(92 days)
The Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) Percutaneous Transluminal Anqioplasty (PTA) device with various shaft lengths. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold & strain relief that allows for the 0.018" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide, EtQ) and is intended for single use only.
The provided text is an FDA 510(k) clearance letter and its associated summary for a medical device: the "Advance Serenity™ 18 Hydrophilic PTA Balloon Dilatation Catheter." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness of a novel device through clinical trials and rigorous statistical validation against predefined acceptance criteria.
Therefore, the information regarding acceptance criteria, study design for proving device performance, sample sizes for test sets, establishment of ground truth, expert adjudication, MRMC studies, standalone performance, training set details, and ground truth for training data is not present in the provided text.
The document primarily outlines:
- Acceptance Criteria (Implicit via Substantial Equivalence): The implicit acceptance criterion for this 510(k) submission is that the device must be shown to be "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use, similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.
- Reported Device Performance: Instead of a detailed table of acceptance criteria and performance against them, the document lists bench tests performed to demonstrate that the small changes (expanded matrix of balloon sizes) compared to the predicate device do not compromise safety or effectiveness.
Here's a breakdown of what is available and what is missing from your request based on the provided text:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific performance metrics in a table. The overall acceptance criterion is "substantial equivalence" to the predicate.
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Reported Device Performance: The document lists bench tests performed, indicating that the results "demonstrate that the technological differences identified do not raise new questions of safety or effectiveness." Specific quantitative results or acceptance criteria for these bench tests are not provided.
Performed Bench Tests (as listed):
- Rated burst pressure (RBP)
- Inflation & deflation time
- Balloon diameters at nominal pressure to RBP
- Simulated use - Pushability & Trackability & Sheath Compatibility
- Coating integrity (b)
- Multiple inflation/fatigue & leak test
- Tensile strength Balloon to Shaft (proximal bond)
- Particulate
- Balloon Length & Marker Band Position (Leveraged from predicate)
- Radiopacity (Leveraged from predicate)
- Ancillary Tool Compatibility (Guidewire) (Leveraged from predicate)
- Catheter Effective Length (Leveraged from predicate)
- Tensile Strength Manifold to Shaft (Manifold Bond) (Leveraged from predicate)
- Tensile Strength (Distal / Tip Bond) (Leveraged from predicate)
- Tip Profile (Geometry of the catheter most distal tip) (Leveraged from predicate)
- Simulated Use, Push & Track (Leveraged from predicate)
- Flexibility & Kink (Leveraged from predicate)
- Coating Lubricity (Leveraged from predicate)
- Coating Integrity (a) (Leveraged from predicate)
- Torque Strength (Leveraged from predicate)
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Sizes: Not specified. This document refers to bench testing of a medical device, which typically involves a number of units tested to engineering specifications, but these numbers are not disclosed.
- Data Provenance: The tests are bench tests, not clinical data, so country of origin/retrospective/prospective doesn't apply in the same way. The manufacturer is based in Ireland (Creagh Medical Ltd. dba Surmodics, Inc.).
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 is not part of a bench test evaluation for a substantial equivalence determination. Experts are not typically used to establish "ground truth" for physical device performance metrics like burst pressure.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable to bench testing.
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. This device is a physical catheter, not an AI/software device that assists human readers.
- The document explicitly states: "No clinical studies were required for the Advance Serenity 18 Hydrophilic PTA Balloon Dilatation Catheter."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as it's not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. Performance is measured against engineering specifications and industry standards for physical device properties, not against "ground truth" derived from clinical data or expert consensus.
8. The sample size for the training set
- Not applicable; there is no training set for a physical medical device. (This is relevant for AI models).
9. How the ground truth for the training set was established
- Not applicable; there is no training set.
In summary, the provided FDA document is a 510(k) clearance letter for a physical medical device, based on demonstrated "substantial equivalence" through bench testing, not clinical studies or AI model validation. Therefore, most of the detailed information requested regarding clinical study design, data characteristics, expert involvement, and AI model evaluation (points 2-9) is not found in this type of submission.
§ 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).