AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS

K062850 · United States Surgical, A Division of Tyco Healthc · GDW · Oct 23, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062850
• Device Name: AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Oct 23, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The autosuture™ Circular EEA™ 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, including bariatric surgery.

Device Story

The autosuture™ Circular EEA™ surgical stapler is a manual surgical instrument used to create circular anastomoses in the alimentary tract. The device places a circular, double staggered row of titanium staples while simultaneously resecting excess tissue. It is intended for use by surgeons in both open and laparoscopic surgical environments. The device functions as a mechanical stapling tool; it does not involve electronic processing, software, or automated algorithms. By facilitating tissue connection and resection, the device assists in surgical reconstruction, potentially reducing operative time and improving procedural outcomes compared to manual suturing.

Clinical Evidence

In-vitro and in-vivo testing performed to verify substantial equivalence to the predicate device.

Technological Characteristics

Manual surgical stapler; titanium staples; wire gauge diameter modified from predicate. Materials comply with ISO 10993-1. Mechanical actuation; no energy source; no software.

Indications for Use

Indicated for patients undergoing open or laparoscopic surgical procedures requiring creation of anastomoses throughout the alimentary tract, including bariatric surgery.

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™ Premium Plus CEEA™ Disposable Stapler (K024275)

Submission Summary (Full Text)

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K062850 page 1/1

510(k) Summary of Safety and Effectiveness

SUBMITTER:

United States Surgical, a division of Tyco Healthcare Group LP 150 Glover Avenue Norwalk, CT 06856 Tel. No .: [phone]

CONTACT PERSON: Frank Gianelli Senior Associate, Regulatory Affairs

DATE PREPARED: September 21, 2006

## TRADE/PROPRIETARY NAME: autosuture™ Circular EEA™ surgical staplers

COMMON/USUAL NAME: Implantable Staple

CLASSIFICATION NAME: Implantable Staple

PREDICATE DEVICE(S): autosuture™ Premium Plus CEEA™ Disposable Stapler (K024275)

DEVICE DESCRIPTION: The autosuture™ Circular EEA™ family of staplers place a circular, double staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. They are indicated for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries.

INTENDED USE: The autosuture™ Circular EEA™ 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, including bariatric surgery.

TECHNOLOGICAL The autosuture™ EEA™ stapler is identical to the predicate CHARACTERISTICS: device in terms of intended use and it operates in a similar manner as the predicate device. The only difference is a modification of the wire gauge diameter of the titanium staple.

MATERIALS: All components of the autosuture™ EEA™ stapler are comprised of materials which are in accordance with ISO Standard 10993-1.

PERFORMANCE DATA: In-vitro and in-vivo tests were performed to verify that the modified autosuture™ EEA™ stapler is substantially equivalent to the predicate device for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three abstract human profiles facing right. The profiles are arranged in a stacked formation, creating a sense of depth and unity. Encircling the caduceus is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

United States Surgical a division of Tyco Healthcare Group, LP % Mr. Frank Gianelli Senior Associate, Regulatory Affairs 195 McDermott Road North Haven, Connecticut 06473

OCT 2 3 2006

Re: K062850

Trade/Device Name: autosuture™ EEA" Surgical Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: September 22, 2006 Received: September 26, 2006

Dear Mr. Gianelli:

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 such 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); 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.

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Page 2 - Mr. Frank Gianelli

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

elkerson

Mark N. Melker Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use

510(k) Number (if known): K0628SO

Device Name: autosuture™ EEA™ Surgical Stapler

Indications For Use:

The autosuture™ Circular EEA™ 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, including bariatric surgery.

Prescription Use X (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

Division of General, Restorative. and Neurological Devices

**510(k) Number** L062850

United States Surgical Premarket Notification

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