(23 days)
Not Found
No
The document describes a physical catheter device and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as a 'mechanism for the infusion of various diagnostic, embolic, and therapeutic agents,' but it is not itself a therapeutic agent or device. It facilitates the delivery of such agents.
No
The device is an infusion catheter, which is used to deliver substances (including diagnostic agents) into the body, but it does not perform diagnostic functions itself. Its primary function is infusion, not diagnosis. While it can be used for "superselective angiography," which is a diagnostic procedure, the catheter itself is a tool for the procedure, not a diagnostic device that interprets or processes information to make a diagnosis.
No
The device description clearly describes a physical catheter with a shaft, lumen, radiopaque markers, and coatings, indicating it is a hardware device. The performance studies also focus on physical properties and performance of the catheter.
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 derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a tool used during medical procedures within the body.
N/A
Intended Use / Indications for Use
The PROWLER® SELECT™ 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.
Product codes
74KRA
Device Description
The PROWLER® SELECT™ 10 and 14 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 .014" and smaller 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
Design verification testing showed that the PROWLER® SELECT™ 10 and 14 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 and 14 Infusion Catheters with and without pre-shaped tips are biocompatible.
Key Metrics
Not Found
Predicate Device(s)
K965181, K972518, K993266, K003925
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
Attachment 4
. . . . . . . . . . . . . . . . . . . . . .
MAR 2 7 2002
p.1 /2 0-000020
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
March 1, 2002 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name / Common Name | Trade Name: PROWLER® SELECT™ 10 and 14 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™ 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 and 14 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 .014" and smaller 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
The predicate devices are listed in the table below: Predicate Devices
| 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 |
Summary of Studies
Design verification testing showed that the PROWLER® SELECT™ 10 and 14 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 and 14 Infusion Catheters with and without pre-shaped tips are biocompatible.
Summary of Substantial Equivalence
The PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips are substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2002
Ms. Maritza Celaya Sr. Regulatory Affairs Associate Cordis Neurovascular, Inc. 14000 N.W. 57th Court Miami Lakes, FL 33014
Re: K020680
PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without preshaped tips Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: March 1, 2002 Received: March 4, 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.
3
Page 2 - Ms. Maritza Celaya
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 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) 594-4586. 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,
Elias Mallis
Ron
Bram Zuckerman, M.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 1 of 10 - 0 0 0 Effective Date: 11/15/00
Page 1 of 1
510(k) Number (if known): K020680
Device Name: PROWLER® SELECT™ 10 and 14 Infusion Catheters (with and without pre-shapes)
Indications for Use Statement
The PROWLER® SELECT™ Infusion Catheters are intended to be used as a mechanism for the interiment of variousing of vailouire I he F N W HER SEELCY - Intelsion Catents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire diagnoste, ontoone, and therepount and ingraphy of the peripheral and coronary vasculatures.
Division of Cardiovascular & Respiratory Devices 510(k) Number 112200 mostis Kozo680
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
OR
Over-The-Counter Use