(59 days)
Not Found
No
The summary describes algorithmic changes for ectopy rejection but does not mention AI or ML, nor does it provide details about training or test sets typically associated with such technologies.
No.
The device is a diagnostic tool designed to detect and record cardiac arrhythmias, not to treat them.
Yes
Explanation: The device is indicated to detect cardiac arrhythmias, which is diagnosing a medical condition.
No
The device description explicitly states that the BIOMONITOR III and BIOMONITOR IIIm are "programmable, subcutaneous insertable cardiac monitors" and mentions "subcutaneous ECGs (sECGs)", indicating a physical, implantable hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the body.
- Device Description: The BIOMONITOR III/BIOMONITOR IIIm is an insertable cardiac monitor that records subcutaneous ECGs. This means it is placed inside the body and directly monitors physiological signals.
- Intended Use: The intended use is to detect cardiac arrhythmias by monitoring the heart's electrical activity in vivo.
Therefore, because the device is implanted and monitors physiological signals directly within the body, it falls under the category of an in vivo diagnostic or monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MXD
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.
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)
AF Detect Study: The basic AF detection algorithm in BIOMONITOR IIIm remains unchanged compared to the predicate BIOMONITOR III. In the BIOMONITOR IIIm device, the AF detection algorithm has been extended with an additional parameter to identify and reject specific patterns associated with ectopy rhythms. An AF Detect study was conducted and the results of the study demonstrate the substantial equivalence of BIOMONITOR IIIm and BIOMONITOR III utilizing real-world clinical data while the additional ectopy rejection parameter resulted in further improvement of the performance in terms of reduction of false AF snapshots.
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:
- Software Testing
- Electromagnetic Compatibility Testing
- Mechanical Testing
- Electrical Testing
1.5T and 3.0T MRI Testing: BIOTRONIK conducted validation testing according to the Joint Working Group's International Technical Specification for ISO/TS 10974: 2018.
No clinical performance data was submitted or relied upon in support of the substantial equivalence determination.
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 contains the logo of the U.S. Food & 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.
April 23, 2020
BIOTRONIK, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, Oregon 97035
Re: K200444
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: February 21, 2020 Received: February 24, 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 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
1
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 medical devices and radiation-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
Jennifer Shih 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) K200444
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.
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 word "BIOTRONIK" in large, bold, dark blue letters, with a smaller, light blue circle containing the letters "BIO" to the left. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, light blue font.
510(k) Summary
BIOMONITOR III and BIOMONITOR IIIm, Implantable Cardiac Monitors
Traditional 510(k) Premarket Notification
-
Submission Information 1.
Date prepared February 19, 2020 -
Contact Jon Brumbaugh VP, Requlatory Affairs and Compliance 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
Subject Devices 2.
- 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, K190548, cleared July 5, 2019
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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 quadrants. To the right of the circle is the word "BIOTRONIK" in large, bold, blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller font.
4. Device Descriptions
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.
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 device is supported by the information included in the premarket notification. This includes the following information:
- . Description of the subiect 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 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.
| Technical Data | Predicate BIOMONITOR III | Updated BIOMONITOR III and BIOMONITOR IIIm |
|---|---|---|
| FDA Clearance | K190548, Predicate | Subjects of this 510(k) |
| Indications | 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 III/BIOMONITOR IIIm senses | |
| subcutaneous electrocardiograms (SECG) using two | ||
| integrated electrodes and has the capability of detecting a | ||
| number of arrhythmias. Like the predicate device, | ||
| BIOMONITOR III/BIOMONITOR IIIm sends recorded SECG | ||
| and statistics to the Home Monitoring Service Center. | ||
| Dimensions (mm) | 47.5 x 8.3 x 4.3 (can) | |
| Length x Width x Height | 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 Updated BIOMONITOR III, BIOMONITOR IIIm and Predicate, BIOMONITOR III
7. Non-Clinical Performance Data
The following performance data are provided in support of the substantial equivalence determination:
7.1 AF Detect Study:
The basic AF detection algorithm in BIOMONITOR IIIm remains unchanged compared to the predicate BIOMONITOR III. In the BIOMONITOR IIIm device, the AF detection algorithm has been extended with an additional parameter to identify and reject specific patterns associated with ectopy rhythms. An AF Detect study was conducted and the results of the study demonstrate the substantial equivalence of BIOMONITOR IIIm and BIOMONITOR III utilizing real-world clinical data while the additional ectopy rejection parameter resulted in further improvement of the performance in terms of reduction of false AF snapshots.
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Image /page/6/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the letters "BIO" stacked on top of each other 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, and below that is the phrase "excellence for life" in smaller, light blue letters.
7.2 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:
- Software Testing
- Electromagnetic Compatibility Testing ●
- . Mechanical Testing
- . Electrical Testing
7.3 1.5T and 3.0T MRI Testing:
BIOTRONIK conducted validation testing according to the Joint Working Group's International Technical Specification for ISO/TS 10974: 2018.
Clinical Performance Data 8.
No clinical performance data was submitted or relied upon in support of the substantial equivalence determination.
9. Conclusion
BIOTRONIK concludes that the Updated BIOMONITOR III and BIOMONITOR IIIm are substantially equivalent to BIOTRONIK's predicate BIOMONITOR III. The subject BIOMONITOR III and BIOMONITOR IIIm devices and the predicate BIOMONITOR III device use the same principles of operation, have similar device features, and there are no new issues of safety or effectiveness. The BIOMONITOR III and BIOMONITOR IIIm devices keep the core software features and functionality as the predicate BIOMONITOR III with only a minor update to the AF Detection Algorithm for BIOMONITOR IIIm. The hardware design is similarly adapted from the predicate with the only significant difference being that the updated BIOMONITOR III and BIOMONITOR IIIm have an updated electronic module. These aspects of equivalence are confirmed by testing provided within the application.