The GTK Veress Needles are intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

Device Description

The structure of the GTK Veress Needles contain inner needle, outer needle, warning block, spring, handle and valve. It contains a spring-loaded blunt stylet mechanism, which is also the major principle mechanism of GTK Veress Needles to achieve the intended use. It is used to establish pneumoperitoneum prior to trocar and cannula insertion in laparoscopic procedures. The veress needle is connected to the insufflators with a luer connector. There are two models of veress needles: VN-120 and VN-150, with different lengths of needle bodies (120mm and 150mm). The GTK Veress Needles are for single use and are supplied sterile. The contact time is no more than 24 hours. The product is sterilized by Ethylene oxide. The manufacture date and expiry date are shown on the labeling. The GTK Veress Needles are only intended for use in a hospital setting/environment.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the GTK Veress Needles, a medical device used in laparoscopic procedures. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing an AI/ML-based device approval. As such, information regarding AI/ML-specific acceptance criteria, ground truth establishment, training/test set sample sizes, and human reader studies (MRMC) is not present.

However, I can extract the relevant acceptance criteria and the study that proves the device meets the acceptance criteria for the GTK Veress Needles as a hardware medical device, based on the provided document.

Acceptance Criteria and Device Performance for GTK Veress Needles

The study demonstrating the device meets acceptance criteria is a series of non-clinical performance tests. The acceptance criteria themselves are implied by the successful completion and meeting of standards for these tests. All listed tests "meet the acceptance criteria," indicating satisfactory performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance	Comments on Meeting Criteria
Biocompatibility	ISO 10993-5: 2009 (In Vitro Cytotoxicity)	Conducted	Met acceptance criteria (implied by "The following tests were conducted" and absence of failure)
	ISO 10993-10: 2010 (Skin Sensitization, Intracutaneous Reactivity)	Conducted	Met acceptance criteria (implied by "The following tests were conducted" and absence of failure)
	ISO 10993-11: 2006 (Acute Systemic Toxicity, Pyrogen test)	Conducted	Met acceptance criteria (implied by "The following tests were conducted" and absence of failure)
	USP 39 <85> (Bacterial Endotoxin test)	Conducted	Met acceptance criteria (implied by "The following tests were conducted" and absence of failure)
Sterilization Validation	ISO 11135:2014 (EO Sterilization)	Conducted	Met acceptance criteria (implied by "The sterilization validation was conducted according to ISO 11135:2014." and absence of failure)
	ISO 10993-7:2008 (EO and ECH Residual)	Evaluated	Met acceptance criteria (implied by "The EO and ECH residual...was evaluated by ISO 10993-7:2008." and absence of failure)
Shelf Life Validation	ASTM F 1980-07 (2011) (Accelerated Aging for 3 years)	Conducted	All results "meet the acceptance criteria."
	ISO 11737-2:2009 (Sterility test after aging)	Conducted	All results "meet the acceptance criteria."
	ASTM D 3078-02:2013 (Vacuum leak test after aging)	Conducted	All results "meet the acceptance criteria."
	ASTM F 88 (Seal strength test after aging)	Conducted	All results "meet the acceptance criteria."
	ASTM F 1929-12 (Leakage (dye penetration) test after aging)	Conducted	All results "meet the acceptance criteria."
	Din 58953-6:2010 (Microbial barrier properties after aging)	Conducted	All results "meet the acceptance criteria."
	Physical performance after natural aging	Conducted	All results "meet the acceptance criteria."
Performance Test - Bench	Appearance	Conducted	All results "meet the acceptance criteria."
	Size	Conducted	All results "meet the acceptance criteria."
	Tip Pull Test	Conducted	All results "meet the acceptance criteria."
	Switch Operation Test	Conducted	All results "meet the acceptance criteria."
	Spring Obturator Operation	Conducted	All results "meet the acceptance criteria."
	Needle Puncture Force Test	Conducted	All results "meet the acceptance criteria."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the sample size (number of devices) used for each non-clinical test. It only states that the tests were "conducted" or "evaluated."
Data Provenance: The tests are non-clinical, meaning they were likely performed in a laboratory setting by the manufacturer, Guangzhou T.K Medical Instrument Co., Ltd., in China. The data would be internally generated prospective test data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable to this type of device submission. Ground truth in this context refers to established engineering and medical device standards (e.g., ISO, ASTM, USP) for performance, sterility, and biocompatibility. There are no human "experts" establishing a "ground truth" in the way one would for an AI/ML-based diagnostic device (e.g., radiologists annotating images).

