HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES

K042148 · Ge Medical Syst. Information Technologies · DQK · Dec 3, 2004 · Cardiovascular

Device Facts

• Record ID: K042148
• Device Name: HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES
• Applicant: Ge Medical Syst. Information Technologies
• Product Code: DQK · Cardiovascular
• Decision Date: Dec 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The Heart Rate Turbulence Analysis Program is intended for use in a hospital, doctor's office, or clinic environment under the direct supervision of a licensed healthcare practitioner. The intended use of the Heart Rate Turbulence Analysis Program is to analyze ECG signals, provide measurements of Heart Rate Turbulence in patients undergoing cardiovascular disease testing for interpretation by qualified healthcare practitioner for the purposes of risk stratification and prediction of sudden cardiac death. The Heart Rate Turbulence Analysis Program only provides measurements, not interpretations. The Heart Rate Turbulence Analysis Program is to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment.

Device Story

Software algorithm for GE electrocardiographic equipment; analyzes ECG signals to measure Heart Rate Turbulence (HRT); calculates variations in RR intervals associated with premature ventricular contractions (PVCs). Used in hospitals, clinics, or doctor's offices under supervision of licensed healthcare practitioners. Provides quantitative measurements only, not clinical interpretations. Healthcare providers use output alongside clinical history and other diagnostic tests to support clinical judgment regarding cardiac risk stratification and sudden cardiac death prediction.

Clinical Evidence

Bench testing only. Quality assurance measures included risk analysis, requirements specification review, code inspections, and software verification and validation testing.

Technological Characteristics

Software algorithm for ECG analysis. Calculates time domain measurements of heart rate (RR) intervals. Enhancements include reporting RR interval variations associated with premature ventricular contractions (PVCs).

Indications for Use

Indicated for patients undergoing cardiovascular disease testing for risk stratification and prediction of sudden cardiac death.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• MARS Unity Workstation with Heart Rate Variability Option (K991786)

Submission Summary (Full Text)

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DEC - 3 2004

K042148

## Section 2 Summary of Safety and Effectiveness

| Date: | August 6, 2004 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| Contact Person: | Lisa M. Baumhardt<br>Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Device:<br>Trade Name: | Heart Rate Turbulence Analysis Program |
| Common/Usual Name: | ECG Analysis Algorithm |
| Classification Names: | 21 CFR 870.1425 Programmable Diagnostic Computer |
| Predicate Device: | K991786 MARS Unity Workstation with Heart Rate Variability Option |
| Device Description: | The Heart Rate Turbulence Analysis Program is a software algorithm that runs in GE Medical Systems Information Technologies electrocardiographic equipment. |
| Intended Use: | The Heart Rate Turbulence Analysis Program is intended for use in a hospital, doctor's office, or clinic environment under the direct supervision of a licensed healthcare practitioner. The intended use of the Heart Rate Turbulence Analysis Program is to analyze ECG signals, provide measurements of Heart Rate Turbulence in patients undergoing cardiovascular disease testing for interpretation by qualified healthcare practitioner for the purposes of risk stratification and prediction of sudden cardiac death. The Heart Rate Turbulence Analysis Program only provides measurements, not interpretations. The Heart Rate Turbulence Analysis Program is to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment. |
| Technology: | The Heart Rate Turbulence Analysis Program employs the same functional technology as the predicate device for calculating variations of heart rate (RR) intervals. An enhancement was made to the reporting of the time domain measurements to include the variation in RR intervals associated with a single premature ventricular contraction (PVC). |
| Test Summary: | The Heart Rate Turbulence Analysis Program and its host electrocardiograph comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Heart Rate Turbulence algorithm:<br><ul><li>Risk Analysis</li><li>Requirements Specification Review</li><li>Code Inspections</li><li>Software Verification and Validation Testing</li></ul> |
| Conclusion: | The results of these measurements demonstrated that the Heart Rate Turbulence Analysis Program is as safe, as effective, and performs as well as the predicate device. |

GE Medical Systems Information Technologies Confidential

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 2004

GE Medical Systems Information Technologies c/o Lisa M. Baumhardt, M.T. (A.S.C.P.) Regulatory Affairs Specialist 8200 West Tower Ave. Milwaukee, WI 53223

Re: K042148

Trade Name: Heart Rate Turbulence Analysis Program Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computers Regulatory Class: II (two) Product Code: DQK Dated: November 29, 2004 Received: November 30, 2004

Dear Ms. Baumhardt:

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 - Ms. Lisa Baumhardt, M.T. (A.S.C.P.)

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of acresed 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 or any I vith 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 (21 CFR Part 820); and if applicable, the electronic for and and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of 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 promanted 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 other general 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,

Duna R. bechner

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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510(k) Number (if known): K 04-2 ) 48

Device Name: Heart Rate Turbulence Algorithm

Indications For Use:

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Prescription Use_X (Per 21 CFR 801.109 Subpart D) OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Dunes R. Vachner

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പ്രീ Cardiovascular Devices

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