(147 days)
The RetroFlexTM Dilator Kit is intended for use in dilation of the peripheral vasculature.
The RetroFlex Dilator Kit offers a variety of sizes and is packaged as either a 4-piece set or a 7-piece set. The dilators are made of polyethylene (LDPE and HDPE) with 20% barium sulfate and 1% titanium dioxide to aid in visualization under fluoroscopy. The RetroFlex Dilator Kit is heat-treated and a one-piece mold with a formed tip. The distal tip is tapered with an inner lumen for tracking a .035" guidewire. The hub on the proximal end is bonded with an adhesive, and the dilators are hydrophilic coated to allow smooth arterial dilation. The device is sold and packaged sterile as a 4-piece or 7-piece kit.
The provided K093554 submission describes the RetroFlex™ Dilator Kit, a vessel dilator for percutaneous catheterization. The submission focuses on non-clinical performance testing rather than studies involving human readers or AI algorithms. As such, many of the requested categories related to AI performance, reader studies, and specific statistical performance metrics cannot be directly addressed from this document.
However, I can extract the acceptance criteria and the types of studies performed as detailed in the submission for this medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Name | Description of Acceptance / Test Objective | Reported Device Performance / Outcome |
|---|---|---|
| Visual Examination | To ensure the device is free from visible defects and meets aesthetic requirements. | Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5) |
| Dimensional Verification | To confirm that the device dimensions (e.g., diameter, length of dilators) conform to design specifications. | Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5) |
| Tensile Strength (Hub/Shaft) | To evaluate the integrity of the bond between the hub and the shaft, ensuring it can withstand forces during use. | Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5) |
| Guidewire Compatibility Test | To verify that the dilator can smoothly track a 0.035" guidewire, allowing for proper introduction. | Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5) |
| Hydrophilic Coating (Friction) Test | To assess the lubricity of the hydrophilic coating to ensure smooth arterial dilation and reduce friction during insertion. | Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5) |
| Packaging Integrity | To ensure the sterile barrier is maintained throughout the shelf life and during transit. | Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5) |
| Product Shelf Life | To determine the stability and integrity of the device over its intended shelf life, ensuring performance and sterility. | Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5) |
| Sterilization Validation | To confirm that the chosen sterilization method effectively renders the device sterile and maintains material compatibility. | Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5) |
| Biocompatibility (MEM, AO, Blood, Mouse Systemic, Rabbit Intracutaneous, Guinea Pig Maximization, Complement Activation) | To ensure the device materials are safe for contact with human tissue and blood, and do not elicit adverse biological responses. | Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5) |
| Microbiology (Endotoxin-Mediated Pyrogenicity) | To detect and quantify endotoxins, ensuring the device is non-pyrogenic. | Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5) |
| Chemical (Material Verification) | To confirm the materials used in the device meet specifications (LDPE, HDPE, Barium Sulfate, Titanium Dioxide). | Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5) |
| Chemical (USP Physico-Chemical Test for Plastic Closures) | To assess the chemical properties of plastic components relevant to closures. | Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5) |
| Chemical (Non-Volatile Residues Test) | To quantify non-volatile residues that might leach from the device materials. | Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes for each non-clinical test. The testing appears to be conducted on manufactured device units, following established in-vitro and laboratory testing standards (ISO 10555-1:1997, Sec 4.5). The data provenance is not explicitly stated in terms of country of origin, but it is generated from laboratory testing of the device itself. Given the nature of these tests (e.g., tensile strength, dimensional verification, biocompatibility), they are inherently prospective for the device design being evaluated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The device is a physical medical device, not an AI or diagnostic imaging system that requires expert interpretation for ground truth establishment. The ground truth for performance (e.g., tensile strength, sterility) is established by predefined engineering and biological standards and test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically used in clinical studies or AI evaluations where multiple readers/interpreters assess data. The tests performed for this device are objective measurements against specifications.
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
No MRMC study was conducted or is applicable to this device submission. This submission does not involve AI or human image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was conducted. This device is a physical medical instrument, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on pre-defined engineering specifications, international standards (e.g., ISO 10555-1:1997), and established biological safety testing protocols. For example, tensile strength ground truth is a specific force value the material must withstand, and biocompatibility ground truth is the absence of cytotoxicity or irritation according to validated assays.
8. The sample size for the training set
This section is not applicable. There is no AI component or training set involved in the validation of this physical device.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for such a purpose.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).