(259 days)
Not Found
No
The description focuses on automated detection of arrhythmias based on ECG analysis, which is a common signal processing task and does not explicitly mention or imply the use of AI/ML algorithms. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".
No
The description states the device is for monitoring and recording arrhythmias, not for treating them.
Yes
Explanation: The device continuously monitors subcutaneous ECG, automatically records the occurrence of arrhythmias (bradvarrhythmia, asystole, or high ventricular rate), and stores ECG recordings from automatically detected or patient-triggered episodes. This collection and analysis of physiological data to identify a medical condition (arrhythmia) is characteristic of a diagnostic device. The "Intended Use / Indications for Use" section also confirms its use for identifying patients at increased risk of or experiencing symptoms suggesting cardiac arrhythmias.
No
The device description explicitly states it is a "small, leadless, implantable device" with "three electrodes on the body of the device," indicating it is a hardware device, not software-only.
Based on the provided information, the BioMonitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside the body (in vitro).
- BioMonitor Function: The BioMonitor is an implantable device that continuously monitors the patient's subcutaneous ECG. It records electrical activity of the heart within the body (in vivo).
- Lack of Sample Analysis: The description does not mention the BioMonitor analyzing any samples taken from the patient. Its function is to detect and record electrical signals directly from the body.
Therefore, the BioMonitor 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 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 .
Product codes (comma separated list FDA assigned to the subject device)
MXD
Device Description
The BioMonitor is a small, leadless, implantable device that uses three electrodes on the body of the device to continuously monitor the patient's subcutaneous ECG. The BioMonitor is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as bradvarrhythmia. asvstole, or high ventricular rate. The device memory can store up to 13.3 minutes of ECG recordings from automatically detected arrhythmias and up to 22.5 minutes of ECG recordings from patient-triggered episodes. When a patient experiences symptoms, the ECG recordings can be manually triggered by placing a magnet over the BioMonitor.
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
Not Found
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)
- Comparison of attributes and specifications of the subject and predicate devices .
- Subject device risk analysis .
- . Subject device validation testing which includes the following testing:
- Functional ö
- Mechanical 0
- Biocompatibility o
- Electrical Safety / EMC 0
- Packaging 0
- Sterilization and Shelf life o
- . Analysis of clinical data to support QRS detection
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.
0
510(k) Summary for BioMonitor Implantable Cardiac Monitor
| Date Prepared | June 5, 2014 | ||
|---|---|---|---|
| Sponsor | BIOTRONIK, Inc. | ||
| 6024 Jean Road | |||
| Lake Oswego, OR 97035 . | |||
| Establishment Registration 1028232 | |||
| Manufacturer | BIOTRONIK SE & Co. KG | ||
| Woermannkehre 1, | |||
| 12359 Berlin, Germany | |||
| 011-49-30-689-05-1210 | |||
| Establishment Registration 9610139 | |||
| Contact Person | Jon Brumbaugh | ||
| VP, Regulatory Affairs and Compliance | |||
| Phone (888) 345-0374 | |||
| Fax (800) 913-6993 | |||
| jon.brumbaugh@biotronik.com | |||
| Device Information | Trade Name | BioMonitor | |
| Common Name | Implantable Cardiac Monitor | ||
| Classification Name | Arrhythmia detector and alarm (including | ||
| ST-segment measurement and alarm) | |||
| Classification | Class II (21 CFR 870.1025) |
General Description:
The BioMonitor is a small, leadless, implantable device that uses three electrodes on the body of the device to continuously monitor the patient's subcutaneous ECG. The BioMonitor is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as bradvarrhythmia. asvstole, or high ventricular rate. The device memory can store up to 13.3 minutes of ECG recordings from automatically detected arrhythmias and up to 22.5 minutes of ECG recordings from patient-triggered episodes. When a patient experiences symptoms, the ECG recordings can be manually triggered by placing a magnet over the BioMonitor.
MXD
Predicate Devices:
-
. Medtronic Reveal XT Model 9529 (K071641, cleared November 21, 2007)
Product Code -
St. Jude Medical Confirm DM 2100 (K081365, cleared August 15, 2008) .
Indication for Use:
The BioMonitor 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 .
