(310 days)
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No
The device description and performance studies focus on the mechanical properties and function of a balloon dilatation catheter, with no mention of AI or ML technologies.
Yes
The device is described as a "Peripheral Balloon Dilatation Catheter" used in "Percutaneous Transluminal Angioplasty" to treat "obstructive lesions" and for "post-deployment dilatation," which are all therapeutic interventions.
No
Explanation: The device, a balloon dilatation catheter, is used for performing angioplasty and dilating obstructive lesions. These are therapeutic interventions, not diagnostic ones.
No
The device description clearly details a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Centurion Peripheral Balloon Dilatation Catheter is used for Percutaneous Transluminal Angioplasty. This is a procedure performed inside the body to widen narrowed blood vessels.
- Intended Use: The intended use is to treat obstructive lesions in arteries and fistulae, and to dilate stents. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The device is a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Centurion Peripheral Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, post-deployment dilatation of peripheral vascular stents and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The catheter is not for use in coronary arteries.
Product codes
74 LIT
Device Description
The Opti-Plast Centurion 5.5F PTA Catheter is a dual lumen catheter with a balloon mounted on its distal end. One lumen accommodates the insertion guidewire and the other provides a channel for inflation and deflation of the balloon with contrast media. The catheter is designed to be used in conjunction with a 0.035" diameter guidewire. There are two radiopaque marker bands secured on the catheter body to indicate the position of the balloon within the vasculature. The balloon inflates to the labeled diameter and length at a 10 atmosphere Operating Pressure. The Rated Burst Pressure of the device ranges from 17-20 atmospheres, depending on balloon diameter (see attached table).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
femoral, iliac and renal arteries, peripheral vascular stents, native or synthetic arteriovenous dialysis fistulae.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Bench testing was conducted for the following characteristics: balloon burst strength, balloon distensibility, balloon inflation/deflation time, balloon fatigue, joints and material strength, catheter balloon profile, introducer sheath compatibility, catheter flow rate and maximum injection pressure, deflatability and trackability, tip torque performance, puncture resistance ("toughness"), balloon scratch resistance, balloon fatigue (cycling to rated burst pressure) within a stent and balloon burst within a stent. The test results indicate that the Opti-Plast Centurion 5.5F PTA Catheter is substantially equivalent to the stated predicate device, that there are no new safety or effectiveness issues, and that the device can be utilized for its stated indication.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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