(58 days)
The MINI LAP Pediatric Instruments with MEDUSA Clamping system are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh, during pediatric surgery.
The MNI LAP Pediatric Instruments with MEDUSA Clamping system are a family of minimally invasive devices intended for pediatric surgery. The devices penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh, during pediatric surgery.
Prior to insertion, the physician must depress the safety button and retract the instrument into the needle. The needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the jaws of the instrument will open. The instrument will be offered in various configurations including babook clamp, bowel clamp, and hernia clamp. The device includes a selfsching safety that prohibits the jaws from returning to their fully retracted position while in use, which acts as a blunt shield for the sharp needle tip.
The device is provided in the following configurations:
| Length | Clamp Type |
|---|---|
| 150mm | Bowel Clamp |
| 150mm | Babcock Clamp |
| 150mm | Hernia Clamp |
The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use ..
The provided document is a 510(k) premarket notification for the MINI LAP Pediatric Instruments with Medusa Clamping System. This type of submission focuses on demonstrating substantial equivalence to pre-existing devices, rather than establishing a device's de novo effectiveness through extensive clinical trials with acceptance criteria and detailed performance studies typically associated with AI/software devices.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
The document mainly provides:
- Device Description: A family of minimally invasive devices intended for pediatric surgery to grasp, hold, and manipulate soft internal tissues and hernia mesh.
- Indications for Use: The devices penetrate soft tissue to access certain areas of the human anatomy and are used to grasp, hold, and manipulate soft internal tissues and hernia mesh during pediatric surgery.
- Technological Characteristics: The manufacturer states the device is substantially equivalent to predicate devices.
- Performance Data: "The subject device has been subjected to and passed a variety of mechanical tests and evaluations. Additionally, the device is composed of biocompatible materials with a history of usage in the medical device industry." This is a high-level statement indicating testing was done, but no specific acceptance criteria or results are provided.
- Predicate Devices: A list of previously cleared devices to which the MINI LAP is compared for substantial equivalence.
Without further detailed study reports, it's impossible to fill out the requested table and answer the specific questions about acceptance criteria and study data.
§ 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.