(34 days)
The Interceptre™ Endoscopic Instruments are indicated for use in endoscopic/laparoscopic procedures.
The Interceptre™ Endoscopic Instruments are a family of graspers, dissectors, and scissors which are intended to be used to grasp, manipulate, cut, cauterize soft tissue.
The Interceptre™ Endoscopic instruments are a line of hand-held , non-sterile, reusable instruments
The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found in a performance evaluation or clinical study report for an AI/ML medical device.
Instead, this document is a 510(k) summary for the "Interceptre™ Laparoscopic Instruments," which are minimally invasive surgical instruments and not an AI/ML device. The document focuses on demonstrating substantial equivalence to predicate devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these concepts are not applicable to the type of device and submission described.
The document demonstrates substantial equivalence by comparing the Interceptre™ Laparoscopic Instruments to legally marketed predicate devices (Karl Storz Take-Apart Endoscopic Instruments and Richard Wolf Laparoscopic Instruments) based on:
- Product Labeling: Non-sterile/reusable
- Materials: Stainless steel/Kynar insulation
- Indications: Endoscopic Surgical Procedures
- Intended Use: Management of Soft Tissue
- Tip Styles: Graspers, dissectors, scissors
- Number of separate components: 3
- Design: Dual/single action jaw design with 360-degree rotation
The FDA's letter states that they reviewed the 510(k) notification and determined the devices are substantially equivalent, allowing them to be marketed. This regulatory process for these types of instruments relies on demonstrating equivalence to existing devices rather than performance against specific analytical or clinical acceptance criteria for an AI/ML algorithm.
§ 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.