(123 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 vasular 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 Teflon, HDPE, and Nylon. The sheath hub and dilator hub all HPDE, while the sheath tube is PTFE (Teflon) and the dilator is either Nylon for the 3F through the 5.5F sizes or HDPE for the 6F through 9F sizes. The Super Sheath's sheath is gray in color, with either a Light Blue Nylon dilator (3F-5.5F) or gray HDPE dilator (6F-9F). The dilator hub 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 2.0 is available in eleven (11) different French sizes ranging from 3F to 9F. The Introducers are available with 5cm, 7cm or 10cm length options.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MARTECH MEDICAL PRODUCTS PTFE Super Sheath Introducer 2.0:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text lists the following in-vitro testing performed:
| Acceptance Criteria (Test) | Reported Device Performance (Outcome) |
|---|---|
| Liquid Leakage | Assured reliable design and performance in accordance with ISO standards and/or internal procedures. |
| Force at Break | Assured reliable design and performance in accordance with ISO standards and/or internal procedures. |
| Simulated Use | Assured reliable design and performance in accordance with ISO standards and/or internal procedures. |
| Equipment Interaction | Assured reliable design and performance in accordance with ISO standards and/or internal procedures. |
| Surface Examination | Assured reliable design and performance in accordance with ISO standards and/or internal procedures. |
| Biocompatibility | Materials used meet the requirements of ISO 10993. |
Note regarding the table above: The document states that these tests were performed "to assure reliable design and performance in accordance with ISO standards and/or internal procedures." It doesn't provide specific quantitative acceptance criteria or detailed numerical results for each test. Instead, it offers a general statement of compliance.
Study Details:
Based on the provided text, the "study" conducted for this medical device is a series of bench/performance data (in-vitro testing) and biocompatibility testing.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size for individual tests (e.g., how many sheaths were tested for liquid leakage or force at break).
- Data Provenance: The data is generated from in-vitro testing. The country of origin is not explicitly stated for the data, but the submitter is based in Harleysville, PA, USA. The study is retrospective in the sense that these tests were conducted on the manufactured product to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the study described is purely for a physical medical device and involves in-vitro (bench) testing and biocompatibility assessments, not the interpretation of human data or images requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging or AI devices that interact with human readers, which is not the nature of the PTFE Super Sheath Introducer 2.0.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm-only performance study was not done. This is not an AI/algorithm-driven device. The performance data is for the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Physical measurement and observation against pre-defined engineering and safety specifications (for liquid leakage, force at break, simulated use, equipment interaction, surface examination).
- Chemical/biological testing against established international standards (ISO 10993 for biocompatibility).
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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).