The Disposable End-to-end Anastomosis Circular Stapler has applications throughout the alimentary tract for the creation of end-to end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.

The Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and for transection and resection and resection of pancreas.

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

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

Device Description

Disposable End-to-end Anastomosis 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 25mm and 31mm three specifications. The staple size is 4.8 mm.

Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit places two, triple-staggered rows of progressive or equal 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 staple sizes 2mm-3mm, 3mm-4mm, 2.5mm, 4.0mm. 4.8mm to accommodate various tissue thicknesses. The device may be reloaded and fired up to 25 times in a single procedure.

Linear Cutting Stapler and Single Use Loading Unit places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 60mm, 80mm and 100mm lengths. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.8mm. It may be reloaded and fired up to 7 times for a total 8 firings in a single procedure.

Disposable Hemorrhoidal Circular Stapler is a set of instrument 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 is available in 33mm one specification. The staple size is 4.5mm. It cannot be reloaded.

AI/ML Overview

This document is a 510(k) Summary for premarket notification of several surgical staplers. It focuses on demonstrating Substantial Equivalence (SE) to legally marketed predicate devices, rather than proving a device meets specific acceptance criteria in a clinical study or demonstrating an improvement in human reader performance with AI assistance.

Therefore, most of the information requested in your prompt (e.g., acceptance criteria for a study, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, type of ground truth, training set specifics) cannot be extracted from this document, as it describes a different type of regulatory submission process.

The document primarily outlines non-clinical testing to establish technical equivalence and mentions no clinical studies were performed for this submission.

Here's what can be extracted based on the provided text, and where your requested information is not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not present "acceptance criteria" in the sense of clinical performance thresholds or a pre-defined set of performance metrics for human-in-the-loop or standalone AI. Instead, it describes non-clinical test conclusions verifying design specifications and substantial equivalence to predicate devices. The "reported device performance" is essentially that the device met these design specifications and performed comparably to predicate devices in bench tests.

Non-Clinical Test Conclusions and Performance (Staplers)

Test Category	Acceptance/Conclusion	Reported Device Performance
Biocompatibility	Conforms to ISO 10993-1, -5, -10 standards.	Device materials are biocompatible (e.g., non-cytotoxic, non-irritating, non-sensitizing).
Sterilization	Conforms to ISO 11137-2 (Radiation) and ISO 11135 (Ethylene Oxide) standards.	Device can be effectively sterilized and maintain sterility.
Packaging Integrity	Conforms to ASTM F 88/F88M-09 (Seal Strength) and ASTM F1929-12 (Dye Penetration).	Packaging maintains seal integrity to protect the sterile device.
Endotoxin Limit	Meets specified endotoxin limit (20 EU).	Device has low endotoxin levels as required.
Bench Test (Swine tissue)	Demonstrated Substantial Equivalence to predicate devices. Includes: Pressure Resistance Test, Closed Staple Height Test, Staple Formation Test, Force Required to Fire Stapler Test.	Proposed devices performed comparably to predicate devices in these tests. For example, Closed Staple Height and Closed Staple Form were found to be "Same" or very similar to predicate devices, and force required to fire was suitable. (Specific numerical performance data like exact pressure resistance values are not provided in this summary, only the conclusion of equivalence).

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for the bench tests. It says "Bench test was conducted on swine stomach and intestine tissue," but the number of samples or animals is not provided.
Data Provenance: The bench tests involved "swine stomach and intestine tissue." The manufacturer is Chongqing Qmi Surgical Co., Ltd. in China. The location where the bench tests were performed is not explicitly stated beyond "Non clinical tests were conducted," but it's implied to be part of the manufacturer's testing or a contracted lab. The data would be considered prospective as it's generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission relies on non-clinical bench testing to demonstrate the physical and functional performance of the staplers against defined engineering specifications and comparison to predicate devices, not on human expert interpretation of medical images or records. Therefore, "ground truth" as typically defined for AI/diagnostic studies (e.g., expert consensus, pathology) is not established by human experts in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3. This is not a study requiring human adjudication for ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This document is for a surgical stapler, not an AI device. The document explicitly states: "No clinical study is included in this submission."

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

Not applicable. This is a hardware device (surgical stapler), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical bench tests, "ground truth" would be the engineering specifications and physical properties of the stapler and the tissue tests. For example, "Closed staple height" is a measurable physical attribute, not a subjective interpretation. Comparison to predicate device performance also serves as a benchmark for equivalence.

8. The sample size for the training set

Not applicable. This device is a surgical stapler, not an AI/machine learning model. There is no "training set."

9. How the ground truth for the training set was established

Not applicable. See point 8.

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 consists of a stylized depiction of a human figure with three faces in profile, overlaid on top of each other. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.

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

March 3, 2017

Chongqing Qmi Surgical Co., Ltd % Ms. Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN

Re: K162947

Trade/Device Name: Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler And Single Use Loading Unit; Linear Cutting Stapler And Single Use Loading Unit: Disposal Hemorrhoidal Circular Stapler

Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: January 24, 2017 Received: January 30, 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 mav 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,

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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Indications for Use

510(k) Number (if known) K162947

Device Name

Disposable End-to-end Anastomosis Circular Stapler, Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit, Linear Cutting Stapler and Single Use Loading Unit, Disposable Hemorrhoidal Circular Stapler

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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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: K162947

1. Date of Preparation: 03/03/2017
1. Sponsor Identification

CHONGQING QMI SURGICAL CO., LTD.

