Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument

K171825 · Hunan Handlike Minimally Invasive Surgery Co., Ltd. · GEI · Feb 13, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K171825
• Device Name: Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument
• Applicant: Hunan Handlike Minimally Invasive Surgery Co., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Endoscopic Instruments are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures.

Device Story

Endoscopic surgical instruments (disposable and reusable) used in endoscopic/laparoscopic general surgery. Devices include monopolar electrosurgical instruments for tissue manipulation, cutting, and coagulation, and non-powered instruments for manipulation and dissection. Instruments feature a handle, shaft, and jaw (dissector, grasper, or scissor). Operated by surgeons in clinical settings. Monopolar variants connect to electrosurgical generators to deliver high-frequency current for cauterization/coagulation. Disposable versions provided sterile; reusable versions require steam sterilization by end-users after initial use. Output is mechanical tissue interaction or thermal coagulation. Benefits include minimally invasive access to internal tissues for surgical intervention.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing, including electrical safety (IEC 60601-1, 60601-1-2, 60601-2-2, 60601-2-18), biocompatibility (ISO 10993), and performance testing (appearance, dimensions, corrosion resistance, holding forces, cutting efficacy, and thermal damage zones on porcine tissue).

Technological Characteristics

5mm diameter, 340mm length. Monopolar electrosurgical or non-powered mechanical. Materials comply with ISO 10993. Sterilization: EO (disposable/reusable) and Steam (reusable). Standards: IEC 60601-1 (General safety), IEC 60601-1-2 (EMC), IEC 60601-2-2 (HF surgical equipment), IEC 60601-2-18 (Endoscopic equipment).

Indications for Use

Indicated for cutting, dissecting, manipulating, and/or cauterizing soft tissue during endoscopic or laparoscopic general surgical procedures.

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

• Endoscopic Surgical Instruments (K132771)
• Endoscopic Monopolar Instruments and Accessories (K102921)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 13, 2018

Hunan Handlike Minimally Invasive Surgery Co., Ltd % Ms. Elly Xu Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen, Guangdong, P.R.China

Re: K171825

Trade/Device Name: Endoscopic Surgical Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 10, 2017 Received: December 18, 2017

Dear Ms. Xu:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Jennifer R. Stevenson -

# 53

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) K171825

Device Name Endoscopic Surgical Instrument

Indications for Use (Describe)

Endoscopic Instruments are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/ laparoscopic, general surgical procedures.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## Product: Endoscopic Surgical Instruments

Version: A/0

## VOL 005_510(k) Summary

This 510(K) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

#### 1. Submission Sponsor

| Applicant Name | Hunan Handlike Minimally Invasive Surgery Co.,Ltd |
|----------------|-----------------------------------------------------------------------------|
| Address | A4, Lugu Yuyuan, #27, Wenxuan Rd, High-tech Zone,<br>Changsha, Hunan, CHINA |
| Post Code | 410205 |
| Phone No. | 86-731-89727782 |
| Fax No. | 86-731-88830694 |
| Contact Person | Hanhan Hu |
| Email | [e-mail] |
| Date Prepared | 2018-2-10 |

#### 2. Submission correspondent

Image /page/3/Picture/10 description: The image shows a company logo with the text "Name" and "Address" above it. The logo is green and features a stylized animal head with wings. Below the logo, there are four Chinese characters, which translate to "Zhuo Yuan Tian Cheng."

Email

Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District, Shenzhen, Guangdong, P.R.China Post Code 518000 Phone No. 86-755-86069197 Contact Person Elly Xu; Field Fu

[e-mail]; [e-mail]

#### 3. Devices Identification

| Trade name | Endoscopic Surgical Instrument |
|-----------------------|------------------------------------------------------|
| Common name | Endoscopic Surgical Instrument |
| Model | Disposable Endoscopic Surgical Instrument |
| | Reusable Endoscopic Surgical Instrument |
| Classification | II |
| Classification name | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation number | 878.4400 |
| Product code | GEI |
| 510(k) review panel | General & Plastic Surgery |
| Performance standards | The performance and safety was evaluated in |

