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510(k) Data Aggregation
(90 days)
The Pacific™ Plus PTA catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Pacific Plus is an Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub, a coaxial dual lumen shaft, and a distal dilatation balloon. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guide wire with a maximum outer diameter of 0.018 inches (0.46 mm). The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. Two radiopaque marker bands are placed under the balloon segment of the catherser shaft to provide visual reference points for balloon positioning within the vessel.
The Pacific Plus catheter is compatible with guidewires with a maximum diameter of 0.018" (0.46 mm) and with 4F or 5F introducer sheaths depending on balloon size. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 90, 130 and 180 cm.
Balloon sizes range from 2.0mm to 7.0mm in diameter, with balloon lengths from 20mm to l 50mm. All balloons reach nominal diameter at 8atm (Nominal Pressure) and have rated burst pressure (RBP) of 22atm, 16atm, 14atm and 12atm depending on the balloon diameter and balloon length.
The manufacturer, Medtronic Vascular, studied the Pacific Plus PTA Catheter.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Pacific Plus PTA Catheter were met through extensive bench and biocompatibility testing. The submission states, "All of the pre-determined acceptance criteria were met and results passed" for both bench and biocompatibility testing. No specific numerical thresholds for acceptance were listed in the provided text, but the qualitative statement confirms that the device performed as required.
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | The bench testing plan was developed with consideration of recommendations from applicable FDA guidance documents, ISO, and ASTM standards. Specific tests included: • Dimensional verification • Balloon preparation, deployment and retraction • Balloon rated burst pressure (RBP) • Balloon fatigue (repeated balloon inflations) • Balloon Compliance • Balloon Inflation/Deflation Time • Catheter Bond Strength • Flexibility and Kink test • Torque Strength • Radiopacity • Coating Integrity • Particulate evaluation • Guide wire compatibility • Introducer sheath compatibility • Coating lubricity | "All of the pre-determined acceptance criteria were met and results passed." |
| Biocompatibility Testing | Biocompatibility testing was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009, FDA Blue Book Memorandum #G95-1, FDA 21 CFR Part 58, and FDA guidance for Class II Special Controls. Specific tests included: • ISO L929 MEM Elution Test • ISO Kligman Maximization Test • ISO Intracutaneous Injection Test • ISO Systemic Injection Test • ISO Material Mediated Rabbit Pyrogen Test • ISO Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay (AMES Test) • ASTM Direct and Indirect Contact Hemolysis Rabbit Blood • ISO Complement Activation Assay (Indirect Contact) • ISO In-vivo Dog Thromboresistance | "All of the pre-determined acceptance criteria were met and results passed." |
2. Sample Size and Data Provenance
The document does not specify the exact sample sizes used for the bench or biocompatibility tests. The data provenance is described as "bench testing" and "biocompatibility testing," implying laboratory-based studies. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, though the nature of the tests suggests prospective laboratory studies.
3. Number, Qualifications, and Adjudication of Experts for Ground Truth
This information is not applicable. The device is a medical catheter, and the "ground truth" for its performance is established through objective engineering bench tests and standardized biological evaluations (biocompatibility). There is no mention of human expert evaluation in establishing ground truth for the device's technical specifications.
4. Adjudication Method
Not applicable for this type of device and testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed. This type of study focuses on the effectiveness of human readers, often with and without AI assistance, typically in image interpretation or diagnostic tasks. The Pacific Plus PTA Catheter is a physical medical device, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Pacific Plus PTA Catheter is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used
The ground truth for the performance of the Pacific Plus PTA Catheter was established through:
- Bench Testing: Objective measurements and observations against pre-defined engineering and performance specifications and industry standards (ISO, ASTM).
- Biocompatibility Testing: Results from standardized biological assays and in-vivo tests to assess the device's interaction with biological systems, ensuring it meets safety criteria.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device. The concept of a "training set" typically applies to machine learning algorithms or AI models. The development of the catheter involved design, material selection, and manufacturing processes, but not a training set in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set in the context of AI/machine learning. The "ground truth" for the device's design and manufacturing was established through engineering principles, material science, and adherence to regulatory standards.
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