(151 days)
The Prelude Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.
The Prelude Guide Sheath Introducer is a sterile, disposable device consisting of a (a) a coil reinforced shaft with an atraumatic tip and the distal end: (b) a hemostasis valve with a side port and color-coded stopcock; and (c) a tapered tip dilator with snap-fit hub at the proximal end.
This is a 510(k) summary for a medical device (Prelude Guide Sheath). The document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data and material comparisons, not on evaluating an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or readily extractable from this specific document.
However, I can provide the acceptance criteria and performance as described for the non-clinical tests.
Acceptance Criteria and Reported Device Performance
The document states that "The results of the testing demonstrated that the subject Prelude Guide Sheath met the predetermined acceptance criteria applicable to the performance of the device." The specific numerical acceptance criteria for each test are not provided in this summary, but the general categories of tests performed are listed. The "Reported Device Performance" for each test is simply that the device met those unstated criteria.
Here's a table based on the provided "Performance Tests" section:
| No. | Verification/Validation Test | Applicable Standard(s) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|---|
| 1 | Insertion Force/Tip Insertion, Peel Back | Internal Requirement | Met internal requirements | Met predetermined criteria |
| 2 | Peak Tensile Force Shaft/Hub & Tip | ISO 10555-1:2013, ISO 10555-3:2013, ISO 11070:2014 | Met standards' requirements | Met predetermined criteria |
| 3 | Visual (Extraneous/Surface Defects) | ISO 11070:2014 | Met standards' requirements | Met predetermined criteria |
| 4 | Sheath Stiffness | Internal Requirement | Met internal requirements | Met predetermined criteria |
| 5 | Sheath Kink | Tested through Validation | Met validation requirements | Met predetermined criteria |
| 6 | Radiopacity marker band & tip | ISO 11070:2014, ASTM F640-12, ISO 10555-1:2013 | Met standards' requirements | Met predetermined criteria |
| 7 | Hydrophilic coating durability & coverage/coating length | Internal Requirement | Met internal requirements | Met predetermined criteria |
| 8 | Hydrophilic Coating Lubricity | Tested through Validation | Met validation requirements | Met predetermined criteria |
| 9 | Coating integrity test (particulate evaluation) | ASTM F1877-16, Class II Special Controls Guidance for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters | Met standards' requirements | Met predetermined criteria |
| 10 | Corrosion resistance | ISO 11070:2014 | Met standards' requirements | Met predetermined criteria |
| 11 | Sheath assembly leak | ISO 11070:2014 | Met standards' requirements | Met predetermined criteria |
| 12 | Hydrogen Peroxide Resistance | ISO 10555-1:2013, ISO 10555-3:2013 | Met standards' requirements | Met predetermined criteria |
| 13 | Radiopacity Dilator | ISO 11070:2014, ISO 10555-1:2013 | Met standards' requirements | Met predetermined criteria |
| 14 | Dilator tip fracture | Internal Requirement | Met internal requirements | Met predetermined criteria |
| 15 | Dilator-to-Hub Tensile | ISO 10555-1:2013 | Met standards' requirements | Met predetermined criteria |
| 16 | Sheath tip to dilator taper length | Internal Requirement | Met internal requirements | Met predetermined criteria |
| 17 | Dilator Stiffness & Hub Snap Force | No Standard - Tested through Validation | Met validation requirements | Met predetermined criteria |
| 18 | Dilator Insertion/Removal from Sheath | No Standard - Testing through Validation | Met validation requirements | Met predetermined criteria |
| 19 | Dimensional tests for OD & ID of sheath & dilator | ISO 11070:2014 | Met standards' requirements | Met predetermined criteria |
| 20 | Curve shape & visual for sheath & dilator | Internal Requirement | Met internal requirements | Met predetermined criteria |
| 21 | Curve Retention | No standard - Testing through Validation | Met validation requirements | Met predetermined criteria |
| 22 | Sheath Effective Length | ISO 10555-1:2013 | Met standards' requirements | Met predetermined criteria |
| 23 | Luer Design Tests | ISO 11070:2014, ISO 594-1: 1986, ISO 594-2:1998 | Met standards' requirements | Met predetermined criteria |
| 24 | Hemostasis Valve Leakage | ISO 11070:2014 | Met standards' requirements | Met predetermined criteria |
| 25 | EO Sterilization Validation | ISO 11135:2014, ISO 10993-7:2008, AAMI TIR28:2016 | Met standards' requirements | Met predetermined criteria |
| 26 | Package Integrity Testing | ISO 11607-1:2019, ISO 11607-2:2019, ASTM D4169-16 | Met standards' requirements | Met predetermined criteria |
| 27 | Biocompatibility Testing (Cytotoxicity, Sensitization, etc.) | ISO 10993-1:2009, ISO 10993-4: 2017, ISO 10993-5:2009, ISO 10993-6:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2017, ISO 10993-12:2012 | Met standards' requirements | Met predetermined criteria |
| 28 | Chemical Characterization – Particulate Analysis | ASTM F1877-16 | Met standards' requirements | Met predetermined criteria |
The remaining requested information is largely irrelevant to this 510(k) submission, as it pertains to AI/ML algorithm validation for which this device is not. This submission focuses on the physical and material characteristics of a medical device (a guide sheath introducer) and its substantial equivalence to existing predicate devices, rather than the performance of an AI/ML system.
Therefore, the following information is not applicable or extractable from the provided document:
- Sample sized used for the test set and the data provenance: Not an AI/ML study, so "test sets" in that context don't apply. The non-clinical tests would have their own sample sizes for a variety of physical or chemical tests, but these are not detailed as a single "test set" for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML study; no "ground truth" in the diagnostic/interpretive sense is established by experts here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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).