(254 days)
The Pressure Connecting Tube is for use during angiography procedures as a connecting line for the injection of liquid, such as radiopaque dye, saline, or other diagnostic fluids.
The Pressure Connecting Tube is a sterile, single use device which can withstand injection pressures to 350~1200psi for use with power injectors to inject contrast media into implanted ports designed for use with power injectors. This device is designed, like other legally marked devices, for one end to connect to the fluid source (such as an angiographic syringe) and the other end to connect to the catheter. The fluid such as radipoaque dye, saline, or other diagnostic fluid is then injected from the syringe, through the connecting tube, into the catheter. The contrast, saline, or other diagnostic fluid is then injected from the syringe through the High Pressure Tube, into the catheter. According to the different pressure maintenance, the material of tube is PVC or PU, and the appearance is clear or braided.
Here's an analysis of the acceptance criteria and study information for the Pressure Connecting Tube (K131770):
Key Takeaways Before Diving In:
- This device is a tubing connector for angiographic procedures. It's a relatively low-risk device.
- The study described is non-clinical testing, meaning it does not involve human subjects. It focuses on device performance and safety characteristics.
- This submission relies heavily on substantial equivalence to a predicate device (K071196), meaning the manufacturer asserts that their device is as safe and effective as a previously cleared device.
- There's no AI component in this device, so questions related to AI-specific metrics like human reader improvement with AI assistance, standalone AI performance, and AI-specific ground truth establishment are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the reference to international standards and manufacturer's internal standards. The "reported device performance" is a confirmation that the device met these standards.
| Acceptance Criterion (Reference Standard/Requirement) | Reported Device Performance |
|---|---|
| Pressure Maintenance (Manufacturer's standard) | The product should fulfill the requirements of pressure maintenance as claimed (350psi, 600psi). The non-clinical testing verified that the proposed device is capable of the intended use, meaning it met these pressure requirements. (Specifically, types for 350psi and 600psi were tested). |
| Packaging: | |
| * Seal strength | Verified (per ASTM F88) |
| * Integrity (Leaks) | Verified (per ASTM F1929) |
| * Vacuum leak | Verified (per ASTM D3078) |
| * Accelerated aging (Sterility Shelf Life) | Verified (per ASTM F1980-07) |
| * General packaging requirements | Verified (per ISO 11607-1) |
| Performance (Luer Taper Connections): | |
| * General Requirements for Conical Fittings (Luer) | Verified (per ISO 594-1) |
| * Lock Fittings for Conical Fittings (Luer) | Verified (per ISO 594-2) |
| Sterilization: | |
| * Process Development, Validation, Routine Control (EtO) | Verified (per ISO 11135-1) |
| * EO/ECH Residuals | Verified (per ISO 10993-7) |
| * Bacterial Endotoxin | Verified (per USP Chapter ) |
| * Sterility | Verified (per USP Chapter ) |
| Biocompatibility: | |
| * Cytotoxicity | Verified (per ISO 10993-5) |
| * Sensitization | Verified (per ISO 10993-10) |
| * Irritation | Verified (per ISO 10993-10) |
| * Systemic Toxicity (Acute) | Verified (per ISO 10993-11) |
| * General Biocompatibility of materials (across all relevant) | All the biocompatibilities of materials meet the requirements of ISO 10993 standards (implying passes for all relevant parts of ISO 10993, not just those explicitly listed in the "Non-Clinical Testing Data" section but also potentially others like material characterization or hemocompatibility if applicable to the device contact. The "Summary of the Biocompatibility Testing" table is empty in the provided text, but the conclusion states it met ISO 10993 requirements). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "The most complicated structure of each pressure type is selected to conduct the performance test." It does not specify an exact number of units/samples for each test. Typically, for such non-clinical tests, a statistically relevant number of samples (often 3-10, sometimes more depending on the test and risk) would be used to demonstrate consistency and robustness, but the exact number is not provided in this summary.
- Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. The manufacturer is based in China: Shenzhen ANT Hi-Tech Industrial Co., Ltd. The data is prospective in the sense that the tests were performed specifically for this submission to verify the device's performance against defined standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a non-clinical device performance and safety study involving physical and chemical testing against engineering standards (e.g., pressure, leaks, biocompatibility, sterility). There is no "ground truth" established by human experts in the way it would be for a diagnostic imaging device. The "ground truth" is defined by the objective measurement results compared to the pass/fail criteria of the referenced international and manufacturer standards.
4. Adjudication Method for the Test Set
- Not Applicable. As this is non-clinical physical and chemical testing, there is no expert adjudication process like 2+1 or 3+1. The results are objective measurements against predefined acceptance criteria from standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs without AI Assistance
- No. This device is a passive, non-AI medical device (a pressure connecting tube). MRMC studies, AI assistance, and related metrics are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is a passive, non-AI medical device. Standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
- Objective Measurements Against Industry Standards and Manufacturer Specifications: The "ground truth" for the non-clinical tests is based on the quantitative and qualitative results derived from testing the device according to established international standards (ISO, ASTM, USP) and the manufacturer's own internal standards for pressure maintenance. For example, pressure maintenance is a quantitative measurement, while sterility is determined by a pass/fail microbiological test as per USP .
8. The Sample Size for the Training Set
- Not Applicable. This is a non-AI medical device; therefore, there is no "training set" in the context of machine learning or AI models. The device's design is based on engineering principles and material science, not learned from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI component or training set, this question does not apply.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).