The Single Patient Use Endo Cutter and Reload is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediativ surgical procedures. It can be used with tissue buttressing materials.

The Single Patient Use Linear Cutter and Reload are intended for use in multiple open or minimally invasive surgical procedures for the transection of tissues. Linear cutters are also intended for creation of anastomoses in these procedures.

The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.

The Single Use Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.

The Single Patient Use Transverse Cutter and Reload is intended for transection and or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures.

Device Description

The Single Patient Use Transverse Cutter and Reload places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. The device is available in 40mm length with reload in 3.8mm and 4.5mm staple size. The device may be reloaded and fired up to 5 times in a single procedure.

Single Use Circular stapler places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 21mm, 29mm, 32mm and 34mm six specifications. The staple sizes are 4.8mm and 5.5mm.

Single Patient Use Endo Cutter and Reload places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in six staple sizes to accommodate various tissue thicknesses: 2.0mm, 2.5mm, 3.5mm, 3.8mm, 4.1mm, 4.2mm. The device may be reloaded and fired up to 5 times in a single procedure.

Single Patient Use Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm, 75mm and 90mm staple for use in various applications. Three staple sizes (2.5mm, 3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 4 times for a total 5 firing in a single procedure.

Single Patient Use Linear Cutter and Reload place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 2.5mm, 4.2mm and 4.5mm. It may be reloaded and fired up to 4 times for a total 5 firings in a single procedure.

Single Use Hemorrhoidal Circular Stapler is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 30mm, 34mm and 36mm four specifications. The staple size is 4.5mm. It cannot be reloaded.

AI/ML Overview

The provided document is a 510(k) Summary for TGS Medical Co., Ltd.'s range of stapling devices (Circular Stapler, Hemorrhoidal Circular Stapler, Linear Stapler, Linear Cutter, Endo Cutter, and Transverse Cutter). The acceptance criteria and supporting studies are presented in the form of non-clinical tests to establish substantial equivalence to predicate devices, rather than a standalone clinical study on the effectiveness of the proposed devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." The acceptance criteria are essentially compliance with specific international and national standards related to medical devices. The reported device performance is that the proposed device complies with these standards, demonstrating substantial equivalence to the predicate devices.

Acceptance Criteria (Standard)	Reported Device Performance
ISO 10993-1:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)	Complies
ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)	Complies
ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Test for irritation and delayed-type hypersensitivity)	Complies
USP 38-NF 33 <85> (Bacterial Endotoxins Tests)	Complies
ASTM F 88/F88M-09 (Standard test method for seal strength of flexible barrier materials)	Complies
ISO 11137-2: 2013 (Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose)	Complies

Additionally, the comparison tables (Table 1 through Table 6) implicitly define acceptance criteria by comparing the proposed device's characteristics against those of the predicate devices. The "reported device performance" in these tables is that the proposed device's characteristics (e.g., intended use, cutting mechanism, operation principle, safety mechanism, closed staple height, closed staple form, patient-contact material, sterilization, endotoxin limit, labeling) are "Same" as or comparable to the predicate devices, or compliant with relevant regulations (e.g., 20 EU for Endotoxin Limit, Conforms with 21 CFR 801 for Labeling).

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

The document states: "Non clinical tests were conducted to verify that the proposed device met all design specifications..." However, it does not provide details on the specific sample sizes used for each of the non-clinical tests (e.g., number of devices tested for seal strength, number of samples for cytotoxicity). The data provenance is also not explicitly stated beyond being "non clinical tests." There is no indication of country of origin for the testing itself, nor whether the data is retrospective or prospective.

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

This information is not provided in the document. The document refers to non-clinical tests against established standards and predicate devices, which implies adherence to standardized methodologies rather than expert consensus on a test set.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The evaluation is based on non-clinical tests against defined standards and comparison to predicate devices, not on human adjudication of a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This information is not applicable. The device is a surgical stapler, not an AI-assisted diagnostic or therapeutic device that involves human readers or an MRMC study.

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

This information is not applicable. The device is a physical surgical stapler, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is implied by the established international and national standards (e.g., ISO 10993 series, USP, ASTM, ISO 11137-2) and the characteristics of the legally marketed predicate devices. The tests evaluate compliance with these standards and equivalence to the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. This document describes a 510(k) submission for mechanical surgical devices, not an AI/machine learning device that requires a training set.

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

This information is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, layered on top of each other. The profiles are connected by a flowing, ribbon-like shape.

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

February 9, 2017

TGS Medical Co., Ltd. % Ms. Diana Hong Mid-Link Consulting Co.,Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K162710

Trade/Device Name: Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler And Reload, Single Patient Use Linear Cutter And Reload, Single Patient Use Endo Cutter And Reload, Single Patient Use Transverse Cutter And Reload

Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: January 6, 2017 Received: January 10, 2017

Dear Ms. Hong:

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

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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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely.

