DISPOSABLE MONITORING ELECTRODES

K041954 · Shanghai Intco Electrode Manufacturing Co., Ltd. · DRX · Sep 15, 2004 · Cardiovascular

Device Facts

• Record ID: K041954
• Device Name: DISPOSABLE MONITORING ELECTRODES
• Applicant: Shanghai Intco Electrode Manufacturing Co., Ltd.
• Product Code: DRX · Cardiovascular
• Decision Date: Sep 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

These disposable noninvasive, hypoallergenic electrodes will be used as a conductive medium between the patient and the diagnostic equipment. Depending on the application, different sizes, shapes and a choice of eigher wet gel or solid hydrogel can be used for better results. These electrodes on be used for short-term or long-term applications, up to 3 days. This product is disposable and should only be used for single use.

Device Story

Disposable, non-invasive, adhesive-backed electrodes serve as conductive interface between patient skin and diagnostic equipment. Device consists of stainless steel snap connector, polypropylene substrate, medical-grade fabric/foam/paper backing, Ag/AgCl-coated carbon-filled sensor, and conductive hydrogel or wet gel. Applied by clinicians in clinical settings for ECG, EEG, bio-feedback, or nerve sensing. Conductive gel and adhesive base provide electrical contact; stainless steel snap connects to lead wires or pinch clips. Device facilitates signal acquisition for diagnostic monitoring; disposable nature reduces cross-contamination risk; conformable materials enhance patient comfort during monitoring periods up to 3 days.

Clinical Evidence

Bench testing only. No clinical data. Effectiveness verified via AAMI standard testing: Bias Current Tolerance, DC Offset Voltage, AC Impedance, Combined Offset and Internal Noise, and Recovery Slope Time. Biocompatibility testing (Cytotoxicity, Sensitization, Primary Skin Irritation) performed per ISO 10993-1 and Tripartite Biocompatibility Guidance.

Technological Characteristics

Materials: Stainless steel snap, polypropylene substrate, medical-grade polyester fabric/polyethylene foam/paper, Ag/AgCl-coated 20% carbon-filled plastic sensor, polyurethane foam, conductive wet/solid hydrogel. Connectivity: Universal stainless steel snap for lead wire/pinch clip. Form factor: Adhesive-backed, low-profile, conformable. Sterilization: Non-sterile.

Indications for Use

Indicated for use as a conductive medium between patients and diagnostic equipment for ECG/EKG cardiac monitoring, EEG brain wave monitoring, bio-feedback, and nerve sensing. Suitable for short-term or long-term applications up to 3 days. Single-patient 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

• Lead-Lok Inc. (K832877)
• Lead-Lok Inc. (K911518/D)

Submission Summary (Full Text)

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SEP 1 5 2004

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## Shanghai Intco Electrode Manufacturing Co. 510(k) Summary

The following information is submitted in accordance with the requirements of 21 CFR 807.92

| Submitter's name: | Shanghai Intco Electrode Manufacturing Co., LTD |
|-------------------|----------------------------------------------------|
| | No. 555 Hubin Road, Zhelin Town, FengXian District |
| | Shanghai, PR China 201417 |
| | Phone: [phone] Ext. 849 |
| | Fax: [phone] |
| | [e-mail] |

| Contact person: | Don Sun, General Manager |
|----------------------|--------------------------------------|
| Date Prepared: | July 8, 2004 |
| Device Name: | Disposable EKG monitoring electrodes |
| Common/Usual Name: | Monitoring Electrodes |
| Classification Name: | Electrodes, cutaneous |
| Predicate devices: | Lead-Lok Inc. K832877. K911518/D |

Device Description: These Monitoring Electrodes are non-sterile, hypoallergenic, disposable, adhesive-backed with conductive centers, composed of materials commonly used in this application:

- First Layer: Stainless Steel snap, that works as a connection point for the diagnostic equipment.
- Second Layer: Polypropylene label substrate, used for reinforcement and a printable surface for branding.
- Third Layer: Various materials i.e., medical grade polyester fabric, polyethylene foam and paper, coated with bio-compatible adhesive.

Fourth Layer: Ag/AgCl. coated, 20% carbon filled plastic sensor.

Gel Foam Layer: Polyurethane foam. Only used for conductive wet gel.

Conductive Gel: Bio-compatible conductive solid hydrogel or wet gel

Fifth Layer: Silicone coated release liner to cover the adhesive and conductive media.

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The electrodes are disposable and designed for single-patient use. They have a low profile construction that uses soft pliable and conformable materials for patient comfort. Because of the adhesive nature no extra securing materials are required to anchor the device to the patient's skin. The electrodes have one universal contact point which is a stainless steel snap. The equipment manufacturers provide the receptacle to this in the form of cither a snap lead wire or a pinch clip.

Technological Characteristics: Our clectrodes are technologically equivalent to the predicate devices. They are physically and technically similar to those currently being marketed for ECG/EKG Cardiac monitoring, EEG brain wave monitoring, Bio-beedback and nerve sensing.

Safety and Effectiveness: Our electrodes are as safe and effective as Lead-Lok Inc. electrodes which were previously found to be substantially equivalent via 510(k) Premarket Notification K832877 and K911518/D.

The only two points of contact to the patients skin are the conductive gel and the adhesive-backed base material. Both conductive gels (wet gel and solid hydrogel), underwent the required skin sensitivity testing criteria as specified in the Triportite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact. These tests include Cytotoxicity, Sensitization, and Primary Skin Irritation (test results attached). As you will see, the solid hydrogel test results mention the name Vermont Medical, Lead-Lok/Shanghai Intco acquired this formula from Vernont Medical through a technology exchange. The adhesive backed materials are purchased from outside suppliers that use medical grade adhesive and also adhere to the same test criteria (test results attached)

The effectiveness of the electrodes was determined by running tests according to AAMI standards i.e., Bias Current Tolerance, DC Offset Voltage, AC Impedance, Combined Offset and Internal Noise, Recovery Slope Time and AC Impedance after Defind (test results attached).

For the above reasons, Shanghai Intco Electrode Manufacturing Co. considers its disposable electrodes to be as safe and effective as the predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2004

Shanghai Intco Electrode Manufacturing Co. Ltd. c/o Mr. Chris Healy Lead-Lok Inc. 500 Airport Way Sandpoint, ID 83864

Re: K041954

Trade Name: Disposable ECG Monitoring Electrodes Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrodes Regulatory Class: Class II (two) Product Code: DRX Dated: September 01, 2004 Received: September 07, 2004

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 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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Page 2 - Mr. Chris Healy

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 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 vours.

Brimma for
Brad 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: KO41954

## DEVICE NAME: Disposable ECG/EKG (Electrocardiogram) sensing electrodes

## INDICATIONS FOR USE:

These disposable noninvasive, hypoallergenic electrodes will be used as a conductive medium between the patient and the diagnostic equipment. Depending on the application, different sizes, shapes and a choice of eigher wet gel or solid hydrogel can be used for better results. These electrodes on be used for short-term or long-term applications, up to 3 days. This product is disposable and should only be used for single use.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR:

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

Blatissima

ion Sign-Off) Division of Cardiovascular Device Page 5

510(k) Number K041954