(36 days)
P950037/S66, P950037/S69
No
The description focuses on rule-based detection of specific arrhythmias and data transmission, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is indicated to detect cardiac arrhythmias and aid in diagnosis, not to treat or provide therapy for them.
Yes
The device's intended use is to "aid in the diagnosis of cardiac arrhythmias that might otherwise go undetected." It detects and records cardiac arrhythmias like atrial fibrillation and bradycardia, providing data for further analysis.
No
The device description explicitly states that the BioMonitor 2 "senses subcutaneous electrocardiograms (SECG) using two integrated electrodes" and mentions "Procedure of implantation," indicating it is a physical, implantable device with hardware components.
Based on the provided information, the BioMonitor 2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- BioMonitor 2 Function: The BioMonitor 2 senses subcutaneous electrocardiograms (SECG) directly from the patient's body. It is an implantable device that monitors electrical activity of the heart in vivo (within the living body).
- Lack of Specimen Analysis: The device does not analyze samples taken from the body. It directly measures a physiological signal.
Therefore, the BioMonitor 2 falls under the category of an implantable medical device used for physiological monitoring and diagnosis of cardiac arrhythmias, not an IVD.
N/A
Intended Use / Indications for Use
The BioMonitor 2 is indicated to detect the following cardiac arrhythmias:
- · Atrial fibrillation,
- · Bradycardia,
- · Sudden rate drop.
- · High ventricular rate (HVR),
- · Asystole.
The BioMonitor 2 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
Product codes
MXD
Device Description
The BioMonitor 2 senses subcutaneous electrocardiograms (SECG) using two integrated electrodes and has the capability of detecting a number of arrhythmias. The BioMonitor 2 uses BIOTRONIK's Home Monitoring to send recorded SECG and statistics to the Home Monitoring Service Center (P950037/S66, dated November 21, 2008; and P950037/S69, dated March 23, 2009) for further analysis. BioMonitor 2 is intended to aid in the diagnosis of cardiac arrhythmias that might otherwise go undetected.
BioMonitor 2 is designed to detect and trigger automatic recording of certain cardiac arrhythmias; these arrhythmias can be classified as follows:
- atrial fibrillation
- bradycardia ●
- sudden rate drop
- high ventricular rate (HVR)
- asystole. .
Patients can also manually trigger recording of the cardiac information by use of the Remote Assistant. The memory capacity of BioMonitor 2 is such that the device can record at least 66 minutes of subcutaneous electrocardiograms (SECG). The device automatically stores a maximum of 55 separately recorded SECG-episodes of 40 seconds each (60 seconds maximum), and a maximum of 4 patient triggered SECG-episodes of 7.5 minutes. The BioMonitor 2 reports the recorded episodes and related statistical data through the physician's programmer and BIOTRONIK's Home Monitoring®
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)
The following performance data were provided in support of the substantial equivalence determination.
To demonstrate that the modified BioMonitor 2 meets the same performance criteria, the following tests were conducted using the same test methods and acceptance criteria as for the predicate device.
- Mechanical system verification of FIT1 and FIT2
- . Visual inspection and handling of FIT1 and FIT2
- Usability testing: system verification and validation
- Visual inspection of labeling ●
- Compatibility testing of BioMonitor 2 with FIT 2 ●
- . Procedure of implantation: Product Validation
- Bioburden
- Pvrogenicitv
- Sterilization validation ●
- . Biocompatibility
- Packaging validation, including seal integrity, environmental conditioning, sealing process, and label integrity
No clinical testing was deemed necessary or completed in the premarket notification submission for a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
P950037/S66, P950037/S69
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.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 29, 2017
BIOTRONIK, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, Oregon 97035
Re: K171514
Trade/Device Name: BioMonitor 2 Insertable Cardiac Monitor 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 22, 2017 Received: May 24, 2017
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 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
1
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 (QS) 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
M.A. Hillebrand
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171514
Device Name
BioMonitor 2 Insertable Cardiac Monitor
Indications for Use (Describe)
The BioMonitor 2 is indicated to detect the following cardiac arrhythmias:
- · Atrial fibrillation,
- · Bradycardia,
- · Sudden rate drop.
