(155 days)
The Attain Clarity™ 6225 Venogram Balloon Catheter is indicated for use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for occlusive venogram imaging.
The Attain Clarity™ 6225 Venogram Balloon Catheter contains one non-latex occlusion balloon catheter, one stopcock and one controlled stroke syringe. It is indicated for use within the coronary sinus and is intended for infusing contrast solutions into the coronary vasculature for occlusive venogram imaging. This device is available in one model, the Attain Clarity™ 6225 Venogram Balloon Catheter.
The Attain Clarity™ 6225 Venogram Balloon Catheter is a non-latex occlusion balloon catheter designed for use within the coronary sinus for infusing contrast solution for occlusive venogram imaging.
The balloon catheter consists of polymeric tubing with an infusion port and an inflation port in the main body of the catheter.
The inflation port features a luer lock at the proximal end. Inflation is achieved through the use of a controlled stroke fixed volume syringe attached to a stopcock. The stopcock is manually attached to the balloon catheter. Both the stopcock and the syringe are supplied with the device.
A silicone balloon is located near the distal end; a marker band is located proximally to the balloon to help with visualizing the location of the balloon under fluoroscopy.
The infusion port has a luer lock at the proximal end.
The Medtronic Attain Clarity™ 6225 Venogram Balloon Catheter is indicated for use within the coronary sinus and is intended for infusing contrast solutions into the coronary vasculature for occlusive venogram imaging. The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Device Integrity | All specified design and performance requirements. | "The Attain Clarity™ 6225 Venogram Balloon Catheter met all specified design and performance requirements." |
| Dimensional Testing | Not explicitly stated, implied to meet design specifications. | Performed and met requirements. |
| Balloon Safety & Performance | Not explicitly stated, implied to meet safety and function standards. | Performed and met requirements. |
| Catheter Safety & Performance | Not explicitly stated, implied to meet safety and function standards. | Performed and met requirements. |
| Compatibility Testing | Not explicitly stated, implied for proper function with associated components/fluids. | Performed and met requirements. |
| Packaging Testing | Not explicitly stated, implied to ensure device integrity during storage/transport. | Performed and met requirements. |
| Biocompatibility | Meets ISO10993-1:2009 for external communicating devices with limited exposure (≤ 24 hours blood contact). | "The biocompatibility evaluation completed verifies that the Attain Clarity™ 6225 Venogram Balloon Catheter is biocompatible." (Specific tests include: Cytotoxicity, Maximisation Sensitization, Acute Intracutaneous Reactivity, Acute Systemic Toxicity, USP Material Mediated Pyrogen, In-vitro Hemolysis, PTT Coagulation, C3a Complement Activation, SC5b-9 Complement Activation, In Vivo Thromboresistance, USP Physicochemical Tests). |
| Sterilization Assurance Level | Minimum Sterility Assurance Level (SAL) of 10^-6. | "The Attain Clarity™ 6225 Venogram Balloon Catheter will be sterilized using a validated Ethylene Oxide (EtO) to a minimum Sterility Assurance Level of 10-6 in compliance with ANSI/AAMI/ISO 11135-1." |
2. Sample Size Used for the Test Set and Data Provenance
The study primarily relied on in-vitro bench tests. The document does not specify a numerical sample size for individual tests, but implies sufficient samples were used to demonstrate compliance. The data provenance is from in-vitro bench testing conducted by the manufacturer, Medtronic Ireland. These are not clinical studies, so the concept of country of origin of patient data or retrospective/prospective does not apply.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission relies on bench testing and established international standards (e.g., ISO, ASTM, USP), rather than expert evaluation of clinical data for ground truth. The "ground truth" for these tests is defined by the parameters and pass/fail criteria of the specified engineering and biocompatibility standards.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation was based on meeting pre-defined criteria of objective bench tests and international standards, not expert adjudication of qualitative data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this is not an AI-based device that requires human interpretation. The device is a medical catheter and its effectiveness is determined by its physical and biological performance characteristics.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study in the context of an algorithm or AI performance was not done. This is a physical medical device (catheter), not a software algorithm.
7. Type of Ground Truth Used
The ground truth used for this device's evaluation was based on:
- Pre-defined design specifications and performance requirements for dimensional, safety, performance, and compatibility testing.
- Internationally recognized biocompatibility standards (e.g., ISO 10993-1), with specific tests having their own established pass/fail criteria.
- Internationally recognized sterilization standards (e.g., ANSI/AAMI/ISO 11135-1) for sterility assurance.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical catheter, not an AI or machine learning model that requires a training set. The concept of a "training set" is irrelevant to this device's evaluation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).