(186 days)
The Tamarin Blue PTCA RX 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. A hydrophilic coating has been applied on the distal portion of catheter i.e., up to the RX port, to improve catheter pushability. The balloon material expands to a known diameter at a specific pressure as defined in the compliance table supplied with the catheter.
The device is supplied sterile and intended for one-time use.
This document is a 510(k) summary for the Tamarin Blue PTCA RX Dilatation Catheter (K210012). It details the device's comparison to predicate and reference devices and non-clinical testing performed to establish substantial equivalence.
Here's an analysis to extract the requested information, although it's important to note that this document pertains to a medical device (catheter) and not an AI/ML-driven diagnostic or image analysis device, which are typically the subject of the detailed acceptance criteria and study design questions you've posed. Therefore, many of the requested fields related to AI/ML performance, ground truth establishment by experts, MRMC studies, training sets, etc., will not be applicable or present in this type of submission.
The information consistently aligns with a submission for a physical medical device, not a software/AI device.
Here's the closest interpretation of your request based on the provided document:
Device Name: Tamarin Blue PTCA RX Dilatation Catheter
Device Type: Medical Device (PTCA Dilatation Catheter)
Acceptance Criteria and Device Performance:
The primary "acceptance criteria" for this device, as detailed in a 510(k) submission, revolve around demonstrating substantial equivalence to a previously cleared predicate device. This is typically achieved through non-clinical bench testing to ensure the device performs as intended and meets established safety and performance standards for its class. The document explicitly states that the technological characteristics (components, design, sterilization method, shelf life, operating principle) are identical to the predicate device, with the only notable difference being the addition of a hydrophilic coating, which was tested and shown not to raise new questions of safety or effectiveness.
1. A table of acceptance criteria and the reported device performance:
Since this is a physical medical device, "acceptance criteria" are not reported as classical sensitivity/specificity/AUC metrics for a diagnostic algorithm. Instead, they are engineering and performance benchmarks validated through bench testing. The document states that the device "met all acceptance criteria."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Coating Performance | Hydrophilic coating performed as intended and did not impact functionality. |
| Coating Integrity & Durability | (Passed, implied by "performed as intended") |
| Balloon Preparation, Deployment, & Retraction | (Passed, implied by "met all acceptance criteria") |
| Balloon Rated Burst Pressure | Passed (Rated Burst Pressure: 16 atm - identical to predicate) |
| Balloon Fatigue | (Passed, implied by "met all acceptance criteria") |
| Balloon Compliance | Semi-compliant (identical to predicate) |
| Balloon Inflation/Deflation | (Passed, implied by "met all acceptance criteria") |
| Particulate | (Passed, implied by "met all acceptance criteria") |
| Biocompatibility | Verified to be the same as predicate/reference devices based on material similarities; subject device is biocompatible. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "sample size" in the context of clinical studies for diagnostic accuracy. The non-clinical bench testing would involve a certain number of manufactured devices for each test (e.g., a specific batch size for burst pressure testing, a number of devices for fatigue testing). These numbers are not detailed in this summary.
- Data Provenance: The testing is non-clinical bench testing, meaning it's performed in a laboratory, not from patient data. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable here as the "ground truth" for a physical device is its adherence to engineering specifications and performance standards, validated through objective bench testing. There are no "experts" establishing ground truth in the sense of medical image interpretation for diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is for objective bench testing, not subjective human interpretations that require adjudication.
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:
Not applicable. This is for an AI/ML-driven diagnostic/image analysis device. This product is a physical medical catheter.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is based on engineering specifications, established performance standards (e.g., burst pressure limits), and material properties. Compliance is demonstrated through objective bench testing.
8. The sample size for the training set:
Not applicable. There is no AI/ML "training set" for this physical device.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML "training set" for this physical device.
Summary of the Study:
The study proving the device meets acceptance criteria is a non-clinical bench testing program. The purpose of this testing was to demonstrate that the Tamarin Blue PTCA RX Dilatation Catheter (K210012), with the addition of a hydrophilic coating, is substantially equivalent to its predicate device (Tamarin Blue PTCA RX Dilatation Catheter, K112735) and equivalent to a reference device (Filao NC RX PTCA Dilatation Catheter, K141933) for the coating aspects.
The testing evaluated various performance characteristics, including:
- Coating Inspection
- Coating Integrity (Performance and Durability)
- Balloon preparation, deployment and retraction
- Balloon Rated Burst
- Balloon Fatigue
- Balloon compliance
- Balloon inflation/deflation
- Particulate
The conclusion from these tests was that the hydrophilic coating performed as intended, did not impact the functionality of the device, and that the subject device "met all acceptance criteria" and is biocompatible. The technological characteristics, intended use, and indications for use were found to be identical or substantially similar, with any differences not raising new questions of safety or effectiveness.
§ 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.