Search Results

The Sapphire NC 24 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

The Sapphire NC 24 Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.5mm to 5.0mm. The balloon material is made of a minimally compliant material, 1.5mm to 3.5mm balloons have a rated burst pressure of 24 atmospheres, 3.75mm to 4.0mm balloons have a rated burst pressure of 22 atmospheres and 4.5mm to 5.0mm balloons have a rated burst pressure of 20 atmospheres. The minimally compliant balloon material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft allows for superior pushability and trackability with a smooth transition to a distal shaft. Two radiopaque platinum/iridium marker bands are located within the balloon segment with the exception of 1.5mm balloon diameter which incorporate a centrally positioned single marker band. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marker sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

The Sapphire NC 24 Coronary Dilatation Catheter demonstrated substantial equivalence to its predicate devices through various performance tests. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

• 1.5mm to 3.5mm balloons: 24 atmospheres
• 3.75mm to 4.0mm balloons: 22 atmospheres
• 4.5mm to 5.0mm balloons: 20 atmospheres | All acceptance criteria met. |
  | Balloon Fatigue | Not explicitly stated, but implied to withstand repeated inflations/deflations. | All acceptance criteria met. |
  | Balloon Compliance | Not explicitly stated, but implied to maintain precise control of balloon diameter and length under high pressure. | All acceptance criteria met. |
  | Balloon Inflation and Deflation Time | Not explicitly stated, but implied to be within acceptable clinical limits. | All acceptance criteria met. |
  | Catheter Bond Strength | Not explicitly stated, but implied to ensure structural integrity. | All acceptance criteria met. |
  | Tip Pull Strength | Not explicitly stated, but implied to ensure secure attachment of the tip. | All acceptance criteria met. |
  | Flexibility and Kink | Not explicitly stated, but implied to allow for smooth navigation through coronary arteries without kinking. | All acceptance criteria met. |
  | Torque Strength | Not explicitly stated, but implied to allow for effective manipulation by the user. | All acceptance criteria met. |
  | Marker Band Radiopacity | Not explicitly stated, but implied to allow for clear visualization under fluoroscopy. | All acceptance criteria met. |
  | Coating Integrity | Not explicitly stated, but implied to ensure smooth passage and minimize friction. | All acceptance criteria met. |
  | Particulate Evaluation | Not explicitly stated, but implied to be below harmful levels. | All acceptance criteria met. |
  | Balloon Rated Burst Pressure (in-stent) | Not explicitly stated, but implied to perform as expected within a stent. | All acceptance criteria met. |
  | Balloon Fatigue (in-stent) | Not explicitly stated, but implied to maintain integrity within a stent. | All acceptance criteria met. |
  | Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Hemocompatibility, Pyrogenicity, Genotoxicity) | Per ISO 10993-1 standards for biological evaluation of medical devices. | All acceptance criteria met. |
  | Packaging and Sterilization Validation | Not explicitly stated, but implied to maintain sterility and device integrity throughout shelf life. | All acceptance criteria met. |
  | Shelf Life | Not explicitly stated, but implied to maintain device performance over a specified period. | All acceptance criteria met. |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each individual performance test. The tests were conducted on the "subject device," implying representative samples of the Sapphire NC 24 Coronary Dilatation Catheter.

The data provenance is not specified, but given that OrbusNeich Medical (Shenzhen) Co., Ltd is located in China, it is highly probable that the testing was conducted in laboratories within China. The study appears to be retrospective in the sense that these tests were performed on finished devices to demonstrate their compliance with pre-defined standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device and study. The testing described is primarily physical, chemical, and biological performance testing of a medical device, not a diagnostic or AI-driven system that would require expert-established ground truth. The acceptance criteria for these tests are typically based on engineering standards, regulatory guidelines (like FDA guidance and ISO standards), and internal design specifications, not expert consensus on interpretations of data.

4. Adjudication Method for the Test Set

This information is not applicable as the study involves objective performance testing against predefined criteria, not subjective interpretations requiring 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation or clinical decision support AI), but not for a physical medical device like a coronary dilatation catheter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This study is focused on the physical and biological performance of a medical catheter, not an algorithm.

7. The type of Ground Truth Used

The "ground truth" for this study is established through:

• Engineering and Design Specifications: The device is designed to meet specific physical dimensions, pressures, and other performance characteristics.
• Regulatory Guidance: Adherence to FDA guidance documents (e.g., "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters") dictates many of the required performance tests and implied acceptance criteria.
• International Standards: Compliance with ISO standards (e.g., ISO 10993-1 for biocompatibility) provides the framework and acceptance criteria for biological safety.
• Predicate Device Performance: The subject device's performance is compared against the known performance characteristics of the predicate device (Sapphire NC Plus Coronary Dilatation Catheter) and reference device (Sapphire II Pro Coronary Dilatation Catheter) to establish substantial equivalence.

8. The Sample Size for the Training Set

There is no training set for this study. This is not a machine learning or AI-driven device. The term "training set" is not applicable to the performance testing of a physical medical device.

9. How the Ground Truth for the Training Set was Established

As there is no training set, this question is not applicable.

Ask a specific question about this device