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 pediatric surgical procedures. It can be used with tissue buttressing materials.

The Single Patient Use Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

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 Hemorrhodial 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, 26mm, 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 five staple sizes to accommodate various tissue thicknesses: 2.0mm, 2.5mm. 3.5mm. 3.8mm and 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 staple line length 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, 3.8mm, 4.2mm. 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 text is a 510(k) summary for several surgical staplers and does not contain the specific information required to answer the prompt questions regarding acceptance criteria and a study proving device performance against those criteria in the context of an AI-powered diagnostic device.

This document describes surgical staplers, which are physical medical devices, not AI-powered diagnostic devices. The performance tests mentioned (pressure resistance, closed staple height, staple formation, force to fire) are mechanical tests of the staplers themselves, comparing them to predicate devices. There is no mention of "acceptance criteria," "reported device performance" in terms of diagnostic metrics, "sample size for test set," "data provenance," "experts creating ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth" (for diagnosis), "training set size," or "ground truth for training set."

The document concludes that the proposed devices are "Substantially Equivalent (SE) to the predicate devices" based on non-clinical tests (biocompatibility and mechanical performance tests). This is a regulatory finding for a traditional medical device, not a performance evaluation for an AI diagnostic algorithm.

Therefore, I cannot extract the requested information from the provided text.

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 a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting health and well-being in the United States.

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

July 14, 2017

Golden Stapler Surgical Co., Ltd. % Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China

Re: K162707

Trade/Device 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

Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: June 15, 2017 Received: June 19, 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

David Krause -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K162707

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 Hemorrhodial 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.

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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S001

Exhibit #2 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K162707

1. Date of Preparation: 07/12/2017
1. Sponsor Identification

Golden Stapler Surgical Co., Ltd.

Building 7A, Jiangsu Wujin Sci-Tech Pioneer Park, 256, Mid Mingxin Road, Hutang Town, Wujin District, Changzhou, Jiangsu Province, China

Establishment Registration Number: Not yet registered

Contact Person: Hao Chao Position: General Manager Tel: +86-519-85070751 Fax: +86-519-85070752 Email: Victor.chao@goldenstapler.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 4.

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 Subsequent Product Code: GAG Regulation Number: 21CFR 878.4750 Review Panel: General& Plastic Surgery

Intended Use Statement:

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

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, urologic, thoracic, and pediatric surgical procedures. It can be used with tissue buttressing materials.

The Single Patient Use Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

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

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Device Description

Identification of Predicate Devices న్.

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S001

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

Identification of Reference Devices 6.

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

1. 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 provided in this submission include:

Biocompatibility Test

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S001

Cytotoxicity Test	ISO 10993-5:2009
Skin Sensitization Test	ISO 10993-10:2010
Irritation Test	ISO 10993-10:2010

Performance tests performed on both subject device and predicate device include

Pressure Resistance Test in tissue (porcine intestine) Closed Staple Height Test in tissue (porcine intestine) Staple Formation Test in tissue (porcine intestine) Force to Fire Stapler Test in tissue (porcine intestine) Staple Line Integrity and Staple Formation in thick tissue (porcine stomach)

1. Clinical Test Conclusion
  No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 9.

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

Item	Proposed Device	Predicate Device 6K062869
Product Code	GDW	Same
Regulation Number	21 CFR 878.4750	Same
Intended Use	The Single Patient Use TransverseCutter and Reload is intended fortransection, resection and/or creationof anastomoses. The instrument hasapplication in multiple open orminimally invasive general(gastrointestinal and skeletal musclestapling), gynecologic, urologic, andthoracic surgical procedures.	Same
Cutting Mechanism	Curved Knife	Same
Operation Principle	Manual	Same
Safety Mechanism	Reset Knob is used for preventingfrom mis-firing	Same
Closed staple height	1.5mm, 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

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E2 510(k) Summary

Item	Proposed Device	Predicate Device 2
Product Code	GDW	K983536
Regulation Number	21 CFR 878.4750	Same
Intended Use	The Single Use Circular Stapler hasapplication throughout the alimentarytract for end to end, end to side andside to side anastomoses.	Same
Cutting Mechanism	Circular Knife	Same
Operation Principle	Manual	Same
Safety Mechanism	Insurance is used for preventing frommis-firing	Same
Closed staple height	1.0~2.5mm	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 2 Comparison of Technology Characteristics for Single Use Circular Stapler

