AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER

K100242 · Surgical Devices, A Division of Tyco Healthcare · FZP · Feb 17, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100242
• Device Name: AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER
• Applicant: Surgical Devices, A Division of Tyco Healthcare
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Feb 17, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic marking.

Device Story

The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is a manual surgical instrument containing 16 titanium clips. Used in laparoscopic procedures, the device is introduced through a trocar sleeve. The operator (surgeon) uses a trigger handle to advance a clip into the distal jaws and close them around a vessel, duct, or tubular structure to achieve occlusion. The device also serves for radiographic marking. It features a 33 cm shaft, shaft rotation knob, and clip counter window. The device provides mechanical ligation, aiding in hemostasis and structure management during minimally invasive surgery.

Clinical Evidence

No clinical data. Substantial equivalence supported by in-vitro and in-vivo bench testing to verify performance in occluding vessels and tubular structures.

Technological Characteristics

Manual mechanical clip applier; 33 cm shaft length; contains 16 titanium clips. Materials comply with ISO 10993-1. Device is designed for use through a trocar sleeve.

Indications for Use

Indicated for patients undergoing laparoscopic surgical procedures requiring dissection and occlusion of blood vessels, ducts, and other tubular structures, or for radiographic marking.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Auto Suture™ ENDO CLIP™ III 5mm Clip Applier (K071406, K061288)
• Auto Suture™ ENDO CLIP™ Disposable Clip Applier (K883018)

Submission Summary (Full Text)

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Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien)

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## KI00242

| 510(k) Summary of Safety and Effectiveness | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | FEB 1 7 2010<br>Surgical Devices, a global business unit<br>of Tyco Healthcare Group LP (d/b/a Covidien)<br>60 Middletown Avenue<br>North Haven, CT - 06473<br>Tel. No.: [phone] |
| CONTACT PERSON: | Nishith Desai<br>Associate Manager, Regulatory Affairs |
| DATE PREPARED: | January 20, 2010 |
| TRADE/PROPRIETARY NAME: | Auto Suture™ ENDO CLIP™ III 5mm Clip Applier |
| COMMON/USUAL NAME: | Implantable Clip |
| CLASSIFICATION NAME: | Implantable Clip |
| PREDICATE DEVICE(S): | Auto Suture™ ENDO CLIP™ III 5mm Clip Applier (K071406,<br>K061288) and Auto Suture™ ENDO CLIP™ Disposable Clip<br>Applier (K883018) |
| DEVICE DESCRIPTION: | The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier<br>contains 16 titanium clips. The applier is designed for<br>introduction and use through an appropriately sized trocar<br>sleeve, or larger with the use of a converter. The ENDO<br>CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft<br>rotation knob, clip counter window and a 33 cm shaft with jaws<br>at its distal end. Squeezing the handle places a titanium clip in<br>the jaws and closes the jaws to close the clip on the vessel or<br>structure. |
| INTENDED USE: | The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is<br>primarily indicated for patients undergoing laparoscopic<br>surgical procedures involving dissection and occlusion of blood<br>vessels, ducts and other tubular structures, and for<br>radiographic marking. |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is<br>identical to the predicate device in terms of intended use and it<br>operates in a similar manner as the predicate device. |
| MATERIALS: | All patient contact components of the Auto Suture™ ENDO<br>CLIP™ III 5mm Clip Applier are comprised of materials which<br>are in accordance with ISO Standard 10993-1. |
| PERFORMANCE DATA: | In-vitro and in-vivo tests were performed to verify that the<br>ENDO CLIP™ III 5mm Clip Applier was substantially<br>equivalent to the predicate devices in occluding vessels and<br>other tubular structures and to validate that the ENDO CLIP™<br>III 5mm Clip Applier performed as intended. |

Confidential

Special 510(k) for Auto Suture ENDO CLIP III 5mm

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

Surgical Devices, a division of Tyco Healthcare Group LP % Nishith Desai 60 Middletown Avenue North Haven, Connecticut 06473

FEB 1 7 2010

Re: K100242

Trade/Device Name: Auto Suture™ ENDO CLIP™ III 5mm Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP, GDO Dated: January 26, 2010 Received: January 27, 2010

Dear Nishith Desai:

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 - Nishith Desai

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/ReportalProblem/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 vours.

boirlane Bruchn

Mark N. Melkerso 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

KI00242 510(k) Number (if known): __

Device Name: Auto Suture™ ENDO CLIP™ III 5mm Clip Applier

Indications For Use:

The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is primarily indicated for patients undergoing laproscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic marking.

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 Kreeftmann

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

510(k) Number K100242

Confidential

Special 510(k) for Auto_Suture ENDO CLIP III 5mm

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