The Disposable Endoscopic Staplers and Reload Unit have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses.

The Disposable Hemorrhoidal Cutter Staplers have application for general treatment of hemorrhoids.

Disposable Linear Cutter Staplers have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.

Device Description

Disposable circular staplers place 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 23mm, 32mm and 34mm four specifications. The staple height is 4.8mm.

Disposable Endoscopic Staplers and Reload Unit place two, triple-staggered rows of progressive 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 2.5mm, 4.0mm, 4.8mm four staple sizes and 3.0~~4.0, 4.0~~5.0 two progressive staple sizes to accommodate various tissue thicknesses. The device may be reloaded and fired up to 10 times in a single procedure.

Disposable Hemorrhoidal Cutter Staplers are 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 is available in 32mm two specifications. The staple size is 4.0mm. It cannot be reloaded.

Disposable Linear Cutter Staplers place 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 5 times in a single procedure.

AI/ML Overview

The provided text describes a 510(k) premarket notification for disposable endoscopic staplers and reload units, disposable hemorrhoidal cutter staplers, disposable linear cutter staplers, and disposable circular staplers. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

Missing Information: It's critical to note that this document is a 510(k) summary, not a full study report. As such, it primarily focuses on demonstrating substantial equivalence based on non-clinical performance testing against predicate devices and adherence to relevant standards. It explicitly states "No clinical study is included in this submission," which means the questions regarding human reader studies (MRMC), standalone algorithm performance, and training/test set details for AI/ML models are not applicable to this submission. The "device" in question refers to medical staplers, a physical medical device, not a software algorithm.

Therefore, the answers below will focus on the information relevant to the provided document, specifically the non-clinical performance and substantial equivalence.

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

The document doesn't present a single, consolidated table of acceptance criteria and reported performance in a pass/fail format typical for each specific test item. Instead, it states that "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."

The implied acceptance criteria are compliance with the listed standards and demonstrating performance comparable to predicate devices in specific ex-vivo tissue and in-vivo animal model tests.

Here's a summary of the performance claims based on the described non-clinical tests:

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Meet requirements of ISO 10993 series and USP for cytotoxicity, irritation, skin sensitization, acute toxicity, pyrogenicity, genotoxicity, implantation, and chemical characterization.	"Biocompatibility test was conducted on the proposed device, the test performed on the device includes cytotoxicity, irritation, skin sensitization acute toxicity test and pyrogenicity. Genotoxicity and implantation were evaluated for the permanent contact staple. In addition, chemical characterization was performed on the staple to evaluate the leachable substance and toxicological risk was assessed for the characterized substance." (Implied to have met acceptance, as substantial equivalence was claimed)
Sterilization: Comply with ISO 11135 for ethylene oxide sterilization.	(Implied to have met acceptance, as substantial equivalence was claimed)
Packaging Seal Integrity: Meet ASTM F 88/F88M-15 for seal strength and ASTM F1929-15 for leak detection.	(Implied to have met acceptance, as substantial equivalence was claimed)
Functional Performance (Ex-vivo tissue): Demonstrate comparable performance to predicate in Pressure Resistance Test, Closed Staple Dimension Test, Staple Formation Test, and Force Required to Fire Stapler Test on porcine stomach and intestine tissue.	"Ex-vivo tissue test was conducted on porcine stomach and intestine tissue for both proposed device and predicate device to evaluate the device performance. The test items include Pressure Resistance Test, Closed Staple Dimension Test, Staple Formation Test and Force Required to Fire Stapler Test." (Implied to have met acceptance, as substantial equivalence was claimed)
Functional Performance (In-vivo animal model for thin tissues): Demonstrate comparable performance to predicate in Burst pressure, closed staple height, and staple formation in jugular vein test on a porcine model (for 2.5mm staple height).	"Besides tissue test, jugular vein test was conducted on a porcine model to evaluate the device performance in thin tissues. This test was conducted on both proposed device and predicate device for 2.5mm staple height. Burst pressure, closed staple height and staple formation were evaluated in jugular vein test." (Implied to have met acceptance, as substantial equivalence was claimed)
Endotoxin Limit: Meet 20EU limit.	Tables 1, 2, 3, 4 consistently list "Endotoxin Limit: 20EU" for both proposed and predicate devices, implying this was met.
Labeling: Conforms with 21CFR 801.	Tables 1, 2, 3, 4 consistently list "Labeling: Conforms with 21CFR 801" for both proposed and predicate devices, implying this was met.
Key Specifications Matching or Being Equivalent to Predicate: (e.g., operation principle, cutting mechanism, safety mechanism, suture/staple dimensions where applicable)	Numerous comparisons in Tables 1-4 demonstrate similarity or equivalence in specifications between proposed and predicate devices. For example, all proposed devices share "Manual" Operation Principle, specific cutting mechanisms (Circular or Linear Knife), and "Safety Release is used for preventing from mis-firing."

