(120 days)
No
The summary describes a physical catheter device and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used to infuse therapeutic agents, indicating its role in administering treatments.
Yes
The "Intended Use / Indications for Use" section states that the catheters are intended for the "selective infusion of various diagnostic... agents." This indicates a role in diagnostic procedures.
No
The device description clearly details physical components like a single lumen, variable stiffness shaft, hydrophilic coating, PTFE lining, and stainless steel braid, 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 used for the infusion of agents into the body (peripheral, coronary, and neurovasculatures). This is an in vivo (within a living organism) application.
- Device Description: The description details a catheter designed for physical insertion and delivery within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease. This device does not perform such analysis on specimens.
Therefore, the CES Infusion Catheter is 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
CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures. The catheters can also be used to exchange one guidewire for another or provide support to facilitate the placement of guidewires.
Product codes
KRA
Device Description
The CES Infusion Catheters contain a single lumen and a variable stiffness shaft in order to traverse and deliver agents to the coronary, peripheral and neurovasculatures. The outside of the shaft includes a hydrophilic coating and the lumen is lined with PTFE in order to increase lubricity and trackability. The proximal shaft is reinforced with a stainless steel braid to enhance pushability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary and neurovasculatures
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)
Not Found
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
Image /page/0/Picture/0 description: The image shows two lines of text. The first line reads "0-000016". The second line reads "K972518". The text appears to be handwritten in a bold, sans-serif font.
Summary of Safety and Effectiveness
NOV - 4 1997
| General
| Provisions | Common or Usual Name: Continuous Flush Catheter |
|---|---|
| Trade Name: CES Infusion Catheters, including Transit™ Infusion Catheter RapidTransit™ Infusion Catheter Speedster™ Infusion Catheter Prowler™ Infusion Catheter |
| Predicate | The predicates are listed in the table below |
|---|---|
| Devices | Devices |
| Device | Company | 510(k) Number,
Clearance Date | Product Code | Predicate for: |
|----------------------------------------------------------|--------------------------------------|----------------------------------|--------------|------------------------------------------------------|
| CES Infusion
Catheters | Cordis Endovascular
Systems, Inc. | K965181, 3/21/97 | KRA | Design, materials,
sterilization and
packaging |
| Venture™ II
Infusion Catheter | Scimed Life Systems | K945904, 5/19/95 | KRA | Indications/claims |
| UltraFuse-X™
Infusion/Guide Wire
Exchange Catheter | Scimed Life Systems | K952872, 7/27/95 | KRA | Indications/claims |
Classification Class II
Performance Performance standards have not been established by the FDA under Standards Section 514 of the Food, Drug and Cosmetic Act.
1
| Intended Use | CES Infusion Catheters are intended to be used as a mechanism for
the selective infusion of various diagnostic, embolic and therapeutic
agents into the peripheral, coronary and neurovasculatures. The
catheters can also be used to exchange one guidewire for another or
provide support to facilitate the placement of guidewires. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | The CES Infusion Catheters contain a single lumen and a variable
stiffness shaft in order to traverse and deliver agents to the coronary,
peripheral and neurovasculatures. The outside of the shaft includes a
hydrophilic coating and the lumen is lined with PTFE in order to
increase lubricity and trackability. The proximal shaft is reinforced
with a stainless steel braid to enhance pushability. |
| Biocompatibility | All applicable biocompatibility tests were successfully performed on
the CES Infusion Catheters. |
| Summary of
Substantial
Equivalence | The CES Infusion Catheters are substantially equivalent* in design,
materials, sterilization and indications for use to other commercially
available catheters. |
- A statement of substantial equivalence to another product is required by 21CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seg. (1977).
2
Image /page/2/Picture/10 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 an abstract symbol resembling an eagle or a stylized human profile, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
. . . . . . .
Ms. Lisa Wells Cordis Endovascular Systems, Inc. 14740 N.W. 60th Avenue Miami Lakes, Florida 33014
Re : K972518 CES Infusion Catheters Regulatory Class: II (two) Product Code: 74 KRA - -Dated: October 22, 1997 Received: October 23, 1997
Dear Ms. Wells:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
NOV - 4 1997
3
Page 2 - Lisa Wells
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ·
4
510(k) Number: K972518
INDICATIONS FOR USE
CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures. The catheters can also be used to exchange one guidewire for another or to provide support to facilitate the placement of guidewires.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Tan A. Pr
(Division Sign-Off) Division of Cardinatoriatoria: Respiratory, and Neurological Devices 9725 18 510(k) Number _