BIOMONITOR IV

K230375 · Biotronik, Inc. · MXD · May 19, 2023 · Cardiovascular

Device Facts

• Record ID: K230375
• Device Name: BIOMONITOR IV
• Applicant: Biotronik, Inc.
• Product Code: MXD · Cardiovascular
• Decision Date: May 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The BIOMONITOR IV is indicated to detect the following cardiac arrhythmias: - Atrial fibrillation - Bradycardia - Sudden rate drop - Tachycardia - Pause The BIOMONITOR IV 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.

Device Story

BIOMONITOR IV is a programmable, subcutaneous insertable cardiac monitor (ICM). It senses subcutaneous ECGs (sECG) via two integrated electrodes; automatically records cardiac arrhythmias (AF, bradycardia, pause, sudden rate drop, tachycardia); and supports patient-activated recording via Remote Assistant III during symptomatic episodes. Data is transmitted wirelessly to the BIOTRONIK Home Monitoring® system for physician review. The device aids in diagnosing cardiac arrhythmias in patients with transient symptoms or increased risk. It features updated electronic chipsets, improved pause sensitivity, and provides PVC/PAC counts in daily burden trends. It is intended for use in clinical settings or home environments under physician supervision.

Clinical Evidence

No clinical performance data was submitted or relied upon. Substantial equivalence is supported by bench-level mechanical and electrical verification testing.

Technological Characteristics

Subcutaneous insertable cardiac monitor; two integrated electrodes for sECG sensing. Features updated electronic chipset. Wireless connectivity to Home Monitoring system. MR Conditional. Software includes arrhythmia detection algorithms for AF, bradycardia, pause, sudden rate drop, and tachycardia.

Indications for Use

Indicated for patients with clinical syndromes/situations at increased risk of cardiac arrhythmias or experiencing transient symptoms suggesting arrhythmia. Detects atrial fibrillation, bradycardia, sudden rate drop, tachycardia, and pause. Not for pediatric use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BIOMONITOR III and BIOMONITOR IIIm (K221856)

Submission Summary (Full Text)

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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.

May 19, 2023

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

Re: K230375

Trade/Device Name: BIOMONITOR IV 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: April 20, 2023 Received: April 20, 2023

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed
Sara M. by Sara M. Royce
-S
Royce -S Date: 2023.05.19
20:38:13 -04'00'

for

Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K230375

Device Name BIOMONITOR IV

Indications for Use (Describe)

The BIOMONITOR IV is indicated to detect the following cardiac arrhythmias:

- · Atrial fibrillation
- · Bradycardia
- Sudden rate drop
- · Tachycardia
- · Pause

The BIOMONITOR IV 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, a medical technology company. The logo consists of the BIOTRONIK name in bold, dark blue letters, with the tagline "excellence for life" in a smaller, lighter font below. To the left of the name is a circular symbol with the letters "BIO" inside.

# 510(k) Summary: BIOMONITOR IV, Implantable Cardiac Monitors Traditional 510(k) Premarket Notification

#### 1. Submission Information

Date prepared April 20, 2023

- Contact Jon Brumbaugh VP, Regulatory Affairs and New Product Development BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 Phone [phone] [e-mail]
- Manufacturer BIOTRONIK SE & Co. KG Woermannkehre 1, 12359 Berlin, Germany Registration number 9610139

#### 2. Subject Devices

- Trade Name BIOMONITOR IV
- Common Name Implantable Cardiac Monitor

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

- Classification Class II (21 CFR 870.1025)
Product Code MXD

#### Predicate Device 3.

BIOTRONIK BIOMONITOR III and BIOMONITOR IIIm, K221856, cleared July 27, 2022

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Image /page/4/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 font.

#### 4. Device Descriptions

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

The BIOMONITOR IV is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial fibrillation (AF), bradyarrhythmia, pause, sudden rate drop, or tachycardia. In addition, the BIOMONITOR IV can be activated by the patient using the Remote Assistant III to record cardiac rhythm during symptomatic episodes. BIOMONITOR IV 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.

