GTK Trocars

K193272 · Guangzhou T.K Medical Instrument Co., Ltd. · GCJ · Jul 9, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K193272
• Device Name: GTK Trocars
• Applicant: Guangzhou T.K Medical Instrument Co., Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 9, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The GTK Trocars has an application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments.

Device Story

GTK Trocars are single-use surgical instruments used to create a port for endoscopic access to the abdominal cavity. The device consists of a cannula, stopcock, trocar cap, and obturator. Available in bladeless, optical, and bladed configurations, the trocar is inserted through a skin incision into the abdominal cavity; the obturator is then removed to allow the insertion of endoscopic instruments through the cannula. The trocar cap features a universal seal to accommodate various instrument diameters, while the cannula valve maintains pneumoperitoneum. Used by surgeons in clinical settings, the device facilitates minimally invasive surgery by providing a stable, sealed access point. The device benefits patients by enabling endoscopic procedures with reduced trauma compared to open surgery.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, biocompatibility testing (ISO 10993-5, -10, -11), and animal studies. Bench tests verified appearance, dimensions, visualization quality, obturator compatibility, insertion/removal forces, and leak rates. Animal studies confirmed ability to access the abdominal cavity, maintain pneumoperitoneum, and manipulate instruments.

Technological Characteristics

Single-use, sterile (EO) trocar system. Components: cannula, stopcock, trocar cap, obturator. Available in bladeless, optical, and bladed models. Diameters 3-12mm, lengths 55-100mm. Biocompatibility per ISO 10993. Mechanical insertion/puncture principle. No software or electronic components.

Indications for Use

Indicated for patients undergoing endoscopic procedures requiring a port for entry for endoscopic instruments.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Unimax Trocar System (K112358)

Submission Summary (Full Text)

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July 9, 2020

Guangzhou TK Medical Instrument Co., Ltd. % Elly Xu. Consultant Manager Shenzhen Joyantech Consulting Co., Ltd No. 55 Shizhou Middle Road, Nanshan District Shenzhen, Guangdong China 518000

Re: K193272

Trade/Device Name: GTK Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 26, 2020 Received: July 6, 2020

Dear Elly 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Long Chen. Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K193272

Device Name GTK Trocars

Indications for Use (Describe)

The GTK Trocars has an application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments.

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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# 510(k) Summary

# 1. Submission Sponsor

| Applicant Name | Guangzhou T.K. Medical Instrument Co., Ltd. |
|----------------|------------------------------------------------------------------------------------------------------------------|
| Address | A601, Guangzhou International Business Incubator,<br>Guangzhou Science Park, Guangzhou,<br>Guangdong, P.R. China |
| Post Code | 510663 |
| Phone No. | 86-20-32290169 |
| Fax No. | 86-20-32290395 |
| Contact Person | Ms. Tracy Weng |
| Date Prepared | July 9, 2020 |

# 2. Submission correspondent

| | Name | Shenzhen Joyantech Consulting Co., Ltd | |
|--|----------------|--------------------------------------------------------------------------------------------|-----------------|
| | Address | Room 1122, No.55 Shizhou Middle Road, Nanshan<br>District, Shenzhen, Guangdong, P.R. China | |
| | | Post Code | 518000 |
| | | Phone No. | 86-755-86069197 |
| | Contact Person | Field Fu; Elly Xu | |
| | Email | [e-mail] | |

# 3. Devices Identification

| Trade name | GTK Trocars |
|-----------------------|--------------------------------------------------------------------------------------------|
| Common name | Trocar |
| Model | CT |
| Classification | II |
| Classification name | Endoscope and accessories |
| Regulation number | 876.1500 |
| Product code | GCJ |
| 510(k) review panel | General & Plastic Surgery |
| Performance standards | Biocompatibility tests were done in conformance<br>with relevant requirements of ISO10993. |

# 4. Legally Marketed Predicate Devices

| Trade Name | Unimax Trocar System |
|-------------------|----------------------|
| Regulation number | 876.1500 |

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| Regulation class | II |
|------------------|-----------------------------|
| Regulation name | Endoscope and accessories |
| 510(k) Number | K112358 |
| Product Code | GCJ |
| Manufacturer | Unimax Medical Systems Inc. |

# 5. Device Description

The GTK Trocars has an application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments. The available model of the Trocar is model CT.

All the trocars have the similar structure. They are composed of cannula, stopcock, trocar cap, and obturator. The trocar cap has a universal seal which accommodates instruments of different diameters. The cannula has a valve which ensures the sealing performance.

The CT trocar consists of an obturator assembly and a cannula assembly. The obturator assembly can be assembled with the cannula assembly by indicator fitting. And Model CT includes CT bladeless trocar, CT optical trocar, and CT bladed trocar.

