(29 days)
The Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
The Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System has three components: a proprietary IVL Catheter, an IVL Generator, and an IVL Connector Cable. The IVL Catheter has integrated lithotripsy emitters and is designed to enhance percutaneous transluminal angioplasty by enabling delivery of the calcium disrupting capability of lithotripsy prior to full balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood.
The IVL Catheter is delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat lesion. The balloon is partially inflated and the lithotripsy emitters are energized thereby generating pulsatile mechanical energy within the balloon at the target treatment site and allowing subsequent dilation of a peripheral arterv stenosis using low balloon pressure. The IVL Generator delivers energy through the IVL Connector Cable to the pulse emitters located inside the balloon in the IVL Catheter. The IVL Catheter is a single-use device supplied sterile to the customer. The IVL Generator and IVL Connector Cable are non-sterile reusable devices.
This document is a 510(k) Premarket Notification for the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System, specifically focusing on minor modifications to the IVL Catheter. The document asserts substantial equivalence to a previously cleared predicate device (K180454).
Based on the provided text, the device in question is a medical device and not an AI/ML-driven diagnostic tool. Therefore, the questions related to AI/ML specific acceptance criteria, test set composition, expert ground truth establishment, MRMC studies, standalone algorithm performance, and training set details are not applicable to this submission. The device's performance is demonstrated through design verification and validation testing of the physical device, not through an AI/ML model's performance on annotated data.
Here's the breakdown based on the information provided, and where the requested details are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes various performance tests conducted to demonstrate that the IVL System design output meets product design input requirements and conforms to user needs. These are engineering and mechanical performance criteria for a physical device.
| Acceptance Criterion (Design Input) | Reported Device Performance (Test Results) |
|---|---|
| Sheath compatibility | Met requirements |
| Nominal balloon diameter | Met requirements |
| Balloon compliance (at 10 ATM) | Met requirements |
| Nominal balloon working length (at 6 ATM) | Met requirements |
| Inflation (to 6 ATM) / Deflation times (from 10 ATM) | Met requirements |
| Crossing profile | Met requirements |
| Distal tip profile and Tip durability | Met requirements |
| Marker band alignment | Met requirements |
| Distal & Proximal bond strength | Met requirements |
| Catheter torsional strength | Met requirements |
| Emitters and marker band bond strength integrity | Met requirements |
| Pressure leakage during lithotripsy treatment | Met requirements |
| Minimum RBP | Met requirements |
| System burst | Met requirements |
| Balloon fatigue (multiple inflations) | Met requirements |
| Emitter spacing & emitter to marker band spacing | Met requirements |
| Maximum total pulsing cycles | Met requirements |
| Catheter compatibility with OTW peripheral balloon angioplasty accessories | Met requirements |
| Catheter compatibility with specific lithotripsy generator and its accessories | Met requirements |
| Catheter enables smooth delivery through tortuous anatomy via femoral approach & crosses lesions without undue difficulty | Met requirements |
| Catheter maintains structural integrity prior to and during delivery, treatment, and retraction | Met requirements |
2. Sample size used for the test set and the data provenance:
This is not applicable in the context of an AI/ML test set. The "test set" here refers to the physical devices (IVL Catheters) and their components that underwent various engineering and mechanical tests. The document does not specify the number of units tested for each criterion, but it implies a standard process of design verification and validation testing. The "data provenance" would refer to the conditions under which these physical tests were performed, which are standard laboratory/manufacturer testing environments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth in this context refers to the performance specifications of the physical device, established through engineering requirements and testing. It does not involve expert annotation of images or data, as there is no AI/ML component.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this refers to a process typically used for human annotation disagreements in AI/ML model training/testing. The device undergoes objective physical and mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
Not applicable. MRMC studies are used to evaluate human reader performance, typically in diagnostic imaging, with and without AI assistance. This device is a physical medical instrument, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This question concerns the performance of an AI algorithm in isolation. This device is a physical system.
7. The type of ground truth used:
The "ground truth" for this device's performance is established by engineering specifications, design requirements, and objective physical/mechanical measurements rather than expert consensus, pathology, or outcomes data in the sense of a diagnostic claim. The tests verify that the device meets its design inputs and functions as intended, providing "objective evidence."
8. The sample size for the training set:
Not applicable. This device is not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no AI/ML training set.
§ 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).