Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads

K161757 · Victor Medical Instruments Co., Ltd. · GDW · Dec 5, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161757
• Device Name: Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads
• Applicant: Victor Medical Instruments Co., Ltd.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Dec 5, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Single Use Endoscopic Linear Cutters and Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. The Single Use Curved Cutters are intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and sketal muscle), gynecologic, urologic, and thoracic surgical procedures. The Single Use Circular staplers have application throughout the alimentary tract for the creation of end-toside and side-to-side anastomoses in abdominal or thoracic surgeries. The Single Use Linear Staplers and Reloads have application in transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. The Single Use Linear Cutters and Reloads have application in abdominal, gynecological, thoracic and pediatic surgery transection, resection and the creation of anastomoses. The Single Use Hemorrhoidal Staplers have application for general treatment of hemorrhoids.

Device Story

Manual surgical stapling instruments; used in open or minimally invasive procedures; place titanium staples in staggered rows while simultaneously cutting tissue (except linear staplers). Input: manual activation by surgeon via handle squeeze. Output: stapled and transected tissue. Used in OR by surgeons. Benefits: facilitates tissue resection and anastomosis creation. Includes curved cutters, circular staplers, endoscopic linear cutters, linear staplers, linear cutters, and hemorrhoidal staplers. Some models support multiple reloads per procedure.

Clinical Evidence

No clinical data. Bench testing only. Testing included biological evaluation (ISO 10993-1, -5, -10), sterilization validation (ISO 11137-2), and mechanical performance testing (pressure resistance, staple formation, firing force) on swine tissue.

Technological Characteristics

Materials: Unalloyed titanium, stainless steel, polycarbonate, or ABS. Manual operation. Irradiation sterilization. Staple configurations: staggered rows (curved, circular, linear). Connectivity: None. Software: None.

Indications for Use

Indicated for patients undergoing abdominal, gynecologic, pediatric, thoracic, urologic, or general gastrointestinal/skeletal muscle surgery requiring tissue transection, resection, or anastomosis, and for the treatment of hemorrhoids.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Disposable Circular Stapler, Disposable Linear Staplers and Reloads, Disposable Hemorrhoidal Stapler, Disposable Linear Cutter Staplers and Reloads, Disposable Curved Cutter Stapler (K131511)
• Endo GIA Staplers (K111825)

Submission Summary (Full Text)

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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 eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the eagle.

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

December 5, 2016

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

Re: K161757

Trade/Device Name: Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters And Reloads, Single Use Endoscopic Linear Cutters And Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers And Reloads

Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: October 31, 2016 Received: November 4, 2016

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 [phone] or [phone] 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 [phone] or [phone] 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) K161757

### Device Name

Single Use Curved Cutters, Single Use Circular Staple Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads

### Indications for Use (Describe)

The Single Use Endoscopic Linear Cutters and Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

The Single Use Curved Cutters are intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and sketal muscle), gynecologic, urologic, and thoracic surgical procedures.

The Single Use Circular staplers have application throughout the alimentary tract for the creation of end-toside and side-to-side anastomoses in abdominal or thoracic surgeries.

The Single Use Linear Staplers and Reloads have application in transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.

The Single Use Linear Cutters and Reloads have application in abdominal, gynecological, thoracic and pediatic surgery transection, resection and the creation of anastomoses.

The Single Use Hemorrhoidal Staplers have application for general treatment of hemorrhoids.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## Exhibit #3 510(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: K161757

- 1. Date of Preparation: 12/05/2016
- Sponsor Identification 2.

## Victor Medical Instruments Co., Ltd.

NO.21, Huafeng Road, Qishuyan District, Changzhou City, Jiangsu P.R.213018 China

Establishment Registration Number: 3012428834

Contact Person: Yunhuo Chen Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- Designated Submission Correspondent 3.
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: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: Single Use Curved Cutters

Single Use Circular Staplers Single Use Endoscopic Linear Cutters and Reloads Single Use Linear Staplers and Reloads Single Use Linear Cutters and Reloads Single Use Hemorrhoidal Staplers 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

Indication for Use:

The Single Use Endoscopic Linear Cutters and Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

The Single Use Curved Cutters are intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.

The Single Use Circular staplers have application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

The Single Use Linear Staplers and Reloads have application in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.

The Single Use Linear Cutters and Reloads have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses.

The Single Use Hemorrhoidal Staplers have application for general treatment of hemorrhoids.

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Device Description

The Single Use Curved Cutters place 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 4.8mm staple size.

Single Use 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 25mm, 27mm and 33mm three specifications. The staple is available in two specifications which are 4.8mm, 5.2mm to be used per different thickness of the tissue.

Single Use Endoscopic Linear Cutters and Reloads 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 three staple sizes to accommodate various tissue thicknesses: 2mm-3mm, 4mm-5mm. The device may be reloaded and fired up to 8 times in a single procedure.

Single Use Linear Staplers and Reloads place a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm and 100mm staple line length for use in various applications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 7 times for a total 8 firing in a single procedure.

Single Use Linear Cutters and Reloads 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 7 times for a total 8 firings in a single procedure.

Single Use Hemorrhoidal 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 are available in 32mm, 34mm two specifications. The staple size is 4.0mm. It cannot be reloaded.

