(49 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.
This document is a 510(k) summary for the Pinnacle® Destination® Peripheral Guiding Sheath, not a study report, so it does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in the way a clinical trial or performance study report would.
However, based on the provided text, we can infer the basis of acceptance and the type of "study" conducted for this medical device, which is primarily a demonstration of "substantial equivalence" to a predicate device.
Here's an attempt to answer your questions based on the available information:
Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence)
The primary "acceptance criterion" for this 510(k) submission is Substantial Equivalence to the predicate device, the Carotid Guiding Sheath (K012812) manufactured by Terumo Medical Corporation. This means the new device must perform comparably to the predicate device in terms of safety and effectiveness for its intended use.
| Acceptance Criterion (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Functional Equivalence: Introduction of interventional and diagnostic devices into human vasculature. | Demonstrated through bench and cadaver testing. |
| Material Equivalence: Use of similar materials, with differences not raising new safety/effectiveness issues. | Stated that "Pinnacle® Destination® Peripheral Guiding Sheath uses similar materials as the predicate device." |
| Biocompatibility: Blood contacting materials meeting ISO 10993 standards. | Blood contacting materials were tested and found to be biocompatible. |
| Sterility Assurance: Sterilization validated to ANSI/AAMI/ISO 11135-1994, SAL of 10⁻⁶. | Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide a Sterility Assurance Level of 10⁻⁶. |
| Durability/Shelf Life: Expiration dating. | Expiration dating for the device will be 30 months. |
Study Information (as inferrable from the 510(k) Summary)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "bench and cadaver testing" but does not provide details on the number of samples or subjects involved in these tests.
- Data Provenance: The testing was likely conducted in a laboratory or clinical setting (cadaver testing) by the manufacturer (Terumo Medical Corporation). The document does not specify the country of origin of the data beyond the manufacturer's location in Elkton, MD, USA. It is prospective testing designed to support the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. For a device like a guiding sheath, "ground truth" typically relates to objective physical and mechanical properties, as well as biological responses (biocompatibility), rather than expert interpretation of medical images or diagnostic outcomes. Testing would involve engineers, materials scientists, and possibly medical professionals for cadaver use, but not in the sense of establishing a "ground truth" for diagnostic accuracy.
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Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for studies involving subjective human assessment (e.g., image interpretation). This device's evaluation is based on objective measurements and performance in bench and cadaver testing.
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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:
- No. This is not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a manual guiding sheath, not an algorithm. Performance was evaluated through "bench and cadaver testing."
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The type of ground truth used:
- For bench testing: Engineering specifications, material properties, and physical performance characteristics (e.g., lubricity, flexibility, burst pressure, tensile strength, flow rates).
- For cadaver testing: Practical usability, navigation capabilities, and potentially observable tissue interaction in a simulated anatomical environment.
- For biocompatibility: Laboratory test results demonstrating compliance with ISO 10993.
- For sterility: Validation results to achieve the specified Sterility Assurance Level (SAL).
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The sample size for the training set:
- Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set." The materials and design are based on established engineering principles and comparison to a known predicate device.
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How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this type of device.
§ 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).