A Zone 1st floor, Yangliu Road No.2 North New Zone, Chongqing China

Establishment Registration Number: Not yet registered

Contact Person: Kang Li Position: General Manager Tel: +86-23-67300630 Fax: +86-23-63053502 Email: kang.li@qmimed.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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4. Identification of Proposed Device

Trade Name: Disposable End-to-end Anastomosis Circular Stapler

Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit Linear Cutting Stapler and Single Use Loading Unit Disposable Hemorrhoidal Circular Stapler 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 Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit has applications in abdominal, gynecologic, pediatic and thoracic surgery for resection and creation of anastomosis. They may be used for transection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

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

Device Description

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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 25mm and 31mm three specifications. The staple size is 4.8 mm.

5. Identification of Predicate Devices

Predicate Device 1 510(k) Number: K062850 Product Name: autosuture™ Circular EEATM surgical staplers

Predicate Device 2 510(k) Number: K111825 Product Name: Endo GIATM Staplers

Predicate Device 3 510(k) Number: K051301 Product Name: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories

Predicate Device 4 510(k) Number: K061156 Product Name: ENDOPATH Linear Cutters and Staplers

Non-Clinical Test Conclusion 6.

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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:

A 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
A USP 38-NF 33 <85> Bacterial Endotoxins Tests
ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials; A
ISO 11137-2: 2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose
ISO 11135: 2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
A ASTM F88/F88-09 Standard test method for seal strength of flexible barrier materials.
ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

Bench test was conducted on swine stomach and intestine tissue for both proposed device and predicate device to determine substantially equivalence. The bench tests include following tests

Pressure Resistance Test
Closed Staple Height Test
Staple Formation Test
Force Required to Fire Stapler Test
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 1	Item	Proposed Device	Predicate Device 2	Predicate Device 4
Product Code	GDW	K062850	Product Code	GDW	K111825	K061156
Regulation Number	21 CFR 878.4750	Same	Regulation Number	21 CFR 878.4750	Same	Same
Intended Use	The Disposable End-to-endAnastomosis Circular Stapler hasapplications throughout thealimentary tract for the creation ofend-to end, side-to-side andend-to-side anastomoses in both openand laparoscopic surgeries, includingbariatric surgery.	Same	Intended Use	The Universal Endoscopic Linear Cutting Staplerand Single Use Loading Unit has applications inabdominal, gynecologic, pediatric and thoracicsurgery for resection, transection and creation ofanastomosis. They may be used for transection andresection of liver substance, hepatic vasculature andbiliary structures and for transection and resectionof pancreas.	Same	The ENDOPATH Endocutter 60 EndoscopicLinear Cutter is intended for transection,resection, and/or creation of anastomoses.The instrument has application in multipleopen or minimally invasive general,gynecologic, urologic, thoracic, andpediatric surgical procedures. It can be usedwith staple line or tissue buttressingmaterials.
Cutting Mechanism	Circular Knife	Same	Cutting Mechanism	Linear Knife	Same	Same
Operation Principle	Manual	Same	Operation Principle	Manual	Same	Same
Safety Mechanism	Insurance is used for preventing frommis-firing	Same	Safety Mechanism	Green button is used for preventing from mis-firing	Same	Same
Closed staple height	2.0mm	Same	Closed staple height	1.0, 1.5, 1.75, 2.0mm0.75~~1.25, 1.25~~1.75mm	1.0, 1.5, 2.0mm0.75~~1.25, 1.25~~1.75mm	1.0, 1.5, 1.8mm
Closed staple form	Image: staple form	Same	Closed staple form	Image: staple form	Same	Same
Sterilization	Irradiation Sterilization	EO Sterilization	Sterilization	Irradiation Sterilization	EO Sterilization	EO Sterilization
Endotoxin Limit	20 EU	Same	Endotoxin Limit	20 EU	Same	Same
Labeling	Conforms with 21 CFR 801	Same	Labeling	Conforms with 21 CFR 801	Same	Same

Table 1 Comparison of Technology Characteristics for Disposable End-to-end Anastomosis Circular Stapler

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Table 2 Comparison of Technology Characteristics for Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit

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Item	Proposed Device	Predicate Device 2
Product Code	GDW	K111825
Regulation Number	21 CFR 878.4750	Same
Intended Use	The Linear Cutting Stapler andSingle Use Loading Unit hasapplications in abdominal,gynecological, pediatric and thoracicsurgical procedures for resection,transection and creation ofanastomosis. The stapler may be usedfor occlusion of the left atrialappendage in open procedures. Theymay be used for transection andresection of pancreas.	Same
Cutting Mechanism	Linear Knife	Same
Operation Principle	Manual	Same
Closed staple height	1.5mm, 2.0mm	1.0mm, 1.5mm, 2.0mm
Closed staple form	Image: staple form	Same
Sterilization	Irradiation Sterilization	EO Sterilization
Endotoxin Limit	20 EU	Same
Labeling	Conforms with 21 CFR 801	Same

Table 3 Comparison of Technology Characteristics for Linear Cutting Stapler and Single Use Loading Unit

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Item	Proposed Device	Predicate Device 3
Product Code	GDW	K051301
Regulation Number	21 CFR 878.4750	Same
Intended Use	The Disposable 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	Insurance is used for preventing from mis-firing	Same
Closed staple height	2.0mm	Same
Closed staple form	Image: staple form	Same
Sterilization	EO Sterilization	Same
Endotoxin Limit	20 EU	Same
Labeling	Conforms with 21 CFR 801	Same

Table 4 Comparison of Technology Characteristics for Disposable 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.