STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0

K080461 · Philips Medical Systems · MLD · Mar 13, 2008 · Cardiovascular

Device Facts

• Record ID: K080461
• Device Name: STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
• Applicant: Philips Medical Systems
• Product Code: MLD · Cardiovascular
• Decision Date: Mar 13, 2008
• 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/s] prms 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 or ventricular ectopic Note: beats. The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatric and adult patients with and without symptoms of arrhythmia. QT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagrosis of those measurements.

Device Story

Philips ST/AR ST and Arrhythmia Software (Release J.0) processes ECG signals to monitor heart rate, arrhythmias, and ST segments. Used in hospital/clinical environments by healthcare professionals. Software modifications include Atrial Fibrillation alarm, configurable heart rate alarms, and invalid QT measurement messaging. Device provides real-time events/alarms to clinicians to support cardiac assessment and treatment decisions. Operates as part of patient monitoring systems.

Clinical Evidence

No clinical data. Performance established via bench testing, including system-level tests, performance tests, and hazard analysis. Pass/Fail criteria based on predicate specifications.

Technological Characteristics

Software-based arrhythmia and ST-segment monitoring algorithm. Operates on patient monitoring systems. Features include ECG signal processing for heart rate, arrhythmia detection, and ST-segment analysis. Connectivity via integration with Philips monitoring hardware.

Indications for Use

Indicated for neonatal, pediatric, and adult patients requiring cardiac arrhythmia monitoring and/or ST segment monitoring (adults only) to assess treatment or exclude symptoms. Contraindicated for ST analysis on 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)
• ST/AR ST and Arrhythmia Software (K021251)
• ST/AR ST and Arrhythmia Software (K033513)
• ST/AR ST and Arrhythmia Software (K040357)
• ST/AR ST and Arrhythmia Software (K070260)
• GE Dash monitor (K073462)
• GE EK-Pro Arrhythmia Detection Algorithm (K031320)

Submission Summary (Full Text)

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K080461
pi/2

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 8807.92.

- The submitter of this premarket notification is: 1. Zety Billard Regulatory Affairs Specialist Ultrasound & Monitoring Systems Philips Medical Systems 3000 Minuteman Road, MS0480 Andover, MA 01810-1099
Tel: [phone] Fax: [phone] Email: [e-mail] MAR 1 3 2008

This summary was prepared on 15 February 2008.

- The name of this device is the Philips ST/AR ST and Arrhythmia Software, Release J.0. 2. Classification names are as follows:

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

- 3. The new device is substantially equivalent to the previously cleared ST/AR ST and Arrhythmia Software device marketed pursuant to K964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260 and the GE Dash monitor K073462 and GE EK-Pro Arrhythmia Detection Algorithm K031320.
- 4. The modification is a software-based change that adds the following features: - Atrial Fibrillation alarm
- Heart Rate configuration to short or yellow long alarm
- Addition of messages indicating causes of invalid OT measurement
- న. The new device has the same Indications for Use and Intended Use as the legally. marketed predicate devices.
- 6. The new device has the same technological characteristics as the legally marketed predicate devices.
- 7. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of 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

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K080461
p2/2

test results showed substantial equivalence. The results demonstrate that ST/AR Release J.0 meets all defined reliability requirements and performance claims.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2008

Philips Medical Systems c/o Ms. Zety Billard Regulatory Affairs Specialist Ultrasound and Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099

Re: K080461

Star St and Arrhythmia Software Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: MLD, DSI, MHX Dated: February 15, 2008 Received: February 20, 2008

Dear Ms. Billard:

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. Zety Billard

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/industry/support/index.html.

Sincerely yours,

Blfimmuma for

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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## 3.1 ODE Indications Statement

## Indications for Use

510(k) Number (if known):

Device Name:

Indications for 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/s] prms 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 or ventricular ectopic Note: beats.
The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatric and adult patients with and without symptoms of arrhythmia. QT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagrosis of those measurements.

| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|----------------------------------------------|---|
|----------------------------------------------|---|

AND/OR

| Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---------------------------------------------|--|
|---------------------------------------------|--|

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
MintamoreSign-C Concurrence of CDRH, Office of Device Evaluation (ODE) Ivision of Cardiovascular Devices 510(k) Number

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