INTCO TAB ELECTRODE

K093327 · Shanghai Intco Electrode Manufacturing Co., Ltd. · DRX · May 10, 2010 · Cardiovascular

Device Facts

• Record ID: K093327
• Device Name: INTCO TAB ELECTRODE
• Applicant: Shanghai Intco Electrode Manufacturing Co., Ltd.
• Product Code: DRX · Cardiovascular
• Decision Date: May 10, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

INTCO Tab Electrodes are designed for use with general electrocardiographic procedures when ECG monitoring is deemed necessary by a physician. Such procedures include ECG surveillance and diagnosis recording. INTCO Tab Electrodes are non-sterile and are to only be used on intact (uninjured) skin.

Device Story

Disposable ECG tab electrode; used for ECG surveillance and diagnostic recording. Input: electrical signals from patient skin. Output: conductive interface for ECG monitoring equipment. Composed of PET tape, Ag/AgCl or carbon conductive layer, and conductive gel. Applied to patient skin by clinician. Non-sterile; intended for intact skin. Benefits: provides reliable signal acquisition for cardiac monitoring.

Clinical Evidence

Bench testing only. Device conforms to ANSI/AAMI EC12:2000/(R)2005 consensus standards. Biocompatibility testing per ISO 10993-1 confirmed conductive gel is non-irritating, non-cytotoxic, and non-sensitizing. Accelerated aging tests support 24-month shelf life.

Technological Characteristics

Materials: PET tape, Ag/AgCl or carbon conductive layer, conductive gel. Form factor: Tab electrode, 10 electrodes per siliconized card. Connectivity: Passive interface for ECG monitoring. Standards: ANSI/AAMI EC12:2000/(R)2005, ISO 10993-1.

Indications for Use

Indicated for patients requiring ECG surveillance and diagnostic recording during general electrocardiographic procedures. For use on intact (uninjured) skin 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

• Leonard Lang GmbH Skintact ECG Tab Electrode (K030509)

Submission Summary (Full Text)

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510(K) Summary

093327

## MAY 1 0 2010

| Date: | 10/22/2009 |
|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted on behalf of: | Michael Zhu<br>Shanghai Intco Electrode Manufacturing Co., Ltd.<br>No. 1299, Hubin Rd, Fengxian District<br>Shanghai China<br>Tel: ++ 0086-21-57451159<br>Fax: ++ 0086-21-57451877 |
| Submitted by: | Lead-Lok, Inc.<br>814 Airport Way<br>Sandpoint, ID 83864 |
| Contact person: | Chris Healy, President<br>Tel: [phone] Fax [phone] |
| | |
| Trade Name:<br>Common Name:<br>Classification Name<br>Product Panel<br>Product Code<br>Product Class<br>Regulatory Reference: | INTCO Tab Electrode<br>Disposable ECG Electrode<br>Electrode, Electrocardiograph<br>Cardiovascular<br>DRX<br>Class II Device<br>CFR 870.2360 |
| Predicate Device | Leonard Lang GmbH Skintact ECG Tab Electrode K030509 |
| Description: | INTCO Tab electrodes are composed of PET tape, Ag/AgCl or carbon<br>conductive layer, and a conductive gel. These are configured as ten<br>electrodes applied to a siliconized card, with 10 cards per pouch |
| Intended Use: | INTCO Tab Electrodes are designed for use with general<br>electrocardiographic procedures when ECG monitoring is deemed<br>necessary by a physician. Such procedures include ECG surveillance and<br>diagnosis recording. INTCO Tab Electrodes are non-sterile and are to only<br>be used on intact (uninjured) skin. |
| Substantial Equivalence: | INTCO Tab Electrodes with solid adhesive gel are substantially equivalent to<br>Skintact ECG Tab Electrodes (K030509). Physical and technical<br>characteristics, including materials used, intended use, and conformance to<br>standards are comparable. |
| Performance Summary: | INTCO Tab Electrodes have been tested and conform to recognized<br>consensus standard 3-52: ANSI/AAMI EC12:2000/(R)2005 |
| Biocompatibility: | The biological safety of the INTCO Tab electrodes has been assured<br>through the selection of materials which demonstrate appropriate levels of<br>biocompatibility. The conductive gel has been tested on the basis of ISO<br>10993-1 and found to be non-irritating, non-cytotoxic, and non sensitizing. |
| Shelf life: | Accelerated aging tests were performed to substantiate an expiration of 24<br>months. |
| Conclusion: | INTO Tab Electrodes are substantially equivalent to the predicate device<br>approved as K020003 and do not introduce new issues of safety or<br>effectiveness. |

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Image /page/1/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, and three human faces in profile are visible within the eagle's body. The seal is black and white.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAY 1 0 2010

Shanghai Intco Electrode Manufacturing Co., Ltd c/o Mr. Chris Healy Lead-Lok, Inc. 814 Airport Way Sandpoint, ID 83864

Re: K093327

> Trade/Device Name: Intco Tab Electrode Regulatory Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: II (two) Product Code: 74 DRX Dated: April 23, 2010 Received: April 27, 2010

Dear Mr. Healy:

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 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. Chris Healy

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

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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## Indications for Use

KO73327 510(k) Number (if known):

Device Name: INTCO Tab Electrode

Indications for Use:

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

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.C.

diovascular Devices

510(k) Number K093327

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