CARDIOFAX CE, MODEL ECG-1500 A

K052511 · Nihon Kohden America, Inc. · DPS · May 24, 2006 · Cardiovascular

Device Facts

• Record ID: K052511
• Device Name: CARDIOFAX CE, MODEL ECG-1500 A
• Applicant: Nihon Kohden America, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: May 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Cardiofax V electrocardiograph is intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a patient record (monitor and recorder) and prepare a record and/or provide wireless transmission of data to a remote printer and/or computer. For non-interpretive applications, the device is 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 and older. 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

Portable ECG acquisition terminal; measures up to 15-lead ECG waveforms via electrodes. Transforms electrical heart signals into visual displays, printed records, or digital data for remote filing systems via wireless LAN. Used in clinical settings by healthcare professionals. Provides waveform measurements and diagnostic interpretations on an advisory basis to assist physicians. Includes keyboard data entry, internal battery, and AC power. Optional PC memory card and external printer support. Output allows physicians to review rhythm and morphology assessments to support clinical decision-making; interpretation is not the sole basis for diagnosis.

Clinical Evidence

Bench testing only. Device subjected to electromagnetic, environmental, safety, and performance testing. Software validation confirmed operation within specifications. No clinical trial data provided.

Technological Characteristics

Portable ECG acquisition terminal; 3 to 15 channel selectable formats. Features keyboard, internal battery with recharging circuit, and AC power. Connectivity via wireless LAN. Complies with IEC 60601-1 and 21 CFR 868.1030 (electrode lead wires/cables).

Indications for Use

Indicated for patients age 3 years and older for interpretive ECG analysis; non-interpretive applications indicated for all patient populations as determined by a clinician.

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.

Submission Summary (Full Text)

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## NIHON KOHDEN AMERICA

# 510K SUBMISSION FOR ECG-1500A Series

# SECTION 2 - 510(K) SUMMARY August 2005

052511
page 1 of 1

Name and Address of Applicant Nihon Kohden America, Inc. Attn: Regulatory Affairs Serrah Namini 90 Icon St. Foothill Ranch, Ca 92610 [phone] Ext 4401 Fax: [phone]

#### MAY 2 4 2006

Trade Name: ECG-1500A series / Cardiofax V Common Name: Electrocardiograph or ECG Classification Name: The device has been classified as Class II by the Division of Cardiovascular Device Classification Panel under 21 CFR Part 870.2340 "Electrocardiograph" per 74LOS.

Nihon Kohden's ECG-1500A series is intended for medical purposes to process the electrical signals produced by the heart through electrocardiograph electrodes and to produce a visual display, to produce a record and/or to transmit data to a remote computer. The product is a portable ECG acquisition terminal, which measures up to 15 lead ECG waveforms. The measured ECG waveforms are analyzed and a patient record is prepared for transfer to an ECG data filing system thru a wireless LAN or may be printed by integral printer with optional model available with recorder. Measurements and waveforms and diagnostic information are offered to physicians on an advisory basis.

The ECG-1500A series prepares a full page file with 3 to 15 channel selectable formats, waveform display and waveform analyses with measurements. The device includes keyboard data entry, battery with internal battery recharging circuit and AC power operation , all of which are features of the predicate devices. The new device offers an optional PC memory card, comparable to the predicate Nihon Kohden's ECGs. The new device does offer an external optional printer and uses a different type of battery. These changes have been made to address user preferences and do not affect the indication for use or safety and efficacy of the new device.

The device complies with the IEC 60601-1 standard and sub-clause 56.3(c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables.

The device was subject 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-1500A series is substantially equivalent to our predicate devices.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2006

Ms. Serrah Namini Regulatory Affairs, Associate Director Nihon Kohden America, Inc. 90 Icon St. Foothill Ranch, CA 92610

Re: K052511

Trade Name: Cardiofax CE, Model ECG-1500 A Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: April 19, 2006 Received: April 19, 2006

Dear Ms. Namini:

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.

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

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Page 2 - Ms. Serrah Namini

comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the 110 110 - 110 millions (21); good manufacturing practice requirements as set CITY art 607), labeling (21 OF X Part 820), and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro needs (2001) (2006) 100 as described in your Section 510(k) I mis letter will anow you to begal finding of substantial equivalence of your device to a legally prematication. The PDF micing of casification 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 If you deale specific acreeliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Wher general information on your responsibilities under the Act may be obtained from the Other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address [phone] 61 (a.qov/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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#### NIHON KOHDEN AMERICA

### G. Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Cardiofax V ; ECG-1500A series Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Cardiofax V electrocardiograph is intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a patient record (monitor and recorder) and prepare a record and/or provide wireless transmission of data to a remote printer and/or computer.

For non-interpretive applications, the device is 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 and older. 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

B.B.maritana

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)