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510(k) Data Aggregation
(60 days)
The Shockwave Medical IVL System with the Javelin Peripheral IVL Catheter is intended for lithotripsy-enabled modification and crossing of calcified lesions in the peripheral vasculature, including the iliac, femoral, popliteal, and infra-popliteal arteries, prior to final treatment.
Not for use in the coronary, carotid, cerebral, or pulmonary 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. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves modify calcified plaque in peripheral arteries. Energizing the intravascular lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion and allowing dilation of peripheral artery stenosis.
The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter consists of three main components: the IVL Catheter, the IVL Generator, and the IVL Connector Cable. The Shockwave Javelin IVL Catheter is comprised of a catheter with an integrated emitter located near the distal end to enable the localized delivery of acoustic pressure pulses in the peripheral vasculature. The emitter is racilitate catheter visibility under fluoroscopy and is surrounded by a fluid-filled space (IVL window) that allows for the transmission of acoustic pressure pulses.
The Shockwave Javelin Peripheral IVL Catheter shaft contains a lumen to pressurize and a lumen to de-pressurize the catheter with saline (the medium to create IVL), a guidewire lumen, and a lithotripsy emitter. The emitter is enclosed within a non-expandable polymer fluid-filled space (i.e., IVL window) containing saline that is connected to the proximal shaft, inlet and outlet ports, and is tapered down to the distal tip of the catheter. The IVL window is located near the distal tip of the catheter. The emitter is radiopaque to facilitate catheter visibility under fluoroscopy and is surrounded by the IVL window that allows for the transmission of acoustic pressure pulses. The IVL window is designed to provide a static catheter profile.
The IVL Generator and Connector Cable are used with the Shockwave Javelin Peripheral IVL Catheter to deliver localized, lithotripsy-enabled modification and crossing of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal - PG) | Reported Device Performance | Achieved? |
|---|---|---|
| Primary Safety Endpoint: 30-Day MAE rate ≤ 11.2% | 1.1% (1/90) with upper 95% Confidence Limit of 6.0% | Yes (p=0.0012) |
| Primary Effectiveness Endpoint: Technical Success (final residual stenosis ≤50% without flow-limiting dissection ≥ Grade D) ≥ 85.0% | 99.0% (97/98) with lower 95% Confidence Limit of 94.4% | Yes (p<0.0001) |
Additional Performance Data (Secondary Endpoints):
| Metric | Reported Performance |
|---|---|
| Serious angiographic complications (flow-limiting dissection ≥ Grade D, perforation, distal embolization, or acute vessel closure) at final timepoint | 1.0% (1/98) |
| IVL Technical Success (post-dilatation residual stenosis <50% without flow-limiting dissection ≥ Grade D) | 89.7% (87/97) |
| IVL Device Success (ability to deliver, advance, pressurize, pulse, flush, retrieve Javelin IVL catheter) | 93.0% (107/115) |
| Technical Success (final residual stenosis ≤30% without flow-limiting dissection > Grade D) | 78.6% (77/98) |
| Post-Javelin mean residual stenosis | 59.1 ± 18.4% |
| Post-Javelin residual stenosis ≤ 50% | 36.5% (31/85) |
| Post-Javelin residual stenosis ≤ 30% | 3.5% (3/85) |
| Post-dilatation mean residual stenosis | 31.3 ± 13.7% |
| Post-dilatation residual stenosis ≤ 50% | 93.8% (91/97) |
| Post-dilatation residual stenosis ≤ 30% | 50.5% (49/97) |
| Final mean residual stenosis | 23.0 ± 9.1% |
| Final residual stenosis < 50% | 100% (98/98) |
| Final residual stenosis ≤30% | 79.6% (78/98) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Data for the first 90 consecutively enrolled subjects across both studies (pooled analysis cohort) was used for safety endpoints and 98 target lesions for effectiveness endpoints (as 97/98 for technical success, and 1/98 for complications). 115 catheters for IVL Device Success.
- Data Provenance: Prospective, multi-center, single-arm studies (FORWARD PAD IDE Study and New Zealand/Australia Mini-S Feasibility Study). Subjects were enrolled at 19 clinical sites: 15 in the United States, and 4 in Australia & New Zealand.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document explicitly states that a "Core Lab" assessed angiographic characteristics (mean reference vessel diameter, mean minimum lumen diameter, percentage diameter stenosis, mean lesion length, and all residual stenosis and dissection findings). It also mentions an "independent Clinical Events Committee" that adjudicated all Major Adverse Events (MAEs). However, the number of experts in these core labs or committees and their specific qualifications (e.g., number of years of experience, specialization) are not provided in the given text.
4. Adjudication Method for the Test Set
- Major Adverse Events (MAEs): Adjudicated by an independent Clinical Events Committee. The specific method (e.g., 2+1, 3+1) is not detailed.
- Angiographic Assessments (e.g., residual stenosis, dissections, complications): Assessed by an angiographic Core Lab. The specific adjudication method is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
The provided text describes a single-arm study evaluating the treatment of calcified lesions with the Shockwave Javelin Peripheral IVL Catheter. It does not mention a comparative effectiveness study involving multiple human readers with and without AI assistance (MRMC study). Therefore, there is no information on the effect size of human readers improving with AI vs. without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is not an AI algorithm. It is a medical device (intravascular lithotripsy system) that directly treats calcified lesions. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable.
7. The Type of Ground Truth Used
- Safety Endpoints (MAE): Adjudicated clinical outcomes by an independent Clinical Events Committee.
- Effectiveness Endpoints (Technical Success, residual stenosis, complications): Angiographic assessments performed by an angiographic Core Lab. This suggests expert review of imaging data.
8. The Sample Size for the Training Set
The provided text describes clinical studies (FORWARD PAD IDE Study and Feasibility Study) that generated data to demonstrate the device's performance for regulatory submission. It does not mention a "training set" in the context of an algorithm or AI model development. The data described is for clinical validation of the device itself.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for an algorithm, this question is not applicable based on the provided text.
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