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Item	Proposed Device	PredicateDevice 5K061156	ReferenceDevice 1K080839	ReferenceDevice 2K112056	Item	Proposed Device	Predicate Device 4
Product Code	GDW	Same	Same	Same			K111825
RegulationNumber	21 CFR 878.4750	Same	Same	Same	Product Code	GDW	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	Regulation Number	21 CFR 878.4750	Same
CuttingMechanism	Linear Knife	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
OperationPrinciple	Manual	Same	Same	Same	Cutting Mechanism	N.A.	Same
SafetyMechanism	Green button for preventing frommis-firing	Same	Same	Same	Operation Principle	Manual	Same
Closed stapleheight	0.75, 1.0, 1.5, 1.8, 2.2mm	1.0, 1.5,1.8, 2.0mm	0.75mm	2.3mm	Safety Mechanism	Safety release for preventing frommis-firing	Same
Closed stapleform	Image: staple form	Image: staple form	Image: staple form	Image: staple form	Closed staple height	1.0mm, 1.5mm, 2.0mm	Same
Patient-contactmaterial	Unalloyed TitaniumAcrylonitrile-Butadiene-StyreneStainless Steel	Unknown	Unknown	Unknown	Closed staple form	00	00
Sterilization	Irradiation Sterilization	EOSterilization	EOSterilization	EOSterilization	Patient-contactmaterial	Unalloyed TitaniumPolycarbonateStainless Steel	Unknown
EndotoxinLimit	20 EU	Same	Same	Same	Sterilization	Irradiation Sterilization	EO Sterilization
Labeling	Conforms with 21 CFR 801	Same	Same	Same	Endotoxin Limit	20 EU	Same
Labeling	Conforms with 21 CFR 801	Same

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

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E2 510(k) Summary

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

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Item	Proposed Device	Predicate Device 3K020779
Product Code	GDW	Same
Regulation Number	21 CFR 878.4750	Same
Intended Use	The Single Patient Use Linear Cutterand Reload have application ingastrointestinal, gynecologic,thoracic, and pediatric surgery fortransection, resection, and/or creationof anastomoses and can be used withstaple line or tissue buttressingmaterials, such as bovinepericardium.	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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E2 510(k) Summary

Item	Proposed Device	Predicate Device 1
		K030411
Product Code	GDW	Same
Regulation Number	21 CFR 878.4750	Same
Intended Use	UseHemorrhoidalTheSingleStapler has applicationCircularthroughout the anal canal to performsurgical treatment of hemorrhoidaldisease.	Same
Cutting Mechanism	Circular Knife	Same
Operation Principle	Manual	Same
Safety Mechanism	Safety release for preventing frommis-firing	Same
Closed staple height	0.8~2.0mm	Same
Closed staple form	B	儿
Patient-contact	Unalloyed Titanium
material	Polycarbonate	Unknown
	Stainless Steel
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

10. Substantially Equivalent (SE) Conclusion

Biocompatibility testing was performed on the proposed devices; including cytotoxicity, skin sensitization and irritation tests. The test results demonstrate that the device does not introduce any biocompatibility concerns. The proposed device is sterilized by radiation, a different method than the predicate, and sterility was established per ISO ISO11137. Therefore, testing demonstrates that the difference in patient contact material and sterilization method will not affect substantial equivalence.

The performance tests include pressure resistance test which is intended evaluate integrity of staple line, force to fire a stapler test which is intended to evaluate the force to fire a stapler, staple formation test which is intended to evaluate stapler formation characteristics, and closed staple height test which is intended evaluate whether the closed staple height can meet pre-defined criteria. The test results for both proposed device and predicate device was analyzed by statistical methods to ensure the sample size was appropriate to detect a meaningful difference between testing groups. The results show that there are no significant difference between proposed device and predicate device. Based on the comparison and performance test result 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.