(122 days)
Not Found
No
The document describes automatic arrhythmia detection based on predefined classifications (atrial fibrillation, bradyarrhythmia, etc.) and comparison to a predicate device with the same clinical functionality. There is no mention of AI, ML, or any learning algorithms.
No
The device is a monitor designed to record and detect cardiac arrhythmias, not to treat them.
Yes
The device is designed to automatically record the occurrence of arrhythmias and classify them (atrial fibrillation, bradyarrhythmia, asystole, sudden rate drop, or high ventricular rate), and can be activated by the patient to record cardiac rhythm during symptomatic episodes. These functions are indicative of a diagnostic purpose.
No
The device description explicitly states that the BIOMONITOR III is a "programmable, subcutaneous insertable monitor able to record subcutaneous ECGs (sECGs) and other physiological parameters," indicating it is a physical, implantable hardware device.
Based on the provided information, the BIOMONITOR III is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- BIOMONITOR III Function: The BIOMONITOR III is an implantable subcutaneous monitor that records subcutaneous ECGs (sECGs) and other physiological parameters directly from within the patient's body. It analyzes these signals to detect and classify cardiac arrhythmias.
- No Specimen Examination: The device does not examine specimens (like blood or tissue) in vitro (outside the body). It directly measures electrical activity and other parameters in vivo (within the body).
Therefore, the BIOMONITOR III falls under the category of an implantable medical device used for monitoring physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BIOMONITOR III 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 is a programmable, subcutaneous insertable monitor able to record subcutaneous ECGs (sECGs) and other physiological parameters.
The BIOMONITOR III is 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 can be activated by the patient to record cardiac rhythm during symptomatic episodes. BIOMONITOR III 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. The BIOMONITOR III is smaller than the predicate BioMonitor 2 while maintaining the same clinical functionality.
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)
Pre-clinical Study: A preclinical study was performed in accordance with 21 CFR Part 58. The study was designed to assess whether the BIOTRONIK BIOMONITOR III ICM is safe and additionally to provide a comparison to the predicate device, BioMonitor 2. This study successfully demonstrated no safety issues related to the BIOMONITOR III incision tool, FIT OneStep insertion tool, or the implant itself. In addition, the study demonstrated equivalent QRS detection performance between BIOMONITOR III and the predicate device over the course of the implantation period.
Usability Testing: Usability/human factors aspects of BIOMONITOR III have been assessed, designed and validated in conformance to IEC 62366-1, in the context of the FDA's Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Medical Devices. Based on these tests, the BIOMONITOR III user interfaces were found to be safe and effective for the intended users, uses and use environments.
Validation and Verification Testing: The BIOMONITOR III, delivery tools, and Remote Assistant III have undergone thorough validation and verification testing to ensure final device functionality. The following categories of tests were performed and passed:
- Particulate Matter Validation
- Mechanical Verification and Validation
- Electrical Verification and Validation
- Biocompatibility
- Sterilization Validation
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)
Reference Device(s)
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.
0
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.
July 5, 2019
Biotronik, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, Oregon 97035
Re: K190548
Trade/Device Name: BIOMONITOR III, Remote Assistant III 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 4, 2019 Received: June 6, 2019
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,
for Nicole Goodsell External Heart Rhythm and Rate Team 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
2
Indications for Use
510(k) Number (if known) K190548
Device Name BIOMONITOR III
Indications for Use (Describe)
The BIOMONITOR III 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 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, dark blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter blue font.
510(k) Summary BIOMONITOR III, Implantable Cardiac Monitor Traditional 510(k) Premarket Notification
1. Submission Information
Date prepared March 1, 2019
- 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 Device
- Trade Name BIOMONITOR III
- Common Name Implantable Cardiac Monitor
Classification Name Recorder, Event, Implantable Cardiac (With Arrhythmia Detection)
- Classification Class II (21 CFR 870.1025)
Product Code MXD
Predicate Device 3.
BIOTRONIK BioMonitor 2, K152995, cleared April 11, 2016
BIOTRONIK. Inc 6024 lean Road ke Oswego, OR 97035 800-547-039. elephone 800-291-0470 www.biotr onik.com
Image /page/3/Picture/16 description: The image shows the text "Page 1 of 4". This text indicates that the image is the first page of a document that has a total of four pages. The text is written in a bold, sans-serif font and is positioned at the top of the image.
