(30 days)
No
The document describes a standard insertable cardiac monitor that detects arrhythmias based on predefined criteria. There is no mention of AI, ML, or any learning algorithms used for detection or analysis. The performance studies focus on hardware changes and functionality verification, not on the performance of an AI/ML model.
No.
The device is indicated to detect cardiac arrhythmias, not to treat them. Its function is to record and monitor, not to provide therapy.
Yes
The device is indicated to "detect" and "record the occurrence of arrhythmias," which are processes of identifying a medical condition.
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," indicating a hardware component that is inserted into the patient. The summary also mentions "Verification Testing for BIOMONITOR III and BIOMONITOR IIIm hardware changes."
No, 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.
- Device Function: The BIOMONITOR III/BIOMONITOR IIIm 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 samples taken from the body.
- Intended Use: The intended use is to detect cardiac arrhythmias by monitoring electrical activity within the body, not by analyzing biological samples.
Therefore, based on the provided information, the BIOMONITOR III/BIOMONITOR IIIm falls under the category of an implantable medical device, not an In Vitro Diagnostic.
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
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), bradvarrhythmia, 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)
Not Found
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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July 27, 2022
BIOTRONIK, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and New Product Development 6024 Jean Road Lake Oswego, Oregon 97035
Re: K221856
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: June 24, 2022 Received: June 27, 2022
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
1
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 (QS) 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,
for Hetal Odobasic 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) K221856
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.
Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
BIOMONITOR III and BIOMONITOR IIIm, Implantable Cardiac Monitors
Special 510(k) Premarket Notification
-
Submission Information 1.
July 26, 2022 Date prepared -
Contact Jon Brumbaugh VP, Requlatory Affairs and New Product Development BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 Phone (888) 345-0374 jon.brumbaugh@biotronik.com
-
BIOTRONIK SE & Co. KG Manufacturer 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, K201865, cleared December 08, 2020
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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 four quadrants. To the right of the circle is the word "BIOTRONIK" in large, bold, dark blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in smaller, light gray letters.
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), bradvarrhythmia, 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.
6. Technological Characteristics
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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| Technical Data | Predicate BIOMONITOR
III, BIOMONITOR IIIm | Updated
BIOMONITOR III and
BIOMONITOR IIIm |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| FDA Clearance | K201865, 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)
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 Updated BIOMONITOR III, BIOMONITOR IIIm and Predicate, BIOMONITOR III
Several device hardware changes were implemented with this Special 510(k). These changes are being made to optimize manufacturing and prepare for further automation of the manufacturing process. The effect on determination of substantial equivalence was minimal as there was no associated change to intended use, indications for use, or fundamental technology and no additional questions regarding safety or effectiveness.
7. Non-Clinical Performance Data
The following performance data are provided in support of the substantial equivalence determination :
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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 hardware changes
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 III and BIOMONITOR IIIm with hardware changes are 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. The hardware design is adapted from the predicate with minor component changes. These aspects of equivalence are confirmed by testing provided within the application.