- 5. Identification of Predicate Devices
Predicate Device 1 510(k) Number: K131511

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Product Name: Disposable Circular Stapler Disposable Linear Staplers and Reloads Disposable Hemorrhoidal Stapler Disposable Linear Cutter Staplers and Reloads Disposable Curved Cutter Stapler

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

- б. 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:

- 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
- > USP 38-NF 33 <85> Bacterial Endotoxins Tests
- > ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
- > ASTM F1140/F1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages;
- > ISO 11137-2: 2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose

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
- A Staple Formation Test
- > Force Required to Fire Stapler Test
- 7. 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 | K131511 |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Single Use Curved Cutters are intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures | Same |
| Cutting Mechanism | Curved Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Reset Knob is used for preventing from mis-firing | Same |
| Closed staple height | 2.0mm | 1.9mm |
| Closed staple form | Image: staple form | Image: staple form |
| Patient-contact material | Unalloyed Titanium<br>Polycarbonate<br>Stainless Steel | Same |
| Sterilization | Irradiation Sterilization | Same |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |

## Table 1 Comparison of Technology Characteristics for Single Use Curved Cutters

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| Item | Proposed Device | Predicate Device 1 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Product Code | GDW | K131511 |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Single Use Circular staplers have<br>application throughout the alimentary<br>tract for the creation of end-to-end,<br>end-to-side and side-to-side<br>anastomoses in abdominal or thoracic<br>surgeries. | Same |
| Cutting Mechanism | Circular Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Insurance is used for preventing from<br>mis-firing | Same |
| Closed staple height | 2.0mm, 2.2mm | Same |
| Closed staple form | Image: staple form | Image: staple form |
| Patient-contact<br>material | Unalloyed Titanium<br>Acrylonitrile-Butadiene-Styrene<br>Stainless Steel | Similar |
| Sterilization | Irradiation Sterilization | Same |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |

Table 2 Comparison of Technology Characteristics for Single Use Circular Staplers

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| Item | Proposed Device | Predicate Device 2 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| | | K111825 |
| Product Code | GDW | Same |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Single Use Endoscopic Linear<br>Cutters and Reloads have<br>applications in abdominal,<br>gynecologic, pediatric and thoracic<br>surgery for resection, transection and<br>creation of anastomosis. They may be<br>used for transection and resection of<br>liver substance, hepatic vasculature<br>and biliary structures and for<br>transection and resection of pancreas. | Same |
| Cutting Mechanism | Linear Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Green button for preventing from<br>mis-firing | Same |
| Closed staple height | 0.8-1.5mm, 1.5-2.25mm, 2.25-3.0mm | Same |
| Closed staple form | Image: staple form | Image: staple form |
| Patient-contact material | Unalloyed Titanium<br>Acrylonitrile-Butadiene-Styrene<br>Stainless Steel | Unknown |
| Sterilization | Irradiation Sterilization | Unknown |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |

Table 3 Comparison of Technology Characteristics for Single Use Endoscopic Linear Cutters and Reloads

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| Item | Proposed Device | Predicate Device 1 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Product Code | GDW | K131511 |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Single Use Linear Staplers and Reloads have application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. | Same |
| Cutting Mechanism | N.A. | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Safety release for preventing from mis-firing | Same |
| Closed staple height | 1.5mm, 2.0mm | 1.5mm, 1.8mm |
| Closed staple form | | Image: Closed staple form |
| Patient-contact material | Unalloyed Titanium<br>Polycarbonate<br>Stainless Steel | Same |
| Sterilization | Irradiation Sterilization | Same |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |

Table 4 Comparison of Technology Characteristics for Single Use Linear Staplers and Reloads

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| Item | Proposed Device | Predicate Device 1 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| | | K131511 |
| Product Code | GDW | Same |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Single Use Linear Cutters and Reloads have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses. | Same |
| Cutting Mechanism | Linear Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Safety release for preventing from mis-firing | Same |
| Closed staple height | 1.5mm, 2.0mm | 1.5mm, 1.8mm |
| Closed staple form | Image: staple form | Image: staple form |
| Patient-contact material | Unalloyed Titanium<br>Polycarbonate<br>Stainless Steel | Same |
| Sterilization | Irradiation Sterilization | Same |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |

Table 5 Comparison of Technology Characteristics for Single Use Linear Cutters and Reloads

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| Item | Proposed Device | Predicate Device 1 |
|--------------------------|---------------------------------------------------------------------------------------------|--------------------|
| Product Code | GDW | K131511 |
| Regulation Number | 21 CFR 878.4750 | Same |
| Intended Use | The Single Use Hemorrhoidal Staplers have application for general treatment of hemorrhoids. | Same |
| Cutting Mechanism | Circular Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Safety release for preventing from mis-firing | Same |
| Closed staple height | 2.0mm | 1.9mm |
| Closed staple form | Image: staple form | Image: staple form |
| Patient-contact material | Unalloyed Titanium<br>Acrylonitrile-Butadiene-Styrene<br>Stainless Steel | Same |
| Sterilization | Irradiation Sterilization | Same |
| Endotoxin Limit | 20 EU | Same |
| Labeling | Conforms with 21 CFR 801 | Same |

Table 6 Comparison of Technology Characteristics for Single Use Hemorrhoidal Cutters

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