Jennifer R. Stevenson -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) K162710

K16271U

Device Name

Indications for Use (Describe)

The Single Use Circular Stapler has application throughout the alimentary tract for end to side and side to side anastomoses.

The Single Use Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.

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.

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510(k) Summary

1. Sponsor Identification

TGS Medical Co., Ltd.

Building 17, No.8 Jinfeng Road, High-tech Zone, Suzhou, Jiangsu Province, China

Establishment Registration Number: Not yet registered

Contact Person: Hua Cao Position: General Manager Tel: +86-512-86867776 Fax: +86- 512-86867070 Email: caohua@tgsmedical.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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Identification of Proposed Device 3.

Trade Name: Single Use Circular Stapler

Single Use Hemorrhoidal Circular Stapler Single Patient Use Linear Stapler and Reload Single Patient Use Linear Cutter and Reload Single Patient Use Endo Cutter and Reload Single Patient Use Transverse Cutter and Reload

Common Name: Stapler and Reload

Regulatory Information Classification Name: Staple, Implantable Classification: II Product Code: GDW Regulation Number: 21CFR 878.4750 Review Panel: General& Plastic Surgery

Classification Name: Stapler, Surgical; Classification: I Exempt Regulation Number: 21CFR 878.4800 Review Panel: General & Plastic Surgery

Intended Use Statement:

The Single Use Circular Stapler has application throughout the alimentary tract for end to side and side to side anastomoses.

The Single Patient Use Endo Cutter and Reload is intended for transection, and/or creation of The instrument has application in multiple open or minimally invasive general, anastomoses. gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with tissue buttressing materials.

The Single Patient Use Linear Cutter and Reload are intended for use in multiple open or surgical procedures for the transection of tissues. Linear cutters are also intended for creation of anastomoses in these procedures.

The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection of tissue and creation of

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anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.

The Single Use Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

The Single Patient Use Transverse Cutter and Reload is intended for transection, resection and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures.

Device Description

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1. Identification of Predicate Devices
  Predicate Device 1 510(k) Number: K030411 Product Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories

Predicate Device 2 510(k) Number: K983536 Product Name: PROXIMATE® Curved and Straight Intraluminal Staplers

Predicate Device 3 510(k) Number: K020779 Product Name: ENDOPATH and PROXIMATE Linear Cutters and Staplers

Predicate Device 4 510(k) Number: K111825 Product Name: DST Series™ Staplers

Predicate Device 5 510(k) Number: K061156 Product Name: ENDOPATH Linear Cutters and Staplers

Predicate Device 6 510(k) Number: K062869 Product Name: CONTOUR™ Curved Cutter Stapler and Reloads

న. Identification of Reference Devices
Reference Device 1 510(k) Number: K080839 Product Name: Echelon™ Gray Cartridge-45mm

Reference Device 2 510(k) Number: K112056 Product Name: Echelon Endoscopic Linear Cutter Reload, Black

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6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
USP 38-NF 33 <85> Bacterial Endotoxins Tests
ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
ISO 11137-2: 2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose
1. Clinical Test Conclusion

No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device 6
Product Code	GDW	K062869
Regulation Number	21 CFR 878.4750	Same
Intended Use	The Single Patient Use Transverse Cutter and Reload is intended for transection, resection and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures.	Same
Cutting Mechanism	Curved Knife	Same
Operation Principle	Manual	Same
Safety Mechanism	Reset Knob is used for preventing from mis-firing	Same
Closed staple height	1.5mm, 2.0mm	Same
Closed staple form	Image: staple form	Image: staple form
Patient-contact material	Unalloyed TitaniumPolycarbonateStainless Steel	Unknown
Sterilization	Irradiation Sterilization	EO Sterilization
Endotoxin Limit	20 EU	Same
Labeling	Conforms with 21 CFR 801	Same

Table 1 Comparison of Technology Characteristics for Single Patient Use Transverse Cutter and Reload