#### 5. Indications for Use

While the indications for use for the BIOMONITOR IV are identical to the predicate device, the nomenclature has been slightly modified to align with the current ICM market expectations.

The BIOMONITOR IV is indicated to detect the following cardiac arrhythmias:

- . atrial fibrillation
- bradycardia
- sudden rate drop ●
- tachycardia ●
- pause

The BIOMONITOR IV is indicated for:

- Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias .
- Patients who experience transient symptoms that may suqqest 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 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 the word "BIOTRONIK" in large, bold, dark blue letters, with the tagline "excellence for life" in smaller, lighter blue letters underneath. To the left of the word "BIOTRONIK" is a circular symbol divided into four quadrants, with the letters "B," "I," "O," and "T" in each quadrant.

| Technical Data | Predicate BIOMONITOR III,<br>BIOMONITOR IIIm | BIOMONITOR IV |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Clearance | K221856, Predicate | Subject of this 510(k) |
| Indicated for use | The BIOMONITOR III/IIIm is<br>indicated to detect the following<br>cardiac arrhythmias:<br>• Atrial fibrillation<br>• Bradycardia<br>• Sudden Rate Drop<br>• High Ventricular Rate<br>(HVR)<br>• Asystole<br>The BIOMONITOR<br>III/BIOMONITOR IIIm is<br>indicated for use in:<br>• Patients with clinical<br>syndromes or situations at<br>increased risk of cardiac<br>arrhythmias<br>• Patients who experience<br>transient symptoms that<br>may suggest a cardiac<br>arrhythmia<br>The device has not been tested<br>for and it is not intended for<br>pediatric use. | The BIOMONITOR IV is<br>indicated to detect the following<br>cardiac arrhythmias:<br>• Atrial fibrillation<br>• Bradycardia<br>• Sudden rate drop<br>• Tachycardia<br>• Pause<br>The BIOMONITOR IV is<br>indicated for use in:<br>• Patients with clinical<br>syndromes or situations at<br>increased risk of cardiac<br>arrhythmias<br>• Patients who experience<br>transient symptoms that may<br>suggest a cardiac arrhythmia<br>The device has not been tested<br>for and it is not intended for<br>pediatric use. |
| Principle of Operation | The BIOMONITOR IV senses subcutaneous electrocardiograms<br>(sECG) using two integrated electrodes and has the capability of<br>detecting a number of arrhythmias. Like the predicate device,<br>BIOMONITOR IV sends recorded sECG and statistics to the Home<br>Monitoring Service Center. | |
| Dimensions (mm)<br>Length x Width x Height | 47.5 x 8.3 x 4.3 (can)<br>77.5 x 8.6 x 4.6 w/ lead | |
| Volume | 1.9 cc | |
| Weight | 4.0 g | |
| AT/AF | 40 s/episode | |
| | 30 s prior auto activation | |
| | 10 s post auto activation | |
| MR Conditional | Yes | |

## Table 1. Comparison of BIOMONITOR IV and Predicate, BIOMONITOR III and BIOMONITOR lllm

The following technological differences exist between the subject and predicate devices:

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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 to the left of the word "BIOTRONIK" in large, bold, blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter blue font.

- Minor wording updates to harmonize the 'Indication for Use' verbiage with the US ICM . market
- . An update of the electronic chipset
- On-demand transmission of patient triggered episode (up to 2) recordings of at least . 7.5 min per day
- . Improved pause sensitivity
- . PVC and PAC counts included with daily burden trends

#### Non-Clinical Performance Data 7.

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

#### Validation and Verification Testing: 7.1

The BIOMONITOR IV has underqone thorough validation and verification testing to ensure final device functionality. The following categories of tests were performed and passed:

• Mechanical and Electrical Verification Testing for BIOMONITOR IV

#### 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 IV is 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.