(86 days)
Not Found
Cordis Opta 5 ™ PTA Balloon Catheter, Cordis Mega PTA Balloon Catheter, Meditech Ultra-Thin™/Blue Max Balloon Catheter, Cook Accent® Balloon Angioplasty Catheter
No
The device description focuses on the mechanical aspects of a balloon catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is intended to dilate stenoses in peripheral arteries, which is a therapeutic intervention.
No
The device is a PTA Balloon Catheter intended to dilate stenoses in peripheral arteries, which is a therapeutic function, not a diagnostic one. It is used for treatment, not for identifying a disease or condition.
No
The device description clearly details a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware medical device, not software-only.
Based on the provided information, the Cordis Opta 5™ PTA Balloon Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The Cordis Opta 5™ PTA Balloon Catheter is a device used inside the body to physically dilate stenoses (narrowings) in arteries. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it is for "dilat[ing] stenoses in peripheral arteries." This is a treatment, not a diagnostic test.
- Device Description: The description details the physical components and how it is used for inflation and guidewire tracking, all related to its function within the body.
Therefore, the Cordis Opta 5™ PTA Balloon Catheter is an in vivo (used within the body) therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cordis Opta 5TM PTA Balloon Catheter is intended to dilate stenoses in peripheral arteries and is applied to the iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries.
Product codes
Not Found
Device Description
The Cordis Opta 5TM PTA Balloon Catheter 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 catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.
The recommended working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. 3mm through 10mm diameter balloons reach their nominal size between 5 and 6 atm internal pressure. The 12mm diameter balloons reaches its nominal size between 3 and 4 atm internal pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal size pressure range.
The injectate lumen is used to deliver contrast medium by using a 10-cc syringe, hand injection only (150 psi maximum), and to track the catheter over a prepositioned guidewire. The compatible guidewire size, catheter shaft French size and catheter length are printed on the injectate lumen hub.
The inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the balloon lumen hub.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries (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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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 Opta 5 ™ PTA Balloon Catheter, Cordis Mega PTA Balloon Catheter, Meditech Ultra-Thin™/Blue Max Balloon Catheter, Cook Accent® Balloon Angioplasty 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
un-aunly ?
Page 42 of 91 ' 7/25/96
SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Provisions
Common or Usual Name: PTA Balloon Catheter
Opta 5TM PTA Balloon Catheter Proprietary Name:
II. Name of Predicate Devices
Cordis Opta 5TM PTA Balloon Catheter Cordis Mega PTA Balloon Catheter Meditech Ultra-Thin™/Blue Max Balloon Catheter Cook Accent® Balloon Angioplasty 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 Cordis Opta 5™ PTA Balloon Catheter is intended to dilate stenoses in peripheral arteries and is applied to the iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries.
The Cordis Opta 5TM PTA Balloon Catheter 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 catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.
The recommended working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. 3mm through 10mm diameter balloons reach their nominal size between 5 and 6 atm internal pressure. The 12mm diameter balloons reaches its nominal size between 3 and 4 atm internal pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal size pressure range.
The injectate lumen is used to deliver contrast medium by using a 10-cc syringe, hand injection only (150 psi maximum), and to track the catheter over a prepositioned guidewire. The compatible guidewire size, catheter shaft French size and catheter length are printed on the injectate lumen hub.
OCT 23 1996
K962945
1
00-00043
The inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the balloon lumen hub.
VI. Biocompatibility
All materials used in the Opta 5TM PTA balloon catheter are biocompatible.
VII. Summary of Substantial Equivalence
The Cordis Opta 51M PTA Balloon Catheter and the referenced current Cordis Opta 5 ™ PTA Balloon Catheter, Cordis Mega PTA Balloon Catheter, Meditech Ultra-Thin™/Blue Max Balloon Catheter and Cook Accent® Balloon Angioplasty Catheter are similar in their basic design, construction, indication for use and performance characteristics.