(144 days)
The A-Lap™ set has application for use in the creation and maintenance of an operative cavity such as the gynecologic, general, urologic and thoracic procedures. The set may be used in procedures to create and maintain a port of entry and for temporary retracting of tissue.
The A-Lap™ retractor has application for use in the creation and maintenance of an operative cavity such as the gynecologic. general, urologic and thoracic procedures. The device may be used in procedures requiring temporary retracting of tissue.
The EZaxess is intended for use in creating and for maintaining a port of entry in gynecologic, general, urologic and thoracic procedures.
The A Lap™ set is laparoscopic surgical device compose of two components:
A-Lap™ Retractor - a surgical retraction instrument used to move, retain or hold back internal organs in the operative region during laparoscopic surgery. The device purposes is to widen the access area to the treatment site (the surgical field), to grasp and retract the surrounding tissues, to maintain the resultant size of the access area and to secure the retracted tissue or organs by holding it away from the surgical site. The retraction is achieved by a 12 cm X 12 cm polyester mesh connected to stainless steel wires.
EZaxess - a laparoscopic port included a 170 mm long and 10mm in diameter bladeless trocar and flexible cannula (10cm long and 10mm in diameter). The device is used to create and maintain a port of entry during laparoscopic surgery. The A Lap™ set is intended to be use for various laparoscopic surgical procedures, such as gynecologic, general, urologic and thoracic procedures. It is fully disposable and is intended for single use only.
Here's an analysis of the provided text regarding the A-Lap™ Set, A-Lap™ Retractor, and EZaxess devices, focusing on acceptance criteria and the study that proves the devices meet them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format with corresponding reported device performance metrics. Instead, it refers to general compliance with standards and equivalence to predicate devices. The "performance" is primarily assessed through design analysis, in vitro, and in vivo data to confirm safety and effectiveness, and substantial equivalence.
Based on the text, the implicit acceptance criteria and reported performance relate to:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility | Verified: Materials confirmed biocompatible according to ISO 10993-1 for external communicating, blood contact, short 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.