ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS

K130738 · Nanjing Maidixin Medical Device Co., Ltd. · GDW · Dec 13, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K130738
• Device Name: ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS
• Applicant: Nanjing Maidixin Medical Device Co., Ltd.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Dec 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Endoscopic Linear Cutting Staple Use Loading Units have applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures.

Device Story

Endoscopic linear cutting stapler with single-use loading units (SULU); manual operation; used in general, gynecologic, pediatric, and thoracic surgery. Device places four or six rows of titanium staples while simultaneously dividing tissue along a central line. Available in straight and articulating configurations. Reloadable up to 10 times per procedure. Includes safety mechanism (green button) to prevent misfiring. Used by surgeons in clinical settings to facilitate tissue resection and anastomosis creation; benefits include standardized staple placement and efficient tissue division.

Clinical Evidence

No clinical data. Bench testing only, including physical performance, endotoxin, package integrity, and shelf-life testing.

Technological Characteristics

Manual endoscopic linear stapler; titanium staples (ASTM F 67-06); stainless steel body; straight and articulating SULU configurations; closed staple heights 0.75-2.0 mm; irradiation sterilization (SAL 10^-6).

Indications for Use

Indicated for patients undergoing general, gynecologic, pediatric, or thoracic surgery requiring tissue resection, transection, or creation of anastomoses, including liver substance, hepatic vasculature, and biliary structures.

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

• Endoscopic Linear Cutting Staplers with Single Use Loading Units (K120179)

Submission Summary (Full Text)

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Section III 510(k) Summary

Project #: M0032012Aa

## DEC 1 3 2013

Proposed Device Identification 4.

> Proposed Device Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units Device Common Name: Stapler

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

### Intended Use Statement:

The Endoscopic Linear Cutting Staple Use Loading Units have applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures.

#### Predicate Device Identification 5.

510(k) Number:K 120179

Product Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units Manufacturer: Reach Surgical, Inc.

#### 6. Device Description

The proposed devices, Endoscopic Linear Cutting Staplers with Single Use Loading Units (SULU), are sterilized and disposable surgical instruments, which have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and billiary structures.

It places four or six rows of titanium staples and simultaneously divides the tissue from central line. The Endoscopic Linear Cutter Staplers can be adapted for all of the SULU sizes available, and they may be reloaded and fired no more than 10 times in a single procedure.

The SULU has two configurations: (1) Straight SULU and (2) Articulating SULU, each of them has various specifications.

- Non-Clinical Test Conclusion 7.
111-2

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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. These tests include: Physical Performance Testing, Endotoxin Testing, Package Integrity Testing, and Shelf Life Testing.

- 8. Substantially Equivalent (SE) Conclusion
The following table compares the proposed device to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

| Item | Proposed Device | Predicate Device |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Product Code | GDW | Same |
| Regulation Number | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The Endoscopic Linear Cutting Staplers with Single<br>Use Loading Units have applications in general,<br>gynecologic, pediatric and thoracic surgery for<br>resection, transection, and creation of anastomoses.<br>They may be used for transection and resection of<br>liver substance, hepatic vasculature and biliary<br>structures. | Same |
| Cutting Mechanism | Linear | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Green button for preventing from mis-firing. | Same |
| Suture Length | 46, 61 mm | Similar |
| Closed Staples Height | 0.75, 1.0, 1.5, 2.0 mm | Same |
| Closed Staples Form | Image: staple form | Same |
| Staple Materiel | Unalloyed Titanium conforms to ASTM F 67-06 | Same |
| Stapler Materials | Stainless Steel | Same |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Similar |

.Table 111-1 Comparison of Technology Characteristics

The proposed device, Endoscopic Linear Cutting Staplers with Single Use Loading Units, is determined to be Substantially Equivalent (SE) to the predicate device, Endoscopic Linear Cutting Staplers with Single Use Loading Units (K120179), in respect of safety and effectiveness.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another, representing health and human services.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Nanjing Maidixin Medical Device Company, LTD % Ms. Diana Hong Mid-Link Consulting Company LTD P.O. Box 120-119 Shanghai, China 200120

December 13, 2013

Re: K130738

Trade/Device Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: November 7, 2013 Received: November 12, 2013

Dear Ms. Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Diana Hong

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

For

Sincerely vours.

Joshua

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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## Section II Indications for Use

510(k) Number: K130738 Device Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units

Indications for Use:

The Endoscopic Linear Cutting Staple Use Loading Units have applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D)

OR

OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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# David Krause SS

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130738

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