ECG ELECTRODES APRON

K982470 · Tapuz Medical Technology , Ltd. · DRX · Oct 14, 1998 · Cardiovascular

Device Facts

• Record ID: K982470
• Device Name: ECG ELECTRODES APRON
• Applicant: Tapuz Medical Technology , Ltd.
• Product Code: DRX · Cardiovascular
• Decision Date: Oct 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

The ECG Electrodes Apron is a reusable electrode system intended for use in rest ECG recording. The ECG Electrodes Apron is compatible for use with most ECG instruments on the market.

Device Story

ECG Electrodes Apron is a reusable electrode system for rest ECG recording. Device consists of gold-plated electrodes cast into a hyper-flexible silicone apron with copper conductors. Apron stretches to fit various body shapes and sizes. Connects to standard ECG instruments via standard cable. Used in clinical settings by healthcare providers to acquire electrical signals from patient skin for diagnostic ECG monitoring. Benefits include ease of application and compatibility with most existing ECG instrumentation.

Clinical Evidence

No clinical data. Effectiveness established through comparative bench testing with market-cleared predicate devices.

Technological Characteristics

Materials: gold-plated electrodes, copper conductors, silicone apron. Form factor: flexible, stretchable apron. Connectivity: standard cable interface for ECG instruments. Biocompatibility: tested per ISO 10993-1.

Indications for Use

Indicated for rest ECG recording in patients of all body shapes and sizes, men and women alike.

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.

Predicate Devices

• Paljet-B (Golden Gate Bio-Device) (K973663)
• Electrode set of the Mortara Model Eli 100 (Mortara Instruments) (K920627)
• Electrode set of the Cardiofax ECG 6551 (Nihon Kohden) (K863116)

Submission Summary (Full Text)

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# 510(k) Summary TAPUZ Medical Technology Ltd. ECG Electrodes Apron 510(k) Number K 9824 7d

#### Applicant's Name:

TAPUZ Medical Technology Ltd. 1 Alon Hatavor St. Caesarea Industrial Park 38900, Israel

## Contact Person:

Shoshana Friedman Push-med Ltd. 117 Ahuzah St. Ra'ananna 43373, Israel Tel: [phone] Fax: [phone]

#### Date Prepared:

July 12, 1998

#### Trade Name:

ECG Electrodes Apron

## Classification Name:

Electrocardiograph Electrodes

#### Classification:

The FDA has classified electrocardiograph electrodes as a class II device (product code 74 DRX) and it is reviewed by the Cardiovascular Devices Branch.

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## 1982470

#### Indication for Use:

The ECG Electrodes Apron is a reusable electrode system intended for use in rest ECG recording. The ECG Electrodes Apron is compatible for use with most ECG instruments on the market.

#### Device Description:

ECG Electrodes Apron is a system of ECG electrodes cast in a The hyper-flexible silicone apron The electrodes are gold-plated and the conductors are made of copper. The entire apron, including the conductors, is flexible and can be stretched to fit all body shapes and sizes, men and women alike. The apron is connected by a standard cable and is compatible with almost any type of commonly used ECG instrument.

#### Performance Standards:

No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act.

#### Safety and Effectiveness:

The biological safety of the ECG Electrodes Apron has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility and verified through biocompatibility testing per ISO 10993-1.

The effective performance of the ECG Electrodes Apron has been established through comparative testing with market-cleared devices.

#### Substantial Equivalence:

The ECG Electrodes Apron is substantially equivalent to the Paljet-B (Golden Gate Bio-Device) cleared under K973663, the electrode set of the Mortara Model Eli 100 (Moratara Instruments) cleared under K920627, and the electrode set of the Cardiofax ECG 6551 (Nihon Kohden) cleared under K863116. Furthermore, in respect to performance, the ECG Electrodes Apron is substantial equivalent to most of the reusable electrode sets and may be connected to most of the ECG instruments on the market.

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OCT 1 4 1998

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Akiva Sharon, M.D., M.Sc. Managing Director TAPUZ Medical Technology Ltd. 1 Alon Hatavor Street, P.O.B 3559 Caesarea Industrial Park 38900 ISRAEL

Re: K982470 ECG Electrodes Apron Regulatory Class: II (two) Product Code: 74 DRX Dated: July 12, 1998 Received: July 16, 1998

Dear Dr. Sharon:

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 Failure to comply with the GMP regulation may result in assumptions. 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 - Akiva Sharon, M.D., M.Sc.

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"(21CFR 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. 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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### INDICATIONS FOR USE

**510(k) Number (if known):** K982470

Device Name:

ECG Electrodes Apron

Indications for Use:

The ECG Electrodes Apron is a reusable electrode system intended for use in rest ECG recording. The ECG Electrodes Apron is compatible for use with most ECG instruments on the market.

## (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

N. Della Tilla

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Dev 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________