· 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

This document, K201865, is a 510(k) Premarket Notification for the BIOMONITOR III and BIOMONITOR IIIm, which are implantable cardiac monitors. The core of this submission is about confirming substantial equivalence to an existing predicate device (K200444). The specific change addressed in this 510(k) is the enabling of the temperature sensor for data transmission and its associated alerts and display.

Based on the provided text, the device itself (BIOMONITOR III/IIIm) already had acceptance criteria and studies for its primary function (arrhythmia detection) from when its predicate (K200444) was cleared. This 510(k) focuses specifically on the newly enabled feature – the temperature sensor. Therefore, the acceptance criteria and study detailed below will relate primarily to this new feature, as "no clinical performance data was submitted or relied upon in support of the substantial equivalence determination" for the overall device.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them, specifically for the newly enabled temperature sensor feature:

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

The document does not provide a formal table of acceptance criteria for the temperature sensor feature in terms of numerical thresholds for accuracy, precision, or other performance metrics. However, it does state the reported device performance:

Acceptance Criteria Category (Derived)	Reported Device Performance (for Temperature Sensor)
Accuracy of Temperature Measurement	"measurement accuracy of within 0.1℃ when compared to a clinical reference"
Functionality	"thorough validation and verification testing to ensure final device functionality."
Safety and Effectiveness	"The enabling of the temperature sensor for data transmission introduces no new issues of safety or effectiveness."
Equivalence	"identical physical device characteristics as well as software features and functionality" (for primary device functions), and "hardware design remains unchanged" (for temperature sensor).

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

Test Set Sample Size: "Performance of the temperature sensor was validated in swine". The exact number of swine (sample size) used is not specified in the provided text.
Data Provenance: The study was "Animal Testing" (specifically in swine). The location of this animal testing (country of origin) is not specified in the document. It is implicitly a prospective study, as it describes a validation of the sensor.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states "when compared to a clinical reference" for the temperature sensor validation. It does not specify the number of experts, their qualifications, or how they established the "clinical reference" ground truth.

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

The document does not describe any human adjudication method. The comparison for the temperature sensor was against a "clinical reference," which implies a direct measurement or standard, not subjective expert agreement.

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

No MRMC study was done, nor is it applicable to the specific change being addressed in this 510(k). This submission is for enabling a sensor and transmitting its data, not for an AI that assists human readers in interpreting an image or signal. The device is an "Arrhythmia Detector And Alarm," and its primary function involves automated detection. The new feature is a temperature sensor.

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

Yes, for the temperature sensor, the "Performance of the temperature sensor was validated in swine for detection of fever to a measurement accuracy of within 0.1℃ when compared to a clinical reference." This is a standalone validation of the sensor's accuracy. The device's primary arrhythmia detection functionality is also largely standalone/algorithm-only, as it automatically detects arrhythmias.

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

For the temperature sensor, the ground truth was a "clinical reference" measurement. This indicates comparison against a recognized standard or highly accurate measurement technique in a clinical setting (in this case, in swine).

8. The sample size for the training set

The document does not provide information about a training set. The device's primary function is based on established arrhythmia detection algorithms, and the temperature sensor is a direct physical measurement. There is no mention of machine learning models requiring training data for this specific 510(k) submission.

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

Not applicable, as no training set is mentioned for the temperature sensor feature, nor is the underlying arrhythmia detection algorithm (which would have had its own training/development data) the subject of this specific 510(k) clearance.

Summary

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December 08, 2020

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

Re: K201865

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: October 21, 2020 Received: October 22, 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

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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,

Jennifer Shih Assistant Director 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) K201865

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 111/BIOMONITOR Illm 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)
-------------------------------------------------

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 letters "BIO" inside of a circle on the left, followed by 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 and BIOMONITOR IIIm, Implantable Cardiac Monitors

Traditional 510(k) Premarket Notification

1. Submission Information

Date prepared	September 2, 2020
Contact	Jon BrumbaughVP, Regulatory Affairs andComplianceBIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035Phone (888) 345-0374jon.brumbaugh@biotronik.com

Manufacturer BIOTRONIK SE & Co. KG 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, K200444, cleared April 23, 2020

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Image /page/4/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.

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.

Technological Characteristics 6.

The substantial equivalence claim between the subject and the predicate devices is supported by the information included in the premarket notification. This includes the following information:

Description of the subject and predicate devices including the addition of ● temperature change alerts and display through BIOTRONIK's Home Monitoring System
. 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 tagline "excellence for life" in a smaller, lighter blue font.

K201865

Table 1. Comparison of the Predicate and Subject Devices
Technical Data	Predicate BIOMONITOR IIIand BIOMONITOR IIIm	BIOMONITOR III andBIOMONITOR IIIm
FDA Clearance	K200444, Predicate	Subjects of this 510(k)
Indications	Patients with clinical syndromes or situations at increased riskof cardiac arrhythmiasPatients who experience transient symptoms that may suggesta cardiac arrhythmiaThe device has not been tested for and it is not intended forpediatric use
Principle of Operation	The BIOMONITOR III/BIOMONITOR IIIm senses subcutaneouselectrocardiograms (SECG) using two integrated electrodesand has the capability of detecting a number of arrhythmias.Like the predicate device, BIOMONITOR III/BIOMONITOR IIImsends recorded SECG and statistics to the Home MonitoringService Center.
Temperature SensorData	Transmission of temperaturesensor data from the subjectdevice to the HomeMonitoring System	Transmission of temperaturesensor data from the subjectdevice to the Home MonitoringSystem, implementation ofassociated alerts and displayof historical trends andtemperature changes
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

てったり o Drodic

The newly available feature included in this 510(k) is the ability to measure core body temperature and the effect on determination of substantial equivalence was minimal as there was no associated change to intended use, indications for use, or hardware and no additional questions regarding safety or effectiveness.

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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 cross through it, followed by the word "BIOTRONIK" in large, bold, dark blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter font.

7. Non-Clinical Performance Data

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

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 Temperature Sensor .

7.2 Animal Testing:

Performance of the temperature sensor was validated in swine for detection of fever to a measurement accuracy of within 0.1℃ when compared to a clinical reference

8. Clinical Performance Data

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

9. Conclusion

The subject BIOMONITOR III/BIOMONITOR IIIm devices and predicate BIOMONITOR III/BIOMONITOR IIIm devices are identical. They have the same principle of operation and identical physical device characteristics as well as software features and functionality. The enabling of the temperature sensor for data transmission introduces no new issues of safety or effectiveness. Additionally, the hardware design remains unchanged. These aspects of equivalence are confirmed by testing provided within the application.

Therefore, the BIOMONITOR III/BIOMONITOR IIIm were determined to be substantially equivalent to the primary predicate devices.

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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.