NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH

K972310 · Nihon Kohden America, Inc. · DPS · Aug 20, 1997 · Cardiovascular

Device Facts

• Record ID: K972310
• Device Name: NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH
• Applicant: Nihon Kohden America, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Indications for Use

The QP-932E Exercise Test Option with its parent device, the Nihon Kohden Cardiofax ECG-9320A Electrocardiograph, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and to prepare a record of the electrical signals produced by the heart. The QP-932E will develop a report based upon acquired data and subsequent calculations. The ECG-9320A with QP-932E Exercise Test Option will be available for use by a physician within a hospital, laboratory, clinic or in a remote environment under the supervision of a physician.

Device Story

The QP-932E Exercise Test Option is an accessory for the Nihon Kohden Cardiofax ECG-9320A Electrocardiograph. It processes electrical signals from ECG electrodes to generate visual displays, records, and reports based on acquired data and calculations. Used in hospitals, clinics, or remote settings under physician supervision. The device aids clinical decision-making by providing diagnostic cardiac data. It benefits patients by enabling exercise-based cardiac assessment.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including electromagnetic, environmental, safety, and performance testing, and software validation to confirm operation within specifications.

Technological Characteristics

Accessory for ECG-9320A Electrocardiograph; processes electrical signals from electrodes; provides visual display and printed reports; non-sterile; software-based data processing and calculation.

Indications for Use

Indicated for use by physicians in hospitals, laboratories, clinics, or remote environments under physician supervision to process ECG signals, produce visual displays, and generate reports based on acquired data and calculations for cardiac monitoring.

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

• Nihon Kohden Cardiofax, Model ECG-8340A Electrocardiograph (K865032)
• Quinton Instrument Company Model Q710 Exercise and Resting ECG System (K945626)

Submission Summary (Full Text)

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KY 12310

NIHON KOHDEN AMERICA, INC. June 19, 1997

510(k) NOTIFICATION QP-932E Exercise Test Option

SECTION 2 - 510(K) SUMMARY

ﻤﺴﺴﺴ

Same

Name and Address of Applicant Nihon Kohden America, Inc. 2601 Campus Drive Irvine, California 92612-1601

## AUG 20 1997

Contact Person and Telephone Mr. Gary Reasoner Director of Product Operations [phone] ext. 3387

The QP-932E Exercise Test Option is an optional accessory for the Nihon Kohden Cardiofax, Model ECG-9320A Electrocardiograph, per 510(k) #K961272, commercial distribution certification dated November 1, 1996. The device has been classified as Class II by the Division of Cardiovascular, Respiratory, and Neurological Devices and the Cardiovascular Device Classification Panel under 21 CFR Part 870.2340 "Electrocardiograph" as per part 74 DPS.

Common names for the ECG-9320A Cardiofax device with the QP-932E Exercise Test Option include Electrocardiograph and Cardiograph.

The predicate devices are the Nihon Kohden Cardiofax, Model ECG-8340A Electrocardiograph per 510/k) #K865032. commercial distribution certification dated March 10, 1987 and the Quinton Instrument Company Model Q710 Exercise and Resting ECG System per 510(k) #K945626, commercial distribution certification dated June 28, 1995.

The QP-932E Exercise Test Option with its parent device, the Nihon Kohden Cardiofax ECG-9320A Electrocardiograph, is intended for medical purposes the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and to prepare a record of the electrical signals produced by the heart. The QP-932E will develop a report based upon acquired data and subsequent calculations. The ECG-9320A with QP-932E Exercise Test Option will be available for use by a physician within a hospital, laboratory, clinic or in a remote environment under the supervision of a physician.

To date, no performance standards or special controls are known or established for this device as required by Section 514 of the Food, Drug and Cosmetic Act and implemented by 21 CFR part 861.

The device is not intended to be sterile.

The Nihon Kohden Cardiofax ECG-9320A Electrocardiograph was subject to electromagnetic, environmental, safety and performance testing. These tests verified the operation of the device.

Software validation tested the operation of the software functions of the results confirmed that the device performed within specifications.

Therefore based on the above, Nihon Kohden believes that the QP-932E Exercise Test Option for the ECG-9320A Cardiofax Electrocardiograph is substantially equivalent to the Nihon Kohden Cardiofax, Model ECG-8340A Electrocardiograph and the Quinton Instrument Company Model Q710 Exercise and Resting ECG System.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

AUG 20 1997

Mr. Gary Reasoner Nihon Kohden America, Inc. 2601 Campus Drive Irvine, California 92715

Re: K972310 Nihon Kohden QP-932E Exercise Test Option for the ECG-9320A Cardiofax Electrocardiograph Requlatory Class: II (two) Product Code: 74 DPS Dated: June 19, 1997 Received: June 20, 1997

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 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 Requlation (QS) for Medical Devices: General requiation (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 requlations.

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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/dsmamain.html".

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. June 19, 1997

## G. Indications for Use Statement:

The QP-932E Exercise Test Option with its parent device, the Nihon Kohden Cardiofax ECG-9320A Electrocardiograph, is intended for medical purposes used to process the. ........................................................................... electrical signals transmitted through two or more electrocardiograph electrodes to === produce a visual display and to prepare a record of the electrical signals produced by the heart. The QP-932E will develop a report based upon acquired data and subsequent calculations.

The ECG-9320A with QP-932E Exercise Test Option will be available for use by a physician within a hospital, laboratory, clinic or in a remote environment under the supervision of a physician.

FOR prescription use: ✓

A

8/20/91

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