(98 days)
The EZDilate 3-Stage Balloon Dilatation Catheters are in adult populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of Oddi with or without prior sphincterotomy.
The EZDilate 3-Stage Balloon Dilatation Catheter consists of a semi-compliant nylon blow molded balloon; and, a shaft that communicates a fluid passage for expansion and collapse of the balloon portion, operated by an inflation device. The EZDilate Wire Guided Balloon is designed to be used with a 0.035 in. (0.89mm) guidewire and has a wire lumen sized appropriately. Each balloon catheter is packaged with a soft tip 0.035 in. (0.89mm) guidewire pre-loaded into the guidewire lumen. All wire-guided balloons with have lengths of 5.5cm and a catheter length of 240cm. The balloon is inflated with a 60cc inflation device, which will be sold separately. The suggested inflation device is manufactured by Atrion (K032840).
The provided text describes a 510(k) premarket notification for a medical device, the EZDilate 3-Stage Balloon Dilatation Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or developing new acceptance criteria through extensive clinical studies. Therefore, much of the information requested in your prompt (e.g., sample size for test/training sets, number/qualifications of experts for ground truth, MRMC studies, standalone performance, adjudication methods) is not typically part of a 510(k) submission for this type of device and is not present in the provided document.
The "acceptance criteria" for a 510(k) are primarily demonstrating that the new device performs as intended and is as safe and effective as its predicate. The "study that proves the device meets the acceptance criteria" refers to the engineering and bench testing performed to show the device's functional integrity and similarity to the predicate.
Here's an attempt to answer your questions based on the available information, with explanations where information is not applicable or provided:
1. A table of acceptance criteria and the reported device performance
For a 510(k) relating to a balloon dilatation catheter, "acceptance criteria" are essentially the performance specifications derived from the device's design and intended use, and often benchmarked against its predicate. "Reported device performance" comes from bench testing. The document lists the types of tests performed.
| Acceptance Criteria (Implied from tests and predicate comparison) | Reported Device Performance (Summary from "Summary of Performance Testing") |
|---|---|
| Mechanical Integrity/Dimensions: | Passed: |
| - Correct dimensions | - First Article Inspection (Dimensional Measurements) |
| - Resistance to tensile forces | - Tensile Testing |
| - Ability to withstand repeated stress | - Fatigue Testing |
| - Proper Luer connection | - Luer Gauging Test |
| - Balloon working length as specified | - Balloon Working Length |
| - Appropriate tip stiffness | - Tip Stiffness Testing |
| Balloon Functionality: | Passed: |
| - Consistent expansion across 3 stages | - Compliance Testing |
| - Resistance to rupture at specified pressures | - Balloon Burst Testing |
| - Ease of insertion | - Balloon Insertion Force Testing |
| - Low friction for movement within scope | - Balloon Friction Testing |
| - Effective deflation | - Balloon Deflation Testing |
| - Compatibility with endoscopes | - Balloon Endoscope Compatibility Testing |
| Biocompatibility: | Passed: |
| - Non-toxic, non-irritating, non-sensitizing | - ISO 10993-1, 10993-5, 10993-7, 10993-10 (Compliance to standards) |
| Sterility/Shelf Life: | Passed: |
| - Sterile upon delivery (EO sterilization) | - Sterilization validated (Ethylene oxide) |
| - Maintains integrity over time | - Six month shelf life data submitted (product launched with 3-year shelf life post-submission) |
| Packaging Integrity: | Passed: |
| - Maintain sterility and product integrity | - ISTA P2A, ASTM D4169-09, ASTM F2096-11, ASTM F88/F88M:2009, |
| ASTM F1886/F1886M:2009, ASTM F1980-07 (Compliance to standards) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. For bench testing of physical devices, sample sizes are typically determined by statistical methods for specific tests but are not explicitly reported in this summary.
- Data Provenance: The study described is entirely in-vitro bench testing of the device's physical and functional properties, performed by the manufacturer/contract manufacturer. There is no patient data involved (retrospective or prospective). The location of the testing laboratories is not specified beyond the manufacturer's location in the USA.
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. "Ground truth" in the context of device performance in a 510(k) for this type of device is established through engineering specifications, material properties, and comparison to the predicate device's known performance characteristics. Expert panels for diagnostic accuracy or clinical outcomes are not part of this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices, to resolve disagreements among human readers or experts. This submission is based on 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
- Not applicable. MRMC studies are typically for diagnostic AI-powered devices to assess how the AI impacts human reader performance. The EZDilate is a physical medical device (catheter) and does not involve AI assistance or human readers in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm. "Standalone performance" refers to the performance of a diagnostic algorithm without human intervention, which is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this device, the "ground truth" for the bench testing is defined by engineering specifications, material standards (e.g., ISO, ASTM), and the performance characteristics of the legally marketed predicate device (Boston Scientific CRE Dilatation Balloon K112994). The tests confirm that the EZDilate catheter meets these predefined physical and functional benchmarks.
8. The sample size for the training set
- Not applicable. There is no concept of a "training set" for physical medical device submissions like this. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable, as there is no 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.