(77 days)
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No
The device description focuses on the physical components and mechanical function of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "Opta5 PTA balloon catheters is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulac," which indicates it is used for treatment.
No
The device is described as a balloon catheter intended to dilate stenoses, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical balloon catheter with hardware components like a balloon, marker bands, and lumens. It does not mention any software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to dilate blood vessels and treat lesions. This is an in vivo procedure.
- Device Description: The description details a physical catheter with a balloon designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside the body, which is the defining characteristic of an IVD.
Therefore, this device is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Opta5 PTA balloon catheters is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulac.
Product codes
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Device Description
The Cordis Opta5 PTA balloon catherer is a coaxial design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.
The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nommal size at pressures greater than the nominal pressure.
The balloon lumen is used to milate and deflate the ballown - The nommal balloon size is printed on the hub.
The injectate lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 500 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon. The tip length of the long tip version is approximately 10cm and is provided with side holes.
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
iliac, femoral, ilio-femoral, popliteal infra popliteal and renal arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Cordis Opta5 PTA balloon catheter, Cordis Ducor PTA catheter, Cordis Nylex angiographic catheter, Meditech Ultra-Thin balloon catheter
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
SUMMARY OF SAFETY EFFECTIVENESS
000034
I. General Provisions
网 AY ் 1997
Common or Usual Name: PTA Balloon Catheter
Proprietary Name: Opta5 ™ PTA Balloon Catheter
II. Name of Predicate Devices
| - Cordis Opta5 PTA Balloon Catheter | - Cordis Nylex Angiographic Catheter |
|---|---|
| - Cordis Ducor PTA Catheter | - Meditech Ultra-Thin Balloon Catheter |
III. Classification
Class II
IV. Performance Standards
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description
The Opta5 PTA balloon catheters is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulac
The Cordis Opta5 PTA balloon catherer is a coaxial design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.
The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nommal size at pressures greater than the nominal pressure.
The balloon lumen is used to milate and deflate the ballown - The nommal balloon size is printed on the hub.
The injectate lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 500 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon. The tip length of the long tip version is approximately 10cm and is provided with side holes.
1
VI. Biocompatibility
All materials used in the Opta5 PTA balloon catheter are brocompatible.
VII. Summary of Substantial Equivalence
The Cordis Opta5 PTA balloon catheter and the referenced current Cordis Opta5 PTA balloon catheter, Cordis Ducor PTA catheter, Cordis Nylex angiographic catheter and Meditech Ultra-Thin balloon catheter are similar in their basic design, construction, indication for use and performance characteristics.