(86 days)
The U.S. Surgical Auto Suture* Laparoscope** device has indication solely for illumination and visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic and thoracoscopic procedures.
The U.S. Surgical Laparoscope** device is a reusable and rigid laparoscope based on existing laparoscopy technology.
The provided text is a 510(k) summary for the Auto Suture* Laparoscope** Device. It primarily focuses on demonstrating substantial equivalence to a predicate device (Imagyn MicroLap™ Laparoscope K965055) rather than presenting a detailed study with acceptance criteria and specific performance metrics.
Therefore, the document does not contain information to construct a table of acceptance criteria and reported device performance, nor does it describe a study proving the device meets particular acceptance criteria.
Here's why and what information is missing:
- Acceptance Criteria and Device Performance: The summary does not define any specific performance metrics (e.g., optical resolution, field of view, illumination intensity, durability, safety parameters) or corresponding acceptance criteria. It broadly states the device is "a reusable and rigid laparoscope based on existing laparoscopy technology" and intends for "illumination and visualization."
- Study Description: The document is a regulatory submission for substantial equivalence, not a clinical or engineering study report. It states that "All component materials of the laparoscope are comprised of materials which are in accordance with ISO Standard # 10993-1," which refers to biocompatibility, but this isn't a performance study.
Missing Information:
- Table of Acceptance Criteria and Reported Device Performance: Not present in the document.
- Sample size used for the test set and the data provenance: Not mentioned as no specific test set study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth establishment for a test set is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not indicated. The document focuses on device characteristics and intended use, not clinical efficacy or reader performance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
- The type of ground truth used: Not applicable as no ground truth for performance evaluation is described.
- The sample size for the training set: Not applicable as this is a physical medical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) summary serves to demonstrate substantial equivalence by comparing the new device's design, materials, and intended use to a legally marketed predicate device, rather than providing detailed performance study results with specific acceptance criteria.
§ 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.