1
Technological Characteristics and Substantial Equivalence:
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 .
| Technical Data | BioMonitor | Reveal XT | Confirm DM 2100 |
|---|---|---|---|
| FDA Clearance | Subject | K071641 | K081365 |
| Dimensions (mm) | |||
| Length x Width x Height | 53.3 x 42.7 x 7.1 | 19 x 62 x 8 | 18.5 x 56.3 x 8 |
| Volume | 12.5 cc | 9 cc | 6.5 cc |
| Weight | 26 g | 15 g | 12 g |
| Longevity | 48 months | 36 months | 36 months |
| Subcutaneous ECG Recording | Yes | Yes | Yes |
| Pre and Post Event Storage | Yes | Yes | Yes |
| SEGM Storage | 35.8 min | ||
| 22.5 min for patient triggered | |||
| events | |||
| 13.3 min for auto-activated | |||
| events | |||
| Longest/oldest/newest | 49.5 min | ||
| 22.5 min for patient | |||
| triggered events | |||
| 27 min for auto-activated | |||
| events | |||
| 3 most recent episodes | 48 min | ||
| 3 most recent | |||
| episodes | |||
| Patient Activation | 7.5 min per event | ||
| 7 min prior to activation | |||
| 0.5 min following activation | 7.5 min per event | ||
| 6.5 min prior to activation | |||
| 1 min for auto-activated | |||
| events | 1- 4 min prior to | ||
| activation | |||
| 10-60s post | |||
| activation | |||
| Asystole | |||
| Brady/rate drop | |||
| VT-FVT | 40 s/episode | ||
| 30 s prior auto activation | |||
| 10 s post auto activation | 1 min/episode | ||
| 30 s prior auto activation | |||
| Last 30 s of episode | 10 - 60 s prior | ||
| activation | |||
| 10- 60s post | |||
| activation | |||
| AT/AF | N/A | 1 min/episode | |
| 30 s prior auto activation | |||
| Last 30 s of episode | 10 - 60 s prior | ||
| activation | |||
| 10- 60s post | |||
| activation | |||
| Vector Mapping Required | No | Yes | Yes |
| Sampling Rate | 128 Hz | 256 Hz | 128 Hz |
| Auto Activation Triggers | Yes | Yes | Yes |
| Manual (Patient) Activation | |||
| Trigger | Yes | Yes | Yes |
| High Rate Trigger | Yes | Yes | Yes |
| Programmable High Rate Count | Yes | Yes | Yes |
| Low Rate Trigger | Yes | Yes | Yes |
Table 1: BioMonitor Compared to Predicate Devices
2
| Technical Data | BioMonitor | Reveal XT | Confirm DM 2100 |
|---|---|---|---|
| FDA Clearance | Subject | K071641 | K081365 |
| Asystole Trigger | Yes | Yes | Yes |
| Remote Monitoring | Home Monitoring daily | ||
| transmissions | CareLink | Transtelephonic | |
| Monitoring (TTM) | |||
| QRS Detection | Combination signal from 3 | ||
| vectors | One vector detection | One vector detection |
Summary of Testing:
The substantial equivalence claim between the subject and the predicate device is supported by the information included in this premarket notification. This includes the following:
- Comparison of attributes and specifications of the subject and predicate devices .
- Subject device risk analysis .
- . Subject device validation testing which includes the following testing:
- Functional ö
- Mechanical 0
- Biocompatibility o
- Electrical Safety / EMC 0
- Packaging 0
- Sterilization and Shelf life o
- . Analysis of clinical data to support QRS detection
Conclusion:
.
BIOTRONIK considers the BioMonitor implantable cardiac monitor to be substantially equivalent to legally marketed predicate devices through the data and information presented. No safety or effectiveness issues were identified.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 Now Hampshire Avenue Document Control Center WO66-GHO9 Silver Spring, MD 20993-0002
Image /page/3/Picture/3 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
June 6, 2014
Biotronik, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035 US
Re: K132960 Trade/Device Name: BioMonitor ICM 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: May 30, 2014 Received: June 2, 2014
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. 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
4
Page 2 - Jon Brumbaugh
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
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for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K132960
Device Name: BioMonitor Indications for Use:
The BioMonitor 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 .
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Date
2014.06.06
09:32:04 -04'00'
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