KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS

K132771 · Qingdao Kingston Medical Devices, Ltd. · GEI · Oct 28, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K132771
• Device Name: KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS
• Applicant: Qingdao Kingston Medical Devices, Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Endoscopic Surgical Instruments are intended for cutting, grasping, dissecting and coagulation of soft tissue in endoscopic surgical procedures. They are intended for single patient use.

Device Story

Disposable endoscopic surgical instruments; 5mm diameter; 330mm or 420mm length. Composed of handle, shaft, and jaw (dissector, grasper, or scissor). Used in endoscopic surgery for soft tissue manipulation and coagulation. Operated by surgeons in clinical settings. Devices are single-use and supplied sterile. Functionality includes mechanical grasping/cutting and electrosurgical coagulation. Benefits include tissue management during minimally invasive procedures.

Clinical Evidence

Bench testing only. Includes electrical safety testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2) and functional bench testing (transverse/longitudinal/ratchet holding force, cutting efficacy, and thermal effects on tissue).

Technological Characteristics

Disposable, single-use instruments. 5mm diameter; 330mm or 420mm length. Composed of biocompatible materials. Electrosurgical functionality. Standards: IEC 60601-1 (General safety), IEC 60601-1-2 (EMC), IEC 60601-2-2 (Electrosurgical safety). Supplied sterile.

Indications for Use

Indicated for cutting, grasping, dissecting, and coagulation of soft tissue during endoscopic surgical procedures. For single patient use.

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

• GENICON, Electrosurgical Instrumentation (K061417)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 28, 2014

Qingdao Kingston Medical Devices Ltd. Wu Hanhua Quality Manager No. 5 Seoul Road Free Trade Zone Qingdao 266555 China

Re: K132771

Trade/Device Name: Endoscopic Surgical Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 17, 2014 Received: September 29, 2014

Dear Hanhua:

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# David Krause -S

- for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K132771

Device Name: Endoscopic Surgical Instruments

Indications for Use:

Endoscopic Surgical Instruments are intended for cutting, grasping, dissecting and coagulation of soft tissue in endoscopic surgical procedures. They are intended for single patient use.

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)

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Image /page/3/Picture/0 description: The image shows the logo for Qingdao Kingston Medical Devices Ltd. The logo features the word "Kingston" in a stylized, bold font, with the company name written in a smaller, simpler font underneath. To the right of the text is a graphic of a stylized crown or burst symbol. The logo is black and white.

# 510(k)Summary

### 510(k) Owner

Qingdao Kingston Medical Devices Ltd. No.5 Seoul Road, Free Trade Zone,Qingdao,China Phone:[phone] Fax:[phone]

#### Contact Person

Wu Hanhua Quality Manager Email:[e-mail]

#### Date Prepared

September 17, 2014

#### Name of Device

Trade Name:Kingston Endoscopic Surgical Instruments Common Name: Endoscopic Surgical Instruments Classification Name:Electrosurgical,cutting&coagulation&accessories Product Code:GEI Regulation Number:21 CFR 878.4400 Class:Il

#### Device description

The Endoscopic Surgical Instruments are disposable,single use,individually packaged devices that are composed of biocompatible materials. The instruments are 5mm in diameter as well as 330mm (or 420mm) in length.

The instruments consist of handle, shaft and dissector /grasper/scissor jaw.

#### Intended use

The Endoscopic Surgical Instruments are intended for cutting, grasping,dissecting and coagulation of soft tissue in endoscopic surgical procedures.They are intended for single patient use.

#### Predicate Device

GENICON, Electrosurgical Instrumentation previously cleared under 510(k) K061417

#### Technological Characteristics

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Image /page/4/Picture/0 description: The image contains the logo for Qingdao Kingston Medical Devices Ltd. The logo features the word "Kingston" in a stylized, bold font, with the company name written in a smaller font underneath. To the right of the text is a graphic element that appears to be an abstract design, possibly representing a medical device or a symbol related to the company's field.

The technological characteristics are the same as or equivalent to the predicate device.

## Performance Data

Evidence of safety and effectiveness was obtained from electrical safety testing and function bench testing as following:

Testing in accordance with IEC 60601-1

Testing in accordance with IEC 60601-1-2

Testing in accordance with IEC 60601-2-2

Function bench testing such as Transverse holding force,Longitudinal holding force,Ratchet holding force and Cutting efficacy,Thermal effects on Tissue.

## Conclusion

Because the Endoscopic Surgical Instruments is composed of the same material,has the same design and dimensions,and is supplied sterile,it is as safe,as effective,and performs as well as the predicate device,we can conclude that the new device is substantially equivalent to the predicate device under the Federal Food,Drug,and Cosmetic Act.