NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES

K984504 · Nihon Kohden America, Inc. · LOS · Apr 15, 1999 · CV

Device Facts

• Record ID: K984504
• Device Name: NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES
• Applicant: Nihon Kohden America, Inc.
• Product Code: LOS · CV
• Decision Date: Apr 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Attributes: Pediatric

Intended Use

The ECG-9110K and ECG-9130K Cardiofax Q 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-9110K and ECG-9130K 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 solo basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.

Device Story

Cardiofax Q (ECG-9110K/ECG-9130K) processes electrical signals from heart via electrodes; produces visual display and printed record. Used by clinicians in medical settings. Includes interpretive program assessing ECG waveform rhythm and morphology to assist physician diagnosis. Interpretive output serves as diagnostic aid, not sole basis for clinical decision-making; requires review by qualified physician. Benefits include standardized waveform analysis and documentation of cardiac electrical activity.

Clinical Evidence

Bench testing only. Electromagnetic, environmental, safety, and performance testing procedures performed. Software validation conducted. No clinical data provided.

Technological Characteristics

Electrocardiograph; Class I, Type CF defibrillator discharge protection. Complies with IEC 601-1, IEC 601-2-25, CSA 601-1, and 21 CFR 868. Non-sterile, non-contacting device. Software-based interpretive program for rhythm and morphology assessment.

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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APR 15

K984504

NIHON KOHDEN AMERICA, INC. December 17, 1998

510(k) NOTIFICATION ECG-9110K and ECG-9130K Cardiofax Q

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-9110K and ECG-9130K 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-9110K and ECG-9130K include ECG and electrocardiograph.

Nihon Kohden's model ECG-9130K are intended for medical purposes to process the electrical signals transmitted through two or more electrodes and to produce a visual display and/or prepare a record of the electrical signals produced by the heart.

The ECG-9110K and ECG-9130K 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-9110K and ECG-9130K 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-9110K and ECG-9130K were subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software of the device. The results confirmed that the device performed within specifications.

Therefore based on the above, Nihon Kohden believes that the ECG-9110K and ECG-9130K are substantially equivalent to the ECG-9320A.

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Image /page/1/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 an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 1999

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

Re: K984504 Nihon Kohden ECG-9110K and ECG-9130K Cardiofax Q Requlatory 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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 regulatory 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 requlation (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,

sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. 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. December 17, 1998

510(k) NOTIFICATION ECG-9110K and ECG-9130K Cardiofax Q

G. Indications for Use Statement

K984504 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ECG-9110K and ECG-9130K Cardiofax Q

Indications for Use:

The ECG-9110K and ECG-9130K Cardiofax Q 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-9110K and ECG-9130K 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 solo 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)

Atl. R. Ciarkowsl.

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

510(k) Number K984504

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use -------

(Optional Formal 1-2-96)