(109 days)
The NC Euphora™ Rapid Exchange 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 balloon dilatation catheter is also indicated for post deployment expansion of balloon expandable stents.
The NC Euphora™ RX Balloon Dilatation catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure as defined in the product labelling. The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guidewire to position the catheter. Radiopaque balloon marker bands enable accurate placement. Shaft markers for brachial and femoral techniques are in place. The NC Euphora device is available in balloon diameters of 2.0mm to 5.0mm and in balloon lengths of 6mm to 27mm. The NC Euphora device has a nominal pressure of 12atm and a rated burst pressure of 20atm.
This document is a 510(k) summary for the Medtronic NC Euphora Rapid Exchange Balloon Dilatation Catheter, demonstrating its substantial equivalence to a predicate device. It focuses on non-clinical performance and biocompatibility rather than clinical studies.
Here's an analysis based on your request, structured to address the points directly from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance values for each test. Instead, it states that the device met all specified design and performance requirements.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Design Verification In-vitro Testing: | |
| Effective length performance specifications | Met all specified requirements |
| Catheter Profile | Met all specified requirements |
| System Pressure Capability & System Pressure Capability (in Stent) | Met all specified requirements |
| Balloon Fatigue & Balloon Fatigue (in Stent) | Met all specified requirements |
| Balloon Compliance | Met all specified requirements |
| Balloon Inflation and Deflation Time | Met all specified requirements |
| Catheter Bond Strength | Met all specified requirements |
| Coating Integrity | Met all specified requirements |
| Coating Particulate Evaluation | Met all specified requirements |
| Flexibility and Kink | Met all specified requirements |
| Torque Strength | Met all specified requirements |
| Biocompatibility Testing (for an external communicating device with limited exposure ≤ 24 hours): | |
| Cytotoxicity Study using ISO MEM Elution method | Met all specified requirements |
| ISO Maximisation Sensitisation Study | Met all specified requirements |
| ISO Acute Intracutaneous Reactivity | Met all specified requirements |
| ISO Acute Systemic Toxicity | Met all specified requirements |
| USP Material Mediated Pyrogen Study in Rabbits | Met all specified requirements |
| In Vivo Thromboresistance Study | Met all specified requirements |
| ASTM In-vitro Haemolysis | Met all specified requirements |
| ASTM Partial Thromboplastin Time (PTT) Coagulation Testing | Met all specified requirements |
| C3a Complement Activation Assay Study | Met all specified requirements |
| Sc5b-9 Complement Activation Assay Study | Met all specified requirements |
| USP Physicochemical Tests | Met all specified requirements |
| Sterilization Validation: | |
| Achieved minimum Sterility Assurance Level (SAL) of 10-6 | Validated for E-beam sterilization in accordance with ISO11137, EN556 and TIR33 to achieve a minimum SAL of 10-6. |
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: The document does not specify the sample sizes used for the in-vitro bench tests or biocompatibility tests. It only lists the types of tests performed.
- Data Provenance:
- Country of Origin: The applicant is Medtronic, Inc., Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. This suggests the testing was either conducted in Ireland or sponsored by the Irish entity.
- Retrospective or Prospective: The testing described (in-vitro bench tests, biocompatibility tests, pre-clinical in-vivo (non-GLP) studies) are inherently prospective tests performed to qualify the device.
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 and not provided in the document. The document describes non-clinical testing (bench, biocompatibility, non-GLP in-vivo for radiopacity) rather than studies that would involve human expert interpretation for ground truth establishment (e.g., image analysis by radiologists).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document. Adjudication methods typically apply to clinical studies where multiple human readers assess a common set of cases, and a process is used to resolve disagreements or establish a consensus ground truth. The presented studies are non-clinical.
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, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical investigation has been performed for this device." The device is a physical medical device (balloon dilatation catheter), not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical catheter, not an algorithm. Standalone performance typically refers to the performance of an AI algorithm independent of human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since this submission is for a physical device and relies on non-clinical testing for substantial equivalence, the "ground truth" refers to established engineering specifications, material standards, and biological safety standards.
- For design verification in-vitro testing: Engineering specifications, recognized industry standards, and regulatory guidance documents (e.g., "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010").
- For biocompatibility testing: International standards (e.g., ISO10993-1:2009, USP, ASTM) define the acceptance criteria for biological safety.
- For pre-clinical in-vivo (non-GLP) studies for radiopacity: Visual assessment by trained personnel against a defined standard for visibility.
8. The sample size for the training set
This information is not applicable and not provided. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The device's design is based on engineering principles and previous device experience.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above (not an AI/ML device requiring a training set). The "ground truth" for the device's design and manufacturing is established through engineering design specifications, material science, and manufacturing process controls.
§ 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.