(62 days)
The Sapphire NC Plus Coronary Dilatation Catheter is indicated for:
- · balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
- · balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
- · in-stent restenosis
- · post-delivery expansion of balloon expandable coronary stents
Note: The subject device was tested on the bench with the OrbusNeich Blazer Cobalt-Chromium (CoCr) All stents should be deployed in accordance with the manufacturer's indications and instructions for use.
The Sapphire NC Plus coronary dilatation catheter is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter with a working length of 140cm. The proximal shaft is a polymer coated stainless steel hypotube. Lubricious coatings are applied to the distal section. The non-compliant balloons, available in diameters from 2.0-4.0mm and lengths from 8-18mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements. This Special 510(k) describes the modification to the Sapphire NC PTCA catheters including a change to the hydrophilic coating and also a change in the brand name to Sapphire NC Plus.
The provided text describes the Sapphire NC Plus Coronary Dilatation Catheter and its submission for 510(k) clearance by OrbusNeich Medical, Inc. It details the device's indications for use, description, and performance testing conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that "The test results met all acceptance criteria, were similar to the predicate device, and ensure that the Sapphire NC Plus coronary dilatation catheter design and construction are suitable for its intended use." However, it does not provide a specific table or quantified acceptance criteria values for each test. Instead, it lists the types of tests performed.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| In Vitro Performance | Met all acceptance criteria; similar to predicate device |
| Rated Burst Pressure | Met all acceptance criteria; similar to predicate device |
| Balloon Fatigue | Met all acceptance criteria; similar to predicate device |
| Balloon Compliance | Met all acceptance criteria; similar to predicate device |
| Catheter Bond Strength | Met all acceptance criteria; similar to predicate device |
| Tip Pull Strength | Met all acceptance criteria; similar to predicate device |
| Coating Integrity | Met all acceptance criteria; similar to predicate device |
| Particulate Evaluation | Met all acceptance criteria; similar to predicate device |
| Biocompatibility (Cytotoxicity) | Met all acceptance criteria; similar to predicate device |
| Biocompatibility (Sensitization) | Met all acceptance criteria; similar to predicate device |
| Biocompatibility (Intracutaneous Reactivity) | Met all acceptance criteria; similar to predicate device |
| Biocompatibility (Acute Systemic Toxicity) | Met all acceptance criteria; similar to predicate device |
| Biocompatibility (Hemocompatibility - Hemolysis, Complement Activation, Prothromboplastin Time, Platelet and Leukocyte Counts, In Vivo Thromboresistance) | Met all acceptance criteria; similar to predicate device |
| Biocompatibility (Pyrogenicity) | Met all acceptance criteria; similar to predicate device |
| Biocompatibility (Genotoxicity - Bacterial Mutagenicity, In Vitro Mouse Lymphoma) | Met all acceptance criteria; similar to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any of the performance tests.
The data provenance is for a medical device (catheter) and the tests conducted are in vitro (bench testing) and biocompatibility (laboratory testing) rather than clinical studies with patient data. Therefore, concepts like country of origin for patient data and retrospective/prospective don't directly apply in the usual clinical study sense. The data originates from the manufacturer's testing to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable in the context of this device submission. The "ground truth" for a medical device's engineering and biocompatibility performance is established by standardized testing methods and regulatory guidelines, not by expert consensus on individual cases or images.
4. Adjudication Method for the Test Set
This information is not applicable as the testing involves objective measurements against established criteria, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or AI algorithms that assist human readers in interpreting medical data. This submission is for a medical catheter, where performance is evaluated through bench testing and biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by objective measurements and laboratory analyses against predefined engineering specifications and international standards for medical devices and biocompatibility. This is distinct from pathology, expert consensus, or outcomes data typically associated with diagnostic or prognostic devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not described here.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set is mentioned or implied for this 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.