(116 days)
The Mozec(TM) NC - 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(TM) NC - Rx PTCA Balloon Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.
Mozec™ NC - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a non-compliant balloon, a soft tip, a coaxial dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium markers contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec™ NC balloon's working length. The Mozec™ NC balloons are offered in diameters ranging from 2.00mm to 4.50mm and lengths varying from 8mm to 38mm.
This document describes the Mozec™ NC – Rx PTCA Balloon Dilatation Catheter. The information needed to address the user's request, specifically regarding acceptance criteria and the study that proves the device meets the acceptance criteria, is limited to the non-clinical performance data provided. There is no mention of an AI-based device or a comparative effectiveness study involving human readers. The document pertains to a medical device approval through a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing, rather than extensive clinical efficacy trials.
Here's a summary of the available information based on the provided text, with many fields indicated as "Not Applicable" or "Not Provided" due to the nature of the device and the submission document:
1. A table of acceptance criteria and the reported device performance
The document states: "The Mozec™ NC – Rx PTCA Balloon Dilatation Catheter met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents and test protocols." However, the specific quantitative acceptance criteria and the detailed reported device performance values are not explicitly provided in this summary. The summary lists the types of tests performed, which implies these tests had corresponding acceptance criteria.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Dimensional verification | Met criteria |
| Balloon preparation, deployment and retraction | Met criteria |
| Balloon rated burst pressure and Balloon compliance | Met criteria |
| Balloon fatigue | Met criteria |
| Balloon inflation and deflation time | Met criteria |
| Bond strength | Met criteria |
| Flexibility and kink test | Met criteria |
| Balloon rated burst pressure (In stent) | Met criteria |
| Balloon fatigue (In Stent) | Met criteria |
| Radiopacity | Met criteria |
| Torque test | Met criteria |
| Performance testing on the Looper Clip accessory | Met criteria |
| Biocompatibility (ISO 10993-1) | Met criteria (no safety/efficacy issues) |
| - In Vitro Cytotoxicity study | Met criteria |
| - Skin Sensitization Study | Met criteria |
| - Intracutaneous reactivity test | Met criteria |
| - Acute Systemic Toxicity Study | Met criteria |
| - In vitro Hemolysis test Study | Met criteria |
| - In vitro C3a and SC5b-9 complement activation Assay | Met criteria |
| - Material Mediated Pyrogen Test | Met criteria |
| - In vivo thromboresistance | Met criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size used for the test set: Not provided. The document mentions "performance testing," but does not specify the number of devices or components tested for each category.
- Data provenance: Not explicitly stated, but assumed to be internal testing conducted by Meril Life Sciences Private Limited, which is based in India. The testing is non-clinical/bench testing.
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. This request is relevant for AI/diagnostic devices where expert ground truth is established. This document describes a PTCA Balloon Dilatation Catheter, for which ground truth is typically established through engineering and biological testing against established standards, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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. This is not an AI-assisted diagnostic device. No MRMC study was conducted or is relevant to this device.
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. Performance is assessed through engineering and biocompatibility testing of the physical catheter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: For the non-clinical performance testing, the "ground truth" refers to established engineering standards, FDA guidance documents (e.g., "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters"), and ISO standards (e.g., ISO 10993-1 for biocompatibility). The device's performance is compared against these predetermined specifications and accepted norms for safety and function.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.