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This instrument has been designed to be used with the Olympus endo-therapy Accessories. The instrument is used for the guiding and exchanging endoscopic accessories for the biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

Coated guidewire. Removal of the guidewire is not necessary during sphinctecterotomy. Three guidewire configurations, straight, V taper and angled tip. These instruments have been designed to be used with the Olympus Endo-Therapy Accessories.

The provided 510(k) summary for the Accellent, Inc. Disposable Guidewire (K072354) does not contain a study that demonstrates the device meets specific acceptance criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Olympus Guidewire G-205-3545S, G205-3.545A #K021179) by comparing key features such as intended use, materials, and sterilization method. This is a common approach for Class II medical devices seeking 510(k) clearance, where direct clinical trials or extensive performance studies with acceptance criteria are often not required if substantial equivalence can be shown.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about a study that proves the device meets acceptance criteria, as such information is not present in the provided text.

Here's why and what information is available:

• No Acceptance Criteria or Performance Data: The document explicitly states: "When compared to the predicate device, the new device does not incorporate any significant changes in the intended use, method of operation, materials, or design that could affect the safety or effectiveness." This statement, along with the comparison table, serves as the primary "proof" for substantial equivalence rather than a detailed performance study against predefined acceptance criteria.
• Focus on Substantial Equivalence: The entire submission hinges on demonstrating that the Accellent Disposable Guidewire is as safe and effective as a legally marketed predicate device. This is achieved by showing similarities in design, materials, and intended use, and by asserting that there are no significant changes that would raise new questions of safety or effectiveness.

Summary of available information as per your requested points (where applicable):

1. A table of acceptance criteria and the reported device performance:

   • Not Applicable. The submission does not define specific acceptance criteria or report performance data against them. The "performance" is implicitly deemed equivalent to the predicate device due to no significant changes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable. No test set or associated data is described, as the submission relies on substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not Applicable. No ground truth establishment for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. No adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not Applicable. This is a medical device (guidewire), not an AI-powered diagnostic tool. MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not Applicable. No ground truth as typically understood for diagnostic device evaluation is used. The "ground truth" for showing substantial equivalence is the predicate device itself and its established safety and effectiveness profile.

8. The sample size for the training set:

   • Not Applicable. No "training set" in the context of machine learning or complex device development is described.

9. How the ground truth for the training set was established:

   • Not Applicable.

What the document does provide in relation to demonstrating "performance" (via substantial equivalence):

• Predicate Device: Olympus Guidewire G-205-3545S, G205-3.545A (#K021179)
• Comparison of Features (Table 1):
  • Intended Use: Identical for both predicate and new device (guiding and exchanging endoscopic accessories for the biliary duct, including common bile, cystic, pancreatic, right and left hepatic ducts).
  • Materials:
    • Predicate: Nickel Titanium alloy, Polyurethane -coating, Hydrophilic -coating, Silicone - coating
    • New Device: Nickel Titanium alloy, Polytetrafluoroethylene PTFE, Pebax, Lubricious
    • (Note: While some materials differ in coating/polymer type, the submission implies these differences do not affect safety or effectiveness significantly enough to require new studies beyond this comparison.)
  • Sterilization Method: Identical (Ethylene Oxide).

Essentially, the "proof" for this guidewire's acceptability is its demonstrated similarity to an already legally marketed and safe device.

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