(24 days)
The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.
The Pinnacle® Destination® Peripheral Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Peripheral Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (Devices with TBV Valve only).
The provided document is a 510(k) summary for the Pinnacle® Destination® Peripheral Guiding Sheath. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance as would be expected for a novel device.
Therefore, many of the requested details regarding acceptance criteria, study design parameters (sample size, data provenance, expert adjudication, MRMC study, standalone performance), and ground truth establishment are not applicable or not provided in this document because it's a submission for a substantially equivalent medical device, not a new clinical trial of a diagnostic or AI-driven aid.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Performance | Equivalent performance to the predicate device in intended use. | "The performance of the Pinnacle® Destination® Peripheral Guiding Sheath is substantially equivalent to the performance of the unmodified Peripheral Guiding Sheath. The equivalence was shown through bench and vessel model testing." (Section H) |
| Biocompatibility | Blood contacting materials meet ISO 10993 "Biological Evaluation of Medical Devices - Part I: Evaluation and Testing" for "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)". | "The blood contacting materials were found to be biocompatible." (Section I) |
| Sterilization | Sterilization conditions validated to provide a Sterility Assurance Level (SAL) of 10^-6 in accordance with EN ISO 11135-1. | "Sterilization conditions have been validated in accordance with EN ISO 11135-1...to provide a Sterility Assurance Level of 10^-6." (Section I) |
| Shelf Life/Expiration | Device maintains safety and effectiveness for a specified period. | "Expiration dating for the Pinnacle® Destination® Peripheral Guiding Sheath will be 30 months." (Section I) |
| Design/Materials | Differences in materials from the predicate device do not raise new safety or effectiveness issues. | "The Pinnacle® Destination® Peripheral Guiding Sheath uses similar materials as the predicate device. Differences in materials between the two devices do not raise any new issues of safety and effectiveness." (Section F) |
| Substantial Equivalence | Device is substantially equivalent in intended use, design, principle of operation/technology, materials, and performance to the predicate device, and any differences do not raise new issues of safety or effectiveness. (This is the overarching acceptance criteria for a 510(k) approval). | "The Pinnacle® Destination® Peripheral Guiding Sheath submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the Pinnacle® Destination® Peripheral Guiding Sheath (K051601 and K080415)...Differences between the devices do not raise any issues of safety or effectiveness." (Section J) |
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 mentions "bench and vessel model testing" but does not specify sample sizes for these tests.
- Data provenance is not specified. These would typically be laboratory-based tests.
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 / not provided. The testing described (bench and vessel models, biocompatibility, sterilization) does not involve expert interpretation or ground truth establishment in the way a diagnostic imaging study would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / not provided. Adjudication is relevant for interpreting subjective assessments, which is not the primary mode of testing for this type of device (an introducer sheath).
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
- Not applicable. This device is a manual catheter introducer, not an AI-assisted diagnostic or interventional tool. Therefore, an MRMC study with AI assistance is entirely irrelevant.
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 operated manually, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For performance testing (bench and vessel models), the "ground truth" would be established engineering and biomechanical specifications and measurements compared to the predicate device's performance.
- For biocompatibility, the ground truth is established by the results of standardized biological tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993.
- For sterilization, the ground truth is established by microbiological challenge testing validating the sterilization cycle to achieve the specified SAL.
8. The sample size for the training set
- Not applicable / not provided. No "training set" is relevant for a device like this, which is compared to a predicate based on physical and material properties and performance in bench/vessel models.
9. How the ground truth for the training set was established
- Not applicable / not provided. As there is no training set for this type of device, ground truth establishment for it is not relevant.
In summary: The document is a 510(k) submission for a substantially equivalent medical device. The "study" described is a series of bench and vessel model tests, along with biocompatibility and sterilization validations, to demonstrate equivalence to a previously cleared predicate device. It does not involve human readers, AI algorithms, or extensive clinical trials with detailed statistical endpoints that would require the typical "acceptance criteria" breakdown seen for diagnostic devices or AI-driven systems.
§ 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).