(244 days)
The Mozec™ - Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Mozec™ - Rx PTCA Balloon Dilatation Catheter (balloon models 2.25mm to 4.50mm) is also indicated for post-delivery expansion of balloon expandable stents.
Mozec™ - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a semi-compliant balloon, a soft tip, a dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium marker(s) contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec ™ balloon's working length (2.00 mm to 4.50 mm sizes) or the center of the balloon's working length (1.50 mm size). The Mozec"™ balloons are offered in diameters ranging from 1.50mm to 4.50mm and lengths varying from 9mm to 41mm.
The provided document describes the Meril Life Sciences Mozec™ - Rx PTCA Balloon Dilatation Catheter and its conformity to acceptance criteria through non-clinical performance data.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device was subjected to performance testing as recommended in the "Guidance for Industry and FDA Staff- Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010)."
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Physical/Mechanical | Dimensional verification | Met predetermined criteria |
| Balloon preparation, deployment and retraction | Met predetermined criteria | |
| Balloon rated burst pressure | Met predetermined criteria | |
| Balloon compliance | Met predetermined criteria | |
| Balloon fatigue | Met predetermined criteria | |
| Balloon inflation and deflation time | Met predetermined criteria | |
| Catheter bond strength(s) | Met predetermined criteria | |
| Tip pull test | Met predetermined criteria | |
| Flexibility and kink test | Met predetermined criteria | |
| Radiopacity | Met predetermined criteria | |
| Coating integrity | Met predetermined criteria | |
| Particulate evaluation | Met predetermined criteria | |
| Balloon rated burst pressure (In stent) | Met predetermined criteria | |
| Balloon fatigue (In Stent) | Met predetermined criteria | |
| Biocompatibility (ISO 10993-1) | Cytotoxicity | Met predetermined criteria |
| Sensitization | Met predetermined criteria | |
| Irritation / Intracutaneous reactivity | Met predetermined criteria | |
| Systemic Toxicity | Met predetermined criteria | |
| Hemolysis | Met predetermined criteria | |
| C3a complement activation | Met predetermined criteria | |
| SC5b-9 complement activation | Met predetermined criteria | |
| In vivo thromboresistance | Met predetermined criteria | |
| Material mediated pyrogenicity | Met predetermined criteria |
Conclusion: The document explicitly states: "The Mozec™ - Rx PTCA Balloon Dilatation Catheter met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols. No safety and efficacy issues were raised during the testing program."
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 non-clinical performance data, which typically refers to laboratory testing and does not involve human subjects or clinical data. Therefore, terms like "test set sample size," "country of origin," "retrospective or prospective" are not applicable in this context. The tests were performed on the device itself.
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 information is not applicable. For non-clinical performance testing of a medical device like a balloon catheter, "ground truth" is typically established by engineering specifications, validated test methods, and regulatory standards rather than expert medical consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation where multiple human experts assess the same cases and a method is needed to resolve discrepancies. The provided document describes non-clinical, laboratory-based 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
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to the Mozec™ - Rx PTCA Balloon Dilatation Catheter. This device is a physical medical instrument, not an AI or imaging diagnostic tool that would be evaluated for its impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical balloon catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests conducted, the "ground truth" would be established by engineering specifications, regulatory standards, and validated test methods. For example, the rated burst pressure has a defined specification, and the test method measures if the device meets that specification. Biocompatibility tests rely on established ISO standards.
8. The sample size for the training set
This information is not applicable. The document describes the testing of a physical medical device, not a machine learning model, and therefore there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for a physical medical device.
§ 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.