AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR

K081169 · Covidien Lp, Formerly Registered AS United States · GCJ · May 23, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K081169
• Device Name: AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR
• Applicant: Covidien Lp, Formerly Registered AS United States
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The autosuture™ VERSAPORT™ PLUS Bladeless trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

Device Story

The autosuture™ VERSAPORT™ PLUS Bladeless trocar is a surgical instrument used to create and maintain a port of entry for endoscopic procedures. The device consists of an obturator with two linear non-bladed fins, a non-bladed rounded pin tip, and a spring-loaded shield, along with a cannula sleeve. The sleeve housing contains an internal seal to maintain pneumoperitoneum during instrument insertion or withdrawal. It includes a stopcock valve for insufflation and desufflation. Available in diameters from 5mm to 15mm, with fixed or removable seal systems and optional fixation sleeves. Used by surgeons in clinical settings (OR) to facilitate access for endoscopic instruments.

Clinical Evidence

In-vitro and in-vivo testing performed to verify performance and validate intended use. No clinical trial data provided.

Technological Characteristics

Materials comply with ISO 10993-1. Features non-bladed obturator with 2 linear fins, rounded pin tip, and spring-loaded shield. Includes internal seal for pneumoperitoneum maintenance and stopcock valve. Available in 5mm-15mm diameters. Offered with or without fixation sleeve.

Indications for Use

Indicated for patients undergoing gynecologic, general, thoracic, or urologic endoscopic procedures requiring a port of entry.

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

• autosuture™ VERSAPORT
• Ethicon Excel™

Submission Summary (Full Text)

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Ko81169

## 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | 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 USA | MAY 23 2008 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON: | Tim M. Lohnes, Manager, Regulatory Affairs | |
| DATE PREPARED: | April 28, 2008 | |
| TRADE/PROPRIETARY NAME: | autosuture™ VERSAPORT™ PLUS Bladeless Trocar | |
| COMMON/USUAL NAME: | Surgical Trocar | |
| CLASSIFICATION NAME: | Endoscope and Accessories | |
| PREDICATE DEVICE(S): | autosuture™ VERSAPORT, Ethicon Excel™ | |
| DEVICE DESCRIPTION: | The autosuture™ VERSAPORT™ PLUS Bladeless trocar is<br>available in diameters from 5mm to 15mm, including short,<br>standard and long length cannula. The 5mm VERSAPORT™<br>fixed seal system accommodates 5mm instruments, while the<br>VERSAPORT™ PLUS removable seal systems accommodate<br>instruments ranging from 5 mm to 15 mm (the 10/15mm<br>system includes a converter for 5 mm diameter instruments).<br>There is a stopcock valve for insufflation and rapid<br>desufflation. | |
| INTENDED USE: | The autosuture™ VERSAPORT™ PLUS Bladeless trocar<br>is intended for use in a variety of gynecologic, general,<br>thoracic and urologic endoscopic procedures to create and<br>maintain a port of entry. | |
| TECHNICAL<br>CHARACTERISTICS: | The autosuture™ VERSAPORT™ PLUS Bladeless trocar with<br>and/or without fixation sleeve is equivalent to the predicate<br>devices in terms of its intended use. The autosuture™<br>VERSAPORT™ PLUS Bladeless trocar obturator has 2 linear<br>non-bladed fins, a non-bladed rounded pin tip, and a spring-<br>loaded shield. The trocar sleeve housing contains an internal<br>seal to prevent loss of pneumoperitoneum when instruments<br>are inserted or withdrawn. The device will be offered with<br>and/or without a fixation sleeve. | |
| MATERIALS: | All components of the autosuture™ VERSAPORT™ PLUS<br>Bladeless trocar are comprised of materials which are in<br>accordance with ISO Standard 10993-1. | |
| PERFORMANCE DATA: | In-vitro and in-vivo tests were performed to verify that the<br>performance of the autosuture™ VERSAPORT™ PLUS<br>Bladeless trocar is substantially equivalent to the predicate<br>devices, and to validate that the autosuture™ VERSAPORT™<br>PLUS Bladeless trocar will perform as intended. | |

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2008

Covidien LP % Mr. Tim M. Lohnes Manager, Regultory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K081169

Trade/Device Name: autosuture™ Bladeless VERSAPORT™ PLUS trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 21, 2008 Received: April 24, 2008

Dear Mr. Lohncs:

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. This letter will allow you to begin marketing your device as described in your Scction 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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Page 2 - Mr. Tim M. Lohnes

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 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 Millman

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): _

Device Name:

## autosuture™ Bladeless VERSAPORT™ PLUS trocar

Indications For Use:

The autosuture™ VERSAPORT™ PLUS Bladeless Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

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)

ce of CDRH, Office of Device Evaluation (ODE) or nim Division of General, Restorative and Neurological Devices

Covidien Profes

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