(50 days)
The Sheath Introducer system is indicated for use in percutaneous introduction of catheters and other intravascular devices into the vasculature.
The materials of construction are consistent with introducers presently in Device Description. The product is available in 4 French to 9 French. The sheath lengths are 5cm to 110cm.
This document describes a 510(k) premarket notification for a Catheter Introducer. The information provided heavily focuses on substantial equivalence to predicate devices rather than a direct performance study with acceptance criteria.
The acceptance criteria described in the document are implicitly based on demonstrating that the Galt Medical Catheter Introducer is "substantially equivalent" to predicate devices. This means that its functionality and performance should be comparable to these existing, legally marketed devices.
Based on the provided text, there is no explicit statement of numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) that would typically be seen for a device that relies on a direct performance evaluation against a defined ground truth. Instead, the "acceptance criteria" are met by demonstrating equivalence through non-clinical testing and shared technological characteristics and indications for use.
Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text for certain categories:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance Against Criteria |
|---|---|---|
| Functionality | Comparable functionality to predicate catheter introducers. | "functionality and performance... are comparable to the currently marketed introducers." |
| Performance | Comparable performance to predicate catheter introducers. | "functionality and performance... are comparable to the currently marketed introducers." |
| Tensile Strength | Results comparable to currently marketed introducers. | "Test performed included: tensile strength, and valve leakage." (Results deemed comparable) |
| Valve Leakage | Results comparable to currently marketed introducers. | "Test performed included: tensile strength, and valve leakage." (Results deemed comparable) |
| Indications for Use | Same indications for use as predicate devices. | "Galt Medical's Catheter Introducer has the same indications for use and are otherwise technically the same as the predicate devices." |
| Technological Characteristics | Technically the same as predicate devices (materials, sizes, etc.). | "Galt Medical's Catheter Introducer has the same indications for use and are otherwise technically the same as the predicate devices." |
Study Proving Acceptance Criteria:
The study that proves the device meets the (implicit) acceptance criteria is a non-clinical comparative testing program and a review of technological characteristics against predicate devices.
Detailed Breakdown of Study Information:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The tests mentioned are "tensile strength, and valve leakage," which would involve a certain number of manufactured units of the Galt Medical Catheter Introducer. However, the specific quantity is not reported.
- Data Provenance: The tests were performed on the Galt Medical Catheter Introducer itself. There is no mention of external data or specific countries of origin beyond the company's location (Garland, TX). These were likely prospective tests performed on newly manufactured devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Mentioned. For a device demonstrating substantial equivalence through non-clinical testing (tensile strength, valve leakage), "experts" for ground truth in the traditional sense (e.g., clinical diagnosis) are not required. The "ground truth" would be objective measurements of physical properties compared against established benchmarks or predicate device performance.
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Adjudication method for the test set:
- Not Applicable / Not Mentioned. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., imaging, pathology). For non-clinical tests measuring physical properties, the results are quantitative and do not require expert adjudication to establish a "ground truth" among differing opinions.
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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:
- No. This is not an AI/imaging device. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/algorithm device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests (tensile strength, valve leakage) would be objective physical measurements and engineering specifications for the device, benchmarked against the predicate devices' known performance or industry standards. It's not a clinical "ground truth" in the sense of diagnosis or patient outcomes.
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The sample size for the training set:
- Not Applicable. This is a physical medical device, not a machine learning model. There is no "training set."
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).