(10 days)
No
The description focuses on the physical characteristics and intended use of a guidewire, with no mention of AI or ML capabilities.
No
The device is intended to assist medical professionals in the navigation, placement, and exchange of surgical instruments, not to treat a disease or condition itself.
No
The device is a guidewire intended to assist in navigation, placement, and exchange of surgical instrumentation, not to diagnose a condition.
No
The device description clearly states it is a "Laparoscopic Guidewire" with a "radiopaque body" and "flexible, tapered tip," indicating it 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 "assist the physician in navigation, placement and exchange of laparoscopic and general surgical instrumentation." This describes a device used during a surgical procedure to manipulate instruments within the body.
- Device Description: The description focuses on the physical characteristics and function of a guidewire used for surgical navigation and placement.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health, diagnose conditions, or monitor treatment.
IVD devices are specifically designed for testing biological samples to provide diagnostic information. This device is a surgical tool used for procedural assistance.
N/A
Intended Use / Indications for Use
The Applied Medical Laparoscopic Guidewire is intended to assist the physician in navigation, placement and exchange of laparoscopic and general surgical instrumentation.
Product codes
Not Found
Device Description
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.
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
physician
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
APPENDIX VIII
MAY - 5 1997 510(k) SUMMARY
| 510(k) NUMBER: | PENDING |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation |
| 26051 Merit Circle, Unit# 103 | |
| Laguna 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, 21CFR |
| 876.5130. | |
| 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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