(113 days)
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
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.
The provided documentation presents a 510(k) summary for the BodyGuardian System. While it lists non-clinical testing performed, it explicitly states "Clinical Testing: Not applicable." Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria based on clinical performance.
However, based on the provided text, here's what can be extracted regarding the device and its testing:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed reported device performance in terms of clinical accuracy (e.g., sensitivity, specificity for arrhythmia detection) as no clinical testing was deemed applicable.
However, the "Non-Clinical Testing" section implies performance was evaluated against internal benchmarks or standards during the following:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from non-clinical testing) |
|---|---|
| Compliance with EMC and electrical safety standards | Passed EMC and electrical safety testing |
| Accurate ECG performance | ECG performance testing conducted |
| Accurate activity level measurement | Activity level measurement validated |
| Accurate respiration rate measurement | Respiration rate measurement validated |
| Software functions correctly and reliably | Software verification and validation completed |
| Biocompatibility of materials | Biocompatibility testing conducted |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical test set was used for performance evaluation according to the document. The non-clinical testing would have used internal test samples, but details on their size or provenance are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical test set with expert-established ground truth was used for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The document states "Clinical Testing: Not applicable," which means no MRMC study, human-in-the-loop performance, or AI assistance was evaluated in a clinical context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document implies standalone testing of components like "ECG performance," "Activity level measurement," and "Respiration rate measurement" during non-clinical testing. However, this is not a comprehensive "standalone" evaluation of the arrhythmia detection algorithm in a clinical context, as clinical testing was not applicable. Details of these individual test methodologies and results are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the ground truth would have been established through controlled electrical signals, mechanical simulations, reference devices, or chemical analysis, depending on the specific test (e.g., calibrated ECG simulators for ECG performance, known activity levels for activity validation). However, the document does not specify these details.
8. The sample size for the training set
Not applicable. The document does not describe the development or training of an AI/ML algorithm that would require a training set in the context of clinical performance. The "software verification and validation" would have involved internal testing against coding standards and functional requirements, but not a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable, as no training set (for AI/ML algorithm) is mentioned or implied.
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Pg lofz
AUG 1 0 2012
8 510(k) Summary
| Submitter: | Preventice, Inc.2765 Commerce Drive NWSuite 220Rochester, MN 55901 |
|---|---|
| Contact Person: | Drew Palin, M.D.Medical Innovation Officerdpalin@preventice.comMobile: 414-688-6858Office : 507-322-3712FAX: 507-281-3630Preventice2765 Commerce Drive NWSuite 220Rochester. MN 55901 |
| Date Prepared: | April 18, 2012 |
| Trade Names: | BodyGuardian System [Preventice BodyGuardian Device(BodyGuardian Control Unit and BodyGuardian SnapStrip), PreventiceBodyGuardian Connect, BodyGuardian Application, PreventicePatientCare, 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 systemprescribed by healthcare providers. It monitors and records a patient'selectrocardiographic (ECG) data, heart rate, respiration rate and activitylevel. The complete system consists of components that collect data,send the data to a remote Preventice computer server, store the data insecure databases, and present the data for review by healthcareprofessionals. |
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pg 20f2
.
510(k) Summary (Continued)
| Intended Use: | The BodyGuardian System detects and monitors non-lethal cardiacarrhythmias in ambulatory patients, when prescribed by a physician or otherqualified healthcare professional. The BodyGuardian System continuouslyrecords, stores and periodically transmits the following physiological data toa remote computer server for up to 30 days at a time:• ECG• Heart rate (including HR variability and HR reliability)• Respiration rate• Activity |
|---|---|
| Comparison ofTechnologicalCharacteristics: | Both the predicate system and the BodyGuardian System are small,ambulatory cardiac monitors that measure ECG, heart rate, respiration rateand activity levels. Both transmit their data to an external device which, inturn, broadcasts the data to a remote computer server that allows healthcareprofessionals to access and review the data. There are no fundamentaldifferences between their technological characteristics. |
| Non-ClinicalTesting: | 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 besubstantially equivalent to the predicate device. |
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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.
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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
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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
§ 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.