HRV TOOLS

K040313 · Del Mar Reynolds Medical, Ltd. · DPS · Apr 6, 2004 · Cardiovascular

Device Facts

• Record ID: K040313
• Device Name: HRV TOOLS
• Applicant: Del Mar Reynolds Medical, Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Apr 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

HRV Tools is a software-based analysis program supplied on CD. It accepts electrocardiogram (ECG) data as input; specifically, it processes R-R intervals. The device performs time-domain analysis (analysis of time intervals) and frequency-domain analysis (spectral analysis) to generate numerical outputs. It does not provide clinical diagnoses. The software is intended for use by healthcare professionals to assist in the quantitative assessment of heart rate variability. The output is used by clinicians to inform clinical decision-making regarding cardiac rhythm analysis.

Clinical Evidence

No clinical data provided. Substantial equivalence established via non-clinical bench testing, including validation using the MIT database and verification of algorithm operation and accuracy.

Technological Characteristics

Software-based analysis program. Performs time-domain and frequency-domain (spectral) analysis of ECG R-R intervals. Distributed on CD. Rule-based numerical analysis.

Indications for Use

Indicated for the analysis of basic rhythms of R-R intervals in electrocardiograms to provide numerical data. No specific patient population or contraindications provided.

Regulatory Classification

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.

Predicate Devices

• Marquette Mars Unity workstation with heart rate variability (K991786)
• Medical Predictive Science Corporation HERO (K021230)

Submission Summary (Full Text)

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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 [phone] Fax [phone]

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

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).

## 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
- 2. Validation tests
- Tests to check the operation of the algorithms 3.
- 4. Accuracy tests
- (b) Clinical tests

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

- (c) Conclusions
HRV Tools is equivalent in safety and efficacy to the legally marketed 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 [phone]. 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 [phone] or [phone] 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:

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

| Prescription Use <span></span> X<br>Use<br>(Per 21 CFR 810.109) | OR | Over-the-Counter |
|-----------------------------------------------------------------|----|------------------|
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(Optional Format 1-2-96)

이 지원 : 100 : 100 : 100 : 100 : 100 : 100 : 100 : 100 : 100 : 100 : 100 : 100 : 100 : 100 : 100 : 100 : 100 :

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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