(32 days)
None
Not Found
No
The summary describes a guidewire, a physical medical device used for facilitating placement of other devices. There is no mention of software, algorithms, or any computational processing that would indicate the presence of AI/ML.
No
The device, a guidewire, is intended to facilitate the placement of other devices, not to directly treat a medical condition.
No
The device, a guidewire, is intended to facilitate the placement of other devices (catheters or non-vascular devices) and does not inherently diagnose any medical condition.
No
The device description clearly states it is a guidewire, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the placement of catheters or other non-vascular devices during gastroenterology and urology procedures." This describes a device used within the body to aid in a medical procedure, not a device used to examine specimens outside the body to diagnose or monitor a condition.
- Device Description: The description of the guidewire as a tool for placing other devices further supports its role as a surgical/procedural aid, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes
- Using reagents
Therefore, this device falls under the category of a medical device used for procedural support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
78KOD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
All
Company Name, Address, and Telephone Number
| Lake Region Manufacturing, Inc., (LRM)
340 Lake Hazeltine Drive
| Chaska, 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.