(44 days)
The Destination® Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the Renal Arteries.
The Destination® Renal Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip.
This document describes a 510(k) premarket notification for the "Destination® Renal Guiding Sheath." This is a medical device, and the evaluation focuses on its substantial equivalence to a predicate device, not on complex AI performance metrics. Therefore, many of the requested fields are not applicable in this context.
Here's the breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like a guiding sheath, "acceptance criteria" are typically related to meeting established performance standards (e.g., sterilization, biocompatibility, mechanical integrity) and demonstrating equivalence to a predicate device. Performance is shown through bench and vessel model testing, not statistical metrics like sensitivity/specificity for disease detection.
| Acceptance Criteria / Performance Category | Device Performance (Reported) |
|---|---|
| Intended Use | Introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the Renal Arteries. (Substantially equivalent to predicate) |
| Design / Materials | Uses similar materials to the predicate device. Differences do not raise new safety/effectiveness issues. (Substantially equivalent to predicate) |
| Principle of Operation / Technology | Operated manually or by a manual process. (Substantially equivalent to predicate) |
| Sterilization | Validated in accordance with EN ISO 11135-1 to provide a Sterility Assurance Level of 10-6. |
| Biocompatibility | Blood contacting materials tested in accordance with FDA G95-1 (ISO 10993). Found to be biocompatible for "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)". |
| Mechanical Performance | Demonstrated through bench and vessel model testing. (Substantially equivalent to predicate) |
| Expiration Dating | 30 months. |
| Specifications (Physical) | Sheath Size: 5Fr., Sheath Length: 45-55 cm, Hydrophilic Coating: Distal 5 cm, Distal Shape Configurations: Straight, HS, RDC, LIMA, MP. (Implied to meet design specifications) |
Studies that Prove the Device Meets Acceptance Criteria:
The document states:
- "The performance of the Destination® Renal Guiding Sheath is substantially equivalent to the performance of the unmodified Renal Guiding Sheath. The equivalence was shown through bench and vessel model testing."
- "Sterilization conditions have been validated in accordance with EN ISO 11135-1..."
- "Blood contacting materials were tested in accordance with the test recommendations in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993..."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the summary. For a medical device 510(k), especially one comparing physical characteristics to a predicate, specific "test set" sample sizes or data provenance in the way one would describe for an AI/ML study are not typically detailed in this type of summary document. The "bench and vessel model testing" implies laboratory testing rather than human subject data.
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)
This is not applicable and not provided. The ground truth for device performance in this context would be engineering specifications, physical measurements, and biological compatibility standards, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable and not provided. Adjudication methods are relevant for studies where human interpretation (e.g., of medical images) generates a "ground truth" that needs to be resolved by multiple experts. For physical device performance, this concept doesn't apply.
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
This is not applicable. This device is a physical medical instrument (a guiding sheath), not an AI algorithm or a diagnostic tool that involves human readers interpreting data assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This is a physical medical device, not an 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 established engineering and biocompatibility standards, and measurable physical properties. For example:
- Sterility: Achieves a measured Sterility Assurance Level (SAL) of 10^-6, verified by laboratory testing according to EN ISO 11135-1.
- Biocompatibility: Meets the requirements outlined in ISO 10993 for limited contact with circulating blood, verified by laboratory testing.
- Physical Performance (e.g., torqueability, pushability, trackability): Assessed through "bench and vessel model testing" against a predicate device. The ground truth here would be engineering metrics and comparison to the predicate's established performance.
8. The sample size for the training set
This is not applicable and not provided. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This is not applicable and not provided. This device does not involve machine learning or a training set.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).