4. Adjudication Method for the Test Set

Not applicable. The tests are laboratory-based and measured against predefined quantitative or qualitative standards. There is no human subjective assessment requiring adjudication in the context of this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices, especially those incorporating AI, to assess the impact of the technology on human reader performance. The GTK Veress Needles are a surgical instrument, not a diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm. The device performance is assessed through its physical, material, and functional characteristics.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests for this medical device is based on established international and national standards (e.g., ISO, ASTM, USP) and predefined engineering specifications for acceptable performance (e.g., appearance, size, force, leak resistance). The successful completion of these tests against these benchmarks constitutes the "proof" that the device meets its acceptance criteria for substantial equivalence to a predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires training data.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device.

Summary

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

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.

January 30, 2020

Guangzhou T.K Medical Instrument Co., Ltd. % Christy Young Consultant Shenzhen Joyantech Consulting Co., Ltd 1713A, Block A, Zhongguan Times Square, Liuxian Avenue Xili Town, Nanshan District, Shenzhen Guangdong Province, 518000 CHINA

K193339 Trade/Device Name: GTK Veress Needles Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF, FHO Dated: December 2, 2019 Received: December 2, 2019

Dear Christy Young:

Re:

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); 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 medical devices and radiation-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,

for Sharon M. Andrews Acting Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K193339

Device Name GTK Veress Needles

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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}------------------------------------------------

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	1-28-2020

510(k) Summary

2. Submission correspondent

Name	Shenzhen Joyantech Consulting Co., Ltd
Address	1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong, P.R.China
	Image: [logo]
Post Code	518000
Phone No.	86-755-86069197
Contact Person	Ms. Christy Young; Field Fu
Email	christy@cefda.com;

3. Devices Identification

Trade Name	GTK Veress Needles
Common Name	Veress Needle
Model Names	VN-120 and VN-150
Regulatory Class	II
Classification Name	Laparoscopic insufflator
Classification Number	21 CFR 884.1730
Product Code	HIF; FHO
Product Code Name	Insufflator, Laparoscopic; PneumoperitoneumNeedle
510(k) review panel	Obstetrics/Gynecology; Gastroenterology/Urology

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

4. Leqally Marketed Predicate Devices

Trade Name	Veress Needle
Classification Number	21 CFR 884.1730
Classification Name	Laparoscopic insufflator
Regulatory Class	II
510 (k) number	K172120
Product Code	HIF; FHO
Product Code Name	Insufflator, Laparoscopic; Pneumoperitoneum Needle
Manufacturer	WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.

The predicate device was not subject to a design-related recall.

5. Legally Marketed Reference Devices

Trade Name	Medline Pneumoperitoneum Needle
Classification Number	21 CFR 884.1730
Classification Name	Laparoscopic insufflator
Regulatory Class	II
510 (k) number	K111955
Product Code	HIF; FHO;
Product Code Name	Insufflator, Laparoscopic; Pneumoperitoneum Needle
Manufacturer	Medline Industries, Inc

The reference device was not subject to a design-related recall

6. Device Description

The GTK Veress Needles are for single use and are supplied sterile. The contact time is no more than 24 hours. The product is sterilized by Ethylene oxide. The manufacture date and expiry date are shown on the labeling. The GTK Veress Needles are only intended for use in a hospital setting/environment.

