EKGCARD SYSTEM

K030535 · Qrs Diagnostic, LLC · DPS · Jun 11, 2003 · Cardiovascular

Device Facts

• Record ID: K030535
• Device Name: EKGCARD SYSTEM
• Applicant: Qrs Diagnostic, LLC
• Product Code: DPS · Cardiovascular
• Decision Date: Jun 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Diagnostic ECG for 12 Channel Resting ECG Patient Population: Male/Female, Pediatric to Adult Environment of Use: Hospital, Clinic and Home Use

Device Story

The EKGCard™ System is a diagnostic electrocardiograph that captures cardiac electrical signals via 12-lead ECG cables and electrodes. The device requires a Type II PC Card slot and operates on a Windows CE Pocket PC 2002 platform. It functions as a data acquisition system, recording voltage versus time to produce a graphical ECG record. Used in hospitals, clinics, and home environments, it is operated by healthcare professionals. The system provides clinicians with visual ECG data to assist in diagnosing cardiac abnormalities, monitoring responses to drug therapy, and tracking changes in heart function. It lacks automated interpretation, printing, or transtelephonic transmission capabilities.

Clinical Evidence

Bench testing only. The device was tested for compliance with safety and performance standards including IEC 601-1, IEC 60601-1, IEC 601-2-25, ANSI/AAMI EC11, ANSI/AAMI EC53, ANSI/AAMI ES1, and electromagnetic compatibility standards (EN 60601-1-2, EN 61000 series).

Technological Characteristics

12-channel diagnostic electrocardiograph; Type II PC Card form factor; Windows CE Pocket PC 2002 platform. Features internal isolation and defibrillator protection. Uses standard snap or tab electrodes and banana plug connectors. Complies with IEC 60601-1, IEC 60601-2-25, and ANSI/AAMI EC11/EC53 standards. Non-sterile, prescription-only device.

Indications for Use

Indicated for 12-channel resting ECG diagnostics in pediatric and adult male and female patients. Prescription use only in hospital, clinic, or home settings.

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

• Biolog 3000 (K974351)
• ECG Interface (K974220)

Submission Summary (Full Text)

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K030535

Image /page/0/Picture/1 description: The image shows a logo with the letters QRS in a bold, sans-serif font. The letters are arranged horizontally, with the Q on the left, the R in the middle, and the S on the right. A thin, black oval surrounds the letters, adding a sense of motion or orbit to the design. The logo is simple, yet eye-catching, and would be easily recognizable.

B.

JUN 1 1 2003

510(k) SUMMARY of SAFETY and EFFECTIVENESS

## A. General Information

| 1. | Submitter's Name: | QRS Diagnostic, LLC |
|----|----------------------|---------------------------------------------|
| 2. | Address: | 14755 27th Avenue No.<br>Plymouth, MN 55447 |
| 3. | Telephone: | 763-559-8492, Ext. 952 |
| 4. | Contact Person: | Brad Sorenson |
| 5. | Date Prepared: | December 17, 2002 |
| 6. | Registration Number: | 2133542 |
| | <b>Device</b> | |
| 1. | Name: | EKGCard™ System |
| 2. | Trade Name: | EKGCard™ System |
| 3. | Common Name: | Diagnostic Electrocardiograph |
| 4. | Classification Name: | Electrocardiograph (ECG or EKG) |
| 5. | Product Code: | DPS |
| 6. | Class: | II |
| 7. | Regulation Number: | 870.2340 |

14755 27th Avenue N. • Plymouth, MN 55447 [phone] • FAX [phone] www.QRSdiagnostic.com

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#### C. Identification of Legally Marketed Devices

| 1. Name: | Biolog 3000 and ECG Interface |
|------------------|-----------------------------------|
| 2. K Number: | K974351 and K974220 |
| 3. Date Cleared: | April 1, 1998 and August 25, 1998 |

#### D. Description of the Device

The EKGCard™ System is a diagnostic electrocardiograph (ECG or EKG) for 12 channel resting ECG's. The patient population is for both male and female, pediatric and adult. The system has been tested to the following standards:

- IEC 601-1, 60601-1; 1991 1
- IEC 601-2-25; 1993
- . ANSI/AAMI EC11 - 1991
- . ANSI/AAMI EC53 - 1995
- 트 ANSI/AAMI ES1 - 1993
- 처 CUL 601-1
- UL 2601-1
- 1 EN60601-1-2
- 트 EN 25011
- . EN 61000-4-2
- 트 EN 61000-4-3
- 트 EN 61000-4-4
- 트 EN-61000-4-6
- EN-61000-4-8
- 180 10993
- . 21CFR Part 898
- . 21CFR Part 801
- 1 93/42/EEC
- . EN 980
- 트 21CFR Part820

The EKGCard™ System is an electrocardiograph that detects signals associated with cardiac activity and produces an ECG; a graphical record of the voltage versus time. ECG's are routinely used to diagnose cardiac abnormalities, determine a patient's response to drug therapy, and reveal trends of changes in heart function.

