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K Number
K970041
Device Name
ASCEND BALLOON DAILATION CATHETER
Manufacturer
COOK UROLOGICAL, INC.
Date Cleared
1997-03-19

(72 days)

Product Code
EZN
Regulation Number
876.5470
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

used for ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter.

Device Description

The Ascend™ Balloon Dilation Catheter is used for ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter. The materials used to construct the balloon are urethane and polyethylene. The Ascend™ Balloon Dilation Catheter will be offered in a 7 FR diameter and 40cm to 65cm long catheter with a 5mm to 10mm x 4cm to 12cm balloon.

AI/ML Overview

This 510(k) premarket notification for the Ascend™ Balloon Dilation Catheter (K9700041) does not contain the information requested regarding acceptance criteria, device performance studies, or details about ground truth and sample sizes.

The document is a summary of safety and effectiveness from 1997, focusing on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or performance metrics in the way a modern regulatory submission might.

Specifically, the document states:

  • No acceptance criteria or reported device performance: It merely states the device "will be manufactured according to specified process controls and a Quality Assurance Program" and "will undergo packaging and sterilization procedures similar to devices currently marketed." This does not provide quantitative acceptance criteria or performance data.
  • No mention of any study proving the device meets acceptance criteria: There is no description of any clinical study, in vitro study with defined endpoints, or any data presented to evaluate the device's performance against specific criteria.
  • No sample size for test sets or data provenance: No test sets are mentioned, therefore no sample size or data provenance is provided.
  • No experts used to establish ground truth: No experts are mentioned as no studies are described.
  • No adjudication method: No adjudication method is mentioned as no studies are described.
  • No MRMC comparative effectiveness study: This type of study is not mentioned.
  • No standalone performance study: This type of study is not mentioned.
  • No type of ground truth used: No ground truth is mentioned as no studies are described.
  • No sample size for training set: No training sets are mentioned.
  • No how ground truth for training set was established: No ground truth is mentioned.

Conclusion:

The provided 510(k) summary is extremely brief and only focuses on demonstrating substantial equivalence based on indications for use, materials, and physical construction to existing predicate devices. It does not contain the detailed performance data, acceptance criteria, or study methodologies that your prompt requests. This type of information would be expected in more comprehensive regulatory submissions or clinical study reports, which are not part of this specific 510(k) summary document.

§ 876.5470 Ureteral dilator.

(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).