AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE

K062326 · United States Surgical, A Division of Tyco Healthc · GCJ · Sep 1, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K062326
• Device Name: AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 1, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve 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™ Modified VERSAPORT™ trocar with fixation sleeve is a surgical instrument used to create and maintain a port of entry during endoscopic procedures. It features a sharp linear blade with a spring-loaded locking shield that advances upon entry into a free space to cover the blade, reducing injury risk. The device includes a sleeve with an internal VERSASEAL™ self-adjusting seal, accommodating instruments from 5 mm to 12 mm while maintaining pneumoperitoneum. A stopcock valve allows for insufflation and desufflation. The device is used by surgeons in clinical settings (gynecologic, general, thoracic, urologic). It functions as a mechanical access port; the surgeon inserts the trocar to establish the port, then uses the seal to maintain pressure while manipulating other instruments. The fixation sleeve provides stability during the procedure. Benefits include safe access to internal cavities and maintenance of the surgical environment.

Clinical Evidence

In-vitro and in-vivo testing were performed to verify performance and substantial equivalence to predicate devices. No clinical trial data provided.

Technological Characteristics

Materials comply with ISO 10993-1. Features a sharp linear blade, spring-loaded locking shield, and VERSASEAL™ self-adjusting seal. Available in 5 mm, 11 mm, and 12 mm sizes. Includes a stopcock valve for insufflation/desufflation. Mechanical device; no software or energy source.

Indications for Use

Indicated for use in gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry for patients requiring such procedures.

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 trocar
• Ethicon Endopath™ III Dilating tip Trocar

Submission Summary (Full Text)

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K 062326

## 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | United States Surgical, a division of Tyco Healthcare Group LP<br>150 Glover Avenue<br>Norwalk, CT 06856<br>Tel. No.: [phone] |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SEP - 1 2006 |
| CONTACT PERSON: | Daniel Campion<br>Associate, Regulatory Affairs |
| DATE PREPARED: | August 7, 2006 |
| TRADE/PROPRIETARY NAME: | autosuture™ Modified VERSAPORT™ trocar with fixation<br>sleeve |
| COMMON/USUAL NAME: | Surgical Trocar |
| CLASSIFICATION NAME: | Endoscope and Accessories |
| PREDICATE DEVICE(S): | autosuture™ VERSAPORT trocar, Ethicon Endopath™ III<br>Dilating tip Trocar |
| DEVICE DESCRIPTION: | The autosuture™ Modified VERSAPORT™ trocar with fixation<br>sleeve is available in 5 mm short length, 5 mm regular length,<br>11 mm regular length, 12 mm regular length, and 12 mm long<br>length sizes. The autosuture™ Modified VERSAPORT™ trocar<br>with fixation sleeve has a sharp linear blade with a spring-<br>loaded locking shield. Upon entry into a free space the shield<br>advances to cover the blade, reducing the potential for injury to<br>internal structures. The trocar sleeve contains an internal seal<br>to prevent loss of pneumoperitoneum when instruments are<br>inserted or withdrawn. The VERSASEAL™ self-adjusting seal<br>accommodates instruments ranging from 5 mm to 12 mm and<br>is designed to effectively reduce the seal diameter to allow<br>insertion of smaller instruments. There is a stopcock valve for<br>insufflation and rapid desufflation. |
| INTENDED USE: | The autosuture™ Modified VERSAPORT™ trocar with<br>fixation sleeve is intended for use in a variety of<br>gynecologic, general, thoracic and urologic endoscopic<br>procedures to create and maintain a port of entry. |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The autosuture™ Modified VERSAPORT™ is identical to the<br>predicate devices in terms of its intended use. The device will<br>now be offered with a fixation sleeve and beveled tip. |
| MATERIALS: | All components of the autosuture™ Modified VERSAPORT™<br>trocar with fixation sleeve are comprised of materials which are<br>in accordance with ISO Standard 10993-1. |
| PERFORMANCE DATA: | In-vitro and in-vivo tests were performed to verify that the<br>autosuture™ Modified VERSAPORT™ trocar with fixation<br>sleeve is substantially equivalent to the predicate devices in |
| United States Surgical | Page 22 |

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creation and maintaining a port of entry and to validate that the creation and maintaining a per of only a trocar with fixation sleeve will perform as intended.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 2006

United States Surgical % Mr. Daniel Campion Associate, Regulatory Affairs 150 Glover Avenue Norwalk, Connecticut 06856

Re: K062326

Trade/Device Name: autosuture™ Modified VERSAPORT™ trocar with fixation sleeve Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 8, 2006 Received: August 9, 2006

Dear Mr. Campion:

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. Daniel Campion

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

tur PJok

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): K C 6 2 3 2 b

Device Name: autosuture™ Modified VERSAPORT™ trocar with fixation sleeve

Indications For Use:

The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve 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 × (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)

0 C

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

United States Surgical Premarket Notification

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