K Number
K211811
Device Name
Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers
Date Cleared
2022-03-03

(265 days)

Product Code
Regulation Number
878.4750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
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.
More Information

Not Found

No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI or ML.

No.
Therapeutic devices are generally considered to be those that treat a disease or condition. While these staplers are used during surgical procedures to resect tissue and create anastomoses, which are part of treating a condition, the devices themselves are tools for a surgical procedure, not the treatment itself. They facilitate the surgical repair.

No

The document describes various types of surgical staplers used for resection, transection, and creation of anastomoses, which are therapeutic procedures. There is no mention of the device being used to diagnose conditions.

No

The device description clearly details physical, mechanical staplers made of titanium and other materials, with specific dimensions and mechanisms of action involving squeezing handles and cutting tissue. This is a hardware device, not software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
  • Device Description and Intended Use: The description and intended use clearly indicate that these are surgical staplers used for joining or cutting tissue during surgical procedures within the body. They are used for mechanical manipulation of tissue, not for analyzing samples.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.

Therefore, these disposable staplers fall under the category of surgical instruments, not In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

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.

Product codes

GDW, GAG

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 3.04.0, 4.05.0 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

alimentary tract, general, gynecologic, pediatric, thoracic, abdominal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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 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 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.

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K120179, K161757

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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

2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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3

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

4

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:

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

5

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 3.04.0, 4.05.0 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.

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:

6

  • 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 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 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.

7

8. Substantially Equivalent (SE) Comparison

ItemProposed DevicePredicate Device 1
Product CodeGDWGDW
Regulation Number21 CFR 878.475021 CFR 878.4750
ClassIIII
Indication for UseThe 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 MechanismCircular KnifeCircular Knife
Operation PrincipleManualManual
Safety MechanismSafety Release is used for preventing from mis-firingSafety Release is used for preventing from mis-firing
Specification23, 29, 32, 3417, 23, 25,28, 32, 34
Staple Height4.8mm3.5mm, 4.8mm
Closed staple formImage: stapleImage: staple
Endotoxin Limit20EU20EU
LabelingConforms with 21CFR 801Conforms with 21CFR 801

Table 1 Comparison for the Disposable Circular Staplers

8

| Item | Proposed Device | Predicate Device 1
K120179 | Item | Proposed Device | Predicate Device 1 | Predicate Device 2 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GDW | GDW | Product Code | GDW | K120179
GDW | K161757
GDW |
| 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 Reload
Unit have applications in general, gynecologic,
pediatric and thoracic surgery for resection,
transection, and creation of anastomoses. | The Endoscopic Linear Cutting Staplers
with Single Use Loading Units have
applications in general, gynecologic,
pediatric and thoracic surgery for resection,
transection, and creation of anastomoses.
They may be used for transection and
resection of liver substance, hepatic
vasculature and biliary structures. | The Single Use Endoscopic Linear
Cutters and Reloads can be used in
abdominal, gynecologic, pediatric
and thoracic surgery for resection,
transection and creation of
side-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 from
mis-firing. | Safety Release is used for preventing from
mis-firing. | Green button is used for preventing
from 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, 3.04.0mm,
4.0
5.0mm | 2.0mm, 2.5mm, 3.5mm, 4.0mm, 4.8mm | 2.03.0mm, 3.04.0mm, 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

9

K211811

Table 3 Comparison for the Disposable Endoscopic Staplers and Reload Unit

10

ItemProposed DevicePredicate Device 2
Product CodeGDWK161757
GDW
Regulation Number21 CFR 878.475021 CFR 878.4750
ClassIIII
Indication for UseThe Disposable Hemorrhoidal Cutter Staplers have application for general treatment of hemorrhoids.The Single Use Hemorrhoidal Staplers have application for general treatment of hemorrhoids.
Cutting MechanismCircular KnifeCircular Knife
Operation PrincipleManualManual
Safety MechanismSafety Release is used for preventing from mis-firing.Safety Release is used for preventing from mis-firing.
Specification32, 3432, 34
Staple Height4.0mm4.0mm
Closed staple formImage: stapleImage: staple
Endotoxin Limit20EU20EU
LabelingConforms with 21CFR 801Conforms with 21CFR 801

Table 4 Comparison for the Disposable Hemorrhoidal Cutter Staplers

11

    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.