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

Sample Size: The document does not specify the exact sample sizes for each non-clinical test (e.g., number of porcine tissues, number of jugular veins, number of stapler firings). It only mentions that tests were "conducted on porcine stomach and intestine tissue" and "jugular vein test was conducted on a porcine model."
Data Provenance: The tests were non-clinical (ex-vivo tissue, in-vivo animal model), not human data. The company is Wuxi Beien Surgery Device Co., Ltd. in China, so the testing was likely performed in China or by a lab contracted by them. The data is prospective for these tests, as they were specifically performed to support the 510(k) 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)

This is not applicable as the device is a physical medical stapler, not an AI/ML diagnostic or image interpretation device. "Ground truth" in this context would be objective measurements from physical testing, not expert consensus on medical images.

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

This is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used in consensus reading of medical images, which is not relevant to the non-clinical testing of a surgical stapler.

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

This is not applicable. The document explicitly states: "No clinical study is included in this submission." Furthermore, the device is a surgical stapler, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a surgical stapler, not a standalone algorithm.

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

For the non-clinical performance tests, the "ground truth" was established by objective physical measurements and observations in the ex-vivo tissue and in-vivo animal model tests. For example:

Pressure Resistance: Measurement of burst pressure.
Closed Staple Dimension: Measurement of the physical dimensions of the formed staples.
Staple Formation: Visual and/or microscopic assessment of the formed staples.
Force Required to Fire: Measurement of the mechanical force.
Burst Pressure (Jugular Vein Test): Measurement of pressure the anastomoses could withstand.

For biocompatibility, the "ground truth" was derived from standard biological and chemical testing methods as per ISO and USP guidelines.

8. The sample size for the training set

This is not applicable. This device is not an AI/ML algorithm requiring a training set.

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

This is not applicable. This device is not an AI/ML algorithm requiring a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA 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.

March 3, 2022

Wuxi Beien Surgery Device Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai. 200120 China

Re: K211811

Trade/Device Name: Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: January 25, 2022 Received: January 26, 2022

Dear Diana 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. 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.

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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.

Mark Trumbore 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

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Indications for Use

510(k) Number (if known) K211811

Device Name

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers

Indications for Use (Describe)

The Disposable circular staplers have application throughout the alimentary tract for end to side, and side to side anastomoses.

The Disposable Endoscopic Staplers and Reload Unit have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses.

The Disposable Hemorrhoidal Cutter Staplers have application for general treatment of hemorrhoids.

Disposable Linear Cutter Staplers have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.

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)

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Tab # 6 510(k) Summary

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

The assigned 510(k) Number: _ K211811

1. Date of Preparation: 03/03/2022
1. Sponsor Identification

Wuxi Beien Surgery Device Co., Ltd.

No.99 Furong San Road, Wuxi, 214192, Jiangsu, China

Contact Person: Juan Li Position: Regulatory Affair Specialist Tel: +86-17714968073 Fax: +86-510-8378 2511 Email: juan.li@beien-surgery.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: 360-925-3199 Email: info@mid-link.net

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Identification of Proposed Device 4.

Trade Name: Disposable Endoscopic Staplers and Reload Unit Disposable Hemorrhoidal Cutter Staplers Disposable Linear Cutter Staplers Disposable Circular Staplers Common Name: Stapler and reload

Regulatory Information

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

Classification Name: Stapler, Surgical; Classification: II Product Code: GAG; Regulation Number: 21 CFR 878.4800 Review Panel: General & Plastic Surgery

Indications for Use:

The Disposable circular staplers have application throughout the alimentary tract for end to end, end to side, and side to side anastomoses.

The Disposable Endoscopic Staplers and Reload Unit have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses.

The Disposable Hemorrhoidal Cutter Staplers have application for general treatment of hemorrhoids.

Disposable Linear Cutter Staplers have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.

Device Description:

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anastomosis is created. The stapler are available in 23mm, 32mm and 34mm four specifications. The staple height is 4.8mm.

5. Identification of Predicate Devices

Predicate Device 1 510(k) Number: K120179 Product Name: Circular Staplers with Staples Linear Cutting Staplers with Single Use Loading Units Endoscopic Linear Cutting Staplers with Single Use Loading Units Manufacturer: Reach Surgical, Inc.

Predicate Device 2 510(k) Number: K161757 Product Name: Single Use Hemorrhoidal Staplers Single Use Endoscopic Linear Cutters and Reloads Manufacturer: Victor Medical Instruments Co., Ltd

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:

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ISO 10993-1:2009 Biological evaluation of medical device- Part 1: Evaluation and testing within a risk management process.
ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Test for in vitro cytotoxicity.
ISO10993-10:2010 Biological evaluation of medical devices-Part 10: Test for irritation and delayed-type hypersensitivity.
USP 43-NF 38 <85> Bacterial Endotoxins Test
ASTM F 88/F88M-15 Standard test method for seal strength of flexible barrier materials;
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
USP 43-NF 38 <151> Pyrogen
ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

Ex-vivo tissue test was conducted on porcine stomach and intestine tissue for both proposed device and predicate device to evaluate the device performance. The test items include Pressure Resistance Test, Closed Staple Dimension Test, Staple Formation Test and Force Required to Fire Stapler Test. Besides tissue test, jugular vein test was conducted on a porcine model to evaluate the device performance in thin tissues. This test was conducted on both proposed device and predicate device for 2.5mm staple height. Burst pressure, closed staple height and staple formation were evaluated in jugular vein test.

