MCCARTNEY ACCESS TUBE

K051594 · Gynetech Pty. , Ltd. · HEW · Sep 2, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K051594
• Device Name: MCCARTNEY ACCESS TUBE
• Applicant: Gynetech Pty. , Ltd.
• Product Code: HEW · Obstetrics/Gynecology
• Decision Date: Sep 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The McCartney Access Tube is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and as a template for dissection, while maintaining pneumoperitoneum during laparoscopic hysterectomy. The instrument is indicated for use in laparoscopically assisted vaginal hysterectomies. The instrument is also a conduit for the extraction of specimens.

Device Story

McCartney Access Tube is a sterile, single-use instrument for laparoscopically assisted vaginal hysterectomies. Components include a silicone rubber tube (35mm or 45mm diameter), polypropylene body, and silicone rubber cap. The cap features two valves for 5mm and 10mm instrument access and a stopcock for peritoneal insufflation/desufflation and gas leakage control. The distal tube end is beveled with a textured surface for identification. Used by surgeons in an OR setting to establish a transvaginal entry path for minimally invasive instruments, serve as a dissection template, maintain pneumoperitoneum, and act as a conduit for specimen extraction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: silicone rubber, polypropylene. Form factor: 35mm or 45mm diameter tube with beveled, textured distal end. Features: integrated stopcock for insufflation, dual-valve cap (5mm/10mm ports). Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients undergoing laparoscopically assisted vaginal hysterectomy. Contraindicated when laparoscopic hysterectomy is contraindicated.

Regulatory Classification

Identification

A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.

Predicate Devices

• KOH Colpotomizer System (K954311)

Submission Summary (Full Text)

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K05/594

## SEP - 2 2005

# McCartney Access Tube 510(k) Summary of Safety and Effectiveness Information

| Company | Gynetech Pty. Ltd.<br>P.O. Box 1227<br>Subiaco, Western Australia 6904, Australia |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Dennis Hahn, RAC<br>Director, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | August 29, 2005 |
| Device Name | Trade Name: McCartney Access Tube<br>Classification Name: Culdoscope and Accessories |

Predicate Device KOH Colpotomizer System (K954311)

#### Device Description

The McCartney Access Tube is a sterile, single use instrument consisting of a silicone rubber tube, a polypropylene body and a silicone rubber cap. The McCartney Access Tube is available in 35mm and 45mm diameters. The instrument is packaged with a stopcock that can be inserted on the cap in order to insufflate and desufflate the peritoneum along with minizing gas leakage. The cap has two valves for 5mm and 10mm minimally invasive instrument access. The distal end of the silicone rubber tube is beveled and has a textured surface for internal identification.

#### Indications for Use

The McCartney Access Tube is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and as a template for dissection, while maintaining pneumoperitoneum during laparoscopic hysterectomy. The instrument is indicated for use in laparoscopically assisted vaginal hysterectomies. The instrument is also a conduit for the extraction of specimens.

#### Contraindications:

The McCartney Access Tube is contraindicated when laparoscopic hysterectomy is contraindicated.

#### Comparison of Technological Characteristics

The McCartney Access Tube is similar to the predicate device in that it has a similar intended use. The McCartney Access Tube is different from the predicate device in that is a different design and constructed of different materials from the predicate device.

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Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo features the emblem of the U.S. Department of Health & Human Services. The emblem consists of a stylized caduceus-like symbol with three abstract human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper perimeter of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gynetech Pty. Ltd. % Mr. Dennis Hahn, RAC Director, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road CINCINNATI OH 45242-2839

Re: K051594

SEP - 2 2005

Trade/Device Name: McCartney Access Tube Regulation Number: 21 CFR 884.1640 Regulation Name: Culdoscope and accessories Regulatory Class: II Product Code: HEW Dated: August 15, 2005 Received: August 16, 2005

Dear Mr. Hahn:

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 (Premarket Approval), 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your of substantial equivalence of your device to a legally prematics notification: - rives 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 it you don't upon of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Alloy, production other general information on your responsibilities under the Act from the 001:27). I ou may obtain curers, 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.

Sincercly yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

510 (k) Number (if known):

McCartney Access Tube Device Name:

Indications for Use:

The McCartney Access Tube is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and as a template for dissection, while maintaining pneumoperitoneum during laparoscopic hysterectomy. The instrument is indicated for use in laparoscopically assisted vaginal hysterectomies. The instrument is also a conduit for the extraction of specimens.

Prescription Use Over-The-Counter Use x AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal. and Radiological Device 510(k) Number