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#### K171825

| Hunan Handlike Minimally Invasive Surgery Co.,Ltd | | VOL_005:001_510(K) Summary |
|---------------------------------------------------|--|--------------------------------------------------------------------------------------------|
| Product: Endoscopic Surgical Instruments | | Version: A/0 |
| | | accordance with Electrosurgical Device Guidance<br>of FDA. |
| | | Biocompatibility tests were done in conformance<br>with relevant requirements of ISO10993. |

#### 4. Leqally Marketed Predicate Devices

| Trade Name | Endoscopic Surgical Instruments |
|-------------------|------------------------------------------------------|
| Regulation number | 878.4400 |
| Regulation class | II |
| Regulation name | Electrosurgical, Cutting & Coagulation & Accessories |
| 510(k) Number | K132771 |
| Product Code | GEI |
| Manufacturer | Qingdao Kingston Medical Devices Ltd. |

| Trade Name | Endoscopic Surgical Instruments |
|-------------------|------------------------------------------------------|
| Regulation number | 878.4400 |
| Regulation class | II |
| Regulation name | Electrosurgical, Cutting & Coagulation & Accessories |
| 510(k) Number | K102921 |
| Product Code | GEI |
| Manufacturer | BEMA GmbH & Co. KG |

#### 5. Device Description

Endoscopic Surgical Instrument is a kind of device used to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. The device includes Disposable Endoscopic Surgical Instrument and Reusable Endoscopic Surgical Instrument. Both of the disposable and reusable endoscopic instruments are provided sterile when they're released. After used for the first time, Reusable Endoscopic Instrument needs to be sterilized by the end users. The instruments are 5mm in diameter as well as 340mm in length.

#### 6. Indications for Use Statement

Endoscopic Instruments are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures.

#### 7. Substantial Equivalence Discussion

#### 7.1 Comparison between Disposable Endoscopic Surgical Instrument and K132771

| Characteristic | Disposable Endoscopic<br>Surgical Instrument | Endoscopic Surgical<br>Instrument | Comments |
|----------------|----------------------------------------------|-----------------------------------|----------|
| Indication for | Disposable Endoscopic | The Endoscopic Surgical | Same |

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Hunan Handlike Minimally Invasive Surgery Co.,Ltd

Product: Endoscopic Surgical Instruments

VOL_005:001_510(K) Summary Version: A/0

| use/Intended use | Surgical is designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. | Instruments are intended for cutting, grasping, dissecting and coagulation of soft tissue in endoscopic surgical procedures. They are intended for single patient use. | Same | | |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------------------------------------|------|
| Operation mode | Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue manipulation dissection, and cutting. | Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue manipulation dissection, and cutting. | | | |
| Structure | Handle, shaft and dissector/grasper/scissor jaw | Handle, shaft and dissector/grasper/scissor jaw | | | |
| Diameter | 5mm/34cm | 5mm/33cm (or 42cm) | Similar | | |
| Sterilization | EO | EO | Same | | |
| Single Use | Yes | Yes | Same | | |
| Biocompatibility | Comply with<br>ISO 10993-5<br>ISO 10993-7<br>ISO 10993-10<br>ISO 10993-11<br>ISO 10993-12 | Comply with<br>ISO 10993-5<br>ISO 10993-7<br>ISO 10993-10<br>ISO 10993-11<br>ISO 10993-12 | Same | | |
| | Electric Safety, EMC and<br>Performance Test | IEC 60601-1,<br>IEC 60601-1-2<br>IEC 60601-2-2<br>IEC 60601-2-18 | | IEC 60601-1,<br>IEC 60601-1-2<br>IEC 60601-2-2 | Same |

