(50 days)
The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the ilia-femoral, popliteal, infrapopliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator.
The Shockwave L Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen. and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure.
The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.
This document describes the premarket notification (510(k)) for the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter. It is important to note that this document pertains to a medical device for physical intervention, not an AI/Software as a Medical Device (SaMD). As such, many of the requested criteria, particularly those related to AI model development, ground truth establishment, expert review, and MRMC studies, are not applicable to this device.
The document details the device's design, intended use, and the engineering tests conducted to demonstrate its safety and effectiveness.
Here’s a breakdown of the information provided, addressing the questions where applicable to this medical device:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" in terms of specific numerical thresholds for clinical performance or diagnostic accuracy (as would be seen for a SaMD). Instead, it lists extensive engineering and design verification and validation tests whose successful completion serves as the "acceptance criteria" for demonstrating substantial equivalence. The "reported device performance" is that the device met all these specifications.
| Acceptance Criteria (Type of Test) | Reported Device Performance (Outcome) |
|---|---|
| IVL Catheter Design Verification & Validation Testing: | |
| Guidewire compatibility | Met design specifications |
| Introducer sheath compatibility | Met design specifications |
| Nominal balloon diameter | Met design specifications |
| Balloon diameter at Rated Burst Pressure (RBP) | Met design specifications |
| Balloon length | Met design specifications |
| Balloon inflation time | Met design specifications |
| Balloon deflation time | Met design specifications |
| Usable catheter length | Met design specifications |
| Balloon crossing profile | Met design specifications |
| Catheter distal tip | Met design specifications |
| Distal tip durability | Met design specifications |
| Catheter bonds tensile strength | Met design specifications |
| Catheter torsional strength | Met design specifications |
| Emitter and marker band integrity | Met design specifications |
| System leakage | Met design specifications |
| Minimum balloon RBP | Met design specifications |
| Balloon fatigue (multiple inflations) | Met design specifications |
| Sonic output | Met design specifications |
| Catheter pulse count and pulse rate | Met design specifications |
| Temperature rise | Met design specifications |
| Catheter particle count | Met design specifications |
| Catheter connector length | Met design specifications |
| Catheter connection | Met design specifications |
| Catheter identification | Met design specifications |
| Catheter sterility (visual inspection) | Met design specifications |
| Cable sleeve packaging | Met design specifications |
| Catheter compatibility with materials and accessories commonly used in OTW peripheral balloon angioplasty procedures | Met design specifications |
| Simulated use testing | Performance met design specifications |
| Confirmatory chronic GLP animal testing | Performance met design specifications |
| Overall conclusion: | The performance of the IVL System meets its design specifications and demonstrates substantial equivalence for its intended use. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each engineering test. These tests typically involve a defined number of units tested to statistical confidence levels based on accepted engineering practices and standards (e.g., ISO, ASTM). The "data provenance" is controlled laboratory testing and animal studies, not patient data in the typical sense of a clinical trial for diagnostic performance. The document states "Confirmatory chronic GLP animal testing" was performed, indicating a controlled laboratory environment. No country of origin for such data is explicitly mentioned, but it's generated by Shockwave Medical, Inc. in Santa Clara, California, USA. The studies are not described as retrospective or prospective in the clinical trial sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. For a physical medical device like this, "ground truth" is established by engineering specifications, physical measurements, and established physiological responses in animal models, not by expert human interpretation of images or other clinical data.
4. Adjudication method for the test set
This question is not applicable. Adjudication is relevant for subjective assessments, particularly in clinical or diagnostic contexts where human interpretation can vary. Engineering tests have objective pass/fail criteria or measurements against specifications.
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 question is not applicable. An MRMC study is relevant for evaluating the performance of AI/SaMD devices, particularly in diagnostic imaging. This submission is for a physical medical device (catheter system), not an AI. The document states: "Results demonstrated that the performance of the IVL System meets its design specifications and demonstrates substantial equivalence for its intended use; therefore, additional clinical data were not required."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as there is no algorithm or AI component to this device.
7. The type of ground truth used
The "ground truth" for this device's performance validation is based on engineering design specifications, physical measurements, and performance in controlled in vitro (bench) and in vivo (animal) studies. This is standard for demonstrating the safety and effectiveness of a physical medical device and its substantial equivalence to a predicate.
8. The sample size for the training set
This question is not applicable. There is no AI model or "training set" for this physical device.
9. How the ground truth for the training set was established
This question is not applicable. There is no AI model or "training set" for this physical device.
§ 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).