(85 days)
The Miniature Laparoscope Set is used to apply and maintain pneumoperitoneum in the usual way, and to introduce telescopes and other auxiliary instruments, such as forceps and scissors for diagnostic and therapeutic purposes.
Cannula and tubes are made of medical grade stainless steel and chrome plated brass.
Telescopes are made of medical grade stainless steel (sleeve), glass-lenses, glassfibers, brass chrome plated (housing) and plastic (eyepiece).
The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device (Mini Laparoscopes). It describes the device, its intended use, and argues for its equivalence to existing devices. However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets acceptance criteria, or any of the detailed AI-related study design elements (sample sizes, expert qualifications, adjudication, MRMC, standalone performance, training set details) requested in your prompt.
The "Performance Data" section explicitly states: "Instruments have been tested to assure the function of the spring loaded cannula and the possibility of steam autoclaving." This refers to basic functional testing, not a clinical study to establish performance against acceptance criteria in the way you've described for AI models. The "Clinical Tests" section explicitly states: "No clinical tests performed."
Therefore, I cannot fulfill your request to describe the acceptance criteria and study as the provided text does not contain this information.
Missing Information:
- Table of acceptance criteria and reported device performance: Not present.
- Sample size used for the test set and data provenance: Not applicable as no clinical test set is mentioned.
- Number of experts used to establish the ground truth...: Not applicable.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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OCT 11 1996
962799
510(k) Summary of Safety and Effectiveness
が
- 1.0 Classification Name: Set Laparoscopy
- 2.0 Common/Usual Name: Veress Cannula Spring Loaded, Telescopes
3.0 Trade Name:
Mini Laparoscopes
4.0 Equivalence:
These devices are equivalent to existing pre-enactment devices sold by Richard Wolf and 510(k) devices sold by Imagyn, Ethicon, and Origin.
5.0 Description:
Cannula and tubes are made of medical grade stainless steel and chrome plated brass.
Telescopes are made of medical grade stainless steel (sleeve), glass-lenses, glassfibers, brass chrome plated (housing) and plastic (eyepiece).
6.0 Intended Use:
The Miniature Laparoscope Set is used to apply and maintain pneumoperitoneum in the usual way, and to introduce telescopes and other auxiliary instruments, such as forceps and scissors for diagnostic and therapeutic purposes.
7.0 Technological Characteristics:
As the intended use describes, the set is miniaturized in diameter and length for minimal invasive laparoscopy. The veress cannula and the tubes are larger in diameter and longer in working length, the telescopes are shorter in length and smaller in diameter.
8.0 Performance Data:
Instruments have been tested to assure the function of the spring loaded cannula and the possibility of steam autoclaving.
9.0 Clinical Tests:
No clinical tests performed.
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10.0 Data Conclusion:
The mentioned R. Wolf Mini Laparoscopy devices are substantially equivalent to existing devices on the market. They have been tested to allow safe usage, with no significant changes during the standard lifetime, when used according to our instructions.
By: Robert J. Casassa
Robert L. Casarsa
Quality Assurance Manager
Date: July 16, 96
ﭘﯿﭙﯿ
§ 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.