· 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), bradvarrhythmia, 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

This FDA filing (K221856) addresses changes to the BIOMONITOR III and BIOMONITOR IIIm, rather than a new device. Therefore, a full clinical study to prove the device meets acceptance criteria as would be required for a completely novel device is not presented. The submission focuses on demonstrating substantial equivalence to the predicate device (BIOMONITOR III and BIOMONITOR IIIm, K201865) following minor hardware changes.

The document explicitly states: "No clinical performance data was submitted or relied upon in support of the substantial equivalence determination." and "The BIOMONITOR III and BIOMONITOR IIIm have undergone thorough validation and verification testing to ensure final device functionality." and "Verification Testing for BIOMONITOR III and BIOMONITOR IIIm hardware changes".

Based on this information, we cannot provide the requested details about acceptance criteria derived from a substantial new clinical study, as such a study was not performed or deemed necessary for this specific submission. The focus was on demonstrating that the minor hardware changes did not negatively impact the established performance and safety characteristics of the already cleared predicate device.

Therefore, the questions regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment (items 1-9 in your request) cannot be answered from the provided document, as these typically relate to a de novo device approval or a submission requiring new clinical evidence.

The document primarily states that the updated device maintains the same principle of operation, physical device characteristics, software features, and functionality as the predicate, with minor component changes for manufacturing optimization. The validation and verification testing mentioned (Section 7.1) would likely be engineering-focused and aimed at confirming that the hardware changes did not introduce new risks or alter the device's electrical or mechanical performance, ensuring it still meets the specifications of the predicate device.

In summary, as per the provided text, a comparative effectiveness study or a new standalone clinical performance study was NOT conducted to prove the device met acceptance criteria, because the submission was a "Special 510(k)" for hardware changes to an already cleared device, not a new device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 27, 2022

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

Re: K221856

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: June 24, 2022 Received: June 27, 2022

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

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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 (QS) 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 Hetal Odobasic 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) K221856

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.

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/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, dark blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter font.

510(k) Summary

BIOMONITOR III and BIOMONITOR IIIm, Implantable Cardiac Monitors

Special 510(k) Premarket Notification

Submission Information 1.
July 26, 2022 Date prepared
Contact Jon Brumbaugh VP, Requlatory Affairs and New Product Development BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 Phone (888) 345-0374 jon.brumbaugh@biotronik.com
BIOTRONIK SE & Co. KG Manufacturer Woermannkehre 1, 12359 Berlin, Germany Registration number 9610139

2. Subject Devices

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 and BIOMONITOR IIIm, K201865, cleared December 08, 2020

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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 four quadrants. To the right of the circle is the word "BIOTRONIK" in large, bold, dark blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in smaller, light gray letters.

Device Descriptions 4.

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.

6. Technological Characteristics

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

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

Technical Data	Predicate BIOMONITORIII, BIOMONITOR IIIm	UpdatedBIOMONITOR III andBIOMONITOR IIIm
FDA Clearance	K201865, 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 intendedfor pediatric 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)Length x Width x Height	47.5 x 8.3 x 4.3 (can)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

Several device hardware changes were implemented with this Special 510(k). These changes are being made to optimize manufacturing and prepare for further automation of the manufacturing process. The effect on determination of substantial equivalence was minimal as there was no associated change to intended use, indications for use, or fundamental technology and no additional questions regarding safety or effectiveness.

7. Non-Clinical Performance Data

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

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Image /page/6/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the letters "BIO" inside of a circle with a plus sign in the middle. To the right of the circle is the word "BIOTRONIK" in large, bold, dark blue letters. Underneath the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter font.

7.1 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:

• Verification Testing for BIOMONITOR III and BIOMONITOR IIIm hardware changes

8. Clinical Performance Data

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

9. Conclusion

BIOTRONIK concludes that the BIOMONITOR III and BIOMONITOR IIIm with hardware changes are substantially equivalent to BIOTRONIK's predicate BIOMONITOR III and BIOMONITOR IIIm. The subject devices and predicate devices have the same principle of operation and physical device characteristics as well as software features and functionality and there are no new issues of safety or effectiveness. The hardware design is adapted from the predicate with minor component changes. 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.