(155 days)
No
The document describes automatic arrhythmia detection based on sECG analysis but does not mention AI, ML, or any related technologies. The performance studies focus on temperature sensor accuracy and general device functionality, not on the performance of an AI/ML algorithm for arrhythmia detection.
No.
The device is indicated to detect cardiac arrhythmias and is described as an insertable cardiac monitor, indicating a diagnostic rather than therapeutic function.
Yes
The device is indicated to detect various cardiac arrhythmias and record sECGs, automatically identifying abnormalities, which are diagnostic functions.
No
The device description explicitly states that the BIOMONITOR III and BIOMONITOR IIIm are "programmable, subcutaneous insertable cardiac monitors able to record subcutaneous ECGs (sECGs) and other physiological parameters." This indicates a physical, implantable hardware component, not a software-only device. The validation and verification testing also includes hardware-related tests like temperature sensor performance.
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 used outside the body.
- Device Description: The BIOMONITOR III/BIOMONITOR IIIm is described as a "programmable, subcutaneous insertable cardiac monitor." This means it is implanted inside the body.
- Input: The device records "subcutaneous ECGs (sECGs)," which are electrical signals from the heart measured from under the skin. This is an in vivo measurement, not an in vitro test on a sample.
Therefore, the BIOMONITOR III/BIOMONITOR IIIm is an implantable medical device that monitors physiological signals within the body, not an in vitro diagnostic device that tests samples outside the body.
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 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.
Product codes
MXD
Device Description
BIOMONITOR III and BIOMONITOR IIIm are programmable, subcutaneous insertable cardiac monitors able to record subcutaneous ECGs (sECG) 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)
No clinical performance data was submitted or relied upon in support of the substantial equivalence determination.
Non-Clinical Performance Data
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
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
-
- Submission Information
| Date prepared | September 2, 2020 |
|---|---|
| Contact | Jon Brumbaugh |
| VP, Regulatory 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
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.
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 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.
| Table 1. Comparison of the Predicate and Subject Devices | ||
|---|---|---|
| Technical Data | Predicate BIOMONITOR III | |
| and BIOMONITOR IIIm | BIOMONITOR III and | |
| BIOMONITOR IIIm | ||
| FDA Clearance | K200444, 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. | ||
| Temperature Sensor | ||
| Data | Transmission of temperature | |
| sensor data from the subject | ||
| device to the Home | ||
| Monitoring System | Transmission of temperature | |
| sensor data from the subject | ||
| device to the Home Monitoring | ||
| System, implementation of | ||
| associated alerts and display | ||
| of historical trends and | ||
| temperature 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/episode | |
| 30 s prior auto activation | ||
| 10 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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