(29 days)
The Sapphire® II PRO balloon dilatation catheter (1.0-1.25mm configurations) is indicated for:
• balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purpose of improving myocardial perfusion
The Sapphire® II PRO Balloon Dilatation Catheter (Ø1.5-4.0mm configurations) 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
The Sapphire® II PRO Balloon Dilatation Catheter is also indicated for:
• percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.
The Sapphire II PRO Balloon Dilatation Catheter is now also available as an over-the-wire balloon catheter with a working length of 150cm. The semi-compliant balloons are available in diameters from 1.0-1.25mm and lengths from 5-15mm with a rated burst pressure of 14 atmospheres. The catheter consists of proximal section with a Y-type hub and distal section with a balloon near the distal tip. The straight port of the hub is the guidewire entrance and the side port is used to inflate and deflate the balloon. The external lumen provides for inflation of the balloon with dilute contrast media solution. The internal lumen permits the use of a standard 0.014 inch guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. Hydrophilic lubricious coatings are applied to the distal section. One radiopaque platinum marker band is located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters and 4F or larger guiding sheaths. Two marked sections (3mm in length) are located on the proximal shaft to indicate catheter position relative to the tip of either guiding catheter or guiding sheath. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
The provided document is a 510(k) summary for the Sapphire II PRO Balloon Dilatation Catheter. It outlines the device's indications for use, technological characteristics, and performance data used to establish substantial equivalence to a predicate device.
However, the document does not contain the specific type of acceptance criteria and study detailed in the request, which typically pertains to the performance evaluation of a diagnostic or AI-driven medical device (e.g., accuracy, sensitivity, specificity, human reader study data). This document describes performance testing for a physical medical device (balloon catheter), focusing on mechanical properties, sterilization, and biocompatibility.
Therefore, I cannot extract the information to fill out the requested table and answer questions 2-9 from the provided text. The document does not describe a study that proves a diagnostic algorithm meets acceptance criteria.
Based on the provided text, here's what can be inferred about the "acceptance criteria" and "study" for this device, though it doesn't align with the template for diagnostic or AI device evaluation:
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Acceptance Criteria (Implied): The acceptance criteria are related to the physical and functional performance of the balloon dilatation catheter. The statement "The Sapphire II PRO balloon dilatation catheter test results met all acceptance criteria and were similar to the predicate device" implies that the device had to pass certain predefined thresholds for parameters such as:
- Balloon Rated Burst Pressure
- Balloon Fatigue
- Balloon Compliance
- Catheter Bond Strength
- Tip Pull Strength
- Radiopacity
- Coating Integrity
- Dimensional Verification
- Shaft Burst
- Balloon Inflation and Deflation Time
- Flexibility and Kinking
- Torque Strength
- Particulate Evaluation
- Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility, Genotoxicity)
- Sterilization
- Visual Inspection
- Balloon Preparation, Deployment, and Retraction
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Study That Proves the Device Meets Acceptance Criteria: The study described is a series of bench tests and laboratory evaluations to demonstrate the physical, mechanical, and biological compatibility of the Sapphire II PRO Balloon Dilatation Catheter. The primary objective was to show that the new over-the-wire design meets the same performance standards as its predicate device (OrbusNeich Sapphire II PRO, K180921) and other reference devices, and that it is safe and effective for its intended use.
Therefore, the requested table and answers to questions 2-9 cannot be fully provided as the information is not present in the supplied text.
Here is what can be extracted or stated based on the provided document in the context of the user's request, acknowledging the mismatch in the type of device and study:
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category (Implied) | Specific Test/Parameter (Examples) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Balloon Rated Burst Pressure | "met all acceptance criteria and were similar to the predicate device" |
| Balloon Fatigue | "met all acceptance criteria and were similar to the predicate device" | |
| Balloon Compliance | "met all acceptance criteria and were similar to the predicate device" | |
| Catheter Bond Strength | "met all acceptance criteria and were similar to the predicate device" | |
| Tip Pull Strength | "met all acceptance criteria and were similar to the predicate device" | |
| Shaft Burst | "met all acceptance criteria and were similar to the predicate device" | |
| Flexibility and Kinking | "met all acceptance criteria and were similar to the predicate device" | |
| Torque Strength | "met all acceptance criteria and were similar to the predicate device" | |
| Dimensional/Visual | Dimensional Verification | "met all acceptance criteria and were similar to the predicate device" |
| Visual Inspection | "met all acceptance criteria and were similar to the predicate device" | |
| Material/Biological | Radiopacity | "met all acceptance criteria and were similar to the predicate device" |
| Coating Integrity | "met all acceptance criteria and were similar to the predicate device" | |
| Particulate Evaluation | "met all acceptance criteria and were similar to the predicate device" | |
| Biocompatibility (Cytotoxicity, Sensitization, Hemocompatibility, etc.) | "met all acceptance criteria and were similar to the predicate device" | |
| Functional (use-related) | Balloon Preparation, Deployment, and Retraction | "met all acceptance criteria and were similar to the predicate device" |
| Balloon Inflation and Deflation Time | "met all acceptance criteria and were similar to the predicate device" | |
| Other | Sterilization | "met all acceptance criteria and were similar to the predicate device" |
| Shelf-Life (Partial) | "met all acceptance criteria and were similar to the predicate device" |
(Note: The table above reiterates that all listed tests for the subject device "met all acceptance criteria and were similar to the predicate device." Specific numerical performance values are not provided in this summary.)
Answers to Specific Questions (based on the provided text's context of a physical device, not a diagnostic/AI device):
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Sample sizes used for the test set and the data provenance:
- Sample sizes: Not specified in the provided text. The text only lists the types of tests performed.
- Data provenance: Not explicitly stated (e.g., country of origin) but implied to be from laboratory testing performed by or for OrbusNeich Medical Trading Inc. The text mentions "Testing was leveraged from the predicate device (K180921) when applicable" and "Additional testing was performed to support the use of the Sapphire II PRO balloon dilatation catheter over-the-wire shaft design," indicating these are laboratory/bench studies, not clinical (retrospective or prospective) patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A) in this context. This question refers to human assessment for ground truth in diagnostic studies. For a physical device, ground truth established by standard testing methods (e.g., measuring dimensions, burst pressure, biocompatibility assays) does not involve human expert consensus in the same way.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. This refers to adjudication in human reader studies for diagnostic accuracy.
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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:
- N/A. This device is a physical balloon catheter, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a physical device, "ground truth" is established by objective, quantitative measurements and standardized laboratory test results based on engineering specifications and regulatory standards (e.g., ISO, ASTM). For example, the "ground truth" for balloon burst pressure is the measured pressure at which the balloon ruptures, compared against a specified acceptance limit. For biocompatibility, it's the results of verified biological assays.
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The sample size for the training set:
- N/A. This device is not an AI model requiring a training set.
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How the ground truth for the training set was established:
- N/A. No training set is used for this type of 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.