(59 days)
The Sapphire II PRO 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
The Sapphire II PRO coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a PTFE coated stainless steel hypotube. Hydrophilic lubricious coatings are applied to the distal section. The semi-compliant balloons, available in diameters from 1.5-4.0mm and lengths from 10-30mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment (there is only one centrally located marker band for the Ø1.5mm configurations). The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
The provided text is related to the FDA 510(k) premarket notification for the "Sapphire II PRO Coronary Dilatation Catheter." This document describes the device, its intended use, and indicates that performance tests were conducted. However, it does not contain specific acceptance criteria values or detailed results of a study in the format requested for AI/medical device performance.
The text details the following about the device's testing:
- Performance Data: "Both in vitro performance tests, such as dimensional verification, balloon preparation, deployment, and retraction, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, and particulate evaluation, and also biocompatibility tests, such as cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, platelet and leukocyte counts, complement activation, and in vivo thromboresistance), pyrogenicity, and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the Sapphire II PRO coronary dilatation catheter."
- Result: "The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Sapphire II PRO coronary dilatation catheter design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)."
Based on the provided text, I cannot complete the table or provide specific answers to most of the numbered questions because the document lacks the detailed information about acceptance criteria values, specific reported device performance values, sample sizes, ground truth establishment, or any mention of AI or MRMC studies.
The questions posed (e.g., sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance for AI) are typically relevant for AI/Machine Learning-based medical devices, which is not what the "Sapphire II PRO Coronary Dilatation Catheter" is. This is a physical medical device (a balloon catheter). Therefore, the requested information structure does not directly apply to this type of device and the information is not present in the document.
However, I can extract what is explicitly stated:
- Study Type: The studies conducted were in vitro performance tests and biocompatibility tests. These are standard for physical medical devices and not related to AI.
- Acceptance Criteria Mention: The document states that "The test results met all acceptance criteria," but it does not specify what those criteria are in quantitative terms.
- Ground Truth: For a physical device like a catheter, "ground truth" typically refers to established engineering specifications, material properties, and biological safety standards, rather than expert consensus on diagnostic interpretations or pathology as would be the case for AI. The document implies these were based on "the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)."
Therefore, many parts of your request are not applicable or cannot be answered from the given text.
Here's a response based on the absence of the requested AI-specific information and what is available:
The provided document describes the FDA 510(k) premarket notification for the "Sapphire II PRO Coronary Dilatation Catheter," a physical medical device, not an AI or software-as-a-medical-device. As such, many of the requested details, particularly those pertaining to AI model evaluation (e.g., test set sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details), are not applicable to this type of submission and are not present in the document.
The document indicates that various in vitro performance and biocompatibility tests were conducted. It states that "The test results met all acceptance criteria," but it does not provide the specific quantitative acceptance criteria or the numerical reported device performance values.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (e.g., Specific Thresholds) | Reported Device Performance (e.g., Measured Value) |
|---|---|
| Not specified in the document. | Not specified in the document. |
| (Document states "test results met all acceptance criteria" and "were similar to predicate devices.") | (Document states "test results met all acceptance criteria" and "were similar to predicate devices.") |
Specific tests conducted include:
- In vitro performance tests: Dimensional verification, balloon preparation, deployment, and retraction, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, and particulate evaluation.
- Biocompatibility tests: Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, platelet and leukocyte counts, complement activation, and in vivo thromboresistance), pyrogenicity, and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma).
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the tests.
- Data Provenance: The tests are described as in vitro (laboratory) and biocompatibility tests. No patient data or clinical study data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical medical device. "Ground truth" for this device type would be engineering specifications and regulatory standards, not expert interpretations of medical images/data.
4. Adjudication method for the test set:
- Not applicable. (No expert review or diagnostic assessment is described for this device's evaluation.)
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is for evaluating diagnostic performance of AI or imaging systems involving human readers. This device is a catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- For in vitro and biocompatibility tests, the "ground truth" would be established engineering specifications, material standards, and regulatory requirements (e.g., ISO standards, FDA guidance documents like the "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)").
8. The sample size for the training set:
- Not applicable. This is not an AI/Machine Learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. (No training set for an AI model.)
§ 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.