(90 days)
The Attachable Cath Lab Hemostasis Valve is indicated to minimize blood loss during the introduction of catheters, guidewires and other intravascular devices into the vasculature.
The Galt Medical Attachable Cath Lab Hemostasis Valve assembly consists of a molded hub with an integrated hemostasis valve, sideport tubing with 3 way stopcock. The design of the Attachable Cath Lab Hemostasis Valve is derived directly from the current line of Galt Medical Cath Lab Introducer Sheath (K043525). The subject and predicate device are both have an integrated hemostasis valve, and side port tubing with stopcock.
The provided text describes a 510(k) submission for a medical device, the "Attachable Cath Lab Hemostasis Valve." However, it does not detail a study that proves the device meets specific acceptance criteria in the manner typically associated with AI/CADe devices, which would involve metrics like sensitivity, specificity, or AUC, established through a rigorous ground truth determination process.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and functional testing. The "acceptance criteria" here are essentially the performance specifications, and the "study" is the non-clinical functional testing performed.
Here's an analysis based on the information provided:
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Specification) | Reported Device Performance (Functional Testing Results) |
|---|---|
| Pressure Withstand: 7 PSI | Device met product specifications (implied: achieved 7 PSI) |
| Vacuum Withstand: 0.47 in-Hg | Device met product specifications (implied: achieved 0.47 in-Hg) |
| Guidewire Insertion Test | Device met product specifications |
| Dilator Insertion Test | Device met product specifications |
| Sidearm Tubing to Hub Pull Force Test | Device met product specifications |
| Spinlock Collar Adapter Pull Test | Device met product specifications |
| Biocompatibility | Demonstrated through predicate devices with identical raw materials and package configuration |
| Sterilization | Adopted into existing ethylene oxide sterilization cycle for a predicate device |
| Packaging Shelf Life | Demonstrated through predicate submissions |
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Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of units tested. The functional testing states it was performed on "4-year aged product," implying a set of devices and potentially new devices.
- Data Provenance: The functional testing was conducted by Galt Medical Corp. on their own manufactured devices. The text does not specify the country of origin of the data beyond being from the manufacturer's internal testing. It is prospective in the sense that the testing was performed for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable in the context of this device and submission type. The "ground truth" for these functional tests is the defined engineering specification (e.g., 7 PSI pressure withstand). The tests themselves are designed to objectively measure whether the device meets these specifications, not to interpret complex medical data requiring expert consensus.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as the tests are objective functional measurements against engineering specifications, not subjective interpretations requiring adjudication.
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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 because the device is a physical medical instrument (hemostasis valve), not an AI/CADe system.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable as the device is not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical functional tests is derived from engineering specifications and established performance standards relevant to the function of such a valve (e.g., ability to withstand a certain pressure, secure insertion of guidewires, pull force thresholds). For biocompatibility and sterilization, the ground truth refers to meeting pre-defined biological safety standards and sterility assurance levels.
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The sample size for the training set
- This is not applicable as the device is a physical medical instrument and does not involve AI or machine learning models that require a training set.
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How the ground truth for the training set was established
- This is not applicable as there is no training set for this type of device.
§ 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.