(86 days)
Merit's Prelude® Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.
The Prelude® Short Sheath Introducer (PSS) consists of a sheath introducer with integral hemostasis valve. The side port extension tubing extending from the sheath hub may be used to infuse solutions and/or for temporary hemodialysis. A vessel dilator snaps securely into the sheath introducer hub. The PSS devices are available in 5 French (F) through 8F sizes in 4cm effective length. The vessel dilator is tipped specifically to accept either a 0.038" (0.97mm) or a 0.018" (0.46mm) diameter guide wire. The device is marketed with and without an appropriately sized guide wire and/or access needle.
The provided text describes Merit Medical Systems, Inc.'s Prelude® Short Sheath Introducer (PSS), a medical device intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis.
Here's an analysis based on your request:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as per submission) |
|---|---|
| Technological Equivalence | The PSS device is "substantially equivalent to those of the predicate device in terms of intended use, clinical utility and mode of operation, user population, basic design, materials, performance, labeling, packaging and sterilization method." |
| Material/Biocompatibility | Tested per ISO 10993-1, ISO 10993-7, and FDA Bluebook memorandum G95-1. Results "met the acceptance criteria." |
| Sterilization Residuals | Tested per ISO 10993-7 and ISO 11135. Results "met the acceptance criteria." |
| Intravascular Catheter Introducer Standards | Tested per ISO 11070: 1998. Results "met the acceptance criteria." |
| Luer Taper Fittings | Tested per ISO 594-1: 1986 and ISO 594-2: 1998. Results "met the acceptance criteria." |
Study Details:
-
Sample size used for the test set and the data provenance: The document does not specify exact sample sizes for each non-clinical test. It states that "Verification and validation studies were conducted in accordance with in-house protocols to mitigate risks identified in the clinical risk assessment conducted by Merit." The data provenance is internal to Merit Medical Systems, Inc. through their in-house protocols, not specified as being from a particular country or retrospective/prospective clinical study.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. The testing was non-clinical performance testing against established international and FDA standards, not a clinical study requiring expert ground truth for interpretation of patient data.
-
Adjudication method for the test set: Not applicable. The testing described is non-clinical performance testing against objective standards, not a clinical study requiring adjudication of expert interpretations.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC comparative effectiveness study was not conducted or mentioned. This submission is for a traditional 510(k) based on substantial equivalence through non-clinical performance testing, not a clinical effectiveness study.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a physical medical instrument (sheath introducer), not an algorithm or AI system.
-
The type of ground truth used: The "ground truth" for the non-clinical performance testing was the established specifications and requirements outlined in the cited ISO standards (e.g., ISO 11070, ISO 594-1, ISO 594-2) and FDA guidance (e.g., ISO 10993 series, G95-1 memorandum). The device's performance was compared against these predefined physical and biological acceptance limits.
-
The sample size for the training set: Not applicable. The device is a physical medical instrument, not an AI/ML algorithm that requires a training set.
-
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of 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).