(23 days)
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, 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 catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a nitinol 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 ald in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
The provided document is a 510(k) summary for the AngioSculpt® PTA Scoring Balloon Catheter. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K100303) rather than presenting a de novo study with specific clinical acceptance criteria for effectiveness.
Therefore, the document does not contain the acceptance criteria or a study proving the device meets those criteria for clinical effectiveness in the way typically expected for a new medical device seeking marketing authorization based on clinical performance.
Instead, the document details bench testing and animal testing to demonstrate safety and performance characteristics for substantial equivalence to a predicate device. These tests are designed to show that the new device performs as expected and does not raise new safety or effectiveness concerns compared to the predicate.
Here's a breakdown of what is in the document related to testing, formatted to address your questions where applicable, but highlighting that no clinical acceptance criteria or human clinical study results are presented:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Disclaimer: This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (bench and animal studies), rather than establishing clinical effectiveness against specific clinical acceptance criteria in a human study. Therefore, the requested information regarding human-in-the-loop performance, multi-reader multi-case studies, effect sizes, specific clinical ground truth, and training set details are not applicable and not found in this regulatory submission.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for substantial equivalence based on bench and animal testing, there are no "acceptance criteria" in the sense of clinical performance metrics for a human study. Instead, the document lists various bench tests and their purpose (e.g., to verify design outputs met design requirements, confirm proper function and durability) and describes the findings from animal testing.
| Acceptance Criterion (Test Objectives) | Reported Device Performance (Summary of Results) |
|---|---|
| Bench Testing: | |
| Balloon Rated Burst Pressure | Conducted to verify that design outputs met design requirements and to confirm proper function and durability. (Specific quantitative results not provided in this summary, but implied to meet requirements.) |
| Balloon Inflation and Deflation | |
| Balloon and Scoring Element Fatigue | |
| Bond Strength | |
| Crossing Profile | |
| Trackability and Pushability | |
| Over-the-Arch Torque Strength | |
| Catheter Body Integrity | |
| Balloon Compliance | |
| Surface Appearance | |
| Secure Edges | |
| Freedom from Interference | |
| Scoring Element Creates Focal Force | |
| Biocompatibility Testing: | |
| Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing |
| Irritation | Non-irritating |
| Systemic Toxicity | Not systemically toxic |
| Hemocompatibility (PTT, Hemolysis) | Non-hemolytic |
| Hemocompatibility (Thrombosis in-vivo) | No thrombo-embolism observed under simulated use conditions. |
| Animal Testing (Acute GLP Study): | |
| Safety & Deliverability | Successfully introduced using standard guide wires and expanded in targeted tissue. No dissection, perforation, or embolization. All devices maintained integrity with no loss of components. All procedures performed with ease, no adverse events. Clinically acceptable. |
| Trackability & Passability | Demonstrated as satisfactory. (Specific quantitative metrics not provided) |
| Device Inflation & Deflation | Demonstrated as satisfactory. (Specific quantitative metrics not provided) |
| Radiopacity | Demonstrated as satisfactory. (Specific quantitative metrics not provided) |
| Device Removal | Demonstrated as satisfactory. (Specific quantitative metrics not provided) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Bench Testing: "Test articles consisted of finished sterilized catheters." (Specific sample sizes for each test are not provided in this summary). Data provenance is from AngioScore, Inc. (Fremont, CA, USA). These are prospective tests performed as part of device development and verification.
- Biocompatibility Testing: Specific sample sizes for each in vitro or in vivo test are not explicitly provided in this summary. The thrombogenicity evaluation was part of a GLP animal study.
- Animal Testing: The study involved one experimental animal (a single animal). The study was acute and conducted in the femoral peripheral arteries. It was a prospective, GLP (Good Laboratory Practice) study.
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)
- Not Applicable. No human clinical study or test set requiring expert ground truth for diagnostic accuracy (common in AI/imaging devices) was conducted. Evaluations were based on physical measurements, biological assays, and observational findings in an animal model by study personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No human clinical study or test set requiring adjudication was conducted.
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 device (balloon catheter), not an AI/imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical medical device (balloon catheter), not an AI/algorithm device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For bench testing, ground truth is based on established engineering principles, material specifications, and regulatory standards.
- For biocompatibility testing, ground truth is based on standard ISO 10993-1 methods and 21 CFR Part 58 GLP regulations, relying on established biological endpoints.
- For animal testing, the "ground truth" (i.e., evaluation of device performance, integrity, and lack of adverse events) was established through direct observation, examination (e.g., for dissection, perforation, embolization), and assessment by the trained GLP study personnel.
8. The sample size for the training set
- Not Applicable. This device is a physical medical device. There is no concept of a "training set" as would be used for an AI/machine learning model.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set for an AI model. For physical device development, "ground truth" is typically defined by design specifications and regulatory standards against which performance is measured.
§ 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).