(28 days)
Not Found
Not Found
No
The document describes a physical medical device (infusion catheter) and its mechanical performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a catheter intended for the infusion of agents and guidewire support, not for direct therapeutic treatment itself.
Yes
The "Intended Use / Indications for Use" section states that the device is intended for the "infusion of various diagnostic... agents" and for "superselective angiography," both of which are diagnostic procedures.
No
The device description clearly describes a physical catheter with a lumen, shaft, coating, and marker, 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:
- Intended Use: The intended use clearly states the device is for the infusion of agents into the vascular system, guidewire exchange/support, and angiography. These are all procedures performed in vivo (within the living body).
- Device Description: The description details a catheter designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body. This device is designed to interact directly with the vascular system within the body.
N/A
Intended Use / Indications for Use
The Prowler Plus Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The Prowler Plus is a single lumen catheter featuring a stiff proximal shaft and a flexible distal section. The catheter's inner diameter accommodates guidewires of .018" and smaller. The catheter body is radiopaque with a distinguishable marker at the distal tip. It includes a hydrophilic coating on the outside of the shaft as well as a PTFE liner on the inner lumen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
vascular systems (Neuro, Peripheral, Coronary)
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification testing showed that the Prowler Plus Infusion Catheter performs as well or better than the predicate devices tested. No new questions of safety and effectiveness were raised. Design verification testing included:
• Pull Strength Test
• Trackability Test
• Dimensional Testing (Tip OD, ID, Body OD, Joint OD, Length Assembly, Hub Taper)
• Static Burst Pressure Test
• Alternative Flow Rate Calculation
• Air Aspiration
• Linear Stiffness Test (Boink)
• Shapeability Test
Prowler Plus Infusion Catheter performs as well or better than the predicate devices tested. No new questions of safety and effectiveness were raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Attachment 4
Summary of Safety and Effectiveness
| General
Provisions | Trade Name: Prowler Plus Infusion Catheter
Common/Classification Name: Infusion Catheter |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate
Devices | Cordis Endovascular Systems, Inc. Prowler Infusion Catheter, and Rapid
Transit Infusion Catheter. |
| Classification | Class II |
| Performance
Standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not established
performance standards. |
| Intended Use
and Device
Description | The Prowler Plus Infusion Catheters are intended to be used as a mechanism for the
infusion of various diagnostic, embolic, and therapeutic agents into the vascular
systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for
superselective angiography of the peripheral and coronary vasculatures.
The Prowler Plus is a single lumen catheter featuring a stiff proximal shaft and a
flexible distal section. The catheter's inner diameter accommodates guidewires of |
| Summary of
Studies | .018" and smaller. The catheter body is radiopaque with a distinguishable marker at
the distal tip. It includes a hydrophilic coating on the outside of the shaft as well as a
PTFE liner on the inner lumen.
Design verification testing showed that the Prowler Plus Infusion Catheter performs as well or
better than the predicate devices tested. No new questions of safety and effectiveness were
raised. Design verification testing included:
• Pull Strength Test
• Trackability Test
• Dimensional Testing (Tip OD, ID, Body OD, Joint OD, Length Assembly, Hub Taper)
• Static Burst Pressure Test
• Alternative Flow Rate Calculation
• Air Aspiration
• Linear Stiffness Test (Boink)
• Shapeability Test |
| Biocompatibility | All materials used in the Prowler Plus Infusion Catheters are biocompatible. |
| Summary of
Substantial
Equivalence | The Prowler Plus Infusion Catheters are substantially equivalent to the previously
cleared Prowler and Rapid Transit Infusion Catheters. |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 1999
Ms. Maritza Celaya Sr. Regulatory Affairs Specialist Cordis Endovascular SystemS, Inc. p.o. Box 025700 Ct. Miami Lakes, FL 33102-5700
Re: K993266 K993266
Trade Name: Prowler Plus Infusion Catheter Regulatory Class: II Product Code: KRA Dated: September 29, 1999 September 30, 1999 Received:
Dear Ms. Celaya:
We have reviewed your Section 510(k) notification of intent to market the f
actived by the becale boys determined the device is We have reviewed your securer state determined the device is device referenced above and we nave associons for use stated in the substantially equivalent (10) the indites marketed in interstate enclosure) to legally marketed breatment date of the Medical Device commerce prior to May 28, 1976, the encements assisted in accordance with Amendments, or to devices that nave been, and Cosmetic Act (Act). You
the provisions of the Federal Food, Drug, and Cosmeral controls the provisions of the rederal rood, bray and the general controls
may, therefore, market the device, subject to the Act may, therefore, market the device, busferols provisions of the Act
provisions of the Act. The general controls provisions of provisions of the Act. The general concross productions of devices, good
include requirements for annual registration, against misbranding include requirements for annual registration, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special If your device is classified (see aboro), it may be subject to such Controls) or class III (reliminer regions affecting your device additional controls. Extrema Requires Title 21, Parts 800 to
can be found in the Code of Federal Requires compliance with e found in the Code of rederal Requirement compliance with 895. 895. A substantially equivalence active requirements, as set forth in the Current General regulation the Current Good Manufacturing Frassis al Devices: General regulation Quality System Regulation (QS) Lockidations inspections, the Food and (21 CFR Part 820) and that, through percula assumptions . Failure to comply
Drug Administration (FDA) will verify such assumptions. In addition, Drug Administration (FDA) will versily bagulatory action. In addition,
with the GMP regulation may result in regulation your device in the with the GMP regulation may rebare in concerning your device in the
FDA may publish further announcements concern to your premarket FDA may publish further announces to your premarket.
Federal Register. Please note: this response thirstion you might rederal Rediscer. Prease noce. Enterespection you might have
notification submission does not affect any for douices notification basmissions of the Act for devices
2
Paye 2 - Ms. Maritza Celaya
under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in This fecter will arrow you oo begin to the FDA finding of substantial your 510(k) prematics. I legally marketed prodicate device results
equivalence of your device to a legally marketed with mown device to equivalence of your device to a regulary
in a classification 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 in II you desire speciele additionally 809.10 for in vitro diagnostic (21 CFR Part over and addressions)
devices), please contact the Office of Compliance at (301) 594-4586. devices), prease concacions on the promotion and advertising of your Additionally, for questions on the primeses (301) 594-4639. Also, as a regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on premarket nocification (arch over may be obtained from the Division of your responsibilities under ens tool -----------------------------------------------------------------------------------------------------------------------------------------(301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
At. A. LiachowsL.
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 2
| 510(k) Number
| (if known) | The 510(k) number has not yet been assigned. |
|---|---|
| Device Name | Prowler Plus Infusion Catheters. |
| Indications for | |
| Use | The Prowler Plus Infusion Catheters are intended to be used as a mechanism for the |
| infusion of various diagnostic, embolic, and therapeutic agents into the vascular | |
| systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for | |
| superselective angiography of the peripheral and coronary vasculatures. |
Indications for Use Statement
PLEASE DO NOT WRITE BEI.OW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEFDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Christopher Witten.
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K993266
× Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use