(80 days)
The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Flash-C PTCA Balloon Dilatation Catheter is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature.
The Flash-C PTCA Balloon Dilatation Catheter is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The Flash-C PTCA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semi-compliant higherpressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.
The provided text describes a 510(k) premarket notification for the "Flash-C PTCA Balloon Dilatation Catheter" and does not contain information about a study proving the device meets acceptance criteria.
The document details the device's intended use, its substantial equivalence to predicate devices, and the performance data refers to a list of in-vitro bench testing and biocompatibility testing. These tests are used to confirm the performance characteristics as compared to the predicate device and meet established specifications, rather than proving achievement of specific clinical acceptance criteria in a study.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from the provided text, as this type of clinical study was not described.
Here's a breakdown of what can be extracted or inferred based on the context of a 510(k) submission for this type of device:
1. Table of acceptance criteria and the reported device performance:
The document broadly states: "All test results demonstrate that the device materials, the manufacturing process, and the design for the Flash-C PTCA Balloon Dilatation Catheter met the established specifications necessary for consistent performance according to its intended use." And "The Flash-C PTCA Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs."
However, specific quantitative acceptance criteria and their corresponding reported device performance values are NOT provided in the text. The document only lists the types of tests performed.
| Acceptance Criterion (Test Type) | Reported Device Performance |
|---|---|
| Biocompatibility Testing: | "Non-toxic and non-sensitizing to biological tissues consistent with its intended use." (Specific quantitative results not provided) |
| ISO MEM Elution Assay | Met established specifications |
| ASTM Hemolysis Assay | Met established specifications |
| Complement Activation C3a and SC5b-9 Assay | Met established specifications |
| Thromboresistance Evaluation | Met established specifications |
| Materials Mediated Rabbit Pyrogen | Met established specifications |
| ISO Guinea Pig Maximization Sensitization | Met established specifications |
| ISO Acute Systemic Injection Test | Met established specifications |
| ISO Intracutaneous Reactivity Test | Met established specifications |
| Pyrogen (LAL) Chromogenic | Met established specifications |
| In-vitro Performance Bench Testing: | "Confirmed the performance characteristics as compared to the predicate device." (Specific quantitative results not provided) |
| Balloon Crossing Profile | Met established specifications |
| Catheter Shaft Diameter | Met established specifications |
| Catheter Working Length | Met established specifications |
| Catheter Inner Diameter | Met established specifications |
| Angioplasty Balloon Rated Burst Pressure | Met established specifications |
| Anchoring Balloon Burst Volume | Met established specifications |
| Angioplasty Balloon Compliance | Met established specifications |
| Balloon Inflation Time | Met established specifications |
| Balloon Deflation Time | Met established specifications |
| Angioplasty Balloon Rated Burst Pressure (in Stent) | Met established specifications |
| Anchoring Balloon Burst Volume (in Stent) | Met established specifications |
| Angioplasty Balloon Fatigue | Met established specifications |
| Anchoring Balloon Fatigue | Met established specifications |
| Catheter Bond Strength | Met established specifications |
| Catheter Tip Pull Strength | Met established specifications |
| Catheter Torque Strength | Met established specifications |
| Simulated Use | Met established specifications |
| Flexibility and Kink Resistance | Met established specifications |
| Radiopacity | Met established specifications |
| Angioplasty Balloon Fatigue (in Stent) | Met established specifications |
| Anchoring Balloon Fatigue (in Stent) | Met established specifications |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the in-vitro or biocompatibility tests.
- Data Provenance: Not specified. These are laboratory bench tests and in-vitro biocompatibility tests, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the "test set" described consists of in-vitro and biocompatibility testing, not human-read clinical data requiring expert ground truth establishment.
4. Adjudication method for the test set:
- Not applicable for the described in-vitro and biocompatibility 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 PTCA Balloon Dilatation Catheter (a physical medical device, not an AI or imaging diagnostic tool). The provided text does not mention any AI component or human reader interpretation studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Not applicable in the sense of expert consensus, pathology, or outcomes data for clinical performance. The 'ground truth' for the in-vitro and biocompatibility tests would be the established engineering specifications and biological safety standards, respectively.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.