(85 days)
No
The summary describes a physical catheter and its accessories for infusion procedures, with no mention of software, algorithms, or any terms related to AI/ML.
No.
The document states that Progreat is intended for the infusion of contrast media, drugs, and embolic materials, which are diagnostic and procedural uses rather than primary therapeutic treatments.
No
The device is an infusion catheter used for delivering substances like contrast media, drugs, or embolic materials, not for diagnosing conditions.
No
The device description clearly outlines physical components like a catheter, guide wire, and syringe, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Progreat Intended Use: The Progreat is intended for the infusion of substances (contrast media, drugs, embolic materials) into the body's vascular system. This is an in vivo procedure, meaning it is performed within the living body.
- Device Description: The description details a catheter designed for insertion into blood vessels, not for analyzing samples outside the body.
Therefore, the Progreat falls under the category of a medical device used for therapeutic and diagnostic procedures performed within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Progreat™ is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels, and all coronary vessels. The Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis in procedures including but not limited to Uterine Fibroid Embolization. The Progreat should not be used in cerebral vessels.
Product codes
KRA
Device Description
The Progreat catherer is available with or without the following accessories: guide wire, inserter, mandrel (stylet), syringe, wire stopper, and Y-connector.
The catheter consists of metal coil reinforced multi-layer polymer tubing. The coil is embedded in the catheter wall the entire length of the catheter. This increases the flexibility, kink resistance, and pressure resistance of the catheter. The inner layer of the catheter is made of PTFE (polytetrafluoroethylene) to ensure smooth movement of devices such as the guide wire. The outer surface of the catheter is coated with a hydrophilic polymer which becomes lubricious when wet with saline solution or blood.
The following are accessories to the catheter and will be supplied in different configurations depending on the product code:
The guide wire has a super-elastic alloy core and is surface coated with a hydrophilic polymer. This cnhances advancement of the guide wire into a peripheral vessel.
The inserter is used to assist the physician in the placement of the guide wire within the catheter.
The mandrel (stylct) is used in the shaping of the catheter for procedures that require a catheter with a tip configuration other than straight.
The syringe is used in the priming of the catheter. The syringe can be filled with heparinized saline solution and then this solution can be injected into the catheter.
The wire stopper can be clipped onto the guide wire to adjust the protruding length of the guide wire.
The Y-connector can be used to connect a power injector unit to the end of the catheter for infusion of contrast media.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels, and all coronary vessels. The Progreat should not be used in cerebral vessels.
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)
A risk/hazard analysis was conducted according to EN1441 Medical devices- Risk analysis and ISO 14971 Medical Devices -Application of risk management to medical devices. There were no new issues of safety and effectiveness with regards to the new indication. No additional testing was deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
SECTION II. SUMMARY AND CERTIFICATION
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
Device Name A.
Progreat™ Proprictary Name Classification Name Diagnostic Intravascular Catheter Angiographic Catheter Common Name
B. Intended Use
The Progreat™ is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels, and all coronary vessels. The Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis in procedures including but not limited to Uterine Fibroid Embolization. The Progreat should not be used in cerebral vessels.
C. Device Description
The Progreat catherer is available with or without the following accessories: guide wire, inserter, mandrel (stylet), syringe, wire stopper, and Y-connector.
The catheter consists of metal coil reinforced multi-layer polymer tubing. The coil is embedded in the catheter wall the entire length of the catheter. This increases the flexibility, kink resistance, and pressure resistance of the catheter. The inner layer of the catheter is made of PTFE (polytetrafluoroethylene) to ensure smooth movement of devices such as the guide wire. The outer surface of the catheter is coated with a hydrophilic polymer which becomes lubricious when wet with saline solution or blood.
The following are accessories to the catheter and will be supplied in different configurations depending on the product code:
The guide wire has a super-elastic alloy core and is surface coated with a hydrophilic polymer. This cnhances advancement of the guide wire into a peripheral vessel.
1
The inserter is used to assist the physician in the placement of the guide wire within the catheter.
The mandrel (stylct) is used in the shaping of the catheter for procedures that require a catheter with a tip configuration other than straight.
The syringe is used in the priming of the catheter. The syringe can be filled with heparinized saline solution and then this solution can be injected into the catheter.
The wire stopper can be clipped onto the guide wire to adjust the protruding length of the guide wire.
The Y-connector can be used to connect a power injector unit to the end of the catheter for infusion of contrast media.
Principle of Operation / Technology D.
The Progreat catheter and the accessories included in this 510(k) are operated manually or by a manual process.
E. Design / Materials
This device is the identical device cleared under K033583. There are no material or design changes therefore there are no new issues of safety and effectiveness.
2
| Part | Progreat Catheter |
|---|---|
| Available Sizes (Fr.) | 2.8/2.7/2.4/2.0 |
| Catheter length | 100-150 |
| Guide wire size | 0.021" |
| Accessories | With guide wire- |
| Syringe, inserter, Y-connector, mandrel (stylet), and wire stopper |
Without guide wire-
Mandrel (stylet) |
Specifications F.
Note: This is the same device cleared under K033583 only the intended use has changed for this premarket notification.
G. Performance
The Progreat catheter is available with or without the following accessories: guide wire, inserter, mandrel (stylet), syringe, wire stopper, and Y-connector. All of the accessories are the same as the ones used with the currently cleared device K033583. This device is the identical device that was cleared under K033583
A risk/hazard analysis was conducted according to EN1441 Medical devices- Risk analysis and ISO 14971 Medical Devices -Application of risk management to medical devices. There were no new issues of safety and effectiveness with regards to the new indication. No additional testing was deemed necessary.
Therefore the performance of the Progreat Catheter is substantially equivalent to the performance of the Progreat, cleared under K033583.
H. Additional Safety Information
Manufacturing controls include visual, functional, dimensional and sterility tests.
The Progreat catheter is classified as an Externally Communicating Device. Circulating Blood, Limited Contact (