SILS STITCH ENDOSCOPIC SUTURING DEVICE

K090419 · Covidien Lp, Formerly Registered AS United States · OCW · Mar 9, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090419
• Device Name: SILS STITCH ENDOSCOPIC SUTURING DEVICE
• Applicant: Covidien Lp, Formerly Registered AS United States
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: Mar 9, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SILS™ Stitch 10 mm single use suturing device has application in endoscopic surgery for the placement of interrupted or running stitches in soft tissues

Device Story

SILS Stitch is a single-use endoscopic suturing device; features two jaws at distal end, opposing handles, and toggle lever at proximal end. Device holds and passes needled suture between jaws; needle transfer achieved by squeezing handles and activating toggle lever to secure needle in jaw. Used in endoscopic surgery by physicians to place interrupted or running stitches in soft tissues. Device facilitates suturing in minimally invasive procedures.

Clinical Evidence

No clinical data. Bench testing only; patient contact materials evaluated per ISO 10993-1:2003.

Technological Characteristics

Single-use endoscopic suturing device; 10 mm diameter. Materials evaluated per ISO 10993-1:2003. Mechanical operation via handles and toggle lever for needle transfer.

Indications for Use

Indicated for use in endoscopic surgery for the placement of interrupted or running stitches in soft tissues.

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

• Modified Endo Stitch™ Endoscopic Suturing Device (K082659)

Reference Devices

• Convenience Kit for Single-Incision Laparoscopic Surgery (K072814)
• SILS™ Port (K082619)

Submission Summary (Full Text)

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### MAR - 9 2009

K090419
Page i/2

#### 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:

Robert Zott Program Director, Regulatory Affairs Phone: [phone] Fax: [phone]

DATE PREPARED:

TRADE/PROPRIETARY NAME:

COMMON/USUAL NAME:

CLASSIFICATION NAME:

PREDICATE DEVICE(S):

PRIOR RELATED SUBMISSION(S):

SILSTM Stitch

February 17, 2009

Endoscopic Suturing Device

Endoscope and accessories

K082659: Modified Endo Stitch™ Endoscopic Suturing Device

The predicate device is manufactured by Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien)

K072814: Convenience Kit for "Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures."

K082619: SILS™ Port for Multiple Instrument Laparoscopic Access Through a Single Incision.

#### SILSTM Stitch is an endoscopic suturing device that contains two jaws at its distal end, with opposing handles and a toggle lever at its proximal end.

DEVICE DESCRIPTION:

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#### INTENDED USE:

#### TECHNOLOGICAL CHARACTERISTICS:

MATERIALS:

#### MATERIALS:

## PERFORMANCE DATA:

For use in endoscopic surgery for the placement of interrupted or running stitches in soft tissues

The device holds and passes a needled suture between the two jaws. The suture needle is passed from one jaw to another by squeezing the opposing handles and secured in each jaw by activating the toggle lever.

All patient contact materials in the SILSTM Stitch have been evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of medical devices -- Part 1: Evaluation and Testing.

No additional in-vitro or in-vivo testing has been performed in support of the intended use of this device.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR - 9 2009

Covidien % Mr. Robert Zott Program Director, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K090419

Trade/Device Name: SILS™ Stitch - Endoscopic Suturing Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated: February 17, 2009 Received: February 18, 2009

Dear Mr. Zott:

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. Robert Zott

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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. Melkerson

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):

KO90419

Device Name:

SILS TM Stitch - Endoscopic Suturing Device

Indications For Use:

The SILS™ Stitch 10 mm single use suturing device has application in endoscopic surgery for the placement of interrupted or running stitches in soft tissues

Prescription Use (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 Knack Mxm 3/9/2009

(Division Sign-Off) Division of General. Restorative. and Neurological Devices

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