WANDY DISPERSVIE ELECTRODE

K121268 · Bio-Med USA, Inc. · ODR · Dec 20, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121268
• Device Name: WANDY DISPERSVIE ELECTRODE
• Applicant: Bio-Med USA, Inc.
• Product Code: ODR · General, Plastic Surgery
• Decision Date: Dec 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Pediatric

Indications 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

Device Story

Wandy Dispersive Electrode provides safe return path for electrosurgical RF current between patient and generator. Device consists of conductive area covered with bio-compatible hydro-gel and non-conductive area made of PE foam or textile fabric with medical-grade adhesive for skin attachment. Single-use, non-sterile device available in three sizes/shapes for adult and pediatric use. Operated by clinicians during electrosurgical procedures; device ensures current return to generator, preventing patient burns. Benefits include secure skin adhesion and reliable electrical path during surgery.

Clinical Evidence

Bench testing only. Includes compliance with IEC 60601-2-2 (General requirements for safety of electrosurgical equipment) and ISO 10993-5 (In vitro cytotoxicity, skin sensitization, and irritation). No clinical data provided.

Technological Characteristics

Single-use, non-sterile dispersive electrode. Materials: PE foam or textile fabric (non-conductive), bio-compatible hydro-gel (conductive), medical-grade adhesive. Dimensions: 3 sizes/shapes. Electrical: 300W, 700mA at 615 ohms for <60 seconds. Standards: IEC 60601-2-2, ISO 10993-1, ISO 10993-5. Connectivity: Connector for electrosurgical generators.

Indications for Use

Indicated for patients undergoing electrosurgical procedures requiring a return path for RF current to the generator. Suitable for adult and pediatric patients where full skin contact is achievable.

Regulatory Classification

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.

Predicate Devices

• Conmed Corp Macrolyte Dispersive Electrode (K100686)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] e mail : [e-mail]

#### 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: [phone] Fax: [phone]

#### 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 | 878.4400<br>Class II |
| Product Code | ODR |

#### 4. Legally marketed Predicate Device

K100686 Conmed Corp Macrolyte Dispersive Electrode

#### 5. 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

# 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 [phone] or [phone] 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