7. Indications for Use Statement

The GTK Veress Needles are intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish

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

pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

8. Substantial Equivalence Discussion

Items	Proposed device	Predicate device	Comments
Trade name	GTK Veress Needles	Veress Needle	/
510(K)submitter	Guangzhou T.KMedical InstrumentCo., Ltd.	WickiMed (Huizhou)Medical EquipmentManufacturing Co., Ltd.	/
510(K) number	/	K172120	/
Classificationregulation	21CFR 884.1730	21CFR 884.1730	Same
Classificationand productcode	Class II ,HIF,FHO	Class II ,HIF,FHO	Same
Common name	Veress Needle	Veress Needle	Same
Intended use	The GTK VeressNeedles are intendedfor percutaneousinsertion into theperitoneal cavity for thepurpose of insufflationwith carbon dioxide toestablishpneumoperitoneumprior to the placementof trocars duringlaparoscopicprocedures.	The Veress Needle isintended forpercutaneous insertioninto the peritoneal cavityfor the purpose ofinsufflation with carbondioxide to establishpneumoperitoneum priorto the placement oftrocars duringlaparoscopicprocedures.	Same
Components	Veress NeedleObturator	Veress NeedleObturator	Same
Model	VN-120 and VN-150	WVN0112T, WVN0115T	/
Length	120mm,150mm	120mm,150mm	Same
Sterilization	EO Sterilized	EO Sterilized	Same
Disposable	Yes	Yes	Same
Materials	Patient-contactingMaterial(Outer tubeinner tube)	SUS304	Patient-contactingMaterial(Outer tubeinner tube)	SUS304	Same
	Handle material	PC	Handle material	PC	Same
Principles of operation	Connect the device to the insufflators with insufflation tubing, insufflating with carbon dioxide to establish pneumoperitoneum.		Connect the device to the insufflators with insufflation tubing, insufflating with carbon dioxide to establish pneumoperitoneum.		Same

Table 1: Substantial equivalence comparison

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

9. Non-Clinical Performance Data

1) Biocompatibility test

The needle (inner and outer) of the GTK Veress Needles are contacting with abdominal skin and abdominal wall tissue of human for less than 24 hours. The following tests were conducted:

ISO 10993-5: 2009-In Vitro Cytotoxicity test;

ISO 10993-10: 2010-Skin Sensitization test and Intracutaneous reactivity test; ISO 10993-11: 2006- Acute systemic toxicity and Pyrogen test;

USP 39 <85>-Bacterial endotoxin test.

2) Sterilization validation

The sterilization validation was conducted according to ISO 11135:2014. The EO and ECH residual of the proposed device was evaluated by ISO 10993-7:2008.

Shelf life validation test 3)

The package verification test on proposed devices were conducted after accelerated aging for 3 years (ASTM F 1980-07 (2011)):

ISO 11737-2:2009-sterility test;

ASTM D 3078-02:2013-vacuum leak test;

ASTM F 88-seal strength test;

ASTM F 1929-12-leakage (dye penetration test);

Din 58953-6:2010-microbial barrier properties (agar contact-attack test); And physical performance of the proposed device was conducted after natural aging. All the results meet the acceptance criteria.

4) Performance test-bench

The performance tests of GTK Veress Needles contain appearance, size, tip pull test, switch operation test, spring obturator operation and needle puncture force test. All the results meet the acceptance criteria. they also demonstrate that the GTK Veress Needles meet the performance characteristics.

10. Statement of Substantial Equivalence

The Indications for Use and technological characteristics for GTK Veress Needles are same to the predicate devices (K172120). The non-clinical performance testing demonstrates that the proposed device is as safe and effective as the predicate devices. Therefore, the results show that it is Substantially Equivalent (SE) between

{7}------------------------------------------------

products and predicate devices.

Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.