(17 days)
The Shockwave Medical 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 artery 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 nonsterile reusable devices.
This document describes the regulatory submission for the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System, specifically for a Special 510(k) Premarket Notification. The submission focuses on modifications to an already cleared predicate device (Shockwave Medical Intravascular Lithotripsy System, K203365). Therefore, the "study that proves the device meets the acceptance criteria" refers to the verification and validation testing performed on these modifications, rather than a full de novo clinical trial.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table with numerical acceptance criteria values and corresponding reported performance metrics. Instead, it broadly states that "objective evidence demonstrating that the IVL System design output meets the product design input requirements as well as that device performance characteristics conform to user needs and intended uses as defined in the product specification was provided."
The types of testing performed, which would be designed against underlying acceptance criteria, are listed as:
| Acceptance Criteria Category | Reported Device Performance Summary (Implicit) |
|---|---|
| Electronic Hardware Design Verification | "Results demonstrated that the performance of the IVL System meets its design specifications for its intended use" for: |
- User interface
- Battery system (charging, management)
- System power supplies
- Internal system verification
- Control system
- Catheter management system
- Pulse delivery system |
| Software Verification and Validation | "Results demonstrated that the performance of the IVL System meets its design specifications for its intended use" for: - Unit Test
- Integration Test
- System Test
- Regression Test |
| Extended Life Testing | "Results demonstrated that the performance of the IVL System meets its design specifications for its intended use" |
| 60601-1 Type Testing (Safety and EMC) | "Results demonstrated that the performance of the IVL System meets its design specifications for its intended use" |
| Transit Testing | "Results demonstrated that the performance of the IVL System meets its design specifications for its intended use" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the testing performed (e.g., number of units tested, number of software test cases). Given that this is a Special 510(k) for modifications to an existing device, the testing would likely involve design verification and validation on a limited sample of physical devices and extensive software testing.
The data provenance is implied to be from internal Shockwave Medical, Inc. testing facilities, as it states "Testing was conducted in accordance with Shockwave Medical's Risk Analysis procedures". It does not specify country of origin for the data or whether the data was retrospective or prospective in detail, but given it's device verification, it would be prospective testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts, qualifications, ground truth establishment) is typically associated with clinical studies involving human interpretation or pathology. Since this submission relies on engineering and software verification and validation, such expert involvement for "ground truth" as it's typically understood in clinical AI/MRMC studies is not applicable or described. The "ground truth" for this device's performance is established by its design specifications and validated through engineering tests.
4. Adjudication Method for the Test Set
Not applicable, as this is primarily engineering and software verification and validation, not a multi-reader clinical study requiring adjudication.
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
No MRMC study was done or described. The device is a physical medical device (catheter, generator) for lithotripsy, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of the physical device itself and its modified hardware and software functionalities. The performance testing done (hardware, software, life testing, safety, EMC, transit) represents the "standalone" performance of the modified device components satisfying their design requirements.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on design specifications and engineering requirements. The performed tests (hardware, software, electrical safety, etc.) verify that the device's output and performance characteristics meet these predefined specifications, which are themselves derived from user needs and intended uses. It is not based on expert consensus, pathology, or outcomes data in the clinical sense, as this is a modification submission for an already cleared device where clinical data was previously provided or deemed unnecessary for the original clearance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/Machine Learning device that requires a "training set". The "training" here refers to the manufacturing and design processes that lead to the device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of an AI algorithm.
§ 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).