(409 days)
The Tamarin Blue® RX PTCA Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.
The Tamarin Blue® PTCA RX Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a single lumen proximally, a dual lumen distally, a semi-compliant inflatable balloon and a soft, tapered distal tip to aid in crossing tight stenoses. One lumen of the catheter's dual lumen is used for inflation and deflation of the balloon, and the other lumen allows guide wire access through the distal part of the catheter. The maximum recommended guide wire diameter is 0.014". A luer lock fitting (Hub) allows connection with an inflation device. Two radiopaque markers on the guide wire lumen tubing provide visual reference points for balloon positioning across the stenosis. The balloon material expands to a known diameter at specific pressure as defined in the compliance table supplied with the catheter.
Here is an analysis of the provided 510(k) summary regarding the Tamarin Blue® PTCA RX Dilatation Catheter, focusing on acceptance criteria and the supporting study information:
Acceptance Criteria and Device Performance
The provided document describes a medical device, the Tamarin Blue® PTCA RX Dilatation Catheter, and its non-clinical testing. It asserts that the device met all the predetermined acceptance criteria of design verification and validation. However, the document does not explicitly list the acceptance criteria values or the specific reported device performance values for each test. It only states that the device successfully met these unlisted criteria.
Therefore, a table with specific acceptance criteria and reported performance cannot be created from the provided text. The document broadly states the types of tests performed.
| Test Category | Acceptance Criteria (Not explicitly stated) | Reported Device Performance (Not explicitly stated) |
|---|---|---|
| Biocompatibility | Would involve meeting standards like ISO 10993 (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, material-mediated pyrogenicity, implantation). Specific limits for extractables or biological responses would be predefined. | The device materials were confirmed biocompatible based on testing results, indicating they met the requirements of ISO 10993 Part 1, 2, 4, 5, 10, 11, 12, ASTM F756-00, and 21 CFR 58 (GLP regulations). |
| Balloon Compliance | Specific diameter at specific pressure (e.g., nominal pressure, rated burst pressure). Defined compliance curve within a specified tolerance from the predicate or design specification. | The balloon material expands to a known diameter at specific pressure as defined in the compliance table supplied with the catheter (table not provided in summary, but implies data exists and was accepted). |
| Balloon Burst Pressure | Minimum burst pressure values for different balloon diameters and lengths, along with a specified safety factor. | Device passed testing for balloon burst pressure. This implies the observed burst pressures met or exceeded the predefined minimums. |
| Balloon Fatigue Endurance | Ability to withstand multiple inflation/deflation cycles (e.g., number of cycles at specific pressure without failure, typically 3 or more cycles). | Device passed testing for balloon fatigue (repeated balloon inflation) endurance, implying it met the required number of cycles without failure. |
| Balloon Inflation/Deflation Performance | Time to inflate and deflate within specified limits; complete deflation allowing re-insertion/repositioning. | Device passed testing for balloon inflation/deflation performance. |
| Bond Strengths | Minimum tensile or shear strength values for critical bonds (e.g., balloon-to-catheter shaft, hub-to-catheter shaft) to prevent dislodgement during use. | Device passed testing for bond strengths. |
| Catheter Dimensions/Profile | Verification of outer diameter, balloon length, shaft diameter, guidewire lumen diameter, distal tip taper against design specifications. | Device passed testing for catheter dimensions and balloon profile. |
| Catheter Body Min. Burst Strength | Minimum pressure at which the catheter shaft maintains integrity. | Device passed testing for catheter body minimum burst strength. |
| Device Preparation | Compatibility with specified guidewires (e.g., 0.014" diameter) and introducer sheaths; smooth passage without damage. | Device passed testing for device preparation (guidewire and introducer compatibility). |
| Flexibility and Kink | Ability to navigate tortuous anatomy without kinking or permanent deformation. Measured by kink resistance at a certain bending radius or force. | Device passed testing for flexibility and kink, indicating it meets the required performance for navigation. |
| Torque | Ability to transmit rotational forces from the proximal end to the distal end efficiently (e.g., torque response, 1:1 torqueability). | Device passed testing for torque. |
| Radiopacity | Visibility of markers and potentially the balloon under fluoroscopy, typically compared to a reference material or having a minimum visibility score. | Two radiopaque markers provide visual reference points, and the device passed testing for radiopacity, confirming their visibility. |
| Coating Integrity | Adherence and durability of any coating, typically assessed after simulated use or handling. No delamination or flaking. | Device passed testing for coating integrity. |
| Particulate Evaluation | Number and size of particulates released from the device, ensuring it's below acceptable limits (e.g., ISO 10993-12, or specific limits for medical devices). | Device passed testing for particulate evaluation, indicating any released particulates are within acceptable limits. |
Study Information
The provided document describes a non-clinical study involving various in vitro tests to demonstrate the safety and effectiveness of the device. It is not a clinical study involving human subjects or AI algorithms.
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the individual non-clinical tests. The document only lists the types of tests performed.
- Data Provenance: The tests are non-clinical (laboratory-based) and conducted according to international standards (ISO, ASTM) and US federal regulations (21 CFR 58 GLP). The country of origin of the data is not explicitly stated, but the sponsor is Natec Medical Ltd. from Mauritius.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document describes non-clinical engineering and materials testing, not a study requiring expert consensus for diagnostic ground truth.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Non-clinical physical and chemical tests have predefined objective pass/fail criteria, not subjective interpretation requiring adjudication.
-
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: Not applicable. No MRMC or AI-related study was performed or mentioned. This device is a physical medical device (catheter), not an AI diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical tests, the "ground truth" is typically defined by pre-established engineering specifications, material standards, and regulatory requirements. For example, a bond strength test would have a minimum force requirement (ground truth) that the device must meet. Biocompatibility has specific toxicological thresholds.
-
The sample size for the training set: Not applicable. There is no training set mentioned as this is not an AI/machine learning study.
-
How the ground truth for the training set was established: Not applicable. There is no training set.
§ 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.