(10 days)
The Applied Medical Laparoscopic Guidewire is intended to assist the physician in navigation, placement and exchange of laparoscopic and general surgical instrumentation.
The Applied Medical Laparoscopic Guidewire is substantially equivalent in function, physical configuration and materials to the Applied Medical Urological Guidewire approved under K944135/A and a guidewire marketed by Cook Urological under K880100. The Applied Medical Laparoscopic guidewire and the predicate devices have a radiopaque body with a flexible, tapered tip allowing ease of access and visibility during placement. Differences include a change of indicated use and a selection of different lengths.
This document is a 510(k) summary for the Applied Medical Laparoscopic Guidewire, submitted in 1997. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not provide the information requested in the prompt regarding acceptance criteria and study details related to device performance in an AI/software context.
The information requested, such as sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, and ground truth establishment, is typically associated with the evaluation of AI-powered medical devices or diagnostic software. The Applied Medical Laparoscopic Guidewire is a physical medical instrument, and its approval process outlined here focuses on mechanical, biocompatibility, and substantial equivalence to existing predicate devices.
Therefore, I cannot extract the requested information from the provided text because it is not relevant to this type of medical device submission.
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APPENDIX VIII
MAY - 5 1997 510(k) SUMMARY
| 510(k) NUMBER: | PENDING |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation26051 Merit Circle, Unit# 103Laguna Hills, California 92653(71) 582-6120 |
| CONTACT PERSON: | Howard V. Rowe |
| DATE OF PREPARATION: | April 22, 1997 |
| NAME OF DEVICE: | Applied Medical Laparoscopic Guidewire |
| CLASSIFICATION NAME: | Urological Catheter and Accessories, 21CFR876.5130. |
| TRADE NAME: | Not Determined |
SUMMARY STATEMENT:
The Applied Medical Laparoscopic Guidewire is intended to assist the physician in navigation, placement and exchange of laparoscopic and general surgical instrumentation. The Applied Medical Laparoscopic Guidewire is substantially equivalent in function, physical configuration and materials to the Applied Medical Urological Guidewire approved under K944135/A and a guidewire marketed by Cook Urological under K880100. The Applied Medical Laparoscopic guidewire and the predicate devices have a radiopaque body with a flexible, tapered tip allowing ease of access and visibility during placement. Differences include a change of indicated use and a selection of different lengths.
Mechanical and biocompatibility tests were performed to verify functional and structural integrity and material safety. All testing has demonstrated that the Applied Medical Laparoscopic Guidewire is comparable to the predicate device and introduces no new safety and effectiveness issues when used as indicated.
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§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.