Search Results
Found 2 results
510(k) Data Aggregation
(42 days)
NovaGold High Performance Guidewire
The NovaGold Guidewire is intended for use in selective cannulation of the billary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic devices during endoscopic procedures.
The NovaGold Guidewire is constructed from a steerable, metallic core with a PTFE polymer coating over the shaft. A hydrophilic coating is applied over the distal portion of the device. The guidewire has a radiopaque, floppy tip.
This document is a 510(k) summary for the NovaGold™ High Performance Guidewire. It describes a medical device and its intended use, and argues for its substantial equivalence to a predicate device. The information provided is for regulatory clearance and does not detail a clinical study proving performance against acceptance criteria in the way requested.
Therefore, many of the requested points cannot be directly answered from the provided text as it focuses on bench testing and comparative characteristics rather than a clinical study with human subjects, established ground truth, or expert review for diagnostic performance.
However, I can extract information related to the functional and safety testing as described:
1. Table of acceptance criteria and reported device performance:
The document states that "representative samples of the device underwent bench testing in accordance to applicable standards and guidances" to "verify that device design met functional and performance requirements." It then lists the types of tests performed. However, it does not explicitly state specific numerical acceptance criteria or the quantitative results (reported device performance) for each test. It only concludes that the data provided "an acceptable assurance of the safety and effectiveness" and demonstrated equivalence to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Fracture resistance | Met requirements (data provides acceptable assurance) |
| Flex resistance | Met requirements (data provides acceptable assurance) |
| Tensile strength | Met requirements (data provides acceptable assurance) |
| Torqueability | Met requirements (data provides acceptable assurance) |
| Torque Strength | Met requirements (data provides acceptable assurance) |
| Tip flexibility | Met requirements (data provides acceptable assurance) |
| Distal fatigue resistance | Met requirements (data provides acceptable assurance) |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified beyond "representative samples of the device."
- Data provenance: Bench testing results, no country of origin is mentioned for the bench tests. The tests are non-clinical, so the concept of "retrospective or prospective" doesn't directly apply in the same way it would to human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the tests performed were non-clinical bench tests on the device itself, not diagnostic performance evaluations requiring expert assessment of medical images or patient outcomes.
4. Adjudication method for the test set:
Not applicable, as this was non-clinical bench testing.
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:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. This device is a guidewire, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this device is a guidewire, not an algorithm, so this is not applicable.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" would be engineering specifications and established performance standards for guidewires, against which the device's physical and mechanical properties were measured. It is not expert consensus, pathology, or outcomes data, as those apply to clinical/diagnostic studies.
8. The sample size for the training set:
Not applicable, as this device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable, as this device does not involve a training set.
Ask a specific question about this device
(143 days)
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
The NovaGold Guidewire is constructed from a steerable, metallic core with a PTFE polymer coating over the shaft. A hydrophilic coating is applied over the distal portion of the device. The guidewire has a radiopaque, floppy tip.
The provided document describes a 510(k) premarket notification for a medical device called the NovaGold™ High Performance Guidewire. This document specifically states that the submission is for establishing substantial equivalence to a predicate device, rather than a study demonstrating clinical effectiveness with acceptance criteria.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The provided text focuses on:
- Predicate Device: K122816; Endscopic Wire Guide manufactured by Wilson-Cook Medical.
- Device Description: Steerable, metallic core with PTFE polymer coating, hydrophilic coating over the distal portion, radiopaque floppy tip.
- Intended Use: Selective cannulation of biliary ducts (common bile, pancreatic, cystic, right and left hepatic ducts) and aiding in placement of diagnostic/therapeutic devices during endoscopic procedures.
- Functional and Safety Testing: Bench testing according to applicable standards and guidances, providing assurance of safety and effectiveness, and demonstrating equivalence to the predicate.
- Comparative Technology Characteristics: Similarities to predicate in intended use, operating principle, packaging/sterilization, nominal diameter, similar lengths, Nitinol alloy core wires, distal radiopaque tip, and lubricious coatings.
- Non-Clinical Tests Submitted:
- Biocompatibility: Cytotoxicity (L-929 MEM Elution, Colony Microassay by Elution), Guinea Pig Maximization Sensitization, Irritation (Intracutaneous Reactivity), Chemical Characterization.
- Bench testing: Coating adherence, corrosion resistance, dimensional measurements, fracture resistance, tensile strength, torqueability.
- Shelf Life Testing: 13-month accelerated aging.
The conclusion is that the NovaGold guidewire is equivalent to the predicate device based on equivalent intended use and no differences raising new safety/effectiveness questions. This is a common approach for 510(k) clearances for devices that do not introduce novel technology or a new intended use.
Ask a specific question about this device
Page 1 of 1