DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER

K121474 · Changzhou Kangdi Medical Stapler Co., Ltd. · GDW · Jul 16, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121474
• Device Name: DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER
• Applicant: Changzhou Kangdi Medical Stapler Co., Ltd.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jul 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Disposable Linear Stapler, Model KYFB-30 / 60 / 90 The Disposable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transaction and resection of internal tissues. Disposable Linear Cutter, Model KYQII-60 / 80 / 100 The Disposable Linear Cutter has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.

Device Story

Disposable linear staplers and cutters deliver two staggered rows of titanium staples to approximate internal tissues. The stapler is available in 30, 60, and 90 mm sizes; the cutter in 60, 80, and 100 mm sizes. Staple height is adjustable to accommodate varying tissue thicknesses. Used in OR settings by surgeons for resection, transection, and anastomosis. The device functions mechanically to deliver and secure staples, providing tissue approximation and closure. Benefits include reliable tissue management during surgical procedures.

Clinical Evidence

Bench testing only. Performance testing confirmed energy requirements for staple delivery and removal were consistent with predicate devices. Biocompatibility testing passed ISO 10993-1, -3, -5, -6, -10, and -11. Sterilization and shelf-life validation performed per ISO 11137, ISO 11737, ISO 11607, and ASTM standards.

Technological Characteristics

Constructed of unalloyed titanium (ISO 5832-2:1999, ASTM F67-06). Mechanical stapling/cutting principle. Available in multiple lengths (30-100 mm). Sterilized via validated methodology (ISO 11137). No software or electronic components.

Indications for Use

Indicated for patients undergoing alimentary tract, thoracic, abdominal, or gynecological surgical procedures, including pediatric patients, requiring resection, transection, or creation of anastomosis of internal tissues.

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

• PROXIMATE Reloadable Linear Stapler, Model TL30, TL60, TL90, TLH30, TLH60, TLH90 (K020779)
• DST Series GIA: Auto Suture GIA Reloadable Stapler, GIA60, GIA80, GIA100 (K111825)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: April 22, 2012

JUL 16. 2012

Company making the submission: Name - Changzhou Kangdi Medical Stapler Co., Ltd Address - No. 167-5, East Road, Changzhou, Jiangsu, China 213022 Telephone - 86-519-85162780 Fax - 86-519-85139853 Contact - Mr. Fleming Jiang Email - [e-mail]

Correspondent: Name: Charles Mack Address: 77325 Joyce Way; Echo, Oregon 97826 Telephone: [phone] Email: [e-mail]

### Device:

Trade/proprietary names:

Disposable Linear Stapler, Model KYFB Disposable Linear Cutter, Model KYQII

Common Name: Implantable Staple Classification Name: Staple, implantable Predicate Devices:

# Linear Stapler:

Ethicon Endo-Surgery, Inc. K020779 The PROXIMATE Reloadable Linear Stapler, Model TL30, TL60, TL90,

TLH30, TLH60, TLH90

#### Linear Cutter:

Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) K111825 DST Series™ GIA™: Auto Suture™ GIA™ Reloadable Stapler, GIA60, GIA80, GIA100

Classifications Names & Citations: 21CFR 878.4520, GDW, Polymer, ENT synthetic-polyamide (mesh or foil material), Class II

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows handwritten text. The first line reads "<12147.4". The second line reads "page 2/3". The text appears to be written in black ink on a white background.

# Description: General Disposable Linear Stapler

The Disposable Linear Stapler delivers two staggered rows of titanium staples to approximate internal tissues. The instrument is available in three sizes to accommodate different tissues. Staple height is adjustable to compensate for various tissue thickness .The 30 mm instruments create a 30 mm staple line, the 60 mm instruments create a 60 mm staple line, the 90 mm instruments create a 90 mm staple line.

# Disposable Linear Cutter

The disposable linear cutter and the cartridge for disposable linear cutter have applications in abdominal gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.

# Indications For Use

Disposable Linear Stapler, Model KYFB-30 / 60 / 90

The Disposable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transaction and resection of internal tissues.

Disposable Linear Cutter, Model KYQII-60 / 80 / 100

The Disposable Linear Cutter has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.

### Technical Characteristics:

The Disposable Linear cutter and Disposable Linear cutter have not changed in basic design. The only difference in the current submitted device is the size of the staples in the submitted device The stable differences are not significant and testing of the staples during insertion and extraction showed that there are no appreciable differences in the energy needed to insert or extract the staples.

### Performance data:

In order to establish substantial equivalence to the identified predicate device's, we performed the following tests:

Bench testing was performed to demonstrate the energy to deliver staples and also to remove staples was consistent with the predicate device. ISO 5832-2:1999 Implants for surgery - Metallic materials -Part 2: Unalloved Titanium and ASTM F67-06 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700).

Biocompatibility testing was performed to ensure the stapler and cutters were constructed of material which passes the ISO 10993 benchmarks. The devices successfully passed tests for ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10 and ISO 10993-11.

As these products are delivered sterility testing was performed to ensure the sterilization methodology was sufficient and that the packaging kept the for the stated 3 year shelf

{2}------------------------------------------------

life. Testing was performed to ISO 11137-1:2006, ISO 11137-2:2006, ISO 11737-1:2006 and ISO 11737-2:2009, ISO 11607-1:2006, ASTM F1929-98 (2004), ASTM F1980-01 and ASTM D3078-02 (2008) with the products successfully passing all tests.

K121474 page 3/3

#### Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Changzhou Kangdi Medical Stapler Co., Ltd. concludes that Disposable Linear Stapler, Model KYFB and Disposable Linear Cutter, Model KYQII are substantially equivalent to predicate devices as described herein.

END

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the edge. In the center of the seal is an image of an eagle.

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

Changzhou Kangdi Medical Stapler Company, LTD % International Regulatory Consultants, LLC Mr. Charles Mack 77325 Joyce Way Echo, Oregon 97826

JUL 16 2012

Re: K121474

Trade/Device Name: Disposable Linear Stapler, Model KYFB-30/60/90, Disposable Linear Cutter, Model K YQII-60/80/100

Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: May 13, 2012 Received: May 18, 2012

Dear Mr. Mack

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

{4}------------------------------------------------

### Page 2 - Mr. Charles Mack

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Sincerely yours,

Erin Keith

Fo Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): 510(k) Number (if known):

K121474

Device Name:

Disposable Linear Stapler, Model KYFB-30 / 60 / 90 Disposable Linear Cutter, Model KYQII-60 / 80 / 100

Indications For Use:

# Disposable Linear Stapler, Model KYFB-30 / 60 / 90

The Disposable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transaction and resection of internal tissues.

# Disposable Linear Cutter, Model KYQH-60 / 80 / 100

The Disposable Linear Cutter has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Raul D. Kane by MM

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

Page 1 of

12