(119 days)
CIRCON's USA Series™ Laparoscopes are intended for use by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs, and canals during endoscopic and laparoscopic surgical procedures. These include, but are not limited to, laparoscopic procedures used in general surgical procedures, cholecystectomy, colon resection or therapeutic thoracoscopy.
CIRCON's USA Series™ Laparoscopes are substantially equivalent to the other currently marketed laparoscopes which are referenced above. CIRCON's USA Series™ Laparoscopes and their predicate devices are all telescopes that incorporate fiber optics and optical lenses within a rigid shaft and are connected to a light source. Several models of CIRCON's USA Series™ Laparoscopes and predicate devices also incorporate a working channel within the diameter of the rigid shaft that allows for the introduction and manipulation of accessory instrumentation for use during the procedure.
Here's a breakdown of the information you requested based on the provided text, though it's important to note that this document is a 510(k) summary, which often relies on comparison to predicate devices rather than extensive new clinical trials to establish acceptance criteria and performance.
Key Observation: The document does not describe a study to prove acceptance criteria in the way a clinical trial for a novel AI device would. Instead, it asserts substantial equivalence to existing predicate devices. This means the acceptance criteria are implicitly met by demonstrating that the new device has "the same general intended use" and "technological characteristics" as previously cleared devices. Therefore, the "study" referred to here is essentially the comparison and justification of equivalence to the predicate devices, rather than a performance study with a test set.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Device provides access, illumination, and visualization of body cavities, hollow organs, and canals during endoscopic and laparoscopic surgical procedures, including (but not limited to) laparoscopic cholecystectomy, colon resection, and therapeutic thoracoscopy. (Same as predicate devices) | CIRCON's USA Series™ Laparoscopes have the same general intended use as the previously cleared predicate devices. |
| Technological Characteristics: Device is a telescope incorporating fiber optics and optical lenses within a rigid shaft, connected to a camera system. May include a working channel for accessory instrumentation. (Same as predicate devices) | CIRCON's USA Series™ Laparoscopes are substantially equivalent to predicate devices; they are all telescopes that incorporate fiber optics and optical lenses within a rigid shaft and are connected to a camera system. Several models also incorporate a working channel. |
| Biocompatibility: Made of medical-grade, biocompatible materials with the same body contact, contact duration, and intended use as predicate devices. | All CIRCON USA Series™ Laparoscopes are made of medical grade biocompatible materials of the same type as used in other biocompatible predicate laparoscopes. |
| Safety and Effectiveness: Raises no new issues of safety or effectiveness. (Implied by substantial equivalence) | CIRCON's USA Series™ Laparoscopes raise no new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size Used for Test Set: Not applicable. The document does not describe a performance study with a distinct test set in the conventional sense for evaluating performance metrics. The "test" is an assertion of equivalence to predicate devices, not a quantitative measure against a sample.
- Data Provenance: Not applicable. There is no mention of specific data derived from a test set, country of origin, or whether it was retrospective or prospective. The justification is based on the characteristics of the device itself and its similarity to existing marketed devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No experts were used to establish ground truth for a test set, as no performance study on a test set (e.g., patient cases) is described. The "ground truth" for substantial equivalence is the FDA's existing clearance of the predicate devices and the manufacturer's assertion that the new device is functionally identical and made of similar materials.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring ground truth establishment or adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This type of study (comparing human readers with and without AI assistance) is not mentioned and is not relevant for a traditional medical device like a laparoscope (which is an instrument, not an AI diagnostic tool).
- Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This concept pertains to AI algorithms. The device described (CIRCON's USA Series™ Laparoscopes) is a physical surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the identified predicate devices, as determined by the FDA's prior clearances. The submission asserts that the new device shares sufficient characteristics and intended use with these predicates that it can be considered equally safe and effective.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this device is not an AI/machine learning algorithm that requires training.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.