(70 days)
The Amulet™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.
The Amulet™ Steerable Delivery Sheath is designed to provide a pathway through which a device may be delivered. The sheath is provided in one size (14F), with a working length of 75 cm and a bi-directional distal tip to provide positioning in the cardiac anatomy. The handle is equipped with a deflection knob to deflect the tip clockwise 120° and counterclockwise 0°. The body of the sheath is radiopaque for visibility under fluoroscopy and has a marker band located in the distal tip. The dilator eases penetration of tissue. The sheath and dilator utilize a dual curve in two dimensions, resulting in a three-dimensional geometry. The 14F flush adapter facilitates the attachment of additional components.
This document is a 510(k) clearance letter for a medical device called the "Amulet™ Steerable Delivery Sheath." The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process does not typically involve comprehensive clinical studies or complex AI performance evaluations.
Based on the provided text, the changes to the device are primarily related to manufacturing processes:
- "The difference between the subject device and predicate is the in-process solvent used to prepare the surface of the distal tip PEBAX extrusions."
- "Additionally, a tip bond tensile specification and in-process tensile test method are being implemented."
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance testing designed to show that these manufacturing changes do not negatively impact the device's function or safety, and that the new device remains substantially equivalent to the predicate. There is no mention of AI, human-in-the-loop studies, multi-reader multi-case studies, or complex ground truth establishment in this document.
Here's a breakdown of the information that can be extracted or inferred from the provided text, presented in the requested format, while acknowledging the severe limitations of this specific document for an "AI" type of study.
Acceptance Criteria and Device Performance for Amulet™ Steerable Delivery Sheath
Summary of Device Modification: The primary difference between the subject device and the predicate device is the "in-process solvent used to prepare the surface of the distal tip PEBAX extrusions." Additionally, a new "tip bond tensile specification and in-process tensile test method are being implemented." The submitted 510(k) is a "Special 510(k)," which is used for modifications to a manufacturer's own legally marketed device where the modified device does not raise new questions of safety and effectiveness.
Study Type: Non-clinical (benchtop) performance testing, process qualifications, and re-evaluation of biocompatibility and sterilization profiles for substantial equivalence demonstration. This is not a clinical study involving human patients, nor an AI performance study.
Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from testing purpose) | Reported Device Performance (as stated or implied) |
|---|---|---|
| Process Qualification | The device must maintain its intended performance characteristics despite changes in manufacturing solvent and the addition of a new tensile test. | "Product performance qualification (PPQ) testing was conducted to demonstrate that the Amulet Steerable Delivery Sheath met performance specifications impacted by these changes." |
| Occluder Retrievals | Capable of facilitating the specified number of occluder retrievals without compromise. | Met performance specifications; further details not provided, but implies successful performance. |
| Delivery Sheath & Implant Damage | No damage to the delivery sheath or the implant during simulated use that would compromise safety/efficacy. | Met performance specifications; implies no unacceptable damage observed. |
| Tensile Bonds During Handoff/Advancement | Tip bond strength must meet the new tensile specification to prevent separation or failure during use. | Met performance specifications, including the new tip bond tensile specification. |
| Biocompatibility | The modified device must remain biocompatible with patient contact type and duration equivalent to the predicate. | "No new materials of construction were introduced... Potential risks identified with changing the surface preparation chemical present negligible risk... no further testing was required." Implies prior biocompatibility data is still valid. |
| Sterilization & Microbiology | Maintain a Sterility Assurance Level (SAL) of 10⁻⁶ and demonstrate no increased microbiological or sterilization risk due to changes. | "The currently established SAL of 10⁻⁶ is not impacted by this change." "No increased microbiological or sterilization risk." |
Important Note: The provided document is for a medical device modification, not an AI or diagnostic device. Therefore, many of the requested bullet points regarding AI-specific evaluation are not applicable. I will address them by stating their non-applicability.
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Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical value (N) for each test. For "Process Qualification," it refers to "Product performance qualification (PPQ) testing." This typically involves a defined number of units tested per batch or according to a statistical sampling plan (e.g., AQL tables), but the specific numbers are not disclosed in this summary.
- Data Provenance: This is non-clinical benchtop testing conducted by the manufacturer, Abbott Medical, in a laboratory setting. It is not patient data; therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in their clinical sense. The testing is essentially "prospective" in that it's performed on newly manufactured samples of the modified device prior to marketing.
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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. This is non-clinical benchtop testing of a physical medical device. "Ground truth" in the context of expert review (e.g., for AI image analysis) is not relevant here. Performance is measured against engineering specifications and industry standards by qualified engineers and technicians.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is non-clinical engineering testing, there are no human "readers" or clinical "adjudication" in the sense of consensus on medical findings. Test results are compared against predefined acceptance criteria from engineering specifications.
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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:
- Not Applicable. This document describes the clearance of a physical medical delivery sheath, not an AI-powered diagnostic device or a device intended for clinical interpretation improvement. No human reader studies or AI assistance are mentioned or relevant to this 510(k).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is established by predefined engineering specifications (e.g., tensile strength values, deflection angles, number of cycles) and adherence to recognized industry standards (e.g., ISO, ASTM). For biocompatibility, it's based on ISO 10993 standards and the assessment of material properties. For sterilization, it's based on ISO 11135 and a Sterility Assurance Level (SAL).
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The sample size for the training set:
- Not Applicable. This device is not an AI model requiring a training set. The "training" for the device's performance is its design and manufacturing process, and its "experience" is validated through the non-clinical tests described.
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How the ground truth for the training set was established:
- Not Applicable. As there is no AI training set, this question is not relevant. The device's foundational "ground truth" (its design and intended performance) is established through extensive engineering design, development, and risk assessment processes preceding this specific 510(k) modification.
§ 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).