DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES

K091672 · Shuyou Electric Medical Science Co., Ltd. · GEI · Dec 4, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091672
• Device Name: DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES
• Applicant: Shuyou Electric Medical Science Co., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Disposable Grounding Pad series devices are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator. The Disposable Electrode series devices are intended to conduct radio frequency (RF) current for cutting and coagulation from the electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.

Device Story

Disposable Grounding Pad and Electrode series are electrosurgical accessories. Grounding pads conduct electrosurgical energy from patient tissue back to an electrosurgical unit (ESU). Electrodes conduct radio frequency (RF) current from the ESU to target soft tissue for cutting and coagulation. Used in clinical surgical settings by healthcare professionals. Devices facilitate electrosurgery, enabling tissue cutting and cauterization during various surgical procedures.

Clinical Evidence

Bench testing only. The devices were tested for compliance with mandatory and voluntary standards, including IEC 60601-1 (General requirements for safety) and IEC 60601-2-2 (Particular requirements for the safety of high frequency surgical equipment).

Technological Characteristics

Electrosurgical accessories (grounding pads and electrodes). Designed for use with high-frequency surgical equipment. Compliant with IEC 60601-1 and IEC 60601-2-2 standards. Disposable, single-use form factor.

Indications for Use

Indicated for patients undergoing surgical procedures requiring electrosurgical cutting and coagulation. Used to conduct RF current to target soft tissue and return electrosurgical energy to the generator.

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

• Skintact Cool Contact Electrosurgical Grounding Plates (K063161)
• E-Z Clean electrosurgical electrodes (K081791)

Submission Summary (Full Text)

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510(k) Report - Section 3 510(k) Summary Report SN: A2009-06-01

## Section 3 510(k) Summary

As required by 807.97

The assigned 510(k) Number is ________________________________________________________________________________________________________________________________________________

| Sponsor | Shuyou Electric Medical Science Co., Ltd. |
|---------------------|--------------------------------------------------------------|
| | Anji · Economic Development Zone Health(medicine) |
| | Industrial Park ,Huzhou ,Zhejiang,China, 313300 |
| | Ms. Wei Liu |
| | Tel:[phone] ext. 801 |
| | Fax: [phone] |
| | Email: [e-mail] |
| Submission | Ms. Diana Hong / Mr. Tarzan Wang |
| Correspondent | Shanghai Mid-Link Business Consulting Co., Ltd |
| | Sute 8D, No. 19, Lane 999, Zhongshan No.2 Road(S) |
| | Shanghai, 200030, China |
| | Tel: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Proposed Product | |
| Trade Name | Disposable Grounding Pad series/ Disposable Electrode |
| | series |
| Product Code: | GEI |
| Regulation Number: | 21 CFR 878.4400 |
| Device Class: | Class II |
| Submission Purpose: | New Device |
| Predicate Device: | Skintact Cool Contact Electrosurgical Grounding Plates |
| | (K063161) |
| | E-Z Clean electrosurgical electrodes (K081791) |
| | |
| Test Conclusion | The Disposable Grounding Pad and Disposable Electrode are |
| | designed, tested and will be manufactured in accordance with |
| | both mandatory and voluntary standards, including: |
| | |
| | IEC 60601-1, Medical Electrical Equipment - Part 1: General |

. 3-1

K091672

4 2009

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510(k) Report – Section 3 510(k) Summary Report SN: A2009-06-01

| Report SN: A2009-06-01 | Requirements for Safety, 1988; Amendment 1, 1991-11,<br>Amendment 2, 1995. |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IEC 60601-2-2, Medical Electrical Equipment - Part 2-2:<br>Particular requirements for the safety of high frequency<br>surgical equipment. |
| SE Determination | The proposed device is Substantially Equivalent (SE) to the<br>predicate device which is US legally market device.<br>Therefore, the subject device is determined as safe and<br>effectiveness. |
| Intended<br>Use/Indication for Use | The Disposable Grounding Pad series devices are to conduct<br>electrosurgical energy from target tissue of a patient back to<br>an electrosurgical unit (ESU), or generator. |
| | The Disposable Electrode series devices are intended to<br>conduct radio frequency (RF) current for cutting and<br>coagulation from the electrosurgical generator to target soft<br>tissue in a broad range of surgical procedures requiring the<br>use of electrosurgery for cutting and cauterization. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an emblem featuring a stylized depiction of an eagle or other bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

## DEC - 4 2009

Shuyou Electric Medical Science Co., Ltd. % Shanghai Mid-Link Business Consulting Co., Ltd. Ms. Diana Hong, General Manager Suite 8D, No. 19, Lane 999, Zhongshan No. 2 Road(S) Shanghai, 200030, China

Re: K091672

Trade/Device Name: Disposable Grounding Pad Series and Disposable Electrode Series Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, ODR Dated: November 13, 2009 Received: November 17, 2009

Dear Ms. Hong:

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 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

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Page 2 – Ms. Diana Hong

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.

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,

Mark McMullen

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

Enclosure

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## Indication For Use

510(k) Number (if known): ___ Pending_________________________________________________________________________________________________________________________________________

Device Name: Disposable Grounding Pad Series

Indications for Use:

The Disposable Grounding Pad series devices are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.

Prescription Use _ J (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Us __ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

FOR M. MELKERSON

on Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091672

Page _1_of_2_

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## Indication For Use

510(k) Number (if known):

Device Name: Disposable Electrode Series.

Indications for Use:

The Disposable Electrode series devices are intended to conduct radio frequency (RF) current for cutting and coagulation from the electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.

Prescription Use (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

FOR M. MELKERSON

K091672 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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