Wandy's Dispersive Electrode is intended use to the patient during Electrosurgical procedures to provide a path for RF current to leave the patient and return to the Generator

Device Description

Wandy Dispersive Electrode is designed to provide a safe return path Electrosurgical current between Generator, to active electrode and to patient without cord. And able to use to any patient if full skin contact available. non sterilized and to use only one time.

The surface of the conductive area is covered with a Bio-compatible Hydro-gel and the surface of the non-conductive area made of PE Foam and Texture Fabric is covered with Medical grade adhesive for maximum skin adhesion. This device are non sterilized and one time use only, available 3 sizes with various shape for Adult / Pediatric

AI/ML Overview

The Wandy Dispersive Electrode is an electrosurgical grounding pad. The provided text, a 510(k) summary, details its safety and effectiveness for FDA clearance.

Here's an analysis of the acceptance criteria and the study information based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance	Study that Proves Device Meets Criteria
Biocompatibility	* Conforms to ISO 10993-1: Biological Evaluation of Medical Device.	Test Report attached (mentioned in section 7. Bio-Compatibility). Details not provided in this summary.
* In vitro Cytotoxicity: ISO 10993-5 (2002)	Conformed	Test Report attached (mentioned in section 7. Bio-Compatibility). Details not provided.
* Skin Sensitization/Irritation: ISO 10993-10 (2009)	Conformed	Test Report attached (mentioned in section 7. Bio-Compatibility). Details not provided.
Electrical Safety/Performance	* Meets IEC 60601-2-2 (Ed 5/9, 2009-02) General requirement for safety.	Bench test done by manufacturer in accordance with IEC 60601-2-2: 2006-59.104.5 / 104.79b(b).(c). Report attached (mentioned in section 6. Intended use). Details not provided.
* Output Power: 300W, 700mA @615 ohms for less than 60 seconds.	Same as predicate cleared electrode device.	Bench testing (explicitly mentioned for electrical safety). Comparison to predicate. No specific study details provided beyond "Bench test done by manufacturer."
Substantial Equivalence	* Substantially equivalent to several predicate devices in respect to intended use, main function, technology, principal operation, and performance. * Does not raise any additional concerns regarding safety and effectiveness.	This is an overall claim based on the technical characteristics and testing described. The 510(k) process itself establishes substantial equivalence. No specific comparative study with the predicate is detailed beyond a statement of "intended use, same output power... as predicate cleared electrode device."

Note: The provided 510(k) summary emphasizes equivalence to a predicate device and adherence to international standards. It references "attached reports" for biocompatibility and bench testing, but the actual data and detailed methodologies of these studies are not included in the provided text.

Study Information (Based on available text)

Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated for any of the tests. The document refers to "Bench test done by manufacturer" and "Test Report attached" for biocompatibility, but no specifics on sample size are provided.
- Data provenance: The tests were conducted by the manufacturer (Wandy Rubber Industrial Co., Ltd) in Taiwan, R.O.C., as indicated by the manufacturer's address. The data is retrospective in the sense that the tests were performed to support the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of this device and submission. The "ground truth" for a medical device like a dispersive electrode is typically established through adherence to recognized international standards (e.g., ISO for biocompatibility, IEC for electrical safety), not through expert consensus on diagnostic images or clinical outcomes. The standards themselves define acceptance criteria.
Adjudication method for the test set:
- Not applicable. The tests performed (biocompatibility, electrical safety) are objective measurements against defined criteria in international standards, not subjective assessments requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This is a therapeutic device (electrosurgical accessory), and such a study is not appropriate or required for its clearance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a way. The device's performance was evaluated in standalone bench tests according to specified standards (e.g., IEC for electrical performance, ISO for biocompatibility) without requiring human intervention in its primary function for the evaluation. These tests assess the device's inherent characteristics.
The type of ground truth used:
- Standards-based performance criteria: For electrical safety, the ground truth is defined by the parameters and limits specified in IEC 60601-2-2. For biocompatibility, it's the criteria outlined in ISO 10993-1, ISO 10993-5, and ISO 10993-10. These are objective engineering and biological safety standards.
- Comparison to predicate device: For technological characteristics like output power, the "ground truth" for substantial equivalence is the established performance of the legally marketed predicate device (K100686 Conmed Corp Macrolyte Dispersive Electrode).
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

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K121268

Summary of safety and effectiveness

DEC 2 0 2012

In accordance with Section 513 (1) of the SMDA as defined in 21CFR part 807.3 this summary is submitted to obtain Pre-Market 510 (K) notification.

