(120 days)
Laparoscopic surgical manual instruments are designed to be used endoscopically through cannula to perform cutting, grasping, dissecting, retracting, and manipulating functions. The Ergonomic handle is intended to be used with 5mm inserts available from K&W and previously cleared under K973259.
Symmetry® laparoscopic surgical manual instruments consist of a handle and a 5mm shaft, which hold various 5 mm inserts cleared under K973259. The shaft comes in two lengths: 33 cm and 45 cm. One handle can be used in combination with a variety of different 5 mm inserts. The handles have monopolar posts which allow them to be used for electrosurgery.
The ergonomic laparoscopic handles have an adjustable grip. They may be used in one of the three handle positions: pistol grip, hybrid, and inline. To change the handle position, retract the position adjustment button and lock the grip in the chosen position. The handle comes in two sizes.
This document describes the Ergonomic Handle (K173272), which is an accessory to laparoscopic surgical manual instruments. The device allows for adjustable grip angles to improve surgeon comfort. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11 (for External Communicating Devices: Tissue/Bone/Dentin with limited contact duration |
§ 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.