(311 days)
The indications for use of the FMD Peripheral Guide Wires F-14 and F-18 :
The FMD Peripheral Guide Wires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
The indications for use of the FMD Guide Wire Extension F-14 EXT :
The FMD Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.
The FMD Peripheral Guide Wires F-14 and F-18 are designed to facilitate the placement of interventional peripheral devices such as dilating balloon catheters, stent delivery systems and other peripheral artery diagnostic or therapeutic devices. The guide wires are available in nominal diameters of 0.014 (F-14) and 0.018 (F-18) inches and nominal lengths from 190cm to 300cm. The F-14 and F-18 guide wires with a length of less than 300 cm are compatible exclusively with the FMD Guide Wire Extension F-14 EXT, which can extend the guide wire length allowing for exchange of Over-The-Wire systems. The guide wires are composed of a stainless-steel core wire and a stainless steel and platinum nickel coil assembly on the distal end of the device. The coil assembly is soldered to the core. The Pt-Ni radiopaque coil allows for visualization while using fluoroscopy. The proximal portion is coated with PTFE. The distal section is coated with hydrophilic coating. All wires are available in a straight tip configuration.
The FMD Guide Wire Extension F-14 EXT is composed of a stainless steel core wire coated with PTFE. It has an outer diameter of 0.014" (0.36 mm) and a length of 165cm. Its distal end contains a connecting hypotube that is compatible with guide wires less than 300cm of both the F-14 and F-18 series.
Attachment of the FMD Guide Wire Extension F-14 EXT to FMD's extendable guide wire creates an extended guide wire that can be used to exchange out a percutaneous transluminal angioplasty (PTA) catheter without removing the original guide wire from the artery. When the exchange is complete, the FMD Guide Wire Extension F-14 EXT can be detached, and the original guide wire can be used in a conventional manner.
This document describes the premarket notification for the FMD Peripheral Guide Wires F-14 and F-18, and the FMD Guide Wire Extension F-14 EXT. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's an analysis based on your request:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria alongside performance data in a detailed quantitative manner. Instead, it broadly states that "The in vitro bench tests demonstrated that the FMD Peripheral Guide Wires F-14 and F-18 met all acceptance criteria and performed similarly to the predicate and reference devices." and for the biocompatibility tests, it indicates "The following biocompatibility tests were completed".
Here's a summary based on the listed tests:
| Test Name | Acceptance Criteria (Not explicitly stated quantitatively, assumed "met industry standards" or "performed comparably to predicate") | Reported Device Performance |
|---|---|---|
| Dimensional Verification | (Implied: Within specified design tolerances) | Met acceptance criteria |
| Visual Inspection | (Implied: Absence of defects) | Met acceptance criteria |
| Simulated Use | (Implied: Functioned as intended in simulated procedures) | Met acceptance criteria |
| Tensile Strength | (Implied: Maintained integrity under tensile forces) | Met acceptance criteria |
| Tip Pull | (Implied: Tip remained securely attached under specified force) | Met acceptance criteria |
| Torque Strength | (Implied: Withstood specified torque without failure) | Met acceptance criteria |
| Torqueability | (Implied: Transmitted torque effectively) | Met acceptance criteria |
| Coating Integrity | (Implied: Coating remained intact after specified tests) | Met acceptance criteria |
| Particulate Evaluation | (Implied: Within acceptable particulate limits) | Met acceptance criteria |
| Lubricity | (Implied: Achieved specified lubricious properties) | Met acceptance criteria |
| Corrosion resistance | (Implied: Showed no significant corrosion) | Met acceptance criteria |
| Kink Resistance | (Implied: Resisted kinking under specified conditions) | Met acceptance criteria |
| Tip Flexibility | (Implied: Exhibited required flexibility) | Met acceptance criteria |
| Radiopacity | (Implied: Visible under fluoroscopy as intended) | Met acceptance criteria |
| Cytotoxicity | (Implied: Non-cytotoxic) | Completed (passed) |
| Sensitization | (Implied: Non-sensitizing) | Completed (passed) |
| Irritation/Intracutaneous Reactivity | (Implied: Non-irritating) | Completed (passed) |
| Acute Systemic Toxicity | (Implied: Non-toxic acutely) | Completed (passed) |
| Material-mediated pyrogenicity | (Implied: Non-pyrogenic) | Completed (passed) |
| SC Sc5b-9 pathway Complement Activation | (Implied: Did not cause significant complement activation) | Completed (passed) |
| In Vivo Thrombogenicity | (Implied: Non-thrombogenic) | Completed (passed) |
| Direct and Indirect Hemolysis | (Implied: Non-hemolytic) | Completed (passed) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical bench test. The data provenance is from non-clinical laboratory testing performed on the FMD Peripheral Guide Wires F-14 and F-18 and FMD Guide Wire Extension F-14 EXT. The country of origin of the data is not explicitly stated, but the applicant and contact information are for FMD Co., Ltd. located in Japan. All data would be considered prospective as it's generated specifically for this submission.
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 as the study described is a series of non-clinical bench tests and biocompatibility tests, not a clinical study involving human data or expert review of images for ground truth. The "ground truth" for these tests would be the established scientific and engineering principles and standards for medical device performance.
4. Adjudication method for the test set
This information is not applicable as the described study involves non-clinical bench testing and biocompatibility assessments, not a clinical trial requiring adjudication of patient outcomes or expert consensus. Decisions would be based on quantitative measurements and established pass/fail criteria for each test.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes the premarket notification for physical guide wires and guide wire extensions, which are mechanical devices, not AI-powered software or diagnostic tools that would involve human readers or AI assistance. The document explicitly states "Clinical evaluation was not required for this device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not done. This submission is for mechanical medical devices, not an algorithm or AI.
7. The type of ground truth used
The ground truth used for this submission is based on established engineering principles, international and national standards (e.g., ISO, ASTM), and the performance characteristics of legally marketed predicate devices. For biocompatibility, the ground truth is based on the results of validated in vitro and in vivo toxicology tests as per relevant standards (e.g., ISO 10993 series).
8. The sample size for the training set
This information is not applicable. The submission is for physical medical devices and does not involve an AI algorithm or a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" in the context of an AI algorithm described in this submission.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.