JIAJIAN SELF-ADHESIVE ELECTRODE

K090198 · Wuxi Jiajian Medical Instrument Co., Ltd. · GXY · Jun 23, 2009 · Neurology

Device Facts

• Record ID: K090198
• Device Name: JIAJIAN SELF-ADHESIVE ELECTRODE
• Applicant: Wuxi Jiajian Medical Instrument Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Jun 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The self-adhesive electrode is intended to be used to apply electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS (Transcutaneous Electrical Nerve Stimulation) EMS (Electrical Muscular Stimulation)

Device Story

Jiajian Self-adhesive Electrode is a non-sterile, flexible, reusable cutaneous electrode; used to deliver electrical stimulation current (TENS/EMS) to patient skin. Device consists of three layers: nonwoven fabric tape; conductive carbon cloth; biocompatible conductive hydrogel. Available in six shapes (round, rectangle, oval, gourd, butterfly, saddle). Features lead wire assembly (min 40mm length) with 2.5mm female socket for connection to nerve/muscle stimulators. Operated by clinicians or patients in clinical or home settings. Output is electrical current distribution across skin surface; facilitates therapeutic stimulation. Benefits include non-invasive delivery of electrical therapy for nerve/muscle stimulation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility testing (ISO 10993-5 cytotoxicity, ISO 10993-10 irritation/sensitization), impedance testing, adhesive testing, and electrical lead wire performance testing per 21 CFR 898 and IEC 60601-1.

Technological Characteristics

Non-sterile, flexible cutaneous electrode. Materials: nonwoven fabric tape, conductive carbon cloth, biocompatible conductive hydrogel. Lead wire assembly: 2.5mm female socket, compliant with 21 CFR 898 and IEC 60601-1. Biocompatibility per ISO 10993-5 and ISO 10993-10. Reusable, single-patient use.

Indications for Use

Indicated for patients requiring electrical stimulation therapy, specifically TENS or EMS, via cutaneous application.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• Self-Adhesive electrodes (K080276)
• SOF-PACH™ Reusable Neurostimulation Electrodes (K020735)

Submission Summary (Full Text)

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Wuxi Jiajian Medical Instrument Co., Ltd Qinghong Rd., Ehu Town, Xishan District, Wuxi, China Phone: [phone] Fax: [phone] URL: www.jiajian-healthcare.com

K09019
ASIAN
佳健医疗

510 k .

大090198

## Section 4 . Premarket Notification [510(k)] Summary [As required by CFR 21 807.92(c)]

Date: Submitter: May 7th 20092 Wuxi Jiajian Medical Instrument Co., Ltd Qinghong Rd., Ehu Town, Xishan District, Wuxi, China 214116 Doris Dong E-mail: autumn [e-mail] Tel: [phone] Fax: [phone] Thomas Pang JUN 23 2009 E-mail: kapo [e-mail] Tel: [phone] Fax: [phone]

Contactor:

US Agent:

Device Summary:

Trade Name: Common or Usual Name: Classification Name: Product Code: Regulation Number: Medical Specialty: Device Class: Device Description:

Jiajian Self- adhesive Electrode Cutaneous electrode Electrode, cutaneous GXY 882.1320 Neurology п

Jiajian branded Self-adhesive Electrodes, wire type, are non-sterile flexible structures, composed of materials commonly used in this application:

First layer: Nonwoven fabric tape

Second layer. Electrically conductive carbon cloth (ValueTrode® Carbon, K970426)

Third layer: Biocompatible conductive hydrogel coupling media (ValueTrode GEL, K970426), which has passed the required skin sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specifeid in ISO ISO 10993-5.

The electrodes are designed for single patient / multiple application use. It can be used for low-frequency or medium-frequency nerve or muscle stimulators, as the conduction film adhered to body skin.

There are six shapes of round, rectangle, oval, gourd, butterfly and saddle of the electrodes.

For the electrical connection, Jianjian provides wire type:

Lead wire assembly - at least 40mm long wire with 2.5mm diameter female socket, connected to one side of the wire.

The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR Part 898 by testing under IEC 60601-1. subclause 56.3(c).

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JIAIAN
佳盛医門

The self-adhesive electrode is intended to be used to apply electrical stimulation current to the patient's skin.

Example electrical stimulations for current applications of the electrodes are: TENS and EMS

#### Substantial Equivalence Infomration:

#### 1) Predicate Device 1:

- 510(k) Number:
Marketing clearance date:

Product name: Manufacturer: Self-Adhesive electrodes

K080276

August 4th, 2008

Cathay healthcare equipment manufacturing. Inc

2) Comparison with predicate device

Similarities:

I ) Similar materials composition and intended use:

2) Both are non-sterile and reusable;

3) Both were established biocompatibility on standards of

ISO 10993-5-1999: Tests for cytotoxicity: In vitro methods:

ISO 10993-10: 2002: Tests for Irritation and Sensitization

4) Both electrodes distributes electrical current evenly.

Differences:

For intended use, the Self-Adhesive electrodes with K080276 is also intended to be used to record physiological signals, while Jiajian Selfadhesive Electrode is not.

3) Conclusion:

JIAJIAN MEDICAL considers Jiajian Self- adhesive Electrode to be as safe and effective as the predicate device of Self-Adhesive electrodes (K080276).

#### 1) Predicate Device 2:

| 510(k) Number: | K020735 |
|---------------------------|------------------------------------------------|
| Marketing clearance date: | July 12th, 2002 |
| Product name: | SOF-PACH™ Reusable Neurostimulation Electrodes |
| Manufacturer: | CATHAY INTERNATIONAL LTD. |

2) Comparison with predicate device

Similarities:

1) Similar materials composition and structures;

2) Similar intended use;

3) Both are non-sterile and reusable;

4) Both were established biocompatibility on standards of ISO 10993-1

5) Both are safe and effective by impedance and adhesive testing

6) Both lead wires conform to FDA 21 CFR Part 898.

#### Differences:

As to the first layer of the material of the electrode, OF-PACHTM Reusable Neurostimulation Electrodes use more kinds of materials, while Jiajian Self- adhesive Electrodes only use nonwoven fabric

#### 3) Conclusion:

JIAJIAN MEDICAL considers Jiajian Self- adhesive Electrode to be as safe and effective as the predicate device of SOF-PACH™ Reusable Neurostimulation Electrodes (K020735).

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

2 3 2009 JUN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wuxi Jiajian Medical Instrument Co., Ltd. c/o Doris Dong Technical Manager Oinghong Rd., Ehu Town Xishan District Wuxi, Jiangsu China 214116

Re: K090198

Trade/Device Name: Jiajian Self-Adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: May 7, 2009 Received: June 2, 2009

Dear Ms. Dong:

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat 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 (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.

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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/CDRH0ffices/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/cdrh/mdr/ 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/cdrl/industry/support/index.html.

Sincerely yours.

Kesia Alexander fa

Marvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Section 3 Statement of Indications for Use

510(k) Number (if known): K090198

Device Name: Jiajian Self- adhesive Electrode

Indications for Use:

The self-adhesive electrode is intended to be used to apply electrical stimulation current to the patient's skin.

Example electrical stimulations for current applications of the electrodes are: TENS (Transcutaneous Electrical Nerve Stimulation) EMS (Electrical Muscular Stimulation)

Prescription Use V (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)

Moncurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Z

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K090198

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