(41 days)
The UDB Catheter is intended to dilate constricted areas of the urethra, prostatic urethra and ureters.
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.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document appears to be a 510(k) summary for a medical device (dilatation catheter) from 1996, focusing on safety and effectiveness, and establishing substantial equivalence to predicate devices. It lists device description, intended uses, and a statement that product testing was conducted, but it does not include details about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement as requested.
Therefore, I cannot provide the requested information.
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JAN 2 8 1997
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510 (k) Summary Of Safety And Effectiveness
| Sponsor: | Boston Scientific CorporationOne 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 proposeddevice can be described by the following deviceclassification 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 proposeddevice 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 |
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14965067 p2012
510 (k) Summary Of Safety And Effectiveness Continued
1
| Description ofDevice: | The UDB Catheter is a combination over-the-wire,non-over-the-wire device. It consists of a two-lumen, cathetershaft with a molded bifurcation, a dilatation balloon and aCoudé tip. A 10 cc luer lock syringe is included in thetray. |
|---|---|
| Intended Uses: | The UDB Catheter is intended to dilate constricted areas of theurethra, prostatic urethra and ureters. |
| SubstantialEquivalence: | The proposed devices are Substantially Equivalent to thepredicate currently marketed devices indicated for use fordilatation of the urethra, prostatic urethra and ureters. |
| Product Testing: | The proposed devices have been tested and compared to the predicatedevices. The results indicate that the proposed devices areSubstantially Equivalent to the predicate devices in terms ofperformance characteristics tested. |
§ 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.