(95 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any AI/ML-specific features or performance metrics.
No
The device is described as a monitor that records cardiac events; it does not treat or directly intervene to alleviate symptoms or disease.
Yes
The device is indicated to "detect the following cardiac arrhythmias" and "automatically record the occurrence of arrhythmias in a patient." These functions classify it as a diagnostic device as it identifies and records medical conditions.
No
The device description explicitly states it is a "programmable, subcutaneous insertable cardiac monitor," indicating it is a physical, implantable hardware device.
Based on the provided information, the BIOMONITOR IV is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- BIOMONITOR IV Function: The BIOMONITOR IV is an insertable cardiac monitor that records subcutaneous ECGs (sECGs) and other physiological parameters directly from within the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to detect cardiac arrhythmias by monitoring the electrical activity of the heart in vivo.
Therefore, the BIOMONITOR IV falls under the category of an implantable medical device used for monitoring physiological signals, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
MXD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The device has not been tested for and it is not intended for pediatric use.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data are provided in support of the substantial equivalence determination:
Validation and Verification Testing: The BIOMONITOR IV has undergone 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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,
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 (888) 345-0374 jon.brumbaugh@biotronik.com
- 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,
BIOMONITOR IIIm | BIOMONITOR IV |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Clearance | K221856, Predicate | Subject of this 510(k) |
| Indicated for use | The BIOMONITOR III/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. | 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. |
| Principle of Operation | The BIOMONITOR IV senses subcutaneous electrocardiograms
(sECG) using two integrated electrodes and has the capability of
detecting a number of arrhythmias. Like the predicate device,
BIOMONITOR IV sends recorded sECG and 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/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.