EK-PRO ARRHYTHMIA DETECTION ALGORITHM

K031320 · Ge Medical Systems Information Technologies · MHX · May 6, 2003 · Cardiovascular

Device Facts

• Record ID: K031320
• Device Name: EK-PRO ARRHYTHMIA DETECTION ALGORITHM
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MHX · Cardiovascular
• Decision Date: May 6, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EK-Pro Arrhythmia Detection Algorithm is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the EK-Pro Algorithm is to monitor ECG parameter data on adult, pediatric and neonatal patients. The EK-Pro Algorithm is designed to monitor ECG parameter data in bedside, portable, and transport monitors that can operate in all professional medical facilities and medical transport modes.

Device Story

Software algorithm for patient monitors; processes ECG data to detect arrhythmia events; computes/trends heart rate, ventricular ectopic beats/min, and ST segment deviations. Used in bedside, portable, and transport monitors; operated by clinicians in professional medical facilities. Output displayed on monitor for clinical review; assists in patient monitoring and clinical decision-making.

Clinical Evidence

Clinical acceptance testing (validation) performed. Results demonstrated the device is as safe and effective as the predicate device in monitoring ECG parameter data.

Technological Characteristics

Software algorithm for ECG parameter monitoring. Operates on patient monitors (bedside, portable, transport).

Indications for Use

Indicated for monitoring ECG parameter data in adult, pediatric, and neonatal patients under direct supervision of a licensed healthcare practitioner in professional medical facilities and transport modes.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Dash 3000/4000 Patient Monitor (K020290)

Submission Summary (Full Text)

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MAY 0 6 2003

## Section 2 Summary of Safety and Effectiveness

| Date: | April 21, 2003 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| Contact Person: | Karen M. Lunde<br>Sr. Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Device:<br>Trade Name: | EK-Pro Arrhythmia Detection Algorithm |
| Common/Usual Name: | Arrhythmia Detection Algorithm |
| Classification Names: | 21 CFR 870.1025 Detector and Alarm, Arrhythmia |
| Predicate Device: | K020290 Dash 3000/4000 Patient Monitor |
| Device Description: | The EK-Pro Arrhythmia Detection Algorithm is a software algorithm that<br>runs in GE Medical Systems Information Technologies patient monitors.<br>When used in a patient monitor, the EK-Pro Algorithm processes the<br>ECG data acquired by the patient monitor to detect various ECG<br>arrhythmia events, and to compute and trend measurements that<br>include heart rate, ventricular ectopic beats per minute, and ST<br>segment deviations. |
| Intended Use: | The EK-Pro Arrhythmia Detection Algorithm is intended for use under<br>the direct supervision of a licensed healthcare practitioner. The<br>intended use of the EK-Pro Algorithm is to monitor ECG parameter data<br>on adult, pediatric and neonatal patients. The EK-Pro Algorithm is<br>designed to monitor ECG parameter data in bedside, portable, and<br>transport monitors that can operate in all professional medical facilities |

- Technology: The EK-Pro Arrhythmia Detection Algorithm employs the same functional technology as the predicate device in the monitoring of ECG parameter data.
- Test Summary: The EK-Pro Arrhythmia Detection Algorithm and its host patient monitor complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the EK-Pro Arrhythmia Detection Algorithm:
- Risk Analysis
- Requirements Specification Review .
- . Code Inspections
- . Software Verification Testing

and medical transport modes.

- Clinical Acceptance Testing (Validation) ●
- The results of these measurements demonstrated that the EK-Pro Conclusion: Arrhythmia Detection Algorithm is as safe, as effective, and performs as well as the predicate device in monitoring ECG parameter data.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 6 2003

GE Medical Systems Information Tech c/o Ms. Karen M. Lunde Senior Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K031320

Trade Name: EK-Pro Arrhythmia Detection Algorithm Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: MHX Dated: April 21, 2003 Received: April 25, 2003

Dear Ms. Lunde:

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.

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

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Page 2 - Ms. Karen M. Lunde

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,

K. DeWitt

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):

510(k) filed on April 21, 2003

EK-Pro Arrhythmia Detection Algorithm Device Name:

Indications For Use:

The EK-Pro Arrhythmia Detection Algorithm is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the EK-Pro Algorithm is to monitor ECG parameter data on adult, pediatric and neonatal patients. The EK-Pro Algorithm is designed to monitor ECG parameter data in bedside, portable, and transport monitors that can operate in all professional medical facilities and medical transport modes.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

VDeleTu

ardiovascular Dev

**510(k) Number** K031320