(170 days)
The Reliant(TM) Multistage Dilatation Balloon Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.
The Reliant™ Multistage Dilatation 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 Reliant™ Multistage Dilatation 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.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the performance tests in the typical sense of a target metric the device must achieve. Instead, it reports the measured values for the proposed device and compares them to the predicate device. The underlying acceptance criterion for these tests is that the new device should be substantially equivalent to the predicate device, meaning its performance characteristics are similar enough not to raise new questions of safety or effectiveness.
| Performance Test | Proposed Device Performance (Reliant™ Multistage Dilatation Balloon Catheter) | Predicate Device Performance (K151671) |
|---|---|---|
| Tensile Strength between Balloon and Double Lumen Tube (N) | $67.11 \pm 2.16$ | $78.11 \pm 9.59$ |
| Tensile Strength between Double Lumen Tube and Junction (N) | $109.99 \pm 2.12$ | $94.67 \pm 3.54$ |
| Biocompatibility - Cytotoxicity | The test article extracts had not a cytotoxic potential. Neither SC extracts nor CSO extracts had a cytotoxic potential. | The test article extracts had not a cytotoxic potential. Neither SC extracts nor CSO extracts had a cytotoxic potential. |
| Biocompatibility - Sensitization | No evidence of causing sensitization in the guinea pig. | No evidence of causing sensitization in the guinea pig. |
| Biocompatibility - Irritation | The test article extracts have no animal intracutaneous reactivity as compared to the control. | The test article extracts have no animal intracutaneous reactivity as compared to the control. |
Note: For tensile strength, the comparison indicates "similar," implying that the measured values, while not identical, are considered acceptable for demonstrating substantial equivalence given the context of the device's function and intended use. For biocompatibility, the results are identical, indicating the proposed device performs the same as the predicate in these aspects.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the exact sample size for the tensile strength tests (e.g., how many balloons were tested). For biocompatibility, the tests are typically performed on a statistically relevant number of samples according to ISO standards, but the specific number is not disclosed.
- Data Provenance: The document does not explicitly state the country of origin for the test data for the tensile strength and biocompatibility tests. Given that Micro-Tech (Nanjing) Co., Ltd. is based in China, it is highly probable the testing was conducted in China or by a contracted lab. The data is retrospective in the sense that these tests were performed on the finished device before this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this document. The "ground truth" for material property tests like tensile strength and biocompatibility is established by standardized laboratory methods and measurements, not by expert consensus or interpretation of images/clinical data. These are objective measures.
4. Adjudication method for the test set
This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. The tests described here are physical and biological material characterization tests, which do not involve such human-based adjudication.
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
This is not applicable. The device is a medical catheter (a physical instrument), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed or is relevant for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. As mentioned above, the device is a physical medical instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed (tensile strength, biocompatibility) is based on:
- Standardized Laboratory Measurements: For tensile strength, the ground truth is the measured force required to break the material, determined by calibrated testing equipment and procedures.
- Standardized Biological Assay Results: For biocompatibility (cytotoxicity, sensitization, irritation), the ground truth is the observable biological response (or lack thereof) in laboratory assays, compared against established biological safety criteria (e.g., ISO 10993 series standards).
8. The sample size for the training set
This is not applicable. The concept of a "training set" (used for machine learning or AI algorithms) does not apply to the development or testing of this physical medical device. Device development involves engineering design, material selection, and physical testing, not algorithm training.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
§ 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.