Width x Height	88.4 length w/ lead	77.5 x 8.6 x 4.6 w/ lead
Volume	5.0 cc	1.9 cc
Weight	10.1 g	4.0 g
AT/AF	40 s/episode30 s prior auto activation10 s post auto activation
MR Conditional	Yes

Table 1. Comparison of BIOMONITOR III and Predicate, BioMonitor 2

7. Non-Clinical Performance Data

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

Pre-clinical Study: 7.1

A preclinical study was performed in accordance with 21 CFR Part 58. The study was designed to assess whether the BIOTRONIK BIOMONITOR III ICM is safe and additionally to provide a comparison to the predicate device, BioMonitor 2.

This study successfully demonstrated no safety issues related to the BIOMONITOR III incision tool, FIT OneStep insertion tool, or the implant itself. In addition, the study demonstrated equivalent QRS detection performance between BIOMONITOR III and the predicate device over the course of the implantation period.

Usability Testing: 7.2

Usability/human factors aspects of BIOMONITOR III have been assessed, designed and validated in conformance to IEC 62366-1, in the context of the FDA's Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering

BIOTRONIK. Inc. 6024 Jean Road Lake Oswego, OR 97035 800-547-0394 Telephone 800-291-0470 www.biotronik.com

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Image /page/6/Picture/1 description: The image shows the logo for BIOTRONIK. The logo consists of the letters "BIO" inside of a circle with a cross through it, followed by the word "BIOTRONIK" in large, bold, blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter font.

to Medical Devices. Based on these tests, the BIOMONITOR III user interfaces were found to be safe and effective for the intended users, uses and use environments.

Validation and Verification Testing: 7.3

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

o Particulate Matter Validation
. Mechanical Verification and Validation
o Electrical Verification and Validation
Biocompatibility
Sterilization Validation

7.4 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 BIOMONITOR III is substantially equivalent to BIOTRONIK's BioMonitor 2. The subject and predicate devices use the same principles of operation, have similar device features. The BIOMONITOR III device keeps the core software features and functionality as the BioMonitor 2, the detection algorithms of BIOMONITOR III being unchanged from the predicate device. Hardware design is similarly adapted from the predicate with the only significant difference being that the BIOMONITOR III implant hardware-platform has been miniaturized with respect to BioMonitor 2. BIOMONITOR III has the same part-rigid part-flexible design and the same overall shape as the predicate device (BioMonitor 2). Usability has been enhanced with minor GUI changes and improvements to the implantation tools. These aspects of equivalence are confirmed by testing provided within the application.

BIOTRONIK. Inc. 6024 Jean Road ake Oswego, OR 97035 800-547-0394 Telephone 800-291-0470 www.biotronik.com

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.