BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY

K013717 · Brentwood Medical Technology Corp. · DPS · Feb 6, 2002 · Cardiovascular

Device Facts

• Record ID: K013717
• Device Name: BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY
• Applicant: Brentwood Medical Technology Corp.
• Product Code: DPS · Cardiovascular
• Decision Date: Feb 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Indications for Use

The intended user of the Brentwood Real Time ST and Arrhythmia Analysis Software Library user is a medical device manufacturer who will integrate it into a computerized device that analyzes ECG signals captured from the human body surface. The library will provide the device with real time ECG signal processing, QRS detection, QRS complex feature extraction, ventricular ectopic beat detection, ST level measurement, rhythm calls, and ventricular fibrillation detection capabilities. The intended user is expected to label the device for use only by or under the supervision of a trained physician. The intended user is further assumed to have a quality system for developing and implementing software. The quality system should call for validating software, including the use of purchased software.

Device Story

Software object library; integrated by manufacturers into computerized cardiac monitoring devices. Inputs: up to 12 leads of captured body surface ECG signals. Processing: real-time signal processing; QRS detection; QRS complex feature extraction; ventricular ectopic beat detection; ST level measurement; rhythm analysis; ventricular fibrillation detection. Outputs: processed cardiac data/alarms for display on host device. Used in clinical settings where host device is deployed; operated by healthcare professionals. Output assists clinicians in cardiac monitoring and decision-making; enables patient monitoring for arrhythmias and ST segment changes.

Clinical Evidence

Bench testing only. Performance evaluated per ANSI/AAMI EC57:1998 using standard databases: AHA, MIT-BIH, NST, and ESC. Endpoints included accuracy of QRS detection, heart rate measurement, VEB detection, ventricular fibrillation detection, and ST segment analysis.

Technological Characteristics

ANSI Standard C (ISO/IEC 9899) callable functions; compiled object library. Designed for integration into host ECG analysis devices. Supports up to 12-lead ECG input. Software-based signal processing and analysis algorithms.

Indications for Use

Indicated for monitoring and detecting QRS complexes, non-paced ventricular ectopic beats, rhythm calls (asystole, bigeminy, couplets, irregular heart rate, pause/missed beat, VEB/minute, run, trigeminy, triplets, ventricular tachycardia), ST segment levels (adults only), and ventricular fibrillation from up to 12-lead body surface ECG in adult, pediatric, and neonatal patients.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• ST/AR ST and Arrhythmia Software, Release D.0 (K003621)

Submission Summary (Full Text)

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

# FEB 0 6 2002

This 510(k) Summary is prepared in accordance with 21 CFR 807.92.

## 1. BASIC INFORMATION

#### 1.1 SUBMITTER

| Name: | Brentwood Medical Technology Corp |
|-----------------|------------------------------------------|
| Address: | 3300 Fujita Street<br>Torrance, CA 90505 |
| Contact Person: | Ruomei Zhang, PhD |
| Phone Number: | [phone] x7210 |

November 6, 2001 Preparation Date:

#### 1.2 DEVICE NAME

The name of the device is the Brentwood Real Time ST and Arrhythmia Analysis Software Library.

The classification name is "Arrhythmia detector and alarm".

The common/usual name is "Patient Monitor".

### 1.3 IDENTIFICATION OF LEGALLY MARKETED DEVICE

Substantial equivalence is claimed to a legally marketed device cleared under the name, "ST/AR ST and Arrhythmia Software, Release D.0". The registered manufacturer of the cleared device is Agilent Technologies, Inc. of Andover, MA, and the 510(k) number is K003621.

### 1.4 DEVICE DESCRIPTION

The Brentwood Real Time ST and Arrhythmia Analysis Software Library is an "object library'. An object library is a collection of callable functions that have been compiled (or assembled) into the native machine code of the computer on which they will execute. An application software program can be written to invoke some or all of the functions in an object library. The compiled (or assembled) application code can be "linked" to the called functions from an object library at the time the executable code image is built. An executable code image created in this manner will contain the application software code and all of the functions it invoked from the object library.

