HRV Tools is indicated when it is desired to analyze the basic rhythms of the R-R intervals in electrocardiograms. It only provides numerical analyses of the input electrocardiogram - the program does not make diagnoses

Device Description

HRV Tools is a software product (supplied on a CD) that analyzes the basic rhythms of the RR intervals in electrocardiograms, both in the time domain (analysis of time intervals) and in the frequency domain (spectral analysis).

AI/ML Overview

Here's an analysis of the provided text regarding the HRV Tools device, focusing on acceptance criteria and study data:

Unfortunately, the provided 510(k) summary for HRV Tools (K040313) is very brief and lacks detailed information regarding specific acceptance criteria, study sizes, expert qualifications, or detailed performance metrics. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with explicit acceptance criteria.

Based on the information available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence to predicate devices in safety and efficacy for analyzing RR intervals in ECGs (time and frequency domains).	"HRV Tools is equivalent in safety and efficacy to the legally marketed predicate devices." (Conclusion on page 2)
Accurate operation of algorithms for RR interval analysis.	"Tests to check the operation of the algorithms 3. Accuracy tests" (Non-clinical tests on page 2)
Ability to analyze basic rhythms of RR intervals in electrocardiograms (time and frequency domains).	"HRV Tools is a software product ... that analyzes the basic rhythms of the RR intervals in electrocardiograms, both in the time domain (analysis of time intervals) and in the frequency domain (spectral analysis)." (Description and Intended Use on page 2)
Does not make diagnoses.	"It only provides numerical analyses of the input electrocardiogram -- the program does not make diagnoses." (Intended Use on page 2 and Indications for Use Form on page 4)

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document mentions "Tests with input data from the MIT database" as a non-clinical test. The MIT-BIH Arrhythmia Database is a public repository, but the specific number of records or patients used from it for testing is not stated.
Data Provenance: The MIT-BIH Arrhythmia Database is likely the source for a portion of the test data. The country of origin for the database is primarily the US (collected at Boston's Beth Israel Hospital and Women's and Infants' Hospital). The study is retrospective in the sense that the database contains previously recorded data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. For the MIT-BIH Arrhythmia Database, annotations (which serve as ground truth) are typically performed by cardiologists or trained technicians, but the document does not elaborate on this for the device's specific testing.

4. Adjudication method for the test set

Adjudication Method: Not specified.

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

MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. The device is a "Heart Rate Variability Analysis Program" and provides numerical analyses, not diagnostic interpretations for human readers to improve upon. The submission states, "It only provides numerical analyses of the input electrocardiogram -- the program does not make diagnoses."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes, the testing described appears to be standalone performance. The device analyzes RR intervals and provides numerical outputs. The non-clinical tests would evaluate the algorithm's performance in processing the input data and generating these numerical analyses. The statement "Clinical tests are not necessary since HRV Tools uses the same technology as the predicate devices" further supports that the focus was on the algorithm's standalone accuracy against known data/reference standards, rather than clinical utility in a human-in-the-loop scenario.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: For the "Tests with input data from the MIT database," the ground truth would likely be the expert-annotated RR intervals and arrhythmia information that are part of the MIT-BIH Arrhythmia Database. The submission does not specify ground truth for other "Validation tests" or "Accuracy tests."

8. The sample size for the training set

Sample Size for Training Set: Not specified. The document only mentions testing with the MIT database, not explicit training data. It's possible the device uses well-established algorithms that don't require novel "training" in the machine learning sense, or that the training data details were not considered necessary for a 510(k) submission focused on substantial equivalence for this type of software.

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not specified, as training set details are absent.

Summary

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Summary

K040313
page 1 of 2

APR - 6 2004	510(k) Summary
	HRV Tools

January 12, 2004

1. Submitter Information

Name: Del Mar Reynolds Medical Ltd.

Address:

1 Harforde Court John Tate Road Hertford, Herts SG13 7NW ENGLAND

Telephone Number: 44-1992-507700

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708

Date Prepared: January 12, 2004

2. Name of Device

Trade Name: HRV Tools Common Name: Heart Rate Variability Analysis Program Classification name: Computers and Software, Medical

3. Equivalent legally-marketed devices.

Marquette Mars Unity workstation with heart rate variability, K991786 (includes frequency-domain)
Medical Predictive Science Corporation HERO, K021230 ם

4. Description

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<040313
page 2 of 2

5. Intended Use

HRV Tools is a software product intended to analyze the basic rhythms of the RR intervals in electrocardiograms, both in the time domain (analysis of time intervals) and in the frequency domain (spectral analysis). It only provides numerical analyses of the input electrocardiogram -- the program does not make diagnoses.

6. Performance Data

(a) Non-clinical tests
- 1. Tests with input data from the MIT database
- 1. Validation tests
- Tests to check the operation of the algorithms 3.
- 1. Accuracy tests
(b) Clinical tests

Clinical tests are not necessary since IIRV Tools uses the same technology as the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 6 2004

Del Mar Reynolds, Ltd. c/o George H. Myers, Sc.D. Official Correspondent Medsys, Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604

Re: K040313

Trade Name: HRV Tools Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: January 12, 2004 Received: February 09, 2004

Dear Dr. Myers:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - George H. Myers, Sc.D.

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

onner R. Willing

( 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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HRV Tools

Page ____ 1___ of ___ 1___

510(k) Number (if known): 卡0403 i 3

Indications for Use Form

Device Name: HRV Tools

Indications for Use:

Prescription Use XUse(Per 21 CFR 810.109)	OR	Over-the-Counter
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(Optional Format 1-2-96)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) number K040313

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Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).