· 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

The BioMonitor 2 senses subcutaneous electrocardiograms (SECG) using two integrated electrodes and has the capability of detecting a number of arrhythmias. The BioMonitor 2 uses BIOTRONIK's Home Monitoring to send recorded SECG and statistics to the Home Monitoring Service Center (P950037/S66, dated November 21, 2008; and P950037/S69, dated March 23, 2009) for further analysis. BioMonitor 2 is intended to aid in the diagnosis of cardiac arrhythmias that might otherwise go undetected.

BioMonitor 2 is designed to detect and trigger automatic recording of certain cardiac arrhythmias; these arrhythmias can be classified as follows:

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

Patients can also manually trigger recording of the cardiac information by use of the Remote Assistant.

The memory capacity of BioMonitor 2 is such that the device can record at least 66 minutes of subcutaneous electrocardiograms (SECG). The device automatically stores a maximum of 55 separately recorded SECG-episodes of 40 seconds each (60 seconds maximum), and a maximum of 4 patient triggered SECG-episodes of 7.5 minutes. The BioMonitor 2 reports the recorded episodes and related statistical data through the physician's programmer and BIOTRONIK's Home Monitoring .

AI/ML Overview

This document is a 510(k) premarket notification for the BioMonitor 2, a device described as an "Arrhythmia Detector and Alarm." The notification details that the device is a modified version of a previously cleared device (BIOTRONIK BioMonitor 2, K152995).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data. Instead, it states: "To demonstrate that the modified BioMonitor 2 meets the same performance criteria, the following tests were conducted using the same test methods and acceptance criteria as for the predicate device." It then lists the types of tests performed.

Test Type	Description/Purpose	Outcome
Compatibility testing	Not specified, but likely refers to ensuring the device components work together and with other systems (e.g., Home Monitoring).	This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use.
Wireless communication user testing	Not specified, but likely related to the functionality and reliability of the device's wireless communication capabilities.	This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use.
Module electrical tests	Testing of individual electrical modules within the device.	This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use.
Device electrical tests	Electrical testing of the complete device.	This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use.
System verification testing	Verification that the entire system, including hardware and software, functions as intended.	This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use.
Software release testing	Testing performed on the device's software prior to release.	This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use.
Product level validation testing	Validation of the overall product's performance against its specifications.	This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use.
Process validation/verification for manufacturing changes	Validation and verification of manufacturing processes, particularly in light of the "minor modifications" and "manufacturing changes" mentioned.	This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use.

Important Note: The document consistently states that "This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use." However, it does not provide the specific numerical acceptance criteria or the raw performance data obtained from these tests. It only lists the types of tests conducted.

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

The document explicitly states: "No clinical testing was deemed necessary or completed in the premarket notification submission for a determination of substantial equivalence."

Therefore, there is no test set in the clinical sense, and thus no sample size or data provenance from clinical studies for this submission. The tests listed are likely engineering and bench-top validation tests rather than human clinical data.

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

Since no clinical testing was performed, there was no "ground truth" for a clinical test set established by experts in this submission.

4. Adjudication Method for the Test Set

As there was no clinical test set for which ground truth was established, there was no adjudication method described.

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 such study was conducted or reported in this submission, as indicated by the statement, "No clinical testing was deemed necessary or completed." The device described is an "Arrhythmia Detector and Alarm," which generally acts as a standalone detection system rather than an AI-assistance tool for human readers in the context of diagnostic image interpretation.

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

The document describes the BioMonitor 2 as sensing subcutaneous electrocardiograms (SECG) and having the "capability of detecting a number of arrhythmias." It also states, "The BioMonitor 2 uses BIOTRONIK's Home Monitoring to send recorded SECG and statistics to the Home Monitoring Service Center for further analysis." and "BioMonitor 2 is designed to detect and trigger automatic recording of certain cardiac arrhythmias."

This strongly implies that the device (or its integrated algorithm) operates in a standalone manner to detect arrhythmias and record data. While the "Home Monitoring Service Center" performs "further analysis," the initial detection and recording of events like atrial fibrillation, bradycardia, sudden rate drop, HVR, and asystole are described as capabilities of the BioMonitor 2 itself. The performance data section refers to "System verification testing" and "Software release testing," which would encompass standalone algorithm performance.

However, specific performance metrics (e.g., sensitivity, specificity, accuracy) for these standalone detections are not provided in this document.

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

The document does not detail the specific ground truth used for verifying the performance of the device's arrhythmia detection capabilities. Given that no clinical testing was performed for this submission, the "ground truth" for the predicate device's initial clearance for arrhythmia detection would have been established through a combination of simulated ECG signals, known cardiac events from existing databases, and potentially clinical studies at the time of the predicate's original submission. However, this submission relies on the "same test methods and acceptance criteria as for the predicate device" for its engineering and functional tests, rather than providing new ground truth establishment for arrhythmia detection.

8. The Sample Size for the Training Set

The document does not mention any training set or machine learning aspects for this submission. This 510(k) is for a "minor modification" to an already cleared device, and the focus is on demonstrating that the modified device meets the performance of the predicate, not on developing or training a new algorithm.

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

As no training set is mentioned, this information is not applicable and not provided.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

March 31, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K170628

Trade/Device Name: BioMonitor 2 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: March 1, 2017 Received: March 2, 2017

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 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

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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 (QS) 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Muda Yellm
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 (if known) K170628

Device Name BioMonitor 2

Indications for Use (Describe)

The BioMonitor 2 is indicated to detect the following cardiac arrhythmias:

· Atrial fibrillation,
· Bradycardia,
· Sudden rate drop.
· High ventricular rate (HVR),
Asystole.

The BioMonitor 2 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

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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1. Submitter

BIOTRONIK 6024 SW Jean Road Lake Oswego, OR 97035 Phone: (888) 345-0374 Fax: 503-451-8519

Contact Person: Jon Brumbaugh

Date Prepared: March 1, 2017

2. Device

Name of Device	BioMonitor 2
Common or UsualName	Insertable Cardiac Monitor
Classification Name	Arrhythmia detector and alarm (including ST-segment measurement andalarm)
Classification	Class II (21 CFR 870.1025)
Product Code	MXD

3. Predicate Devices

BIOTRONIK BioMonitor 2 (K152995, cleared April 11, 2016) o

4. Device Description

BioMonitor 2 is designed to detect and trigger automatic recording of certain cardiac arrhythmias; these arrhythmias can be classified as follows:

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

Patients can also manually trigger recording of the cardiac information by use of the Remote Assistant.

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5. Indications for Use

The BioMonitor 2 is indicated to detect the following cardiac arrhythmias:

Atrial fibrillation. ●
Bradycardia, ●
Sudden rate drop,
High ventricular rate (HVR), ●
Asystole.

The BioMonitor 2 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 o

6. Comparison of Technological Characteristics with the Predicate Device

The technological principles of the subject and predicate device are the differences represent minor modifications to the currently marketed BioMonitor 2 as follows:

. A modified radio frequency integrated circuit
o Manufacturing changes with no effect on performance criteria

7. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

To demonstrate that the modified BioMonitor 2 meets the same performance criteria, the following tests were conducted using the same test methods and acceptance criteria as for the predicate device.

Compatibility testing
. Wireless communication user testing
Module electrical tests ●
Device electrical tests ●
System verification testing
Software release testing
Product level validation testing ●
Process validation/verification for manufacturing changes. ●

No clinical testing was deemed necessary or completed in the premarket notification submission for a determination of substantial equivalence.

8. Conclusions

The subject device results from minor modifications to the predicate device. The performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use.

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.