RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD

K122781 · Covidien, Formerly US Surgical A Divison of Tyco H · GDW · Feb 5, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K122781
• Device Name: RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD
• Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Feb 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

For Stapler: The reusable staplers have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. They may be used for transection and resection of the pancreas. For Reload: The ReliaMax™ single use gastrointestinal anastomosis reload when used with ReliaMax™ reusable gastrointestinal anastomosis stapler have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. They may be used for transection and resection of the pancreas.

Device Story

Reusable surgical stapler with single-use reload; used in abdominal, gynecological, pediatric, and thoracic surgery; operated by surgeons. Device places two double rows of titanium staples while simultaneously cutting and dividing tissue between rows. Reloads available in 2.5mm, 3.8mm, and 4.8mm staple sizes to accommodate varying tissue thicknesses. Stapler available in 60mm and 80mm lengths. Provides mechanical tissue approximation and transection; benefits include standardized staple formation and hemostasis during surgical procedures.

Clinical Evidence

Bench testing only. Performance evaluations included in vitro and in vivo testing: firing and retraction force, clamping and unclamping force, staple formation verification, hemostasis, burst strength, lung air leak, and lifecycle reliability. Results demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Reusable stapler with single-use reload; titanium staples; 60mm/80mm lengths; 2.5mm/3.8mm/4.8mm staple sizes. Materials comply with ISO 10993-1. Mechanical actuation; no energy source or software. Includes plastic components not present in predicate. Sterilization method not specified.

Indications for Use

Indicated for patients undergoing abdominal, gynecological, pediatric, or thoracic surgical procedures requiring resection, transection, or anastomosis, including resection and transection of the pancreas.

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

• DST™ Series GIA™ Staplers (K111825)

Submission Summary (Full Text)

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

Ki22781 Page 1/2

FEB 5 2013

...

### 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | Covidien, Formerly US Surgical A Division of Tyco Healthcare<br>60 Middletown Avenue |
|------------|--------------------------------------------------------------------------------------|
| | North Haven, CT 06473 |
| | Tel. No.: [phone] |

CONTACT PERSON: Mary Mellows Senior, Requiatory Specialist

DATE PREPARED: September 7, 2012

TRADE/PROPRIETARY NAME: ReliaMax™ Gastrointestinal Anastomosis Stapler and Reload

COMMON/USUAL NAME: Surgical Stapler with Implantable Staples

CLASSIFICATION NAME: Staples, Implantable

DST™ Series GIA™ Staplers (K111825) PREDICATE DEVICE(S): .

DEVICE DESCRIPTION: Reusable surgical stapler with a single use reload

INTENDED USE: For Stapler: The reusable staplers have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. They may be used for transection and resection of the pancreas.

> For Reload: The ReliaMax™ single use gastrointestinal anastomosis reload when used with ReliaMax™ reusable gastrointestinal anastomosis stapler have applications in abdominal, gynecological, pediatric and thoracic surgical for resection, transection and creation procedures of anastomosis. They may be used for transection and resection of the pancreas.

TECHNOLOGICAL CHARACTERISTICS:

ReliaMax™ The Gastrointestinal Anastomosis Staplers and Reloads are substantially equivalent to the predicate device (K111825) with regard to the stapling technologies.

The ReliaMax™ Gastrointestinal Anastomosis Staplers will be available in sizes that are encompassed by the predicate (K111825), 60mm and 80mm lengths. ReliaMax™ Reloads will be provided in three staple sizes, similar to the predicate (K111825) to accommodate various tissue thicknesses: 2.5mm, 3.8mm, and 4.8mm.

Identical to the predicate (K111825). ReliaMax™ Reloads will place two double rows of titanium staples and simultaneously cut and divide tissue between the two double rows.

All components of ReliaMax™ Gastrointestinal Anastomosis Staplers and Reloads are comprised of materials that are in accordance with ISO Standard 10993-1.

Covidien Traditional 510(k) Premarket Nolification

MATERIALS:

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

K1227.81 Page 2/2

The materials used in the design of the Reliamax™ are identical to the materials in the DST™ Series GIA™ disposable stapler, with one exception. The Reliamax™ also includes a plastic material, which is not used in the DST series GIA™ disposable stapler. All performance stability and biocompatibility testing was conducted using this material with acceptable results.

#### PERFORMANCE DATA:

In vitro and in vivo performance evaluations were conducted to demonstrate that ReliaMax™ Gastrointestinal Anastomosis Staplers and Reloads are safe and effective and that they perform as intended.

In vitro and in vivo testing to support the intended use of this device includes:

- Firing and Retraction Force o
- Clamping and Unclamping Force 0
- O Staple Formation Verification
- Hemostasis 0
- Burst Strength 0
- 0 Lung Air Leak
- Lifecycle Reliability Test 0

The results of this testing demonstrates that the ReliaMax™ Gastrointestinal Anastomosis Staplers and Reloads are substantially equivalent to the predicate device.

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

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the top half of the circle. Inside the circle is an emblem of an eagle.

## 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

Covidien, Formerly US Surgical Division of Tyco Healthcare % Ms. Mary Mellows Senior Regulatory Specialist 60 Middletown Avenue North Haven, Connecticut 06473

March 15, 2013

Re: K122781

Trade/Device Name: Reliamax™ Gastrointestinal Anastomosis and Reload Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: January 10, 2013 Received: January 28, 2013

Dear Ms. Mellows:

This letter corrects our substantially equivalent letter of February 5, 2013.

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 (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.

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

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

Page 2 - Ms. Mary Mellows

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/ResourcesforYou/Industry/default.htm.

> Sincerely yours, FOR Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Image /page/4/Picture/0 description: The image contains the word "COVIDIEN" in a sans-serif font. To the left of the word is a blue square with a white rectangle in the center and a vertical blue line running through the rectangle. The word "COVIDIEN" is in a dark blue color and is positioned to the right of the blue square. The overall design is simple and corporate.

## Indications For Use

510(k) Number (if known): K122781

Device Name: ReliaMax™ Gastrointestinal Anastomosis Stapler and Reload

Indications For Use:

For Stapler: The reusable staplers have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. They may be used for transection and resection of the pancreas.

For Reload: The ReliaMax™ single use gastrointestinal anastomosis reload when used with ReliaMax™ reusable gastrointestinal anastomosis stapler have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. They may be used for transection and resection of the pancreas.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K122781