(29 days)
The Shockwave Medical Lithoplasty 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 Lithoplasty System has three components: a proprietary balloon catheter, a generator, and a connector cable. The balloon 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 Lithoplasty 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 Shockwave Medical Lithoplasty Generator delivers energy through the Connector Cable to the pulse emitters located inside the balloon in the Lithoplasty Catheter. The Lithoplasty Catheter is a single-use device supplied sterile to the customer. The Generator and Connector Cable are non-sterile reusable devices.
This document describes a 510(k) premarket notification for the "Shockwave Medical Lithoplasty System" (K163306), which is a medical device for lithotripsy-enhanced balloon dilation in peripheral arteries. This submission is for a modified version of a previously cleared device (K161384).
Here's an analysis of the provided information about acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data in a structured format. Instead, it broadly states that:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design Specifications | Meets design specifications. "Results demonstrate that the performance of the Shockwave Medical Lithoplasty System meets its design specifications..." |
| User Needs/Intended Uses | Conforms to user needs and intended uses. "...as well as that device performance characteristics conform to user needs and intended uses as defined in the product specification was provided." |
| Applicable Standards | Testing conducted in accordance with standards. "Testing was conducted in accordance with Shockwave Medical's Risk Analysis and all applicable FDA guidance documents and relevant international standards." |
| Component Level Testing (Tri-port hub) | Successful per ISO 594-1:1986 and ISO 594-2: second edition 1998-09-01. |
| Generator & Connector Cable Safety | Completed successfully per ANSI/AAMI ES60601-1:2005/(R)2012. |
| Electromagnetic Compatibility (EMC) | Met per IEC 60601-1-2:2007/A:2010. |
| Substantial Equivalence | Demonstrated. "Any differences between the Lithoplasty System and predicate device were evaluated through design verification and validation testing which demonstrated device performance and confirmed that there are no new questions of safety or effectiveness. The Lithoplasty System is therefore substantially equivalent to the predicate device." |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Component level testing" for the tri-port hub, and "hardware, electrical performance, electromagnetic compatibility, and software verification and validation tests." However, it does not specify the sample sizes used for these tests.
The data provenance is not mentioned. Given the nature of these tests (design verification and validation), they are typically conducted in a laboratory setting by the manufacturer. They are not clinical studies with patient data from a specific country or with retrospective/prospective data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable to the information provided. The document describes engineering and performance testing of a medical device, not a diagnostic algorithm or image analysis system that requires expert ground truth assessment. The "ground truth" here refers to the device's adherence to engineering specifications and performance standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies involving human assessment (e.g., image interpretation) to resolve discrepancies among experts. The tests described are engineering verification and validation, where performance is measured against objective standards.
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 section is not applicable. The device described is a physical interventional medical device (lithotripsy-enhanced balloon dilatation system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is not an algorithm, but a physical medical system. The performance testing described is for the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering and performance tests described, the "ground truth" implicitly refers to:
- Established engineering specifications and design input requirements: The device's performance was compared against these predefined physical and functional parameters.
- International and national standards: Compliance with standards like ISO 594-1/2, ANSI/AAMI ES60601-1, and IEC 60601-1-2 serves as the ground truth for safety and compatibility.
8. The sample size for the training set
This section is not applicable. The device is not an AI algorithm that requires a training set. The tests performed are for hardware and software verification and validation related to the device's design and manufacturing changes.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set for this type of medical 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).