(113 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data collection, transmission, and storage, without mentioning any analytical or interpretive functions that would typically involve AI/ML.
No.
The device is used to detect and monitor cardiac arrhythmias, recording physiological data for review by healthcare professionals, but it does not directly treat or provide therapy to the patient.
Yes
The device detects and monitors cardiac arrhythmias, records and stores physiological data for analysis by healthcare professionals, which are all functions of a diagnostic device used to identify medical conditions.
No
The device description explicitly states the system consists of "components that collect data, send the data to a remote Preventice computer server, store the data... and present the data". The non-clinical testing section also includes "EMC and electrical safety testing", "ECG performance testing", "Activity level measurement validation", and "Biocompatibility testing", all of which are indicative of hardware components being part of the system, not just software.
Based on the provided information, the BodyGuardian System 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 a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- BodyGuardian System Function: The BodyGuardian System directly monitors physiological data (ECG, heart rate, respiration rate, activity) from the patient's body in vivo (within the living organism). It does not analyze specimens in vitro (outside the body).
- Intended Use: The intended use is to detect and monitor cardiac arrhythmias in ambulatory patients by collecting physiological data directly from the patient.
Therefore, the BodyGuardian System falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The BodyGuardian System detects and monitors non-lethal cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. The BodyGuardian System continuously records, stores and periodically transmits the following physiological data to a remote computer server for up to 30 days at a time:
• ECG
• Heart rate (including HR variability and HR reliability)
• Respiration rate
• Activity
Product codes (comma separated list FDA assigned to the subject device)
MHX, DSI
Device Description
The BodyGuardian System is an ambulatory cardiac monitoring system prescribed by healthcare providers. It monitors and records a patient's electrocardiographic (ECG) data, heart rate, respiration rate and activity level. The complete system consists of components that collect data, send the data to a remote Preventice computer server, store the data in secure databases, and present the data for review by healthcare professionals.
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
Physician or other qualified healthcare professional. Ambulatory patients.
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)
Non-Clinical Testing:
• EMC and electrical safety testing
• ECG performance testing
• Activity level measurement validation
• Respiration rate measurement validation
• Software verification and validation
• Biocompatibility testing
Clinical Testing: Not applicable.
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.
AVIVO Mobile Patient Management System (K083287)
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
Pg lofz
AUG 1 0 2012
8 510(k) Summary
| Submitter: | Preventice, Inc.
2765 Commerce Drive NW
Suite 220
Rochester, MN 55901 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Drew Palin, M.D.
Medical Innovation Officer
dpalin@preventice.com
Mobile: 414-688-6858
Office : 507-322-3712
FAX: 507-281-3630
Preventice
2765 Commerce Drive NW
Suite 220
Rochester. MN 55901 |
| Date Prepared: | April 18, 2012 |
| Trade Names: | BodyGuardian System [Preventice BodyGuardian Device
(BodyGuardian Control Unit and BodyGuardian SnapStrip), Preventice
BodyGuardian Connect, BodyGuardian Application, Preventice
PatientCare, PatientCare Portal for the Web, and PatientCare for iPad |
| Classification: | 21 CFR 870.1025
• Patient Physiological Monitor (with arrhythmia detection)
• Arrhythmia Detector and Alarm |
| Product Codes: | MHX, DSI |
| Predicate Device: | AVIVO Mobile Patient Management System (K083287) |
| Device Description: | The BodyGuardian System is an ambulatory cardiac monitoring system
prescribed by healthcare providers. It monitors and records a patient's
electrocardiographic (ECG) data, heart rate, respiration rate and activity
level. The complete system consists of components that collect data,
send the data to a remote Preventice computer server, store the data in
secure databases, and present the data for review by healthcare
professionals. |
1
pg 20f2
.
510(k) Summary (Continued)
| Intended Use: | The BodyGuardian System detects and monitors non-lethal cardiac
arrhythmias in ambulatory patients, when prescribed by a physician or other
qualified healthcare professional. The BodyGuardian System continuously
records, stores and periodically transmits the following physiological data to
a remote computer server for up to 30 days at a time:
• ECG
• Heart rate (including HR variability and HR reliability)
• Respiration rate
• Activity |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
Technological
Characteristics: | Both the predicate system and the BodyGuardian System are small,
ambulatory cardiac monitors that measure ECG, heart rate, respiration rate
and activity levels. Both transmit their data to an external device which, in
turn, broadcasts the data to a remote computer server that allows healthcare
professionals to access and review the data. There are no fundamental
differences between their technological characteristics. |
| Non-Clinical
Testing: | The following bench testing was conducted on the BodyGuardian System:
• EMC and electrical safety testing
• ECG performance testing
• Activity level measurement validation
• Respiration rate measurement validation
• Software verification and validation
• Biocompatibility testing |
| Clinical Testing | Not applicable. |
| Conclusion: | We conclude that the results of testing show the BodyGuardian System to be
substantially equivalent to the predicate device. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 10 2012
Preventice, Inc c/o Drew Palin, M.D. Medical Innovation Officer 2765 Commerce Drive NW, Suite 220 Rochester, MN 55901
Re: K121197
Trade Name: Preventice BodyGuardian System Regulatory Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: II (two) Product Code: DSI Dated: August 2, 2012 Received: August 3, 2012
Dear Mr. Palin:
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.
3
Page 2 - Mr. Drew Palin
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 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
7 Indications for Use Statement
510(k) Number (if known):
Device Name: BodyGuardian System
Indications for Use:
The BodyGuardian System detects and monitors non-lethal cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. The BodyGuardian System continuously records, stores and periodically transmits the following physiological data to a remote computer server for up to 30 days at a time:
- . ECG
- . Heart rate (including HR variability and HR reliability)
- Respiration rate ●
- Activity .
Over-The-Counter Use Prescription Use X . AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Concurrence of CDRH, Office of Device Evaluation (ODE)
on of Cardiovascular Devices
510(k) Number K121197