(37 days)
The SUPPORTRAK Finishing Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.
The SUPPORTRAK Finishing Wire is intended to facilitate the positioning of a Guidant over-the wire left ventricular coronary venous pace/sense lead. The finishing wire is inserted into the lumen of the implanted lead and serves to stabilize the lead as the guide catheter is removed. A mechanical stop engages with the terminal pin of the lead and controls the position of the wire relative to the lead.
Each finishing wire model is specific to a particular lead length and hence, the location of the mechanical stop along the core wire varies for each SUPPORTRAK model. Also, the proximal end of the wire is formed into a loop to prevent incorrect insertion of the finishing wire in the lumen of the lead.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SUPPORTRAK Finishing Wire:
Acceptance Criteria and Device Performance
The provided 510(k) summary for the SUPPORTRAK Finishing Wire does not explicitly state specific quantitative acceptance criteria or detailed reported device performance in a table format.
Instead, it offers a general statement:
"Testing demonstrated that the SUPPORTRAK Finishing Wire met the acceptance criteria. No new safety or effectiveness issues were raised during the testing program."
This indicates that while acceptance criteria were in place and met, the document does not disclose them in detail. The primary "performance" reported is that the device was found substantially equivalent to its predicate devices.
Given the information provided, a table of acceptance criteria and reported device performance would look like this:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General Performance | (Not explicitly stated) | Met acceptance criteria; no new safety or effectiveness issues. Substantially equivalent to predicate devices. |
| Technological Characteristics | (Not explicitly stated beyond "substantially equivalent" comparisons) | Demonstrated substantial equivalence in Intended Use, Material, Assembly, Design, Package, and Sterilization to predicate devices. |
Study Details from the Provided Text:
Unfortunately, the provided 510(k) summary is very high-level and does not contain the detailed information required for points 2 through 9 regarding the study that "proves the device meets the acceptance criteria."
Here's an assessment of what can and cannot be extracted from the text for each point:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information in text: Not available. The document states "Testing demonstrated...", but provides no details on the sample size of devices tested or the nature of the data (e.g., in vitro, animal, human).
- Conclusion: Unknown.
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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):
- Information in text: Not applicable. This device is a mechanical medical instrument (finishing wire), not an AI or diagnostic imaging device that would typically involve expert ground truth for a "test set" in the way described. The "testing" referred to appears to be engineering and design verification/validation against pre-defined performance specifications, rather than clinical efficacy assessed by experts.
- Conclusion: Not applicable/Unknown.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information in text: Not applicable for the same reasons as point 3.
- Conclusion: Not applicable/Unknown.
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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:
- Information in text: No. This is a medical device (finishing wire), not an AI diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or mentioned.
- Conclusion: Not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information in text: Not applicable. As a mechanical device, there is no "algorithm only" performance. The device is used by a human clinician.
- Conclusion: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Information in text: Not explicitly stated. For a mechanical device, "ground truth" would likely relate to objective engineering measurements and performance specifications (e.g., tensile strength, flexibility, dimensions, biocompatibility, force required for insertion/removal, etc.) rather than clinical endpoints or expert consensus in a diagnostic sense.
- Conclusion: Not specified, but likely based on engineering and performance specifications.
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The sample size for the training set:
- Information in text: No "training set" is mentioned as this is not an AI/machine learning device. The testing likely involved design verification and validation.
- Conclusion: Not applicable.
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How the ground truth for the training set was established:
- Information in text: Not applicable for the same reasons as point 8.
- Conclusion: Not applicable.
Summary of Missing Information: The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to predicate devices. It provides a high-level overview but lacks the granular technical and study design details (like specific test data, sample sizes, expert involvement, or adjudication methods) that would be found in a comprehensive study report or detailed technical file. The "testing data" section is very brief and only states that acceptance criteria were met.
§ 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.