Biocompatibility test was conducted on the proposed device, the test performed on the device includes cytotoxicity, irritation, skin sensitization acute toxicity test and pyrogenicity. Genotoxicity and implantation were evaluated for the permanent contact staple. In addition, chemical characterization was performed on the staple to evaluate the leachable substance and toxicological risk was assessed for the characterized substance.

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
Product Code	GDW	GDW
Regulation Number	21 CFR 878.4750	21 CFR 878.4750
Class	II	II
Indication for Use	The Disposable circular staplers have application throughout the alimentary tract for end to end, end to side, and side to side anastomoses.	The Circular Staplers with Staples have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoseopic surgeries.
Cutting Mechanism	Circular Knife	Circular Knife
Operation Principle	Manual	Manual
Safety Mechanism	Safety Release is used for preventing from mis-firing	Safety Release is used for preventing from mis-firing
Specification	23, 29, 32, 34	17, 23, 25,28, 32, 34
Staple Height	4.8mm	3.5mm, 4.8mm
Closed staple form	Image: staple	Image: staple
Endotoxin Limit	20EU	20EU
Labeling	Conforms with 21CFR 801	Conforms with 21CFR 801

Table 1 Comparison for the Disposable Circular Staplers

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Item	Proposed Device	Predicate Device 1K120179	Item	Proposed Device	Predicate Device 1	Predicate Device 2
Product Code	GDW	GDW	Product Code	GDW	K120179GDW	K161757GDW
Regulation Number	21 CFR 878.4750	21 CFR 878.4750	Regulation Number	21 CFR 878.4750	21 CFR 878.4750	21 CFR 878.4750
Class	II	II	Class	II	II	II
Indication for Use	Disposable Linear Cutter Staplers have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.	The Linear Cutting Staplers with Single Use Loading Units have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.	Indication for Use	The Disposable Endoscopic Staplers and ReloadUnit have applications in general, gynecologic,pediatric and thoracic surgery for resection,transection, and creation of anastomoses.	The Endoscopic Linear Cutting Staplerswith Single Use Loading Units haveapplications in general, gynecologic,pediatric and thoracic surgery for resection,transection, and creation of anastomoses.They may be used for transection andresection of liver substance, hepaticvasculature and biliary structures.	The Single Use Endoscopic LinearCutters and Reloads can be used inabdominal, gynecologic, pediatricand thoracic surgery for resection,transection and creation ofside-to-side anastomosis.
Cutting Mechanism	Linear Knife	Linear Knife	Cutting Mechanism	Linear Knife	Linear Knife	Linear Knife
Operation Principle	Manual	Manual	Operation Principle	Manual	Manual	Manual
Safety Mechanism	Safety Release is used for preventing from mis-firing	Safety Release is used for preventing from mis-firing	Safety Mechanism	Safety Release is used for preventing frommis-firing.	Safety Release is used for preventing frommis-firing.	Green button is used for preventingfrom mis-firing.
Suture Length	60,80,100mm	60mm,80mm,100mm	Suture Length	30mm,45mm,60mm	30mm,45mm,60mm	30mm,45mm,60mm
Closed Staple height	3.8mm, 4.8mm	3.8mm, 4.8mm	Staple height	2.5mm, 3.5mm, 4.0mm, 4.8mm, 3.0~~4.0mm,4.0~~5.0mm	2.0mm, 2.5mm, 3.5mm, 4.0mm, 4.8mm	2.0~~3.0mm, 3.0~~4.0mm, 4.0~5.0mm
Closed staple form	Image: Closed staple form	Image: Closed staple form	Closed staple form	Image: staple form	Image: staple form	Image: staple form
Endotoxin Limit	20EU	20EU	Endotoxin Limit	20EU	20EU	20EU
Labeling	Conforms with 21CFR 801	Conforms with 21CFR 801	Labeling	Conforms with 21CFR 801	Conforms with 21CFR 801	Conforms with 21CFR 801

Table 2 Comparison for Disposable Linear Cutter Staplers

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K211811

	Table 3 Comparison for the Disposable Endoscopic Staplers and Reload Unit

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Item	Proposed Device	Predicate Device 2
Product Code	GDW	K161757GDW
Regulation Number	21 CFR 878.4750	21 CFR 878.4750
Class	II	II
Indication for Use	The Disposable Hemorrhoidal Cutter Staplers have application for general treatment of hemorrhoids.	The Single Use Hemorrhoidal Staplers have application for general treatment of hemorrhoids.
Cutting Mechanism	Circular Knife	Circular Knife
Operation Principle	Manual	Manual
Safety Mechanism	Safety Release is used for preventing from mis-firing.	Safety Release is used for preventing from mis-firing.
Specification	32, 34	32, 34
Staple Height	4.0mm	4.0mm
Closed staple form	Image: staple	Image: staple
Endotoxin Limit	20EU	20EU
Labeling	Conforms with 21CFR 801	Conforms with 21CFR 801

Table 4 Comparison for the Disposable Hemorrhoidal Cutter Staplers

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1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed device is 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.