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Item	Proposed Device	Predicate Device 2	Item	Proposed Device	Predicate	Reference	Reference	Item	Proposed Device	Predicate Device 4
		K983536			Device 5K061156	Device 1K080839	Device 2K112056	Product Code	GDW	K111825
Product Code	GDW	Same	Product Code	GDW	Same	Same	Same	Regulation Number	21 CFR 878.4750	Same
Regulation Number	21 CFR 878.4750	Same	RegulationNumber	21 CFR 878.4750	Same	Same	Same	Intended Use	The Single Patient Use Linear Staplerand Reload has applications inabdominal, gynecological, pediatricand thoracic surgical procedures forresection or transection of tissue andcreation of anastomosis, includingocclusion of the left atrial appendagein open procedures. They may beused for transection and resection ofpancreas.	Same
Intended Use	The Single Use Circular Stapler hasapplication throughout the alimentarytract for end to end, end to side andside to side anastomoses.	Same	Intended Use	The Single Patient Use Endo Cutterand Reload is intended fortransection, resection, and/orcreation of anastomoses. Theinstrument has application inmultiple open or minimally invasivegeneral, gynecologic, urologic,thoracic, and pediatric surgicalprocedures.	Same	Same	Same	Cutting Mechanism	N.A.	Same
Cutting Mechanism	Circular Knife	Same	CuttingMechanism	Linear Knife	Same	Same	Same	Operation Principle	Manual	Same
Operation Principle	Manual	Same	OperationPrinciple	Manual	Same	Same	Same	Safety Mechanism	Safety release for preventing frommis-firing	Same
Safety Mechanism	Insurance is used for preventing frommis-firing	Same	SafetyMechanism	Green button for preventing frommis-firing	Same	Same	Same	Closed staple height	1.0mm, 1.5mm, 2.0mm	Same
Closed staple height	1.0~2.5mm	Same	Closed stapleheight	0.75, 1.0, 1.5, 1.8, 2.0, 2.3mm	1.0, 1.5,1.8, 2.0mm	0.75mm	2.3mm	Closed staple form	Image: staple form	Image: staple form
Closed staple form	Image: staple form	Image: staple form	Closed stapleform	Image: staple form	Image: staple form	Image: staple form	Image: staple form	Patient-contactmaterial	Unalloyed TitaniumPolycarbonateStainless Steel	Unknown
Patient-contactmaterial	Unalloyed TitaniumPolycarbonateStainless Steel	Unknown	Patient-contactmaterial	Unalloyed TitaniumAcrylonitrile-Butadiene-StyreneStainless Steel	Unknown	Unknown	Unknown	Sterilization	Irradiation Sterilization	EO Sterilization
Sterilization	Irradiation Sterilization	EO Sterilization	Sterilization	Irradiation Sterilization	EOSterilization	EOSterilization	EOSterilization	Endotoxin Limit	20 EU	Same
Endotoxin Limit	20 EU	Same	EndotoxinLimit	20 EU	Same	Same	Same	Labeling	Conforms with 21 CFR 801	Same
Labeling	Conforms with 21 CFR 801	Same	Labeling	Conforms with 21 CFR 801	Same	Same	Same

Table 2 Comparison of Technology Characteristics for Single Use Circular Stapler

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Table 3 Comparison of Technology Characteristics for Single Patient Use Endo Cutter and Reload

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Table 4 Comparison of Technology Characteristics for Single Patient Use Linear Stapler and Reload

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Item	Proposed Device	Predicate Device 3
Product Code	GDW	K020779
Regulation Number	21 CFR 878.4750	Same
Intended Use	The Single Patient Use Linear Cutterand Reload are intended for use inmultiple open or surgical proceduresfor the transection and resection oftissues. Linear cutters are alsointended for creation of anastomosesin these procedures.	Same
Cutting Mechanism	Linear Knife	Same
Operation Principle	Manual	Same
Safety Mechanism	Safety release for preventing frommis-firing	Same
Closed staple height	1.0mm, 1.5mm, 1.8mm, 2.0mm	Same
Closed staple form	Image: staple form	Image: staple form
Patient-contactmaterial	Unalloyed TitaniumPolycarbonateStainless Steel	Unknown
Sterilization	Irradiation Sterilization	EO Sterilization
Endotoxin Limit	20 EU	Same
Labeling	Conforms with 21 CFR 801	Same

Table 5 Comparison of Technology Characteristics for Single Patient Use Linear Cutter and Reload

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Item	Proposed Device	Predicate Device 1
Product Code	GDW	K030411
Regulation Number	21 CFR 878.4750	Same
Intended Use	The Single Use Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.	Same
Cutting Mechanism	Circular Knife	Same
Operation Principle	Manual	Same
Safety Mechanism	Safety release for preventing from mis-firing	Same
Closed staple height	0.8~2.0mm	Same
Closed staple form	Image: staple form	Image: staple form
Patient-contact material	Unalloyed TitaniumPolycarbonateStainless Steel	Unknown
Sterilization	Irradiation Sterilization	EO Sterilization
Endotoxin Limit	20 EU	Same
Labeling	Conforms with 21 CFR 801	Same

Table 6 Comparison of Technology Characteristics for Single Use Hemorrhoidal Circular Stapler

Substantially Equivalent (SE) Conclusion 9.

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.