(7 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML technologies.
Yes.
The device is intended to be used as a mechanism for the infusion of "therapeutic agents" into the vascular systems, which is a direct therapeutic application.
Yes
The device is intended for "superselective angiography of the peripheral and coronary vasculatures," which is a diagnostic procedure. It also can be used to infuse "diagnostic" agents.
No
The device description clearly describes a physical catheter with a shaft, lumen, radiopaque markers, and coatings, indicating it is a hardware device.
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 various diagnostic, embolic, and therapeutic agents into the vascular systems," "Guidewire Exchange/Support," and "superselective angiography." These are all procedures performed within the body (in vivo) and involve delivering substances or providing support during interventions.
- Device Description: The description details a catheter designed for insertion into blood vessels. This is consistent with an in vivo medical device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PROWLER® SELECT™ (10, 14 and 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)
74KRA
Device Description
The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-shaped tips are 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 for PROWLER® SELECT™ PLUS, and of 0.014" and smaller for PROWLER® SELECT™ 10 and 14, depending on the catheter type. The catheter body is radiopaque with one or two distinguishable marker(s) 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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification testing demonstrated that the PROWLER® SELECT™ PLUS Infusion Catheters with and without pre-shaped tips performed as intended. No new questions of safety and effectiveness were raised. Design verification testing included:
- . Outer Diameter Dimension Inspection (pre-coating)
- . Visual Inspection
- Flexible Coil Length Inspection/Distal Zone Length Inspection ●
- . Lateral Stiffness
- . Trackability
- Joint Pull Test .
- Static Burst Testing .
All materials used in the PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-shaped tips are biocompatible.
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.
K965181, K972518, K993266, K003925
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
MAY 2 2 2002
Attachment 4
.
12 11
0-000025
Summary of Safety and Effectiveness
| Submitter's
Name/Contact
Person | The submitter of this special 510(k) is:
Cordis Neurovascular, Inc.
14000 N.W. 57th Court
Miami Lakes, Florida 33014
Establishment Registration No. 1058196
Contact: Maritza Celaya
Sr. Regulatory Affairs Associate
Tel: (786) 313-6546
Fax: (786) 313-6480
May 14, 2002 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name /
Common Name | Trade Name: PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and
without pre-shaped tips
Common/Classification Name: Catheters, Continuous Flush |
| 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® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-
shaped tips 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. |
| Device
Description | The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-
shaped tips are 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 for
PROWLER® SELECT™ PLUS, and of 0.014" and smaller for PROWLER® SELECT™ 10
and 14, depending on the catheter type. The catheter body is radiopaque with one or two
distinguishable marker(s) 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. |
Continued on next page
1
Summary of Safety and Effectiveness, Continued
0-000026
| Device | Company | 510 (k) Number | Product Code |
|---|---|---|---|
| PROWLER® Infusion | |||
| Catheters | Cordis Neurovascular, | ||
| Inc. | K965181 | ||
| K972518 | 74KRA | ||
| PROWLER® PLUS | |||
| Infusion Catheters | Cordis Neurovascular, | ||
| Inc. | K993266 | 74KRA | |
| PROWLER® Infusion | |||
| Catheters with pre-shaped | |||
| tips | Cordis Neurovascular, | ||
| Inc. | K003925 | 74KRA | |
| PROWLER® SELECTTM | |||
| 10 and 14 Infusion | |||
| Catheters with and without | |||
| pre-shaped tips | Cordis Neurovascular, | ||
| Inc. | K020680 / 3/27/02 | 74KRA |
The predicate devices are listed in the table below: Predicate Devices
Summary of Studies
Design verification testing demonstrated that the PROWLER® SELECT™ PLUS Infusion Catheters with and without pre-shaped tips performed as intended. No new questions of safety and effectiveness were raised. Design verification testing included:
- . Outer Diameter Dimension Inspection (pre-coating)
- . Visual Inspection
- Flexible Coil Length Inspection/Distal Zone Length Inspection ●
- . Lateral Stiffness
- . Trackability
- Joint Pull Test .
- Static Burst Testing .
All materials used in the PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without pre-shaped tips are biocompatible.
Summary of Substantial Equivalence
The PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters with and without preshaped tips are substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2002
Ms. Maritza Celaya Cordis Neurovascular, Inc. 14000 N.W. 57th Court Miami Lakes, FL 33014
Re: K021591
PROWLER® SELECT™ PLUS Infusion Catheters with and without pre-shaped tips Regulation Number: 870.1210 Regulation Name: Continous Flush Catheter Regulatory Class: Class II (two) Product Code: 74 KRA Dated: May 14, 2002 Received: May 15, 2002
Dear Ms. Celaya:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
3
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,
N. Deetun
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Cordis Franchise Form -- CFF 20-014 Rev.01 Intended Use Statement
Page I of Effective Date: 11/15/00
Cordis
a fohnson-fohnson company
Page 1 of 1
510(k) Number (if known): Ko2159 |
Device Name: PROWLER® SELECT™ (10, 14 and PLUS) Infusion Catheters (with and without pre-shaped tips)
Indications for Use Statement
The PROWLER® SELECT™ (10, 14 and 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
Over-The-Counter Use
Division of Cardiovascular & Respiratory Devices
510(k) Number K021597
OR
Prescription Use √