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 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.

AI/ML Overview

The provided document is a 510(k) Summary of Safety and Effectiveness Information for the McCartney Access Tube dated August 29, 2005. This type of regulatory submission is for medical devices and focuses on establishing substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies or setting performance acceptance criteria with detailed statistical analysis as is common for AI/ML-driven devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in this document, as it falls outside the scope of a traditional 510(k) for a non-AI/ML device.

Specifically:

A table of acceptance criteria and the reported device performance: Not applicable. The document focuses on demonstrating substantial equivalence to a predicate device based on intended use, design, and materials, not on specific performance metrics or acceptance criteria for statistical-based outcomes.
Sample size used for the test set and the data provenance: Not applicable. No clinical test set data or study details are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-driven device, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-driven device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No study requiring ground truth is described.
The sample size for the training set: Not applicable. This is not an AI-driven device, so there is no training set.
How the ground truth for the training set was established: Not applicable. This is not an AI-driven device, so there is no training set or associated ground truth.

Summary of Device Acceptance (from the provided document):

The acceptance of the McCartney Access Tube is based on the FDA's determination of substantial equivalence to a legally marketed predicate device (KOH Colpotomizer System, K954311). This means the FDA found that the new device is as safe and effective as the predicate device.

The FDA's letter states: "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..."

The "study" or evidence proving this equivalence relies on:

Comparison of Intended Use: The McCartney Access Tube has a "similar intended use" to the predicate device.
Comparison of Technological Characteristics: While the McCartney Access Tube has a "different design and constructed of different materials" from the predicate, the 510(k) process concludes that these differences do not raise new questions of safety or effectiveness. The document itself does not detail specific performance characteristics or comparison points other than stating similarity in intended use. It's implicit that the manufacturer provided sufficient information (e.g., bench testing, material safety data) to convince the FDA that the new design/materials do not alter its fundamental safety and effectiveness in its intended application.

Summary

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K05/594

SEP - 2 2005

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

Company	Gynetech Pty. Ltd.P.O. Box 1227Subiaco, Western Australia 6904, Australia
Contact	Dennis Hahn, RACDirector, Regulatory AffairsTelephone: (513) 337-3134Fax: (513) 337-1444Email: dhahn1@eesus.jnj.com
Date Prepared	August 29, 2005
Device Name	Trade Name: McCartney Access TubeClassification Name: Culdoscope and Accessories

Predicate Device KOH Colpotomizer System (K954311)

Device Description

Indications for Use

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 (800) 638-2041 or (301) 443-6597 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:

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)

Page 1 of 1

Nancy C. Brogdon
(Division Sign-Off)

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

Regulation Number and Section

§ 884.1640 Culdoscope and accessories.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.