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 Description

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).

AI/ML Overview

This document is a 510(k) Premarket Notification for the Jiajian Self-adhesive Electrode. It's a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, not a study reporting on specific acceptance criteria and device performance in the way a clinical trial or detailed engineering report would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be directly extracted from this document, as this type of information is generally NOT part of a 510(k) summary for this class of device.

510(k) submissions for devices like a self-adhesive electrode typically focus on demonstrating substantial equivalence in terms of:

Intended Use: The purpose of the device.
Technological Characteristics: How the device works and its materials.
Performance Data: This usually involves non-clinical bench testing (e.g., biocompatibility, electrical performance, adhesive strength) to show it meets recognized standards or performs similarly to the predicate. It does not typically involve extensive clinical trials or human-in-the-loop studies.
Biocompatibility: Showing materials are safe for human contact.

Based on the provided text, here's what can be gathered, addressing the spirit of your request where possible, and noting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of quantitative acceptance criteria with corresponding performance data in the way you might expect from a detailed validation report. Instead, it relies on demonstrating compliance with recognized standards and similarity to predicate devices.

Acceptance Criteria (Implied by Standards/Predicate)	Reported Device Performance
Material Biocompatibility:
- Skin sensitivity testing criteria (ISO 10993-10)	- Biocompatible conductive hydrogel coupling media (ValueTrode GEL, K970426) passed the required skin sensitivity testing criteria as specified in ISO 10993-10
- Cytotoxicity testing criteria (ISO 10993-5)	- Biocompatible conductive hydrogel coupling media (ValueTrode GEL, K970426) passed the required cytotoxicity testing criteria as specified in ISO 10993-5 - Both (predicate and proposed) 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.
Electrical Lead Wire Conformity:
- FDA performance standard 21 CFR Part 898	- 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). - Both predicate 2 and proposed device lead wires conform to FDA 21 CFR Part 898.
Electrical Current Distribution:	- Both (predicate 1 and proposed) electrodes distribute electrical current evenly. (This is a qualitative statement of similarity, not a measured performance against a specific criterion).
Impedance and Adhesive Testing:	- Predicate 2 and proposed device are safe and effective by impedance and adhesive testing. (This indicates that such testing was performed, but specific values or criteria are not detailed in this summary).
Intended Use: (Applying electrical stimulation current)	- The device is intended to be used to apply electrical stimulation current to the patient's skin. (Demonstrated through similarity to predicate devices with the same intended use).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not specified in this 510(k) summary. For devices of this nature, testing typically involves bench-top studies on a certain number of manufactured units rather than large clinical test sets with human subjects.
Data Provenance: Not explicitly stated as "country of origin" for tests, but the manufacturer is Wuxi Jiajian Medical Instrument Co., Ltd in China. The testing itself is referenced against international standards (ISO, IEC) and FDA regulations. It is not specified if tests were retrospective or prospective, but typically bench testing would be considered prospective for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Experts and Qualifications: Not applicable/not specified in this type of 510(k) submission. "Ground truth" in the clinical imaging or diagnostic sense is not relevant for this device. The assessment is primarily based on engineering and biocompatibility testing against established standards.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable/not specified.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

MRMC Study: No, this type of study is not relevant or reported for a self-adhesive electrode. An MRMC study is typically for evaluating diagnostic imaging devices or AI algorithms that assist human readers in interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Not applicable. This device is a passive electrode, not an algorithm.

7. The Type of Ground Truth Used:

Ground Truth: For this device, "ground truth" equates to established international standards (ISO 10993, IEC 60601) and FDA regulations (21 CFR Part 898) for biocompatibility, electrical performance, and safety. The device's performance is measured against the requirements of these standards.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This device is not an AI algorithm that requires a training set. The "design" or "development" of the product is distinct from machine learning training.

9. How the Ground Truth for the Training Set was Established:

Training Set Ground Truth Establishment: Not applicable, as there is no training set for this device.

Summary

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Wuxi Jiajian Medical Instrument Co., Ltd Qinghong Rd., Ehu Town, Xishan District, Wuxi, China Phone: 0510-88745788 Fax: 0510-88746629 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 cool@126.com Tel: 86 21 5834 2283 Fax: 86 21 5834 0486 Thomas Pang JUN 23 2009 E-mail: kapo optik@yahoo.com Tel: 1 626 350 2108 Fax: 1 626 302 3398

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

Comparison with predicate device

Similarities:

I ) Similar materials composition and intended use:

Both are non-sterile and reusable;
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

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.

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.

Comparison with predicate device

Similarities:

Similar materials composition and structures;
Similar intended use;
Both are non-sterile and reusable;
Both were established biocompatibility on standards of ISO 10993-1
Both are safe and effective by impedance and adhesive testing
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 (800) 638-2041 or (240) 276-3150 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)

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

510(k) Number K090198

Page I of 1 Updated December 19th, 2008

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
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.(b)
Classification. Class II (performance standards).