(102 days)
The Radius PTCA Guidewire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. Radius PTCA Guidewires are compatible with all currently approved and marketed PTCA balloon catheters which are labeled for use with an .014 guidewire.
The Radius PTCA Guidewire is constructed from a solid stainless steel core to which a coil is attached to the tapered distal section. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is silicone coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.
The provided document (K970466) is a 510(k) Premarket Notification for a medical device, specifically a PTCA Guidewire. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for a comparative effectiveness study with human readers or AI.
Therefore, many of the requested categories are not applicable to the information contained in this 510(k) summary. I will fill in the applicable information and indicate where information is not present or not relevant to this type of regulatory document.
Here's the breakdown based on the provided text:
Acceptance Criteria and Study Details for K970466:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Functional/Performance | Tensile Strength (Implicit: Comparable to predicate) | In all cases, the performance of the Radius PTCA Guidewires was comparable to that of the predicate ACS guidewires. |
| Torque Strength (Implicit: Comparable to predicate) | In all cases, the performance of the Radius PTCA Guidewires was comparable to that of the predicate ACS guidewires. | |
| Torqueability (Implicit: Comparable to predicate) | In all cases, the performance of the Radius PTCA Guidewires was comparable to that of the predicate ACS guidewires. | |
| Tip Flexibility (Implicit: Comparable to predicate) | In all cases, the performance of the Radius PTCA Guidewires was comparable to that of the predicate ACS guidewires. | |
| Coating Adherence/Integrity (Implicit: Comparable to predicate) | In all cases, the performance of the Radius PTCA Guidewires was comparable to that of the predicate ACS guidewires. | |
| Biocompatibility | Cytotoxicity (Implicit: Acceptable) | All test results were acceptable. |
| Sensitization (Implicit: Acceptable) | All test results were acceptable. | |
| Intracutaneous Toxicity (Implicit: Acceptable) | All test results were acceptable. | |
| Acute Systemic Toxicity (Implicit: Acceptable) | All test results were acceptable. | |
| Material Mediated Pyrogenicity (Implicit: Acceptable) | All test results were acceptable. | |
| ASTM Hemolysis (Implicit: Acceptable) | All test results were acceptable. | |
| Dimensional | G/W Outer Diameter: .014" | Not explicitly stated as meeting, but these are specifications given for the proposed device, implying it was manufactured to these. The overall conclusion states the device meets "minimum requirements that are considered adequate for its intended use" based on technological characteristics. |
| G/W Overall Length: 180cm or 300cm | (See above for dimensional criteria) | |
| Overall Coil Length: 15cm to 30cm | (See above for dimensional criteria) | |
| Radiopaque Length: 3cm to 30cm | (See above for dimensional criteria) | |
| Floppy Tip Length: 2.5cm to 3cm | (See above for dimensional criteria) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided document. The performance tests ("in vitro performance tests") and biocompatibility tests were conducted, but the number of units tested is not disclosed.
- Data Provenance: The tests were conducted by Radius Medical Technologies, Inc. (Maynard, MA, USA), suggesting the data originated in the USA. The tests are "in vitro," so the data is laboratory-generated, not from human subjects. It would be considered prospective for the device's development but conducted prior to market entry.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a guidewire, and its performance is evaluated through objective physical and chemical tests, not through expert interpretation of images or clinical data. Therefore, "ground truth" in the clinical imaging sense is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3. The testing involves measurable parameters (e.g., tensile strength, flexibility, chemical reactions for biocompatibility), not subjective interpretations requiring adjudication.
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. An MRMC study is not relevant for this type of medical device (PTCA Guidewire) as it is not an imaging analysis or diagnostic AI device. This document focuses on the physical and biocompatibility properties of the guidewire itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device's performance is objective measurement against specified engineering requirements and established biocompatibility standards. For substantial equivalence, the performance is compared to the predicate device's established performance, implying the predicate itself served as a benchmark for what constitutes acceptable performance for such a device.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).