PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS

• K Number: K061009
• Device Name: PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS
• Manufacturer: ONSET MEDICAL CORPORATION
• Date Cleared: 2006-05-02 ( 20 days)
• Product Code: EZN
• Regulation Number: 876.5470
• Type: Special
• Panel: GU
• Reference & Predicate Devices: N/A

Intended Use

The Onset Medical Pathway™ Balloon Expandable Ureteral Access Sheath is intended to establish a conduit, during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the ureter by way of the urethra and bladder.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Pathway™ Balloon Expandable Ureteral Access Sheath." This type of document does not contain the detailed information requested regarding acceptance criteria and the specifics of a study proving device performance.

510(k) clearance signifies that a device is "substantially equivalent" to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics, and that it is as safe and effective as the predicate. The FDA review for a 510(k) does not typically involve a new, comprehensive clinical trial for efficacy against specific acceptance criteria in the way a PMA approval might. Instead, it relies on demonstrating equivalence through comparison to existing devices, often including performance testing that is not detailed in the public clearance letter.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily states:

• Device Name: Pathway™ Balloon Expandable Ureteral Access Sheath
• 510(k) Number: K061009
• Indication for Use: To establish a conduit, during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the ureter by way of the urethra and bladder.
• Regulatory Class: II
• Product Code: EZN
• Regulation Name: Ureteral dilator
• Predicate Device: The letter states the device is substantially equivalent to legally marketed predicate devices, but does not explicitly name them.

To obtain the detailed study information you're asking for, you would typically need to refer to the 510(k) summary document or the full 510(k) submission to the FDA, which are sometimes publicly available through different FDA databases, but are not part of this clearance letter.

Regulation Number and Section

§ 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).