(139 days)
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the illiac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
The AngioSculpt PTA Scoring Balloon Catheter with HydroCross™ Coating is a standard twolumen catheter with a scoring balloon near the distal end of the catheter has a conventional nylon-blend balloon with a scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure. As shown below, the catheter has a segment which is coated with a hydrophilic coating (HydroCross™ Coating).
This section describes the acceptance criteria and study proving the device meets said criteria for the "AngioSculpt® PTA Scoring Balloon Catheter with HydroCross™ Coating" based on the provided text.
Based on the provided document, the device described is a medical device, and the information presented is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to a predicate device. This document does not describe the acceptance criteria and a study in the context of an AI/algorithm-driven device's performance metrics (e.g., sensitivity, specificity) against a ground truth established by experts.
Instead, the "acceptance criteria" discussed are related to the safety and effectiveness of a physical medical device, primarily through mechanical testing and biocompatibility testing, to demonstrate its substantial equivalence to a previously cleared predicate device.
Therefore, many of the requested categories for AI/algorithm performance studies are not applicable to this document. I will fill in the applicable information based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding device performance values for each criterion in the manner typical for AI/algorithm validation. Instead, it describes categories of tests performed to verify design outputs met design requirements and to confirm proper function and durability. The general outcome is that the device "demonstrated adequate device performance," and is "non-sensitizing, non-irritating, not systemically toxic, non-hemolytic, and non-mutagenic."
| Acceptance Criteria Category (Evaluated Aspect) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance | |
| Catheter Diameter and Balloon Profile | Design outputs met design requirements; proper function and durability confirmed. |
| Device Preparation, Deployment, and Retraction | Design outputs met design requirements; proper function and durability confirmed. |
| Balloon Inflation and Deflation Time | Design outputs met design requirements; proper function and durability confirmed. |
| Catheter Bond (Tensile) Strength | Design outputs met design requirements; proper function and durability confirmed. |
| Tip Pull Strength | Design outputs met design requirements; proper function and durability confirmed. |
| Torque Strength | Design outputs met design requirements; proper function and durability confirmed. |
| Pushability, Trackability, Secure Edges | Design outputs met design requirements; proper function and durability confirmed. |
| Guidewire Compatibility | Design outputs met design requirements; proper function and durability confirmed. |
| Catheter Effective Length | Design outputs met design requirements; proper function and durability confirmed. |
| Catheter Surface Appearance | Design outputs met design requirements; proper function and durability confirmed. |
| Luer Compatibility | Design outputs met design requirements; proper function and durability confirmed. |
| Coating Length | Design outputs met design requirements; proper function and durability confirmed. |
| Coating Thickness | Design outputs met design requirements; proper function and durability confirmed. |
| Coating Lubricity | Design outputs met design requirements; proper function and durability confirmed. |
| Coating Integrity | Design outputs met design requirements; proper function and durability confirmed. |
| Particulate Evaluation | Design outputs met design requirements; proper function and durability confirmed. |
| Rated Burst Pressure | Design outputs met design requirements; proper function and durability confirmed. |
| Compliance | Design outputs met design requirements; proper function and durability confirmed. |
| Device Fatigue | Design outputs met design requirements; proper function and durability confirmed. |
| Flexibility and Kink | Design outputs met design requirements; proper function and durability confirmed. |
| Biocompatibility | |
| Cytotoxicity | Non-cytotoxic (MEM Elution Test using L-929 Mouse Fibroblast cells). |
| Sensitization | Non-sensitizing (Guinea Pig Maximization Sensitization Test). |
| Irritation | Non-irritating (Intracutaneous Reactivity/Irritation Test). |
| Systemic Toxicity (Acute & Material-Mediated) | Not systemically toxic (Acute Systemic Injection Test, Material Mediated Pyrogens). |
| Hemocompatibility | Non-hemolytic (Partial Thromboplastin Time (PTT), Hemolysis Direct Contact/Extract Method, Direct Contact Complement Activation). |
| Thrombogenicity (in vivo) | No thrombo-embolism observed in GLP animal study under simulated use conditions. |
| Genotoxicity | Non-mutagenic (Reverse Bacterial Mutation, In vitro Mouse Lymphoma Assay-Extended Treatment, Rodent bone Marrow Micronucleus Assays). |
Note: The document states that "Design verification and validation testing demonstrated adequate device performance and confirmed that no new questions of safety or effectiveness for peripheral balloon angioplasty devices were raised."
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document refers to "Test articles consisted of finished sterilized catheters" for bench testing. It does not specify the exact number of devices tested for each mechanical or biocompatibility test. For biocompatibility, it indicates studies were conducted, including a GLP animal study for thrombogenicity.
- Data Provenance: The studies were conducted by Spectranetics, Inc. (the submitter). The context implies these were internal tests conducted to support the 510(k) submission. No information on country of origin of data (beyond the applicant being US-based) or retrospective/prospective nature is explicitly stated, though a GLP animal study would be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to this type of device submission. The "ground truth" for a physical medical device's performance is established by standardized testing methods and regulatory requirements, not expert consensus on diagnostic interpretations.
4. Adjudication method for the test set:
- Not applicable for this type of device validation. Adjudication methods are typically for evaluating human or AI performance against a "truth" in diagnostic settings.
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:
- Not applicable. This device is a physical medical instrument (a balloon catheter), not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument, not an AI algorithm.
7. The type of ground truth used:
- The "ground truth" for the performance of this physical medical device is based on engineering specifications, established standards, and regulatory requirements for mechanical integrity, functional performance, and biocompatibility. For example, for biocompatibility, the ground truth is "non-toxic," "non-irritating," etc., as defined by ISO 10993-1:2009 and FDA GLP regulations. For mechanical tests, the ground truth is that the device must meet predefined design requirements and exhibit proper function and durability.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device requiring a training set.
§ 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).