## 6. Indications for Use Statement

The GTK Trocars has an application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments.

| Item | Proposed Device:<br>GTK Trocars | Predicate Device:<br>Unimax Trocar System<br>(K112358) | Comments |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Product Code | GCJ | GCJ | Same |
| Indication for Use | The GTK Trocars has an<br>application in a variety of<br>endoscopic procedures to<br>provide a port for entry for<br>endoscopic instruments | The Unimax Trocar System,<br>Model: Auto-Locking Trocar,<br>Bladeless Trocar, Visible Trocar,<br>Hasson Trocar, Dilating Trocar,<br>Secondary Trocar, and Thoracic<br>Trocar has application in a<br>variety of endoscopic<br>procedures to provide a port of<br>entry for endoscopic<br>instruments. | Same |
| Device Structure | Cannula, obturator | Cannula, obturator | Same |
| Principles | Trocar is inserted into the skin<br>incision, and punctured into the<br>abdominal cavity.<br>Removed the obturator and<br>make a surgical port for entry. | Trocar is inserted into the skin<br>incision, and punctured into the<br>abdominal cavity.<br>Removed the puncture cone and<br>made a surgical port for entry. | Same |
| Model | CT Bladeless Trocar | Bladeless Trocar | Same |

# 7. Substantial Equivalence Discussion

## 7.1 Comparison between proposed device and Unimax Trocar System

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| Item | Proposed Device:<br>GTK Trocars | Predicate Device:<br>Unimax Trocar System<br>(K112358) | Comments |
|------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|--------------------|
| | CT Optical Trocar | Visible Trocar | Same |
| | CT Bladed Trocar | Auto-locking Trocar | Same |
| | / | Hasson Trocar | / |
| | / | Dilating Trocar | / |
| | / | Secondary Trocar | / |
| | / | Thoracic Trocar | / |
| Size | Diameter: 3~12mm<br>Length: 55~100mm | Diameter: 3~15mm<br>Length: 65~150mm | Similar<br>Issue 1 |
| Sterilization | SAL: 10-6<br>Method: EO Sterilized | SAL: 10-6<br>Method: EO Sterilized | Same |
| Performance | Obturator Compatibility;<br>Insertion & Cannula Stability;<br>Air Leakage | Obturator Compatibility;<br>Insertion & Cannula Stability;<br>Air Leakage | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | Cytotoxicity<br>ISO 10993-5:2009 | ISO 10993-5:2009 | Same |
| | Sensitization<br>, irritation<br>ISO 10993-10:2010 | ISO 10993-10:2010 | Same |
| | Systemic<br>toxicity<br>ISO 10993-11:2006 | ISO 10993-11:2006 | Same |

Issue 1: The diameter of proposed device is covered in predicate device. Regarding to the length, the proposed device has a shorter length, which won't bring in safety issue and may provide more choice to the users.

## 8. Non-clinical Testing

All nonclinical tests performed on new devices are to demonstrate the substantial equivalence to the predicate devices. Tests setup and execution are performed in accordance with applicable standards.

## Biocompatibility testing

The biocompatibility evaluations were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as recognized by FDA. The tests of GTK Trocars include the following tests:

- * Cytotoxicity
- * Sensitization & irritation
- * Acute systemic toxicity
- * Pyrogen test
- * Endotoxin Test

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# Bench testing

The following bench tests were conducted with the GTK Trocars to verify that the proposed device met all design specifications:

- * Appearance
- * Dimensions
- * Endoscope visualization image quality
- * Obturator compatibility
- * Insertion & Cannula stability
- * Insertion force & Removal force
- * Penetration force
- * Leak rate

## Animal study

To demonstrate the operation performance is as safe and as effective as the predicate device, the animal study was carried out to assess the following performance criteria:

- * Ability to access abdominal cavity
- * Ability to maintain Pneumoperitoneum
- * Ability to manipulate instruments for laparoscopic surgery

## Summary

All the testing results, including bench tests, biocompatibility tests and animal study, demonstrate that GTK Trocars meets the requirements of its pre-defined acceptance criteria and intended uses, and it has a safety and effectiveness profile that is similar to the predicate device.

## 9. Clinical Testing

Substantial equivalence does not depend on clinical test data.

## 10. Conclusions

Based on device comparison information and non-clinical bench testing, GTK Trocars and its predicate device have the same indications for use, same structures, similar specifications, and same performance. The bench tests, biocompatibility tests and animal study support that the proposed device is as safety and effectiveness as predicate device, and the differences between them will not raise any safe and effective issue. Therefore the proposed device is substantially equivalent to legally marketed predicate device.