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510(k) Data Aggregation
(68 days)
The Merit S-MAK XL™ is intended for percutaneous placement of up to a 0.038" (.097mm) guide wire or catheter into the vascular system.
The S-MAK XL TM utilizes a small diameter coaxial introducer/dilator pair and guide wire for placement of larger diameter guide wires into the vasculature system when a small needle stick is preferred. The S-MAK XL TM consists of the following components: One (1) 4F Coaxial Introducer/Dilator Pair (30 cm length) One (1) 21 gauge Introducer Needle One (1) 0.018" (0.46mm) 80cm Nitinol/Palladium Guide Wire
The provided text describes the 510(k) summary for the S-MAK XL™ device. Based on the information available, a study was conducted to demonstrate the device's substantial equivalence to predicate devices, focusing on performance and biocompatibility.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantified table format for each test. Instead, it lists the types of performance and biocompatibility tests conducted and states that "Passing results were demonstrated on all tests above." We can infer the acceptance criterion for each test was a "passing result" according to the specified international standards and guidance documents.
| Category | Test Performed | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|---|
| Performance - Bench | Effective Length Introducer and dilator | Passing result per standard | Demonstrated Passing Results |
| Guide wire insertion dilator | Passing result per standard | Demonstrated Passing Results | |
| Catheter insertion - introducer | Passing result per standard | Demonstrated Passing Results | |
| Biocompatibility | Cytotoxicity - Cytoxicity Study Using ISO Elation Method: MEM Extraction | Passing result per ISO 10993-5:2009 | Demonstrated Passing Results |
| Sensitization - ISO Guinea Pig Maximization Test: Sodium Chloride and Sesame Oil Extraction | Passing result per ISO 10993-10:2010 | Demonstrated Passing Results | |
| Irritation - ISO Intracutaneous Study in Rabbits: Sodium Chloride and Sesame Oil Extraction | Passing result per ISO 10993-10:2010 | Demonstrated Passing Results | |
| Acute Systemic Toxicity - ISO Acute Systemic Toxicity Study in Mice: Sodium Chloride and Sesame Oil Extraction | Passing result per ISO 10993-11 (implied) | Demonstrated Passing Results | |
| Pyrogenicity - USP Rabbit Pyrogen Study, Material Mediated: Nonpyrogenic 0.9% Sodium Chloride Extraction | Passing result per USP | Demonstrated Passing Results | |
| Hemocompatibility - ASTM Hemolysis Study Direct Contact and Extract O Method: Phosphate Buffered Saline Extraction | Passing result per ASTM | Demonstrated Passing Results | |
| Hemocompatibility - Indirect Contact Complement Activation Assay | Passing result per standard | Demonstrated Passing Results | |
| Hemocompatibility - In-vitro Assessment of Introducer Thrombosis | Passing result per standard | Demonstrated Passing Results | |
| Sterilization & Packaging | ISO 11135:2014, Sterilization of health care products - Ethylene oxide | Compliance | Implied Compliance |
| ISO 11070:1998, Sterile, single use intravascular catheter introducer | Compliance | Implied Compliance | |
| ISO 10993-7:2008, Biological Evaluation of Medical Devices - Part 7 Ethylene Oxide sterilization residuals | Compliance | Implied Compliance | |
| AAMI/ANSI/ISO 11607-1:2006, Packaging for terminally sterilized medical devices | Compliance | Implied Compliance | |
| ASTM D4169-16, Standards Practice for Performance Testing of Shipping Containers and Systems | Compliance | Implied Compliance | |
| ISO 2233 (2000), Packaging - Complete, filled transport packages and unit loads | Compliance | Implied Compliance |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each performance and biocompatibility test set. The provenance of the data is implied to be from laboratory testing conducted according to the listed international standards (e.g., ISO, ASTM, USP). There is no information about the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of testing performed for the S-MAK XL™. The tests are primarily physical, chemical, and biological evaluations, not requiring expert human interpretation to establish a ground truth in the way medical imaging or diagnostic studies might. The "ground truth" is inherently defined by the technical specifications and standards (e.g., a device either passes a tensile strength test or it doesn't).
4. Adjudication method for the test set
Not applicable. The tests are objective and based on established international standards, not requiring adjudication by multiple experts.
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
Not applicable. The S-MAK XL™ is a medical device (vessel dilator/introducer sheath), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The S-MAK XL™ is a physical medical device, not an algorithm or software. Therefore, standalone algorithm performance testing is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests and biocompatibility tests is based on adherence to the specified international standards and guidance documents (e.g., ISO, ASTM, USP). For instance, for cytotoxicity, the ground truth is whether the device extract causes a cytotoxic effect within defined parameters. For physical performance, the ground truth is whether the device meets its design specifications (e.g., correct length, ability to insert guide wire).
8. The sample size for the training set
Not applicable. As a physical medical device, the S-MAK XL™ does not involve machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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