4
Image /page/4/Picture/1 description: The image contains the logo for BIOTRONIK. The logo consists of the word "BIOTRONIK" in large, bold, dark blue letters. To the left of the word is a circular emblem with the letters "BIO" inside. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter blue font.
Device Description 4.
BIOMONITOR III is a programmable, subcutaneous insertable monitor able to record subcutaneous ECGs (sECGs) and other physiological parameters.
The BIOMONITOR III is 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 can be activated by the patient to record cardiac rhythm during symptomatic episodes. BIOMONITOR III 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. The BIOMONITOR III is smaller than the predicate BioMonitor 2 while maintaining the same clinical functionality.
5. Indications for Use
The indications for use for the BIOMONITOR III are identical to the predicate device.
The BIOMONITOR III 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 followinq 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
- o Validation testing
BIOTRONIK. Inc. 6024 Jean Road Lake Oswego, OR 97035 800-547-0394 Telephone 800-291-0470 www.biotronik.com
Page 2 of 4
5
Image /page/5/Picture/1 description: The image shows the logo for BIOTRONIK. The logo consists of the BIOTRONIK name in bold, dark blue letters. Below the name is the phrase "excellence for life" in a smaller, lighter blue font. To the left of the name is a circular logo with the letters "BIO" inside.
| Technical Data | BioMonitor 2 | BIOMONITOR III |
|---|---|---|
| FDA Clearance | K152995, Predicate | Subject 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 senses subcutaneous electrocardiograms | |
| (SECG) using two integrated electrodes and has the capability of | ||
| detecting a number of arrhythmias. Like the predicate device, | ||
| BIOMONITOR III sends recorded SECG and statistics to the Home | ||
| Monitoring Service Center. | ||
| Dimensions (mm) | 53.4 x 15 x 6 (can) | 47.5 x 8.3 x 4.3 (can) |
| Length x Width x Height | 88.4 length w/ lead | 77.5 x 8.6 x 4.6 w/ lead |
| Volume | 5.0 cc | 1.9 cc |
| Weight | 10.1 g | 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 III and Predicate, BioMonitor 2
7. Non-Clinical Performance Data
The following performance data are provided in support of the substantial equivalence determination:
Pre-clinical Study: 7.1
A preclinical study was performed in accordance with 21 CFR Part 58. The study was designed to assess whether the BIOTRONIK BIOMONITOR III ICM is safe and additionally to provide a comparison to the predicate device, BioMonitor 2.
This study successfully demonstrated no safety issues related to the BIOMONITOR III incision tool, FIT OneStep insertion tool, or the implant itself. In addition, the study demonstrated equivalent QRS detection performance between BIOMONITOR III and the predicate device over the course of the implantation period.
Usability Testing: 7.2
Usability/human factors aspects of BIOMONITOR III have been assessed, designed and validated in conformance to IEC 62366-1, in the context of the FDA's Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering
BIOTRONIK. Inc. 6024 Jean Road Lake Oswego, OR 97035 800-547-0394 Telephone 800-291-0470 www.biotronik.com
6
Image /page/6/Picture/1 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, blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter font.
to Medical Devices. Based on these tests, the BIOMONITOR III user interfaces were found to be safe and effective for the intended users, uses and use environments.
Validation and Verification Testing: 7.3
The BIOMONITOR III, delivery tools, and Remote Assistant III have undergone thorough validation and verification testing to ensure final device functionality. The following categories of tests were performed and passed:
- o Particulate Matter Validation
- . Mechanical Verification and Validation
- o Electrical Verification and Validation
- Biocompatibility
- Sterilization Validation
7.4 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 BIOMONITOR III is substantially equivalent to BIOTRONIK's BioMonitor 2. The subject and predicate devices use the same principles of operation, have similar device features. The BIOMONITOR III device keeps the core software features and functionality as the BioMonitor 2, the detection algorithms of BIOMONITOR III being unchanged from the predicate device. Hardware design is similarly adapted from the predicate with the only significant difference being that the BIOMONITOR III implant hardware-platform has been miniaturized with respect to BioMonitor 2. BIOMONITOR III has the same part-rigid part-flexible design and the same overall shape as the predicate device (BioMonitor 2). Usability has been enhanced with minor GUI changes and improvements to the implantation tools. These aspects of equivalence are confirmed by testing provided within the application.
BIOTRONIK. Inc. 6024 Jean Road ake Oswego, OR 97035 800-547-0394 Telephone 800-291-0470 www.biotronik.com