The Brentwood Real Time ST and Arrhythmia Analysis Software Library consists of a collection of ANSI Standard C (ISO/IEC 9899) callable functions. It provides real time ECG signal processing, QRS detection, QRS complex feature extraction, ventricular ectopic beat detection, ST level measurement, rhythm calls, and ventricular fibrillation detection capabilities for up to 12 leads of captured ECG lead data.

Brentwood will compile the Brentwood Real Time ST and Arrhythmia Analysis Software Library using the compiler specified by an ECG analysis device manufacturer. An object library will be created and delivered to the manufacturer, who can then integrate it into application software for their ECG analysis device(s).

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

## 1.5 INTENDED USE

The intended user of the Brentwood Real Time ST and Arrhythmia Analysis Software Library user is a medical device manufacturer who will integrate it into a computerized device that analyzes ECG signals captured from the human body surface. The library will provide the device with real time ECG signal processing, QRS detection, QRS complex feature extraction, ventricular ectopic beat detection, ST level measurement, rhythm calls, and ventricular fibrillation detection capabilities. The intended user is expected to label the device for use only by or under the supervision of a trained physician. The intended user is further assumed to have a quality system for developing and implementing software. The quality system should call for validating software, including the use of purchased software.

## 1.6 COMPARISON TO CLEARED DEVICE

Both the Brentwood Real Time ST and Arrhythmia Analysis Software Library and the predicate are software only devices that monitor cardiac function. Table 1 compares the features of the Brentwood device to the predicate.

| Feature | Agilent | Brentwood |
|-----------------------------------------------------------------------------------------------|---------|-----------|
| heart rate determination for (paced and non-paced) adult,<br>pediatric, and neonatal patients | yes | yes |
| (non-paced) ventricular arrhythmia calls for adult, pediatric, and<br>neonatal patients | yes | yes |
| (non-paced) ST segment level measurement for adult patients | yes | yes |
| (non-paced) ventricular ectopic beat detection | yes | yes |

## Table 1: Comparison of Brentwood's ST/AR Library to Predicate Device

## 2. PERFORMANCE TESTING

The following testing was performed in accordance with ANSI/AAMI EC57:1998 to evaluate the performance of the Brentwood Real Time ST and Arrhythmia Analysis Software Library. Unless otherwise noted, all testing used the AHA, MIT-BIH, and NST standard databases:

- . accuracy of ORS detection.
- accuracy of heart rate measurement, ●
- accuracy of VEB detection,
- ventricular fibrillation (also CU database), .
- . ST segment analysis (ESC database only)

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three lines extending from the head, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 0 6 2002

Ruomei Zhang, Ph.D. Chief Technical Officer Brentwood Medical Technology Corp. 3300 Fujita Street Torrance, CA 90505

Re: K013717

Trade Name: Brentwood Real Time ST and Arrhythmia Analysis Software Library (ST/AR Library) Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: November 6, 2001 Received: November 8, 2001

Dear Dr. Zhang:

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 - Ruomei Zhang, Ph.D.

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 I 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 Of A rat 007); accems (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) I mis lotter will and in yourse 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 O intor goneral into.itamos turers, 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,

Deatull

am D. Zuci л В kerman. M.D Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use Statement

510 (k) Number (if known)

K013717

Brentwood Real-Time ST and Arrhythmia Analysis Software Library Device Name (referred to as the ST/AR Library).

Indications for Use

The intended user is a medical device manufacturer who will integrate the ST/AR Library into a computerized cardiac monitoring device. The BT71X Blorary integrator will ultimately identify the indications for use, depending on the nature of their device.

The analysis capabilities of the ST/AR Library are indicated for monitoring and detecting the following from up to 12 body surface ECG leads for adult, pediatric, or neonatal patients:

- QRS detection .
- ventricular ectopic beat detection (non-paced only) .
- rhythm call analysis, including asystole, bigeminy, couplets, . irregular heart rate, pause or missed beat, VEB/minute, run, trigeminy, triplets, ventricular tachycardia
- ST segment level measurement (adult patients only) .
- ventricular fibrillation detection .

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE TO ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013717

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use