1. Submitter / Contact person.

Mr. Young Chi, President Bio-Med USA Inc. ( Reg Nr. 2246683) 111 Ellison Street, Paterson, NJ 07505. U.S.A. Tel: 1 973 278 5222 Fax: 201 934 6030 e mail : biomedusa@msn.com

2. Manufacturer

Wandy Rubber Industrial Co., Ltd ( Reg Nr. 3003749270) 48, Lane 392, Fu Teh 1st RD Xi-Zhi dist 221, New Taipei City, Taiwan, R.O.C. Tel: 886 2 2694 3184 Fax: 2 2694 4574

3. Name of Device

Trade name	Wandy Dispersive Electrode
Classification name :	Electrosurgical, Cutting, Coagulation & Accessories
Panel	Plastic and General Surgery
Common name	Grounding Pad
Regulation	878.4400Class II
Product Code	ODR

4. Legally marketed Predicate Device

K100686 Conmed Corp Macrolyte Dispersive Electrode

5. Device Description

Manufactured in accordance with both mandatory and voluntary standards

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IEC 60601-2.2 Medical Electrical equipment part 2-2 Ed 5/9 2009-02 General requirement for safety Performing, Bench test done by manufacturer accordance, IEC 60601-2-2: 2006-59.104.5 / 104.79b(b).(c) / and attached report ISO10993-5 Invitro Cytotoxicity 2002 10 Skin Sensitization / Irritation 2009

6. Intended use

. Wandy's Dispersive Electrode is intended use to the patient during Electrosurgical procedures to provide a path for RF current to leave the patient and return to the Generator

7. Technological Characteristic.

Proposed device are single use, non-sterilized with connector to use with any Electrosurgical device. And designed with PE form or Textile fabric on non conductive area and self-adhesive Hydro-gel on conductive area, with Rectangle shape. This device has same indication for use, same output power (300W, 700mA @615 ohms for less than 60 seconds )as predicate cleared electrode device in the market.

7. Bio-Compatibility

The biological safety of used components of Wandy's Dispersive Electrode was conformed by the guidance of ISO 10993-1: Biological Evaluation of Medical Device

Test Report attached

8. Safety and Effectiveness.

Wandy's Dispersive Electrode is substantially equivalent to several predicate devices that have already been cleared in respect to Intended use. Main function, Technology, Principal operation and performance.

So, it does not raise any additional concerns regarding safety and effectiveness.

Wandy's Rubber Industry will include in this summary with updates on any other information deemed seasonally necessary by the FDA.

End of summary

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of the usual two.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service .

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 20, 2012

Bio-Med USA, Incorporated % Mr. Young Chi President 111 Ellison Street Paterson, New Jersey 07505

Re: K121268

Trade/Device Name: Wandy Dispersive Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: ODR Dated: November 15, 2012 Received: November 20, 2012

Dear Mr. Chi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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 (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. 1

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Page 2 - Mr. Young Chi

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Wandy Rubber

Dispersive Electrode

Indication for use statement

510 (K ) number : 121268

Device name : Wandy's Dispersive Electrode

Indication for use : Wandy's Dispersive Electrode is intended use to the patient during Electrosurgical procedures to provide a path for RF current to leave the patient and return to the Generator

or/and Over the Counter use Prescription use XX (Part 21CFR 801 Sub part C) (Part 21 CFR 801 Sub part D )

Please do not write below line-continued an another pages if needed Concurrence of CDRH, office of Device Evaluation ( ODE )

Brian DN 6

Division of Surgical Devices 510(k) Number: K121268

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.