ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0

K014261 · Philips Medical Systems, Inc. · MHX · Feb 12, 2002 · Cardiovascular

Device Facts

• Record ID: K014261
• Device Name: ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
• Applicant: Philips Medical Systems, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Feb 12, 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 heart rate and produce events/alarms for one of the ECG leads. The cardiotach function is for use on paced and non-paced patients. The intended use of the ST/AR arrhythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient's heart rate and rhythm and produce events/alarms for one of two ECG leads. The arrhythmia analysis algorithm is for use on both paced and non-paced patients. The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST algorithm does not analyze ventricularly paced or ventricular ectopic beats.

Device Story

Software-based cardiac monitoring system; processes ECG signals to detect arrhythmias and ST segment changes. Inputs: ECG leads (single-lead for QRS/arrhythmia; multi-lead for ST). Operation: ST/AR algorithm analyzes heart rate, rhythm, and ST segment elevation/depression; generates alarms/events for clinician review. Used in clinical settings; operated by physicians, nurses, or technicians. Output: Real-time cardiac data, arrhythmia alerts, and ST segment measurements. Assists clinicians in treatment decisions, monitoring treatment adequacy, and symptom diagnosis.

Clinical Evidence

Bench testing only. System-level, performance, and safety testing conducted to verify functionality against predicate specifications. No clinical data provided.

Technological Characteristics

Software-based cardiac monitoring algorithm. Features ST analysis for 12-lead and MCL/V derivations, and single-lead QRS detection with adjustable thresholds. Operates on patient monitoring hardware. No specific materials or energy sources defined as it is a software-only modification.

Indications for Use

Indicated for neonatal, pediatric, and adult patients requiring cardiac arrhythmia monitoring and adult patients requiring ST segment monitoring. Used for paced and non-paced patients. Contraindicated for ST 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)

Submission Summary (Full Text)

{0}------------------------------------------------

## FEB 1 2 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 Requlatory 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 21 December, 2001

- 2. The name of this device is the Philips ST/AR ST and Arrhythmia Software, Release E.0. 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, and K003621.
- The modification is a software-based change that provides ST 4 . analysis for conventional 12-lead, MCL/V ST derivation, and single-lead QRS detection with adjustable QRS detection threshold capabilities.
- 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

20

{1}------------------------------------------------

K014261
page 2 of 2

81

the new device with respect to the predicate. Testing involved 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 meets all reliability requirements and performance claims.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 2 2002

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

Re: K014261

Trade Name: ST/AR and Arrhythmia Software, Model Release E.O. Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: January 31, 2002 Received: February 1, 2002

Dear Mr. Osborne:

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.

{3}------------------------------------------------

Page 2 - Mr. Dave Osborne

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 any is 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 orth 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 promoted 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,

Bram D. Zuckerman, M.D.

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K014261

Page ***_ of _***

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

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

Where the clinician decides to monitor cardiac Indications for Use: multanolision of adult, pediatric, and neonatal patients and/or ST
arrhythmia of adult, pediatric, and neonatal for treatment, to arrily hill of adult, pediaerie, and information for treatment, to segment of addit pacients of girls in the exclude causes of symptoms.

The intended use of the STAR cardiotach is to monitor a neonatal, The Incended use of the Small Card on heart rate and produce pediatic, or addre pacient - ECG leads. The cardiotach function events/alarms for one of one of on paced and non-paced patients.

The intended use of the STAR arrhythmia analysis algorithm is to The Incended use of the oring armical and administration of a monitor a neonatar, pediable) , , , , , , , , , , , , , , , , , , , , , , , , , , , race and veherrousal arber arrhythmia analysis algorithm is one of two boo louing both paced and non-paced patients.

The intended use of the ST/AR ST analysis algorithm is to monitor Ine intended use of the Or ST segment elevation or depression and an addre patient of all possible ECG leads. The ST analysis produce evenes/arazme repatients.

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)

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

Over-The-Counter

Division of Cardiovascular & Respiratory Devices
510(k) Number 201426

q