(29 days)
No
The summary describes a physical catheter and its accessories, focusing on material properties and mechanical performance. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as being used for "drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis," which indicates therapeutic applications.
No
The PROGREAT Catheter is described as being "intended for the infusion of contrast media" and "for drug infusion... and the infusion of embolic materials." These are therapeutic or delivery functions, not diagnostic ones.
No
The device description clearly outlines a physical catheter made of polymer tubing with metal reinforcement, intended for infusion. It also lists various physical accessories. This is a hardware medical 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 or tissue, to detect diseases or other conditions. They are used to diagnose, monitor, or screen for diseases.
- Device Description and Intended Use: The PROGREAT Catheter is a medical device used for the infusion of substances (contrast media, drugs, embolic materials) directly into blood vessels. It is an invasive device used within the body, not for testing samples taken from the body.
The description clearly outlines its function as a delivery system within the vascular system, which is characteristic of a therapeutic or diagnostic device used in vivo, not in vitro.
N/A
Intended Use / Indications for Use
The PROGREAT Catheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels in the lower and upper extremities and all coronary vessels. The PROGREAT Catheter is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.
Product codes
DQO
Device Description
The PROGREAT catheter 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 guide wire has a super-elastic alloy core and is surface coated with a hydrophilic polymer. This enhances 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 (stylet) 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 in the lower and upper extremities and all coronary vessels. The Catheter 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)
The following verification tests were performed to demonstrate the substantial equivalence of the modified device (PROGREAT catheter) to the unmodified device (GT LEGGIERO K981359).
- Ease of removal from holder .
- Frictional resistance of catheter and guide wire .
- Joint strength of hub on catheter and guide wire .
- Pressure resistance of catheter .
- Kink resistance
None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GT LEGGIERO K981359
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(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.
| Proprietary Name | PROGREAT |
|---|---|
| Classification Name | Diagnostic Intravascular Catheter |
| Common Name | Angiographic Catheter |
B. Intended Use
The PROGREAT Catheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels in the lower and upper extremities and all coronary vessels. The PROGREAT Catheter is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.
Note: This is the same intended use as the predicate device - GT LEGGIERO K981359.
C. Device Description
The PROGREAT catheter 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:
1
The guide wire has a super-elastic alloy core and is surface coated with a hydrophilic polymer. This enhances 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 (stylet) 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 accessorics included in this 510(k) are operated manually or by a manual process.
Design / Materials E.
Differences in materials between the PROGREAT catheter and the GT LEGGIERO K981359 raise no new issues of safety and effectiveness.
2
Terumo Medical Corporation Special 510k - PROGREAT Section II. Summary and Certification
| Part | Progreat Catheter | GT
LEGGIERO
K981359 |
|-----------------------|--------------------------------------------------------------------------------------------------|-------------------------------------|
| Available Sizes (Fr.) | 2.8/2.7/2.4/2.0 | 2.9 |
| Catheter length | 100-150 | 100-150 |
| Guide wire size | 0.021" | none |
| Accessories | With guide wire-
Syringe, inserter, Y-connector, mandrel (stylet),
and wire stopper | Y-connector,
mandrel
(stylet) |
| | Without guide wire-
Mandrel (stylet) | |
Specifications F.
Note: The syringe (2.5ml) is cleared under 510(k) K771205. The guide wire, inserter, Y-connector, and mandrel (stylet) are the same devices cleared under 510(k) K915414, Terumo Angiographic Catheter and K981359, GT Leggiero Catheter.
G. Performance
The PROGREAT catheter is available with or without the following accessories: guide wire, inserter, mandrel (stylet), syringe, wire stopper, and Y-connector. The wire stopper is a new accessory, all of the additional accessories are the same as the ones used with currently approved devices.
The following verification tests were performed to demonstrate the substantial equivalence of the modified device (PROGREAT catheter) to the unmodified device (GT LEGGIERO K981359).
- Ease of removal from holder .
- Frictional resistance of catheter and guide wire .
- Joint strength of hub on catheter and guide wire .
- Pressure resistance of catheter .
- Kink resistance �
None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.
3
Therefore the performance of the Progreat Catheter is substantially equivalent to the performance of the GT LEGGIERO, cleared under K981359.
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 ( IQC) premixited in Ur equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have deemined the usedicate devices marketed in interstate
for use stated in the enclosure) to legally matered president device Device Amendments, for use stated in the enclosure) to legally market production in the vevice Amendments, or to
commerce prior to May 28, 1976, the enactment and of the Federal Food, Drug, commerce prior to May 28, 1976, the encordance with the provisions of the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the Fed devices that have been reclassified in accordance wan the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a proval application (PMA).
The Act and Cosmetic Act (Act) that do not require apply of the general controls. Provisions of the Act. The
You may, therefore, market the device, subject to the general contralie You may, therefore, market the device, subject to the general veamnal registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act Include requirements as anst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
em If your device is classified (see above) nito entire) cass it topes affecting your device can
may be subject to such additional controls. Exist. In addition. FDA In additio may be subject to such additional controls. Existing major regal to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In a be found in the Code of Federal Regulations, True 20, and 20, and 2017 and Register.
publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substinat optives with other requirements of the Act
that FDA has made a determination that your device enders . You must that FDA has made a determination inalyon dovice Federal agencies. You must
or any Federal statutes and regulations administered by registration and listin or any Federal statutes and regulations administered to registration and listing (21 l
comply with all the Act's requirements, including, but not limited to set comply with all the Act s requirements, including, but her mint of the only of the many as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirem
5
Page 2 -- Mr. Mark Unterreiner
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (becalems or device as described in your Section 510(k) This letter will anow you to oegin manieting of substantial equivalence of your device to a legally premarket notification: "The PDA miding of casion for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you ucate specific advice 101 Jour 2011) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gelleral informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Thrashtz fr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Note: This is the same intended use as the predicate device, K981359
| 510(k) Number (if known): | K033583 |
|---|---|
| Device Name: | PROGREAT |
Indications For Use:
The PROGREAT Catheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels in the lower and upper vessers up to and morating vessels. The PROGREAT Catheter is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
| (Optional Format 1-2-96) | ||
| (Division Sign-off) | ||
| Division of Cardiovascular Devices | ||
| 12/14/03 |
510(K) Number K033583 (SM. K)