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.

AI/ML Overview

The provided document details the 510(k) premarket notification for the GTK Trocars, asserting its substantial equivalence to a predicate device. However, the document does not contain an "acceptance criteria" table with specific performance metrics and reported device performance for an AI/ML device. It describes testing for a physical medical device (trocars), focusing on biocompatibility, bench testing, and animal studies.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance for an AI/ML device, nor the specific details about test sets, ground truth establishment, expert qualifications, or MRMC studies that would be relevant to an AI/ML device's evaluation.

The document states:

No clinical testing was done: "Substantial equivalence does not depend on clinical test data." This means there was no human clinical study performed to evaluate the device.
Ground Truth for training set: Not applicable as there is no mention of a "training set" or "ground truth" in the context of an AI/ML model. The product is a physical medical device.
Sample size for training set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. The device is a physical trocar, not an AI-assisted diagnostic tool.

Instead, the document describes the following types of studies:

Non-clinical Testing (Physical Device Testing):

Biocompatibility Testing:
- Tests Conducted: Cytotoxicity, Sensitization & irritation, Acute systemic toxicity, Pyrogen test, Endotoxin Test.
- Standards Conformed: ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006.
- Ground Truth: These tests are based on established biological and chemical standards and reactions, not expert consensus on images or data.
Bench Testing:
- Tests Conducted: Appearance, Dimensions, Endoscope visualization image quality, Obturator compatibility, Insertion & Cannula stability, Insertion force & Removal force, Penetration force, Leak rate.
- Ground Truth: These are engineering and performance validation tests against design specifications and industry standards for physical device functionality.
Animal Study:
- Purpose: To demonstrate operational performance.
- Performance Criteria Assessed:
  - Ability to access abdominal cavity
  - Ability to maintain Pneumoperitoneum
  - Ability to manipulate instruments for laparoscopic surgery
- Ground Truth: Based on observed functional performance in an animal model by trained professionals, adhering to veterinary and surgical best practices.

Summary of what is possible to provide based on the document:

Type of Ground Truth Used: For biocompatibility, it's based on established ISO standards for biological evaluation. For bench testing, it's based on design specifications and engineering standards. For the animal study, it's based on observed functional performance in an animal model.
Standalone Performance: The non-clinical tests (biocompatibility, bench, animal study) represent the standalone performance evaluation of the physical device. The document does not describe performance against a specific numerical acceptance criterion in the format of AI/ML metrics (e.g., sensitivity, specificity, AUC).
Sample Size / Data Provenance / Experts / Adjudication: These details are not provided in the context of the physical device testing, as they are often more relevant for clinical trials or AI/ML evaluations. "Sample size" for physical device testing typically refers to the number of units tested, which is not specified but implied by the successful completion of the tests.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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.

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

1. Submission Sponsor

Applicant Name	Guangzhou T.K. Medical Instrument Co., Ltd.
Address	A601, Guangzhou International Business Incubator,Guangzhou Science Park, Guangzhou,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, NanshanDistrict, Shenzhen, Guangdong, P.R. China
	Post Code	518000
	Phone No.	86-755-86069197
Contact Person	Field Fu; Elly Xu
Email	elly@cefda.com

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 conformancewith relevant requirements of ISO10993.

4. Legally Marketed Predicate Devices

Trade Name	Unimax Trocar System
Regulation number	876.1500

{4}------------------------------------------------

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.

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:GTK Trocars	Predicate Device:Unimax Trocar System(K112358)	Comments
Product Code	GCJ	GCJ	Same
Indication for Use	The GTK Trocars has anapplication in a variety ofendoscopic procedures toprovide a port for entry forendoscopic instruments	The Unimax Trocar System,Model: Auto-Locking Trocar,Bladeless Trocar, Visible Trocar,Hasson Trocar, Dilating Trocar,Secondary Trocar, and ThoracicTrocar has application in avariety of endoscopicprocedures to provide a port ofentry for endoscopicinstruments.	Same
Device Structure	Cannula, obturator	Cannula, obturator	Same
Principles	Trocar is inserted into the skinincision, and punctured into theabdominal cavity.Removed the obturator andmake a surgical port for entry.	Trocar is inserted into the skinincision, and punctured into theabdominal cavity.Removed the puncture cone andmade 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

{5}------------------------------------------------

Item	Proposed Device:GTK Trocars	Predicate Device:Unimax Trocar System(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~~12mmLength: 55~~100mm	Diameter: 3~~15mmLength: 65~~150mm	SimilarIssue 1
Sterilization	SAL: 10-6Method: EO Sterilized	SAL: 10-6Method: EO Sterilized	Same
Performance	Obturator Compatibility;Insertion & Cannula Stability;Air Leakage	Obturator Compatibility;Insertion & Cannula Stability;Air Leakage	Same
Single Use	Yes	Yes	Same
Biocompatibility	CytotoxicityISO 10993-5:2009	ISO 10993-5:2009	Same
	Sensitization, irritationISO 10993-10:2010	ISO 10993-10:2010	Same
	SystemictoxicityISO 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

{6}------------------------------------------------

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.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.