(116 days)
The Disposable Multistage Dilation Balloon Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.
The Disposable Multistage Dilation Balloon Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label. The Disposable Multistage Dilation Balloon Catheter is designed to pass through a 2.8mm or greater working channel of an endoscope. It will also accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 in (0.89mm) guidewire preloaded in the guidewire lumen. The guidewire is about 20cm longer than the balloon catheter with the excess length extending from single lumen tube. The guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in locked.
The Micro-Tech (Nanjing) CO., Ltd. Disposable Multistage Dilation Balloon Catheter did not undergo a clinical study. Instead, the device's substantial equivalence to predicate devices was established through bench testing.
Therefore, the following information cannot be extracted from the provided text:
- Acceptance Criteria Table
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for establishing ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
1. Acceptance Criteria and Reported Device Performance
As no clinical study was performed, detailed acceptance criteria and reported device performance in a clinical context are not provided. The substantial equivalence was based on bench testing.
Bench Test Performed:
The following in-vitro performance tests were completed on the Disposable Multistage Dilation Balloon Catheter to demonstrate substantial equivalence to predicate devices:
- Balloon Diameter
- Balloon Length
- Rated Pressure
- Working Length
- Retraction Testing
- Tensile Strength
- Tip Pull Testing
- Endoscopic Compatibility Testing
- Balloon Burst Pressure
- Balloon Fatigue Testing
- Radiopacity
- Balloon Inflation/Deflation Testing
- Package Integrity
- Shelf Life Testing
The conclusion drawn from these tests was that "The Disposable Multistage Dilation Balloon Catheter performs as well as the predicate and is substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance
Not applicable, as no clinical study or test set with patient data was utilized. Substantial equivalence was demonstrated through bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study or ground truth based on expert consensus was established. Substantial equivalence was demonstrated through bench testing.
4. Adjudication method for the test set
Not applicable, as no clinical study or test set requiring adjudication was performed.
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, as this device is a physical medical device (balloon catheter), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as the evaluation was based on in-vitro bench testing, rather than a clinical ground truth.
8. The sample size for the training set
Not applicable, as this device is a physical medical device and not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this device is a physical medical device and not an AI/machine learning algorithm that requires a training set.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.