AUTOSUTURE EEA ORVIL

K093402 · Surgical Devices, A Global Business Unit Tyco · GDW · Nov 12, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K093402
• Device Name: AUTOSUTURE EEA ORVIL
• Applicant: Surgical Devices, A Global Business Unit Tyco
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Nov 12, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DST Series™ EEA™ OrVil™ 21 mm device when used with the DST Series™ EEA™ 21 mm stapler, the DST Series ™ EEA™ OrViJ™ 25 mm device when used with the DST Series™ EEA™ 25mm stapler, and the DST Series ™EEA™ 28 mm device when used with the DST Series ™EEA™ 28 mm stapler has applications 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, including bariatric surgery.

Device Story

DST Series EEA OrVil is a modified detachable anvil accessory for DST Series EEA surgical staplers; used in alimentary tract surgeries (open/laparoscopic, including bariatric). Device features delivery tube and retraction suture; suture allows anvil manipulation if lodged during transit. Operates by mounting anvil on delivery tube; used with stapler to create circular, double staggered row of titanium staples; knife blade resects excess tissue to form anastomosis. Used by surgeons in clinical settings. Benefit: improved anvil retrieval/safety via retraction suture.

Clinical Evidence

No clinical data. Substantial equivalence supported by in-vitro and in-vivo bench testing to validate performance and material safety per ISO 10993-1:2003.

Technological Characteristics

Detachable anvil assembly with delivery tube and retraction suture. Materials evaluated per ISO 10993-1:2003. Used with DST Series EEA staplers to create circular, double staggered row of titanium staples and resect tissue. Available in 21mm, 25mm, and 28mm sizes.

Indications for Use

Indicated for patients undergoing open or laparoscopic alimentary tract surgeries, including bariatric surgery, requiring creation of end-to-end, end-to-side, or side-to-side anastomoses.

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

• Autosuture™ EEA Surgical Stapler™ (K062850)
• Autosuture™ Premium Plus CEEA™ (K024275)

Submission Summary (Full Text)

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#### 5. 510(k) SUMMARY:

510(K) Summary of Safety and Effectiveness:

SUBMITTER:

Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) 60 Middletown Avenue North Haven, CT 06473

CONTACT PERSON:

Rebecca Ronner Associate, Regulatory Affairs Phone: [phone] Fax: [phone]

Autosuture™ EEA TM Orvil TM

Stapler Anvil Accessory

Implantable Staple

Disposable Stapler

October 30, 2009

NOV 1 2 2009

K093402

DATE PREPARED:

TRADE/PROPRIETARY NAME:

COMMON/USUAL NAME:

CLASSIFICATION NAME:

PREDICATE DEVICE(S): (Note: There are no modifications to the previously cleared devices.)

DEVICE DESCRIPTION:

## INTENDED USE:

#### TECHNOLOGICAL CHARACTERISTICS:

K062850: Autosuture™ EEA Surgical Stapler™ The DST Series™ EEA™ 21, 25 or 28 mm stapler,

K024275: Autosuture™ Premium Plus CEEA™

creates a circular, double staggered row of titanium staples. Immediately after staple formation, the stapler knife blade resects the excess tissue, creating a circular anastomosis. The DST Series™ EEA Surgical Stapler comes with a detachable anvil. As an accessory to this instrument we have modified the detachable anvil assembly to create the DST Series OrVil™. The anvil assembly is mounted on a delivery tube and is secured to the tube. A retraction suture is also tied to the anvil assembly.

The DST Series™ EEA™ OrVil™ 21 mm device when used with the appropriate DST Series™ EEA™ stapler has applications 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, including bariatric surgery.

DST Series™ EEA™ OrVil™ Device is equivalent to the predicate devices in terms of its intended use. DST Series™ EEA™ OrVil™ modified the design of the predicate device to include a retraction suture. The suture will allow the anvil to be manibulated in the event it gets lodged in transit. The predicate design was also modified to include 28mm size device.

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MATERIALS: CHARACTERISTICS: DST Series™ EEA™ OrVil™ Devices is comprised of materials which have been evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of medical devices - Part I Evaluation and Testing and is identical to the predicate device.

#### PERFORMANCE DATA:

In-vitro and in-vivo tests were performed to verify that the performance of the DST Series™ EEA™ OrVil™ Device is substantially equivalent to the predicate devices, and to validate the at DST Series™ EEA ™ OrVil™ Device will perform as intended.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird-like figure, with flowing lines representing its wings and body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Surgical Devices Tyco Healthcare Group LP (d/b/a Covidien) % Ms. Rebecca Ronner Associate, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

NOV 12 2009

Re: K093402

Trade/Device Name: DST Series™ EEA™ OrVil™ Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: October 30, 2009 Received: November 2, 2009

Dear Ms. Ronner:

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.

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

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Page 2 - Ms. Rebecca Ronner

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 (OS) 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/CDRH0ffices/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours

Mark N.

Dear Ki

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

Enclosure

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# Indications for Use

- KO93402 510(k) Number (if known):

Device Name: DST Series ™ EEA™ OrVil™

The DST Series ™ EEA™ OrVil™ 21 mm device when used with the DST Series™ EEA™ 21 mm stapler, the DST Series ™ EEA™ OrViJ™ 25 mm device when used with the DST Series™ EEA™ 25mm stapler, and the DST Series ™ EEA™ OrVil™ 28 mm device when used with the DST Series ™EEA™ 28 mm stapler has applications 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, including bariatric surgery.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K093402