NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES

K990031 · Nihon Kohden America, Inc. · LOS · Apr 16, 1999 · CV

Device Facts

• Record ID: K990031
• Device Name: NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES
• Applicant: Nihon Kohden America, Inc.
• Product Code: LOS · CV
• Decision Date: Apr 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Attributes: Pediatric

Intended Use

The ECG-9010K and ECG-9020K Cardiofax GEM electrocardiographs are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or to prepare a record of the electrical signals produced by the heart. For non-interpretive applications, the ECG-9010K and ECG-9020K are intended for use with a full range of patient populations as determined by a clinician. The devices also provide an interpretive ECG program intended for use with patients age 3 years to adult. The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis. Assessments provided by the interpretation program are not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.

Device Story

Cardiofax GEM (ECG-9010K/9020K) processes electrical signals from patient electrodes; produces visual display and printed record of heart activity. Used in clinical settings by healthcare professionals. Includes interpretive program for ECG waveform rhythm and morphology assessment; assists physician diagnosis. Interpretive output requires review by qualified physician; not sole basis for diagnosis. Benefits include standardized waveform analysis and documentation of cardiac electrical activity.

Clinical Evidence

Bench testing only. Electromagnetic, environmental, safety, and performance testing verified device operation. Software validation confirmed performance within specifications.

Technological Characteristics

Electrocardiograph; Class I, Type CF defibrillator discharge protection. Complies with IEC 601-1, IEC 601-2-25, and CSA 601-1. Non-contacting device. Not sterile.

Indications for Use

Indicated for patients age 3 years to adult for interpretive ECG analysis; non-interpretive ECG monitoring indicated for all patient populations as determined by a clinician.

Predicate Devices

• ECG-9320A

Submission Summary (Full Text)

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4/16/99

K G G 6031

NIHON KOHDEN AMERICA, INC. January 4, 1999

## 510(k) NOTIFICATION ECG-9010K and ECG-9020K Cardiofax GEM

SECTION 2 - 510(K) SUMMARY

Name and Address of Applicant Nihon Kohden America, Inc. Attn: Regulatory Affairs 2601 Campus Drive Irvine, California 92612-1601 [phone]

The ECG-9010K and ECG-9020K have been classified as Class III by the Division of Cardiovascular. Respiratory, and Neurological Devices and the Cardiovascular Device Classification Panel under 21 CFR Part 870.2340 "Electrocardiograph" as per 74 LOS.

Common names for the ECG-9010K and ECG-9020K include ECG and electrocardiograph.

Nihon Kohden's model ECG-9010K and ECG-9020K are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and/or prepare a record of the electrical signals produced by the heart.

The ECG-9010K and ECG-9020K devices comply with the IEC 601-1 standard including subclause 56.3(c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables. To date, no other special controls or performance standards are known or established for these devices. The devices are also in compliance with the following voluntary industrial standards: IEC 601-2-25 and CSA 601-1. Defibrillator Discharge Protection: Class I, Type CF.

The ECG-9010K and ECG-9020K are not intended to be sterile.

The devices were determined to be non-contacting. Therefore, good laboratory practice studies were not required per 21 CFR part 58.

The ECG-9010K and ECG-9020K were subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation is performed to test the operation of the device software. The results confirm that the device performs within specifications.

Therefore based on the above, Nihon Kohden believes that the ECG-9010K and ECG-9020K are substantially equivalent to the ECG-9320A.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 1999

Mr. Gary Reasoner Nihon Kohden America, Inc. 2601 Campus Drive Irvine, CA 92612

Re: к990031 Nihon Kohden ECG-9010K and ECG-9020K Cardiofax Gem and Accessories Regulatory Class: III (three) Product Code: 74 LOS Dated: April 6, 1999 Received: April 7, 1999

Dear Mr. Reasoner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Gary Reasoner

This letter will allow you to begin marketing your device as described in your 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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

allahan, Ph.D. Thomas J. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NIHON KOHDEN AMERICA, INC. January 4, 1999

510(k) NOTIFICATION ECG-9010K and ECG-9020K Cardiofax GEM

G. Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ECG-9010K and ECG-9020K Cardiofax GEM

Indications for Use:

The ECG-9010K and ECG-9020K Cardiofax GEM electrocardiographs are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or to prepare a record of the electrical signals produced by the heart.

For non-interpretive applications, the ECG-9010K and ECG-9020K are intended for use with a full range of patient populations as determined by a clinician. The devices also provide an interpretive ECG program intended for use with patients age 3 years to adult.

The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis. Assessments provided by the interpretation program are not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ar. A. Ca. U.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

K990031 510(k) Number_

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)