The System requires a Type II PC Card Slot and Windows CE Pocket PC 2002 and is a Prescription Device.

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#### Intended Use Statement E.

Diagnostic ECG for 12 Channel Resting ECG Patient Population: Male/Female, Pediatric to Adult Environment of Use: Hospital, Clinic and Home Use

#### F. Components/ Part Numbers

- 6000-4332 User's Manual ●
- 7000-1000 WLD ● EKGCard
- ECG Cable 2010-3722 (IEC) ●
- ECG Cable 2010-3721 (AAMI) ●
- Snap Adapters 5000-1861 ●
- Tab Adapters 2000-1858 .
- 2000-1859 Snap Electrodes .
- Tab Electrodes 5000-1858 ●

#### G. Table of Comparisons

The following summary tables of comparisons compare the new device (EKGCard System) to the predicate devices: Biolog 3000 and ECG Interface.

| # | Area | New Device:<br>EKGCard™ System | Predicate Device:<br>Biolog 3000 or<br>ECG Interface | Same | Different |
|----|-----------------------------|------------------------------------|------------------------------------------------------|------|-----------|
| 1 | Indications for<br>Use | ECG and Connection to<br>Pocket PC | ECG and Connection<br>to Pocket PC | X | |
| 2 | Patient Population | Male/Female<br>Pediatric to Adult | Male/Female<br>Pediatric to Adult | X | |
| 3 | Environment | Hospital, Clinic, Home<br>Use | Hospital, Clinic,<br>Home Use | X | |
| 4 | Number of<br>Electrodes | 12 Lead ECG | 12 Lead ECG | X | |
| 5 | Batteries | No | No | X | |
| 6 | Internal Isolation | Yes | Yes | X | |
| 7 | Defibrillator<br>Protection | Yes | Yes | X | |
| 8 | Banana Plugs | Yes | Yes | X | |
| 9 | Types of<br>Electrodes | Snap or Tab | Snap or Tab | X | |
| 10 | CMRR | Yes | Yes | X | |
| 11 | Heart Rate | Yes | Yes | X | |

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| 12 | Standards<br>AAMI, EC11 | Yes | Yes | X | |
|----|--------------------------------|-------------|-------------|---|---|
| 13 | Standards<br>60601-2-25 | Yes | Yes | X | |
| 14 | Interpretation | No | Yes | | X |
| 15 | Transtelephonic | No | Yes | | X |
| 16 | Cable Length<br>3 Feet, 5 Feet | Yes | Yes | X | |
| 17 | Type BF | Yes | Yes | X | |
| 18 | Filters | 50 or 60 Hz | 50 or 60 Hz | X | |
| 19 | Connection Status | Yes | Yes | X | |
| 20 | Electrode<br>Labeling | IEC or AAMI | IEC or AAMI | X | |
| 21 | Print EKG's | No | Yes | | X |
| 22 | Supplied<br>Non-Sterile | Yes | Yes | X | |
| 23 | Prescription<br>Device | Yes | Yes | X | |
| 24 | Safety Standards | Yes | Yes | X | |
| 25 | EMC Standards | Yes | Yes | X | |
| 26 | Operating<br>Conditions | Yes | Yes | X | |

#### H. Discussion of Similarities and Differences

The EKGCard and Biolog 3000 or ECG Interface have the following similarities:

- . Indications for Use
- Patient Population ●
- Environment Number of Electrodes .
- Batteries .
- . Internal Isolation
- Defibrillator Protection .
- Banana Plugs ●
- Types of Electrodes . CMRR
- Heart Rate .
- Standards EC11 ●
- IEC 60601-2-25 .

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- Cable Length ●
- . Type BF
- Filters ●
- Connection Status ●
- Electrode Labeling ●
- . Non-Sterile
- Prescription Device ●
- Safety ●
- EMC ●
- Operating Conditions .

The differences, with comments, are the following:

- Interpretation The EKGCard does not have interpretation, whereas the . Biolog 3000 does or can.
- . Transtelephonic – The EKGCard does not have the capability to transmit ECG's trans-telephonically.
- Print ECG The EKGCard does not yet have the ability to print EKG's. .

The above differences do not raise any new types of safety or effectiveness questions.

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the eagle's body is formed by three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 2003

ORS Diagnostics, LLC c/o Mr. Alan Barker British Standards Institution Maylands Avenue Hemel Hemostead Hertfordshire, HP2 4SQ United Kingdom

Re: K030535

Trade Name: EKGCard™ Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: Undated Received: May 27, 2003

Dear Mr. Barker:

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 -- Mr. Alan Barker

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/dsma/dsmamain.html

Sincerely yours,

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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# K030535

510(k) Number: To be determined

Device Name: EKGCard™ System

## Indications for Use:

- Diagnostic ECG for 12 Channel Resting ECG ●
- Patient Population: Malc/Female/Pediatric to Adult -
- Environment of Use: Hospital, Clinic, and Home Use -
- Prescription Device by a Physician -

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** K030533

OVER-THE-COUNTER USE (optional Form 1-2-96)