(32 days)
The "Intended Use" of the polymer/hydrophilic coated guidewire is to facilitate the placement of catheters or other non-vascular devices during gastroenterology and urology procedures.
LRM produces quidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. Consequently there are a large number of trade and proprietary names not including or associated with LRM. LRM has no proprietary names of its own to be included with this submission. These devices are commonly known as quides, quidewires, or spring quidewires.
This document is a 510(k) premarket notification for a guidewire. It describes the device, its intended use, and its classification. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, or any of the other study-related details requested in your prompt.
Therefore, I cannot provide the requested table or answer the specific questions about the device's performance study based on the provided text. The document focuses solely on the regulatory classification and identification of the device itself, not on data demonstrating its efficacy or safety.
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Company Name, Address, and Telephone Number
| Lake Region Manufacturing, Inc., (LRM)340 Lake Hazeltine DriveChaska, MN 55318 | APR - 5 1996 | APR 3 10 18 |
|---|---|---|
| Telephone: (612) 448-5111 | Fax: (612) 448-3441 |
Device Trade Name/Proprietary Name
క్రిక LRM produces quidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. Consequently there are a large number of trade and proprietary names not including or associated with LRM. LRM has no proprietary names of its own to be included with this submission.
Device Common Names/Unusual Names, and Classification Names
These devices are commonly known as quides, quidewires, or spring quidewires.
The "Intended Use" of the polymer/hydrophilic coated guidewire is to facilitate the placement of catheters or other non-vascular devices during gastroenterology and urology procedures.
The current classification name is Gastroenterology and Urology Catheter Accessory (78KOD).
LRM Establishment Registration Number: 2126666
Classification of Devices
The classification name listed above was originally classified as a Class II device by the Gastroenterology-Urology Review Panel (21 CFR 876.5130)
Applicability of Performance Standards
LRM has determined that no mandatory performance standards have been established for these devices under Section 514 of the Medical Device Amendments to Federal Food, Drug, and Cosmetic Act or by any subsequent regulatory action. LRM has also determined that there are no applicable voluntary standards.
§ 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.