(290 days)
The Sapphire NC ULTRA Coronary Dilatation Catheter is indicated for:
· Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in □ patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
· Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial □ infarction.
· In-stent restenosis.
· Post-delivery expansion of balloon expandable coronary stents.
The Sapphire NC ULTRA Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.75mm to 5.0mm. The balloon material is made of a minimally compliant material, 1.75mm to 4.0mm balloons have a rated burst pressure of 20 atmospheres, and 4.5mm to 5.0mm balloons have a rated burst pressure of 18 atmospheres. The minimally compliant balloon material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability and trackability with a smooth transition to a distal shaft. Two radiopaque platinum/iridium marker bands are located within the balloon segment. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard-length guidewire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.
The provided text is a 510(k) summary for the Sapphire NC ULTRA Coronary Dilatation Catheter. It outlines various performance tests conducted to establish substantial equivalence to a predicate device. However, it does not contain the specific level of detail required to fully answer all aspects of your request, particularly regarding clinical study design, expert qualifications, or detailed performance metrics against acceptance criteria.
Here's an attempt to answer your questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document states: "The test results met all acceptance criteria, which are the same or similar to the predicate device and ensure that the Sapphire NC ULTRA Coronary Dilatation Catheter design and construction are suitable for their intended use."
While it lists the types of tests performed, it does not provide a table with specific acceptance criteria or quantitative performance results for each test. For example, it lists "Balloon Rated Burst Pressure (in-stent)" as a test, but doesn't state what the accepted pressure was or what the device achieved.
Here's a generalized table based on the types of tests mentioned, but without specific numerical criteria or performance data:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| In vitro Performance: | |
| Visual Inspection | Met acceptance criteria |
| Particulate Evaluation | Met acceptance criteria |
| Dimensional Verification | Met acceptance criteria |
| Balloon Compliance | Met acceptance criteria |
| Hub Leakage Test | Met acceptance criteria |
| Balloon Prep, Deployment, Retraction | Met acceptance criteria |
| Balloon Inflation/Deflation Time | Met acceptance criteria |
| Coating Integrity | Met acceptance criteria |
| Balloon Fatigue (in-stent) | Met acceptance criteria |
| Balloon Fatigue | Met acceptance criteria |
| Balloon Rated Burst Pressure (in-stent) | Met acceptance criteria |
| Balloon Rated Burst Pressure | Met acceptance criteria |
| Shaft Burst | Met acceptance criteria |
| Catheter Bond Strength | Met acceptance criteria |
| Tip Pull Strength | Met acceptance criteria |
| Flexibility and Kink | Met acceptance criteria |
| Torque Strength | Met acceptance criteria |
| Marker Band Radiopacity | Met acceptance criteria |
| Biocompatibility: | |
| Cytotoxicity | Met acceptance criteria |
| Sensitization | Met acceptance criteria |
| Intracutaneous Reactivity | Met acceptance criteria |
| Acute Systemic Toxicity | Met acceptance criteria |
| Pyrogenicity | Met acceptance criteria |
| Hemolysis | Met acceptance criteria |
| Partial Thromboplastin Time | Met acceptance criteria |
| Platelet and Leukocyte Counts | Met acceptance criteria |
| Complement Activation | Met acceptance criteria |
| Toxicological Risk Assessment (TRA) of Extractable Chemicals | Met acceptance criteria |
| Other: | |
| Packaging and Sterilization Validation | Met acceptance criteria |
| Shelf Life | Met acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes in vitro performance tests and biocompatibility tests. This means the "test set" refers to material samples (e.g., catheter units, material extracts) used for these laboratory tests, not a clinical patient dataset.
- Sample Size: The document does not specify the sample size for the in vitro or biocompatibility tests.
- Data Provenance: Not applicable in the context of in vitro and biocompatibility testing. These are laboratory tests conducted on device components or finished products.
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 question is geared towards clinical studies involving human interpretation or pathology. Since the provided text only details in vitro and biocompatibility testing, there is no information about experts or their qualifications for establishing ground truth as would be required in a clinical setting. These tests typically follow standardized protocols and are evaluated by lab personnel, not medical experts establishing clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Again, this question is relevant for clinical studies with human assessors. For the in vitro and biocompatibility testing described, adjudication methods like N+1 are not applicable. The results are typically quantitative measurements or observations against predefined pass/fail criteria according to established standards (e.g., ISO, FDA guidance).
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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is an angioplasty catheter, not an AI software or a device that assists human readers in interpreting images. Therefore, this question is not applicable to the information provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is also not applicable. The Sapphire NC ULTRA Coronary Dilatation Catheter is a physical medical device, not an algorithm or software requiring standalone performance testing in that context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the in vitro performance tests, the "ground truth" is established by adherence to predefined engineering specifications, material properties, and performance benchmarks derived from industry standards (e.g., those in the "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters").
For biocompatibility testing, the "ground truth" is established by compliance with international standards like ISO 10993-1, which define acceptable biological responses and safety profiles for medical device materials.
8. The sample size for the training set
This question is applicable to machine learning or AI models. Since the device is a physical medical catheter and the testing described is primarily in vitro and biocompatibility, there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
As there is no training set for a physical medical device, this question is 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.