(264 days)
The PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.
The PTFE Super Sheath Introducer with Sheath/Dilator assembly facilitates vascular access for placement of intravascular catheters. Inserting an introducer needle into the desired vessel allows for initial access to the vascular system. A guide wire is then placed into the vessel through the needle and the needle is then removed. The sheath/dilator assembly is then inserted over the guide wire and into the percutaneous opening to dilate the opening into the vessel. The dilator and guide wire are then removed leaving the sheath in place. A catheter can then be placed through the sheath. Breaking the sheaths hub and peeling the sheath away from the catheter then allows the sheath to be removed. Its frame is composed of mostly HDPE, as the sheath hub, dilator and dilator hub are all HPDE. The sheath tube is composed of PTFE (Teflon). The Super Sheath if gray in color with the exception of the dilator hub which is composed of a different color to identify each individual French size (3F Purple, 3.5F Pink, 4F Red, 4.5F Yellow, 5F Light Gray, 5.5F Dark Gray, 6F Green, 6.5F Light Green, 7F Orange, 8F Blue, and 9F White). The PTFE Super Sheath is available in eleven (11) different French sizes ranging from 3F to 9F. The Introducers are available 3F-7F with a Scm length or 3F-9F in the 10cm length option.
The medical device in question is the "PTFE Super Sheath Introducer" manufactured by MARTECH MEDICAL PRODUCTS. This device is intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.
Based on the provided text, the acceptance criteria and the study that proves the device meets these criteria can be summarized as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| Air Leakage | Performed, results assure reliable design and performance in accordance with ISO standards and/or internal procedures. |
| Liquid Leakage | Performed, results assure reliable design and performance in accordance with ISO standards and/or internal procedures. |
| Force at Break | Performed, results assure reliable design and performance in accordance with ISO standards and/or internal procedures. |
| Simulated Use | Performed, results assure reliable design and performance in accordance with ISO standards and/or internal procedures. |
| Equipment Interaction | Performed, results assure reliable design and performance in accordance with ISO standards and/or internal procedures. |
| Surface Examination | Performed, results assure reliable design and performance in accordance with ISO standards and/or internal procedures. |
| Biocompatibility (ISO 10993) | All biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993. |
| Substantial Equivalence | The device is substantially equivalent to predicate devices (K000313, K053092, K090394) in terms of intended use, anatomical location, general design, and materials. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document does not specify the exact sample sizes used for each in-vitro test. It only states that "in-vitro testing was performed." The provenance of the data is not explicitly mentioned (e.g., country of origin), nor whether the tests were retrospective or prospective, though in-vitro tests are inherently experimental and controlled, rather than observing pre-existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable. The device is a medical introducer sheath, and the testing described is primarily mechanical and material performance (in-vitro bench testing) and biocompatibility, not diagnostic or clinical performance that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the testing involves objective measurements against predefined ISO standards and internal procedures, not subjective human assessment needing adjudication.
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 information is not applicable. The device is a physical medical instrument (introducer sheath), not an AI-powered diagnostic tool, and therefore MRMC studies with human readers are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument; there is no algorithm or AI component involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the in-vitro bench testing, the "ground truth" would be the specifications and requirements outlined in the applicable ISO standards and the manufacturer's internal procedures for device design and performance. For biocompatibility, the ground truth is established by ISO 10993 standards. For the substantial equivalence claim, the ground truth is the performance and characteristics of the legally marketed predicate devices.
8. The sample size for the training set
This information is not applicable as the device is not an AI/machine learning system that requires a "training set." The performance is validated through physical and chemical testing.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above; there is no training set for this device.
§ 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).