PROTAB ECG TABB ELECTRODE

K040784 · Bio Protech, Inc. · DRX · Apr 7, 2004 · Cardiovascular

Device Facts

• Record ID: K040784
• Device Name: PROTAB ECG TABB ELECTRODE
• Applicant: Bio Protech, Inc.
• Product Code: DRX · Cardiovascular
• Decision Date: Apr 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

PROTAB ECG Tab Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include patient ECG surveillance and ECG diagnosis recording. PROTAB ECG Tab Electrodes are nonsterile and are to be used on intact (uninjured) skin.

Device Story

PROTAB ECG Tab Electrodes are disposable, non-sterile surface electrodes used for ECG monitoring and diagnostic recording. Device consists of PET tape, Ag/AgCl ink, and conductive gel; configured as 10 electrodes on a siliconized PET card. Applied to patient skin by clinicians to interface with ECG monitoring equipment. Provides electrical signal conduction from skin to monitor. Benefits include reliable signal acquisition for cardiac surveillance. Used in clinical settings where ECG monitoring is ordered by a physician.

Clinical Evidence

Bench testing only. Device conforms to ANSI/AAMI EC12:2000 standards. Biocompatibility testing performed per ISO 10993-1. Accelerated aging testing supports 24-month shelf life.

Technological Characteristics

Materials: PET tape, Ag/AgCl ink, conductive gel. Form factor: 10 electrodes on siliconized transparent PET card. Standards: ANSI/AAMI EC12:2000 (performance), ISO 10993-1 (biocompatibility). Non-sterile.

Indications for Use

Indicated for patients requiring ECG monitoring or diagnostic recording. For use on intact, uninjured skin. Prescription use only.

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

• Bio Protech, Inc. Telectrode ECG Electrode (K020003)
• Leonard Lang GmbH Skintact® ECG Tab Electrode (K030509)

Submission Summary (Full Text)

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2640784
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APR - 7 2004

## 510(k) SUMMARY

Submitted For: Bio Protech Inc. 1720-26, Wonju Medical Instrument Industry Park Taejang-2 dong, Wonju-si, Gangwon-do Korea Submitted by: E. J. Smith

Smith Associates PO Box 4341 Crofton, MD 21114

January 16, 2004 Date of Submission:

Classification Name:

Electrode, Electrocardiograph Product Code DRX

Class II Device

PROTAB ECG TAB ELECTRODE Proprietary Name:

Common Name: ECG Electrode

Regulatory Reference: CFR 870.2360

Predicate Device: Bio Protech, Inc. Telectrode ECG Electrode K020003 Leonard Lang GmbH Skintact® ECG Tab Electrode K030509

Intended Use: PROTAB ECG Tab Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician.

Such procedures include patient ECG surveillance and ECG diagnosis recording. PROTAB ECG Tab Electrodes are nonsterile and are to be used on intact (uninjured) skin.

Description:

ECG Tab electrodes are composed of a PET tape, Ag/AgCl

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K040784
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ink and a conductive gel. These are configured as 10 (ten) electrodes applied to a siliconized transparent PET card, ten cards per pouch.

| Substantial Equivalence: | PROTAB ECG Tab Electrodes with solid adhesive gel are<br>substantially equivalent to the PROTABECG Tab<br>Electrodes with Skintact@ ECG Tab Electrodes (the<br>manufacturer's predicate - K030509). The Ag/AgCl ink<br>layer added for performance is substantially equivalent to<br>the Bio Protech PRO TECH electrode K020003. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Summary: | PROTAB ECG Tab Electrodes have been tested and<br>conforms to ANSI/AAMI EC12:2000 |
| Biocompatibility Testing: | The biological safety of the PROTAB ECG Tab electrodes<br>has been assured through the selection of materials which<br>demonstrate appropriate levels of biocompatibility. The<br>tests were selected on the basis of ISO 10993-1, Biological<br>Evaluation of Medical Devices - Part 1 - Guidance on<br>selection of tests. |
| Shelf Life: | Accelerated aging testing was performed to substantiate an<br>expiration of 24 months. |
| Conclusion: | This device is substantially equivalent to the devices<br>approved as K020003 and K030509 |

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 7 2004

Bio Protech, Inc. c/o Mr. Ned Devine Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548

Re: K040784

Trade Name: PROTAB ECG TAB ELECTRODE Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II (two) Product Code: DRX Dated: January 21, 2004 Received: March 29, 2004

Dear Mr. Smith:

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.

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Page 2 - Mr. E. J. Smith

Please be advised that FDA's issuance of a substantial cquivalence 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 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]. 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 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,

Dwier R. Lochner

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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## Indications for Use

510(k) Number (if known): K 0 4 0 7 84

Device Name: PROTAB ECG TAB ELECTRODE

Indications for Use:

PROTAB ECG Tab Electrodes are designed for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician.

Such procedures include patient ECG surveillance and ECG diagnosis recording. PROTAB ECG Tab Electrodes are non-sterile and are to be used on intact (uninjured) skin.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

| Nuna R. Lochnes | |
|------------------------------------|--|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |

510(k) Number_k040784

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(Posted November 13, 2003)