SILS PORT MODEL SILSPT15

K093372 · Covidien Lp, Formerly Registered AS Tyco Healthcar · GCJ · Dec 3, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K093372
• Device Name: SILS PORT MODEL SILSPT15
• Applicant: Covidien Lp, Formerly Registered AS Tyco Healthcar
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Dec 3, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SILS™ Port is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures. The SILS™ Port provides the ability to use three conventional laparoscopic trocars and an insufflation port through a single incision while providing the ability to maintain pneumoperitoneum.

Device Story

SILS™ Port 15mm; flexible port device; facilitates single-incision laparoscopic surgery. Device incorporates three laparoscopic trocars and one insufflation tube; allows simultaneous instrument/camera access while maintaining pneumoperitoneum. Used in clinical/surgical settings by surgeons; enables minimally invasive access to abdominal cavity. Benefits include reduced incision count compared to traditional multi-port laparoscopy.

Clinical Evidence

In-vitro and in-vivo testing performed to support intended use. No human clinical trial data provided.

Technological Characteristics

Flexible port housing three laparoscopic trocars and an insufflation tube. Materials evaluated per ISO 10993-1:2003 for biocompatibility. Mechanical device; no energy source or software components.

Indications for Use

Indicated for patients undergoing minimally invasive laparoscopic procedures requiring multiple instrument or camera access to the abdominal cavity through a single incision.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Covidien SILS™ Port (K082619)
• Dexide Trocar (K981941)

Submission Summary (Full Text)

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Covidien EP (formerly registered as Tyco Healthcare, LP)

6093372

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| 510(k) Summary of Safety and Effectiveness | | | |
|--------------------------------------------|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | SUBMITTER: | Covidien LP (formerly registered as Tyco Healthcare, LP)<br>60 Middletown Avenue<br>North Haven, CT 06473<br>Tel. No .: [phone] | |
| | CONTACT PERSON: | Angela Van Arsdale<br>Associate, Regulatory Affairs<br>Phone: [phone]<br>Fax:<br>[phone] | DEC - 3 2009 |
| | DATE PREPARED: | October 30, 2009 | |
| | TRADE/PROPRIETARY NAME: | SILS™ Port | |
| | COMMON/USUAL NAME: | Surgical Trocar | |
| | CLASSIFICATION NAME: | Endoscope and/or accessories | |
| | PREDICATE DEVICE(S): | Covidien SILS™ Port (K082619) | |
| | | Dexide Trocar (K981941) | |
| | DEVICE DESCRIPTION: | Three laparoscopic trocars and an insufflation tube bound by a<br>flexible port. | |
| | INTENDED USE: | The SILS™ Port is indicated for multiple instrument or camera<br>access to the abdominal cavity through a single incision for<br>performing minimally invasive laparoscopic procedures.<br>The SILS™ Port provides the ability to use three conventional<br>laparoscopic trocars and an insufflation port through a single<br>incision while providing the ability to maintain<br>pneumoperitoneum. | |
| | TECHNOLOGICAL<br>CHARACTERISTICS: ` | | |
| | MATERIALS: | All components of the SILS™ Port are comprised of materials<br>that have been evaluated in accordance with ISO 10993-1:<br>2003, Biological Evaluation of medical devices --<br>Part 1: Evaluation and Testing. | |
| | PERFORMANCE DATA: | In-vitro and in-vivo testing has been performed in support of<br>the intended use of this device. | |
| | | | |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Covidien LP % Ms. Angela Van Arsdale Associate, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

DEC - 3 2009

Re: K093372

Trade/Device Name: SILS™ Port 15mm Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: November 24, 2009 Received: November 25, 2009

Dear Ms. Van Arsdale:

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 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

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Page 2 - Ms. Angela Van Arsdale

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/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/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.

Sincerely yours,

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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Covidien LP (formerly registered as Tyco Healthcare, LP)

## Indications For Use

510(k) Number (if known):

Device Name: SILS™ Port 15 mm

Indications for Use:

The SILS™ Port is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures.

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)

Kareem S. Burney for NRO
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093372

Special 510(k) Premarket Notification 10/30/2009

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