(127 days)
The E-Pass is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French.
The guide wire insertion tool helps the guide wire go through the hemostasis valve to reach the guiding catheter.
The torquer provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.
The E-Pass is a unique one-hand operated, "push-pull" hemostatic valve system. It consists of two pieces of silicone hemostasis valve. The quick open-close valve reduces the patient blood loss significantly during endovascular procedures. In the push forward position the valves is 100% open for safe insertion and removal of devices. In the pulled back position the valve is 100% closed and seals smoothly around the inserted devices. Once the valve is closed, devices can still be manipulated freely. E-Pass eliminates the need for rotating hemostatic valve adjustments during the procedure. The E-Pass hemostatic valve system is compatible with most interventional devices based on rapid exchanged and over-the-wire technology. There are three models of the E-Pass: the standard E-Pass and the E-Pass20/E-Pass50. The configuration of the sideport is the only difference among the three models. The sideport of the standard E-Pass ends in a female luer, while the sidearm of the E-Pass 20/ 50ends with a 20/50 cm extension tubing and 3-way stopcock.
The provided text describes a 510(k) summary for the E-Pass™ Hemostasis Valve. However, it does not include detailed acceptance criteria or a comprehensive study report with specific performance metrics to fill a table and address all the requested points.
The document states:
- "The results of the performance testing demonstrated the safety and effectiveness of the E-Pass TM Hemostatic Valve."
- "Performance testing mainly includes the following tests: Visual Inspection for Pouch Integrity, Pouch Peel Test, E-Pass Visual Inspection, Leak Test without products inserted, E-Pass Alarm pressure leak rate, Tensile test on assembly of Extention tube/Y-hub."
This lists the types of tests performed but does not provide the acceptance criteria or reported results for these tests. Therefore, I cannot construct the requested table or answer many of the specific questions.
Here's what can be inferred or stated based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection for Pouch Integrity | Not specified in the provided text. (Typically involves absence of tears, punctures, proper seals, etc.) | "demonstrated the safety and effectiveness" (No specific pass/fail result provided for this test). |
| Pouch Peel Test | Not specified in the provided text. (Typically involves peel strength within a defined range). | "demonstrated the safety and effectiveness" (No specific pass/fail result provided for this test). |
| E-Pass Visual Inspection | Not specified in the provided text. (Typically involves absence of defects, proper assembly, correct labeling). | "demonstrated the safety and effectiveness" (No specific pass/fail result provided for this test). |
| Leak Test without products inserted | Not specified in the provided text. (Typically involves a maximum allowable leak rate under specified pressure). | "demonstrated the safety and effectiveness" (No specific pass/fail result provided for this test). |
| E-Pass Alarm pressure leak rate | Not specified in the provided text. (Typically involves a maximum allowable leak rate at alarm pressure conditions). | "demonstrated the safety and effectiveness" (No specific pass/fail result provided for this test). |
| Tensile test on assembly of Extension tube/Y-hub | Not specified in the provided text. (Typically involves a minimum tensile strength or force required to cause separation). | "demonstrated the safety and effectiveness" (No specific pass/fail result provided for this test). |
| Overall Conclusion | The device is considered "substantially equivalent" to the predicate device based on comparison of technological characteristics such as materials, performance characteristics, and sterilization. The performance testing "demonstrated the safety and effectiveness." | The device was cleared by the FDA, indicating it met the requirements for substantial equivalence. No specific quantitative performance data is provided in the summary. |
Missing Information:
The provided 510(k) summary is very high-level and does not contain the detailed study information regarding acceptance criteria, sample sizes, expert qualifications, adjudication methods, or specific quantitative results typically found in full test reports. This type of detail is usually in the appendices or a more comprehensive submission, not in the summary document provided.
Therefore, for the remaining points, most answers are "Not specified" or "Not applicable" based solely on the provided text.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., retrospective or prospective, country of origin). This involves physical testing of the device, not clinical data that would typically have country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a hemostatic valve, and the testing described consists of engineering/physical performance tests (e.g., leak tests, tensile tests, visual inspections), not clinical studies requiring expert image interpretation or ground truth establishment in a diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As above, this is physical performance testing, not a diagnostic study requiring adjudication of expert interpretations.
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. This device is a hemostatic valve, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a hemostatic valve, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device's performance would be the specifications and requirements for mechanical and sealing integrity, based on engineering standards and design validation.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that would have a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.