BODY SIGNAL ECG ELECTRODE

K031174 · Wandy Rubber Industrial Co., Ltd. · DRX · Jul 10, 2003 · Cardiovascular

Device Facts

• Record ID: K031174
• Device Name: BODY SIGNAL ECG ELECTRODE
• Applicant: Wandy Rubber Industrial Co., Ltd.
• Product Code: DRX · Cardiovascular
• Decision Date: Jul 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

Body Signal ECG Electrodes are designed for use in general electrocardiograph procedures, ordered by a physician, where ECG monitoring is deemed necessary during X-Ray or florescence examination. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Body Signal ECG Electrodes are non-sterile products and should not be applied on injured skin surface.

Device Story

Body Signal ECG Electrode is a passive, non-sterile, disposable surface electrode; used to acquire electrical signals from patient skin for electrocardiograph (ECG) monitoring and diagnostic recording. Device applied by clinical staff in hospital or clinic settings during X-ray or fluorescence procedures. Functions as a conductive interface between patient skin and ECG monitoring equipment; facilitates transmission of cardiac electrical activity to the monitor. Benefits include continuous cardiac surveillance during imaging procedures, allowing clinicians to observe heart rhythm and detect abnormalities in real-time. Device is non-invasive and intended for prescription use only.

Clinical Evidence

Bench testing only.

Technological Characteristics

Passive surface electrode; conductive material interface; non-sterile; disposable form factor. Designed for compatibility with standard ECG monitoring equipment. No active electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring ECG monitoring or diagnostic recording during X-ray or fluorescence examinations. Contraindicated for application on injured skin surfaces.

Regulatory Classification

Identification

An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus has three branches and a wavy design.

JUL 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wandy Rubber Industrial Co., LTD c/o Ms. Janis Yang No. 24, Alley 37, Lane 392 Fu Teh 1st Rd. Shi-Chih China (Taiwan) 221

Re: K031174

Trade Name: Body Signal ECG Electrode Regulation Number: 21 CFR §870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: April 8, 2003 Received: April 14, 2003

Dear Ms. Yang:

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

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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]. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

Kallertu

am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: Not required in order to submit a 510(K) Device Name: Body Signal ECG electrode

Indications For Use:

Body Signal ECG Electrodes are designed for use in general electrocardiograph procedures, ordered by a physician, where ECG monitoring is deemed necessary during X-Ray or florescence examination. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording.

Body Signal ECG Electrodes are non-sterile products and should not be applied on injured skin surface.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ V (Per 21 CFR 801.109)

OR

510(k) Numbe

Over-The-Counter-Use (Optional Format 1-2-96)

V. DeCentu

**(Division Sign-Off)**
Division of Cardiovascular Devices