SILS PORT

K103253 · Coviden (Formerly Registered AS US Surgical, A Div · GCJ · Feb 24, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K103253
• Device Name: SILS PORT
• Applicant: Coviden (Formerly Registered AS US Surgical, A Div
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SILS™ Port device is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures, as well as through the anus to provide access for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision and fistula repair.

Device Story

SILS Port consists of three laparoscopic cannulae and an insufflation tube integrated into a flexible port. Device provides access for multiple instruments or cameras into the abdominal cavity through a single incision or into the rectum via the anus. Used by surgeons in clinical settings to facilitate minimally invasive procedures. Device maintains port security and allows visualization during surgery. Benefits include reduced incision requirements and access for specialized rectal procedures.

Clinical Evidence

Bench testing and animal studies performed. In-vitro testing included suture pull-out strength. In-vivo (porcine) transanal evaluations assessed insertion force, port security, visualization, removal force, and resultant trauma. Results demonstrate the device is safe and effective for transanal access.

Technological Characteristics

Flexible port containing three laparoscopic cannulae and an insufflation tube. Materials evaluated per ISO 10993-1:2009. Mechanical device; no energy source or software components.

Indications for Use

Indicated for patients requiring minimally invasive laparoscopic procedures via single-incision abdominal access or rectal procedures (TEMS, flap revision, fistula repair) via transanal access.

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Richard Wolf Medical Instrument Corp. Transanal Endoscopic Microsurgery (TEM) Combination System and Instrument Set (K000180)
• Covidien SILS Port (K093372)

Submission Summary (Full Text)

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Covidien (formerly registered as US Surgical a division of Tyco Healthcare).

### 7. 510(K) SUMMARY:

# FEB 2 4 2011

510(k) Summary of Safety and Effectiveness:

SUBMITTER: Covidien (formerly registered as US Surgical, a division of Tyco Healthcare) 60 Middletown Avenue North Haven, CT 06473 CONTACT PERSON: Tim M. Lohnes Manager, Regulatory Affairs Phone: [phone] Fax: [phone] [e-mail] alternate contact: [e-mail] DATE PREPARED: November 02, 2010 TRADE/PROPRIETARY NAME: SILSTM Port COMMON/USUAL NAME: Surgical Trocar CLASSIFICATION NAME: Endoscope and/or accessories PREDICATE DEVICE(S): K000180: Richard Wolf Medical Instrument Corp. Transanal Endoscopic Microsurgery (TEM) Combination System and Instrument Set K093372: Covidien SILSTM Port DEVICE DESCRIPTION: Three laparoscopic trocars and an insufflation tube bound by a flexible port. INTENDED USE: For multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures, as well as through the anus to provide access for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision and fistula repair.

* Trademark of Covidien Christina. [e-mail] November 02, 2010

Traditional 510(k) for the SILS* Port for Trans Anal Rectal Access

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## Covidien (formerly registered as US Surgical a division of Tyco Healthcare).

MATERIALS:

CHARACTERISTICS:

PERFORMANCE DATA:

The SILSTM Port allows the use of three laparoscopic cannula and an insufflation port in a body cavity through a single incision or to the rectum via the anus (no incision).

All components of the SILS™ Port are comprised of materials that have been evaluated in accordance with ISO 10993-1: 2009, Biological Evaluation of medical devices -- Part 1: Evaluation and Testing.

In-vivo and in vitro evaluations were performed to support the use of the SILS™ Port device for transanal access for rectal surgery. The testing included in vitro suture pull out testing as well as in vivo (porcine) transanal evaluations including insertion force, port security, visualization, removal force, and resultant trauma. The results of this testing indicate that when used for transanal access for rectal surgery, SILSTM Port is safe and effective and provides equivalent performance to the predicate device(s).

* Trademark of Covidien Christina [e-mail] November 02, 2010

Traditional 510(k) for the SILS* Port for Trans Anal Rectal Access

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with three lines representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES", which is arranged vertically.

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

Mr. Tim M. Lohnes RA Manager Covidien 60 Middletown Avenue NORTH HAVEN CT 06473

FEB 2 4 2011

. Re: K103253 Trade/Device Name: SILS" Port Regulation Number: 21 CFR 8876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ and FER Dated: November 2, 2010 Received: November 30, 2010

Dear Mr. Lohnes:

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 of medical device-related

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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,

Hubert H Humphrey

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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### 6. INDICATIONS FOR USE STATEMENT:

510(k) Number (if known): K103253

Device Name: SILSTM Port

Indications For Use:

The SILS™ Port device is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures, as well as through the anus to provide access for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision and fistula repair.

Prescription Use: X OR Over-The-Counter Use: (Per 21 CFR 801.109)

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

hessen

Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
(510(k) Number K103253

* Trademark of Covidien

November 02, 2010

Attachment B, page 1 of 1

Traditional 510(k) for the SILS* Port for Trans Anal Rectal Access