(78 days)
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.
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.
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.
§ 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.