(63 days)
The Imager Torque Catheter is indicated for use for catheterization in the urinary tract or gastrointestinal tract for the introduction of radiopaque contrast materials.
The Imager Torque Catheter is a single - lumen introduction catheter with a range of tip configurations. The device is flexible catheter with one hole at the tip. A luer lock hub is attached to the proximal end. The catheter is designed to be used with a .038" guidewire if required.
The provided text is a 510(k) summary for a medical device (Imager Torque Catheter). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about performance criteria, study results, or validation data typically associated with AI/ML-driven devices or diagnostic tools.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details because the provided text does not contain that type of information.
The 510(k) summary focuses on device description, intended use, and substantial equivalence, which are core elements for regulatory clearance of conventional medical devices, not performance validation studies for AI algorithms.
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MAR – 4 1997 510(k) Summary Of Safety And Effectiveness
FOI RELEASABLE
| Sponsor: | Boston Scientific CorporationOne Scientific PlaceNatick, MA 01760-1537 |
|---|---|
| Contact Person: | Carol J. HollowayRegulatory Affairs Specialist |
| Submission Date: | December 27, 1996 |
| Description ofDevice: | The Imager Torque Catheter is a single - lumen introductioncatheter with a range of tip configurations. The device is flexiblecatheter with one hole at the tip. A luer lock hub is attached to theproximal end. The catheter is designed to be used with a .038"guidewire if required. |
| Intended Uses: | The Imager Torque Catheter is indicated for use forcatheterization in the urinary tract or gastrointestinal tract for theintroduction of radiopaque contrast materials. |
| SubstantialEquivalence: | The proposed devices are Substantially Equivalent to the predicatecurrently marketed devices indicated for use forcatheterization in the cardiovascular system for the introductionof radiopaque contrast materials and CFR 21 part 878.4200,Introduction / Drainage Catheter. |
§ 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.