(150 days)
Manually operated minimally invasive General & Plastic Surgery Instruments designed to perform specific functions such as aspirating, clamping, cutting, dissecting, draining, grasping, ligating, or suturing during open, mini-open, or endoscopic surgical procedures such as thoracoscopy and laparoscopy.
Sontec Instruments are a family of manual, instruments consisting of Clamps, Forceps, Knot Tiers, Needle Holders, Knot Pushers, Scissors and Suction Tips. These reusable devices are packaged non-sterile and are steam sterilizable.
This document is a 510(k) premarket notification from the FDA, which determines substantial equivalence for medical devices. It does not contain information about the acceptance criteria or a study proving device performance in the way requested for an AI/CADe device.
The requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, and training data) is typically found in performance studies for diagnostic or AI/CADe devices, which this document is not describing.
This 510(k) document is for "General & Plastic Surgery Instruments," which are manual surgical tools like clamps, forceps, and scissors. The substantial equivalence is based on their intended use, design, material, chemical composition, and energy source compared to existing predicate devices.
Therefore, I cannot provide the requested table and study information because this document does not pertain to an AI/CADe device or a study demonstrating diagnostic performance.
Instead, the document focuses on:
- Device Description: Manual, reusable surgical instruments (Clamps, Forceps, Knot Tiers, Needle Holders, Knot Pushers, Scissors, Suction Tips).
- Indications for Use: Performing specific functions (aspirating, clamping, cutting, dissecting, draining, grasping, ligating, probing, or suturing) during open, mini-open, or endoscopic surgical procedures.
- Technological Characteristics: Materials used (Stainless Steel, Titanium, Aluminum 5052, Tungsten Carbide G4) and their conformance to ISO/ASTM standards; cleaning and sterilization procedures (ASTM A380, ASTM F1744, ANSI/AAMI ST79).
- Non-clinical tests: Cleaning, Thermal Disinfection and Steam Sterilization Validations.
- Clinical tests: None (as explicitly stated).
- Substantial Equivalence: Concluded based on intended use, design, material, chemical composition, and energy source being similar to predicate devices, and not introducing new issues of safety or effectiveness.
§ 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.