ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.

K021251 · Philips Medical Systems · DSI · May 7, 2002 · Cardiovascular

Device Facts

• Record ID: K021251
• Device Name: ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
• Applicant: Philips Medical Systems
• Product Code: DSI · Cardiovascular
• Decision Date: May 7, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms. The intended use of the ST/AR cardiotach is to monitor a neonatal, pediatric, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients. The intended use of the ST/AR arrhythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient ECG's for heart rate and ventricular arrhythmias and produce events/alarms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients. The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients.

Device Story

Philips ST/AR ST and Arrhythmia Software (Release E.1) processes ECG signals to monitor heart rate, arrhythmias, and ST segments. System provides cardiotach functionality (heart rate monitoring) and ST segment analysis, with or without arrhythmia analysis. Used in clinical settings by healthcare professionals to monitor paced and non-paced patients. Software analyzes one or two ECG leads for cardiotach/arrhythmia and all possible leads for ST segment analysis. Outputs include events and alarms displayed to clinicians to assist in treatment decisions and patient management.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, performance tests, and hazard analysis. Results demonstrated that Release E.1 meets all reliability requirements and performance claims established for the predicate devices.

Technological Characteristics

Software-based ECG analysis system. Operates as a component of patient monitoring systems. Provides cardiotach, arrhythmia detection, and ST segment analysis. Supports paced and non-paced patient monitoring. Connectivity and hardware platform are consistent with previously cleared predicate versions.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring cardiac arrhythmia monitoring and/or adult patients requiring ST segment monitoring to inform treatment, monitor treatment adequacy, or exclude symptom causes. ST algorithm excludes analysis of ventricularly paced or ventricular ectopic beats.

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

• ST/AR ST and Arrhythmia Software (K964122)
• ST/AR ST and Arrhythmia Software (K991773)
• ST/AR ST and Arrhythmia Software (K001348)
• ST/AR ST and Arrhythmia Software (K003621)
• ST/AR ST and Arrhythmia Software (K014261)

Submission Summary (Full Text)

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## MAY 0 7 2002

## 9.0 510 (k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.

1. The submitter of this premarket notification is: Dave Osborn Regulatory Affairs Engineer Cardiac & Monitoring Systems Group Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1085

> 978 659 3178 Tel: [phone] Fax: Email: [e-mail]

This summary was prepared on 17 April, 2002

- 2. The name of this device is the Philips ST/AR ST and Arrhythmia Software, Release E.1. Classification names are as follows:

| Classification | ProCode | Description |
|----------------|---------|----------------------------------------|
| 870.1025, III | 74 MLD | Monitor, ST Alarm |
| 870.1025, III | 74 DSI | Arrhythmia Detector and Alarm |
| None | 74 MHX | Physiological Monitor, Patient Monitor |

- The new device is substantially equivalent to the previously 3 . cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621 and K014261.
- The modification is a software-based change that provides 4 . Cardiotach functionality without arrhythmia analysis and ST Segment Analysis without arrhythmia analysis.
- The new device has the same Indications for Use as the legally 5. marketed predicate device. Where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
- The new device has the same technological characteristics as the 6. legally marketed predicate device.
- 7. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved

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system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that ST/AR Release E.1 meets all reliability requirements and performance claims.

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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 0 7 2002

Mr. Dave Osborn Quality Program Manager Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099

Re: K021251

Trade Name: Philips Medical Systems ST/AR and Arrhythmia Software, Release E.1. Regulation Name: Arrhythmia Detector and Alarm Regulation Number: 21 CFR 870.1025 Regulatory Class: Class III (three) Product Code: DSI Dated: April 18, 2002 Received: April 19, 2002

Dear Mr. Osborn:

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. Iisting 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 -- Mr. Dave Osborn

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 or car) x 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 Erth 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Darla Tule

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page / of /

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Philips Medical Systems ST/AR Software, Release E.1.

Where the clinician decides to monitor cardiac Indications for Use: arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The intended use of the ST/AR cardiotach is to monitor a neonatal, pediatric, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients.

The intended use of the ST/AR arrhythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient ECG's for heart rate and ventricular arrhythmias and produce events/alarms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients.

The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients.

The ST algorithm does not analyze ventricularly paced Note: or ventricular ectopic beats.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

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Use

(Per 21 CFR 801.109) (Optional Format 1-2-96)

Jada tu

Division of Cardiovascular & Respiratory Devices
510(k) Number K061251