- · High ventricular rate (HVR),
- · Asystole.
The BioMonitor 2 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
| 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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3
1. Submitter
BIOTRONIK 6024 SW Jean Road Lake Oswego, OR 97035 Phone: (888) 345-0374 Fax: 503-451-8519
Contact Person: Jon Brumbaugh
Date Prepared: June 29, 2017
2. Device
| Name of Device | BioMonitor 2 Insertable Cardiac Monitor |
|---|---|
| Common or Usual Name | Insertable Cardiac Monitor |
| Classification Name | Arrhythmia detector and alarm (including ST-segment measurement |
| and alarm) | |
| Classification | Class II (21 CFR 870.1025) |
| Product Code | MXD |
3. Predicate Devices
BIOTRONIK BioMonitor 2 (K152995, cleared April 11, 2016)
4. Device Description
The BioMonitor 2 senses subcutaneous electrocardiograms (SECG) using two integrated electrodes and has the capability of detecting a number of arrhythmias. The BioMonitor 2 uses BIOTRONIK's Home Monitoring to send recorded SECG and statistics to the Home Monitoring Service Center (P950037/S66, dated November 21, 2008; and P950037/S69, dated March 23, 2009) for further analysis. BioMonitor 2 is intended to aid in the diagnosis of cardiac arrhythmias that might otherwise go undetected.
BioMonitor 2 is designed to detect and trigger automatic recording of certain cardiac arrhythmias; these arrhythmias can be classified as follows:
- atrial fibrillation
- bradycardia ●
- sudden rate drop
- high ventricular rate (HVR)
- asystole. .
Patients can also manually trigger recording of the cardiac information by use of the Remote Assistant. The memory capacity of BioMonitor 2 is such that the device can record at least 66 minutes of subcutaneous electrocardiograms (SECG). The device automatically stores a maximum of 55 separately recorded SECG-episodes of 40 seconds each (60 seconds maximum), and a maximum of 4 patient triggered SECG-episodes of 7.5 minutes. The BioMonitor 2 reports the recorded episodes and related statistical data through the physician's programmer and BIOTRONIK's Home Monitoring®
4
5. Indications for Use
The BioMonitor 2 Insertable Cardiac Monitor is indicated to detect the following cardiac arrhythmias:
- Atrial fibrillation, .
- Bradycardia, ●
- Sudden rate drop,
- High ventricular rate (HVR), ●
- . Asystole.
The BioMonitor 2 Insertable Cardiac Monitoris 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. Comparison of Technological Characteristics with the Predicate Device
The technological principles of the subject and predicate device are the same. The differences represent minor modifications to the currently marketed BioMonitor 2 as follows:
- . Dimensional changes to the FIT accessories:
- FIT1 assists to create the device pocket for insertion. Dimensions at the tip and handle of ● this accessory were modified for improved handling.
- . FIT2 supports the device during insertion. Dimensions of this accessory were modified for improved support during insertion.
- Packaging changes to the FIT accessories:
- FIT1 and FIT2 were provided separately in double sterile pouches, and may now be ● provided together in a sterile blister package.
- A visual inspection was added to the receiving inspection of batteries. Subsequent testing . and inspections, including acceptance criteria for device performance, are unchanged.
7. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
To demonstrate that the modified BioMonitor 2 meets the same performance criteria, the following tests were conducted using the same test methods and acceptance criteria as for the predicate device.
- Mechanical system verification of FIT1 and FIT2
- . Visual inspection and handling of FIT1 and FIT2
- Usability testing: system verification and validation
- Visual inspection of labeling ●
- Compatibility testing of BioMonitor 2 with FIT 2 ●
- . Procedure of implantation: Product Validation
- Bioburden
- Pvrogenicitv
- Sterilization validation ●
- . Biocompatibility
- Packaging validation, including seal integrity, environmental conditioning, sealing process, and label integrity
5
No clinical testing was deemed necessary or completed in the premarket notification submission for a determination of substantial equivalence.
8. Conclusions
The subject device results from minor modifications to the predicate device. The performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use.