## 7.2 Comparison between Reusable Endoscopic Surgical Instrument and K102921

| Characteristic | Reusable Endoscopic<br>Surgical Instrument | Endoscopic Monopolar<br>Instruments and<br>Accessories | Comments |
|-------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------|
| Indication for use/<br>Intended use | Reusable Endoscopic<br>Surgical is designed to cut,<br>dissect, manipulate and/or | Endoscopic Monopolar<br>Instruments and<br>Accessories are used in | Same |
| | | | |
| | cauterize various tissues | laparoscopic and other | |
| | during | minimally invasive | |
| | endoscopic/laparoscopic, | procedures for cutting, | |
| | general surgical | dissection, fixation and | |
| | procedures. | taking of biopsy samples, | |
| | | depending on the design | |
| | | of the tip. They are also | |
| | | intended to control | |
| | | bleeding by use of | |
| | | monopolar high-frequency | |
| | | electrical current. | |
| | Devices are either | Devices are either | |
| | monopolar endoscopic | monopolar endoscopic | |
| | instruments for tissue | instruments for tissue | |
| | manipulation and | manipulation and | |
| Operation mode | cutting/coagulation, or | cutting/coagulation, or | Same |
| | non-powered endoscopic | non-powered endoscopic | |
| | instruments for tissue | instruments for tissue | |
| | manipulation dissection, | manipulation dissection, | |
| | and cutting. | and cutting. | |
| | Handle, shaft and | | |
| Structure | dissector/grasper/scissor | Handle, shaft and tip | Same |
| | jaw | | |
| | Assembly type, | Two and Three-piece | Similar, see |
| Design | Tip-detachable type | modular system, | Note 1 |
| | | Single-piece instrument | |
| Diameter | 5mm/34cm | Unknown | See Note 2 |
| Sterilization | EO and Steam | Steam | See Note 3 |
| | Comply with | Comply with | |
| Biocompatibility | ISO 10993-5 | ISO 10993-5 | |
| | ISO 10993-7 | ISO 10993-7 | Same |
| | ISO 10993-10 | ISO 10993-10 | |
| | ISO 10993-11 | ISO 10993-11 | |
| | ISO 10993-12 | ISO 10993-12 | |
| | IEC 60601-1 | IEC 60601-1 | |
| Electric Safety,<br>EMC and | IEC 60601-1-2 | | Same |
| | IEC 60601-2-2 | IEC 60601-1-2 | |
| Performance Test | IEC 60601-2-18 | IEC 60601-2-2 | |

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Hunan Handlike Minimally Invasive Surgery Co.,Ltd

Product: Endoscopic Surgical Instruments

VOL_005:001_510(K) Summary Version: A/0

Note 1: The Assembly type and Tip-detachable type is similar with Two-piece modular system. Both the subject device and the predicate device can be detached into two pieces.

Note 2: The diameter of Reusable Endoscopic Surgical Instrument is similar to Page 4 of 5

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| Hunan Handlike Minimally Invasive Surgery Co.,Ltd | VOL_005:001_510(K) Summary |
|---------------------------------------------------|----------------------------|
| Product: Endoscopic Surgical Instruments | Version: A/0 |

Endoscopic Surgical Instrument (K132711).

Note 3: The reusable endoscopic instruments are provided sterile when they're released from the manufacture. After used for the first time, Reusable Endoscopic Instrument needs to be steam sterilized by the end users. Both the steam sterilization have been validated, and the test reports show that the sterilization effect of the proposed device can achieve a Sterility Assurance Level (SAL) of 10°.

#### 8. Non-clinical Testing

Evidence of safety and effectiveness was obtained from electrical safety testing and performance 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

Testing in accordance with IEC 60601-2-18

Moreover, other performance testing of Endoscopic Surgical Instruments were conducted included appearance, basic dimension, corrosion resistance, transverse holding force, longitudinal holding force, ratchet holding force, cutting efficacy and thermal effects on tissue. The thermal effect have been performed on the fresh pig's liver, kidney and muscle tissue. And the thermal damage zone is measured under magnification using histology after performing cauterizing. All the testing results show that the Endoscopic Surgical Instruments meet the specification and performance characteristics as identified in internal design control procedures.

Biocompatibility testing of the Endoscopic Surgical Instrument confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum G95-11 entitled Use of International Standards ISO 10993-1:2009 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a risk management process. All testings above were conducted per Electrosurgical Device Guidance of FDA.

#### 9. Clinical Testing

Substantial equivalence does not depend on clinical test data.

#### 10. Conclusions

Based on device comparison information and non-clinical testing, the differences between Endoscopic Surgical Instrument and predicate devices will be not raise any new issues of safety and effectiveness, Endoscopic Surgical Instrument is substantially equivalent to legally marketed predicate devices.