(128 days)
CoLign™ The Hemostasis Valve is intended to to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 French or smaller.
The insertion tool facilitates introduction of the guide wire go through the hemostasis valve.
The torquer when inserted into the proximal end of the guide wire provides a handle for easier manipulation of the guide wire.
The CoLign Hemostasis Valve is a device that can be operated with only one hand through its special "push-pull" mechanism. In the pushed-down position, the valve is open for safe insertion and removal of devices. In the pulled-up position, the valve is closed and seals smoothly round the inserted devices. Once the valve is closed, devices can still be manipulated freely. CoLign eliminates the need for adjustment of the hemostasis valve by rotating during the procedure. The CoLign Hemostasis Valve is compatible with most interventional devices based on rapid exchanged and over-the-wire technology. There are three models of the CoLign Hemostasis Valve: the Standard CoLign , the CoLign 20,and the CoLign 50. The configuration of the sideport is the only difference among the three models. The sideport of the Standard CoLign ends in a male luer, while the sidearm of the CoLign 20/50 ends with a 20/50 cm extension tubing and 3-way stopcock.
Here's an analysis of the provided text regarding the CoLign™ Hemostasis Valve, focusing on the acceptance criteria and study data:
It's important to note that the provided text is a 510(k) Premarket Notification for a medical device. This type of submission aims to demonstrate substantial equivalence to a previously legally marketed device (predicate device), rather than proving safety and effectiveness de novo through extensive clinical trials. Therefore, the "acceptance criteria" and "study" information will differ significantly from what one might expect for a novel device requiring a PMA (Premarket Approval).
The "acceptance criteria" in this context refers to the performance characteristics that the CoLign™ Hemostasis Valve needed to meet to be considered substantially equivalent to its predicate device. The "study" refers to the non-clinical performance testing conducted to demonstrate these characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) submission, the acceptance criteria are largely implied by the comparison to the predicate device and the typical tests for this device type. The reported device performance is presented as meeting these criteria.
| Acceptance Criteria Category | Specific Criteria / Measurement | CoLign™ Hemostasis Valve Performance (Reported) |
|---|---|---|
| Material Equivalence | Component materials should be identical or highly similar to predicate. | Identical materials (Poly carbonate for Valve Body, Silicone for O-ring) |
| Optimal Inner Lumen | 7 French (2.33mm/0.092") | 7 French (2.33mm/0.092") |
| Inner Diameter (Narrowest) | 7.2F/2.4mm/0.094" | 7.2F/2.4mm/0.094" |
| Device Diameter Range | Max: 7F/2.33MM/0.092", Min: 0.53F/0.17mm/0.007" | Max: 7F/2.33MM/0.092", Min: 0.53F/0.17mm/0.007" |
| Pressure Resistance (with catheter & guidewire) | 8 bar | 8 bar |
| Pressure Resistance (without device) | 21 bar (predicate) | 20 bar |
| Visual Inspection | Pouch integrity (no damage, proper seal) | Met requirements |
| Pouch Peel Test | Adequate seal strength for packaging | Met requirements |
| Leak Test (without products) | No leakage | Met requirements |
| Leak Test (with guide wire & hypo tube) | No leakage | Met requirements |
| Tensile Test | Assembly of PU tube/PC fitting integrity | Met requirements |
| Product Stability | Shelf life validation | Met requirements |
| Sterilization | Effective sterilization (ETO) | Met requirements |
| Biocompatibility | Hemolysis, Pyrogenicity, other ISO 10993 requirements | All tests met requirements specified in ISO 10993 (Hemolysis, Pyrogenicity) |
Note on "Acceptance Criteria": For a 510(k), the primary "acceptance criterion" is often demonstrated substantial equivalence to the predicate device, which is shown by comparing technological characteristics and performance test results. Many of the reported performances are directly compared against the predicate's stated specifications or generally accepted industry standards for such devices. The "Met requirements" for tests like visual inspection or peel tests imply internal company-defined acceptance criteria based on good manufacturing practices and risk assessment.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes for each of the performance tests (e.g., how many valves were subjected to leak testing or pressure resistance testing). It is typical for such non-clinical tests to use a statistically relevant but often small number of units (e.g., N=3 to N=10 per test) to demonstrate performance.
- Data Provenance: The studies were conducted by Jilin Coronado Medical Ltd. The data is non-clinical performance test data, likely conducted in a controlled laboratory setting (in-house or third-party lab) by the manufacturer. The country of origin for the testing would be China, where the manufacturer is located. The nature of these tests makes them prospective in the sense that they were designed and executed to evaluate the new device's performance against predefined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable to this type of submission. The ground truth for the non-clinical performance tests (e.g., pressure resistance, leak testing, material composition) is established by physical measurement, chemical analysis, and engineering standards. It does not involve human expert interpretation of data like imaging studies.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies where multiple human readers interpret patient data and discrepancies need to be resolved. Performance testing of a physical device against engineering specifications does not involve such human "readings" or adjudication. The results are typically quantitative measurements or qualitative observations that conform to a standard.
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 question is not applicable. An MRMC study is relevant for evaluating the impact of AI on human performance in diagnostic tasks (e.g., radiology). The CoLign™ Hemostasis Valve is a physical medical device (hemostatic valve), not an AI-powered diagnostic tool. Therefore, no MRMC study was performed or is relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
- This question is not applicable. This device is a physical, mechanical medical device. It does not involve any algorithm or AI component, so the concept of "standalone algorithm performance" is irrelevant.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical performance tests is based on established engineering standards, material specifications, and validated test methods. For example:
- Pressure Resistance: Ground truth is a measured pressure, compared against a specified bar value.
- Biocompatibility: Ground truth is determined by compliance with ISO 10993 standards, involving quantitative and qualitative lab tests (e.g., cell culture assays for cytotoxicity, chemical analyses for extractables).
- Leak Test: Ground truth is the absence of fluid leakage under defined conditions.
- Material Composition: Ground truth is the chemical identity of the materials (e.g., polycarbonate, silicone) as confirmed by material testing.
8. The Sample Size for the Training Set
- This question is not applicable. "Training set" refers to data used to train machine learning models. As established, this device is a physical medical component and does not involve AI or machine learning.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8. There is no training set for a device of this type.
§ 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.