(88 days)
Circon's Rigid Culdoscopes and Accessories are intended for viewing pelvic organs endoscopically via a posterior vaginal fornix entry. Culdoscopy is indicated for: Unexplained pelvic pain (acute, chronic), Menstrual abnormalities, Infertility and sterility, Indefinite pelvic mass, Ectopic pregnancy, Pelvic endometriosis, Polycystic ovaries, Pelvic inflammatory disease, Pain mapping, Congenital anomalies of the pelvic organs.
CIRCON's Rigid Culdoscopes and Accessories are rod lens-type endoscopes which consist of imaging optics and fiber optic illumination fibers contained within a stainless steel sleeve. Light from a high intensity light source is transmitted to the scope by a fiber optic light guide that is detachably connected to a light post on the body of the scope. The light is carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the rod lens train. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an eyepiece ocular. The image may be viewed directly through the eyepiece, or the scope may be connected to a video system via a standard endoscopic video coupler.
The provided document is a 510(k) summary for the CIRCON Rigid Culdoscope and Accessories (K980972). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical trials or performance studies with detailed statistical analysis.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement.
Here's why and what the document does provide:
- Acceptance Criteria and Reported Device Performance (1): This information is not present. The 510(k) process for this device relies on demonstrating that the new device is "substantially equivalent" to predicate devices already on the market prior to May 28, 1976. This typically involves comparing design, materials, intended use, and operating principles, rather than presenting new performance data against specific acceptance criteria.
- Sample Size for Test Set and Data Provenance (2): Not applicable, as no performance study data is presented.
- Number of Experts and Qualifications for Ground Truth (3): Not applicable, as no ground truth establishment for a test set is described.
- Adjudication Method (4): Not applicable.
- Multi-reader Multi-case (MRMC) Comparative Effectiveness Study (5): This is not a study type relevant to a 510(k) submission for a culdoscope in 1998, which is focused on physical and functional equivalence to existing devices. Therefore, no such study is described, nor is any effect size for human readers with or without AI assistance.
- Standalone Performance Study (6): No standalone performance study (algorithm only) is mentioned, as this device is a physical medical instrument, not an AI or software-only device.
- Type of Ground Truth Used (7): Not applicable, as no performance evaluations against a ground truth are described.
- Sample Size for Training Set (8): Not applicable, as no machine learning model or training set is involved.
- How Ground Truth for Training Set was Established (9): Not applicable.
What the document does provide in lieu of performance data:
The core of this 510(k) submission is the demonstration of substantial equivalence to predicate devices.
- Name of Device: Rigid Culdoscope and Accessories
- Intended Use: "CIRCON's Rigid Culdoscopes and Accessories are intended to be used for direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures. The system is introduced into the pelvic cavity through the posterior vaginal fornix."
- Indications for Use: Unexplained pelvic pain, menstrual abnormalities, infertility and sterility, indefinite pelvic mass, ectopic pregnancy, pelvic endometriosis, polycystic ovaries, pelvic inflammatory disease, pain mapping, congenital anomalies of the pelvic organs.
- Predicate Devices: ACMI's Decker Culdoscope and Decker Operating Culdoscope, Karl Storz Endoscopy America, Inc.'s Culdoscopes, and Richard Wolf Medical Instrument Corp.'s Fiber Light Culdoscopes. All were marketed prior to May 28, 1976.
- Comparison of Technical Characteristics: "CIRCON's scopes employ the same design considerations and operating principles as the legally marketed predicate devices, and each can be sterilized and reused. Any differences between these culdoscopes do not raise new questions regarding safety or effectiveness."
In summary, this document is a regulatory submission focused on demonstrating equivalence in design and intended use to pre-existing devices, rather than presenting a study proving performance against specific acceptance criteria.
§ 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.