(41 days)
Not Found
Not Found
No
The summary describes a mechanical catheter device and explicitly states that AI, DNN, or ML were "Not Found".
Yes
The device is intended to "dilate constricted areas of the urethra, prostatic urethra and ureters," which directly treats a medical condition.
No
Explanation: The device's intended use is to "dilate constricted areas of the urethra, prostatic urethra and ureters," which is a therapeutic function, not diagnostic.
No
The device description clearly outlines physical components like a catheter shaft, balloon, and tip, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "dilate constricted areas of the urethra, prostatic urethra and ureters." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a catheter with a balloon, designed for physical intervention within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVDs are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a surgical/interventional tool used for treatment.
N/A
Intended Use / Indications for Use
The UDB Catheter is intended to dilate constricted areas of the urethra, prostatic urethra and ureters.
Product codes
78 EZN, 78 KOE, 79 GBA, 79 GCC
Device Description
The UDB Catheter is a combination over-the-wire, non-over-the-wire device. It consists of a two-lumen, catheter shaft with a molded bifurcation, a dilatation balloon and a Coudé tip. A 10 cc luer lock syringe is included in the tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, prostatic urethra, ureters
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)
The proposed devices have been tested and compared to the predicate devices. The results indicate that the proposed devices are Substantially Equivalent to the predicate devices in terms of performance characteristics tested.
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
JAN 2 8 1997
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510 (k) Summary Of Safety And Effectiveness
| Sponsor: | Boston Scientific Corporation
One Scientific Place |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| | Natick, MA 01760-1537 |
| Contact Person: | Carol J. Holloway |
| | Regulatory Affairs Specialist |
| Submission Date: | December 13, 1996 |
| Common/Usual Names: | Dilatation Catheter, Balloon |
| Trade/Proprietary Name: | TBD |
| Classification Name: | Boston Scientific Corporation believes the proposed
device can be described by the following device
classification names: |
| | • Dilator, Catheter, Ureteral (78 EZN) |
| | • Catheter, Urethral Dilator (78 KOE) |
| | • Catheter, Balloon (79 GBA) |
| | • Catheter, Dilator (79 GCC) |
| Device Classification: | Boston Scientific Corporation believes the proposed
device is classified as a Class II device under: |
| | • 21 CFR 876.5470; Ureteral Dilator |
| | • 21 CFR 876.5520; Urethral Dilator |
| | • 21 CFR 878.4200; Introduction/Drainage Catheter |
| | • 21 CFR 876.5130; Urological Catheter |
1
14965067 p2012
510 (k) Summary Of Safety And Effectiveness Continued
1
| Description of
Device: | The UDB Catheter is a combination over-the-wire,
non-over-the-wire device. It consists of a two-lumen, catheter
shaft with a molded bifurcation, a dilatation balloon and a
Coudé tip. A 10 cc luer lock syringe is included in the
tray. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Uses: | The UDB Catheter is intended to dilate constricted areas of the
urethra, prostatic urethra and ureters. |
| Substantial
Equivalence: | The proposed devices are Substantially Equivalent to the
predicate currently marketed devices indicated for use for
dilatation of the urethra, prostatic urethra and ureters. |
| Product Testing: | The proposed devices have been tested and compared to the predicate
devices. The results indicate that the proposed devices are
Substantially Equivalent to the predicate devices in terms of
performance characteristics tested. |