(121 days)
Not Found
No
The device description focuses on the mechanical design and function of a catheter for controlled infusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for the "controlled selective infusion of physician-specified pharmacologic agents into the general vasculature" and for "delivering controlled infusions of intravascular therapeutic solutions," which indicates it is used for delivering treatments.
No
The device is an infusion catheter, intended for delivering pharmacologic agents, not for diagnosis. Its description and intended use focus on controlled infusion, and there is no mention of it being used to identify or determine a medical condition.
No
The device description clearly details a physical catheter with specific dimensions, materials (nylon, platinum/iridium), and features (valves, markers, hub). This indicates a hardware medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- EquaFlow Catheter's Intended Use: The EquaFlow Multivalve Infusion Catheter is intended for the "controlled selective infusion of physician-specified pharmacologic agents into the general vasculature." This means it's used to deliver substances into the body, not to test samples from the body.
- Device Description: The description details a catheter designed for delivering fluids, not for analyzing biological samples.
The information provided clearly indicates that this is a therapeutic device used for delivering medication, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The EquaFlow™ Multivalve Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents into the general vasculature. It is not intended for coronary, pediatric or neonatal use.
Product codes
KRA, DYB
Device Description
The EquaFlow Multivalve Infusion Catheter (MIC) is manufactured as a 4.0 or 5.0 French catheter, available in lengths of 40, 65, 100, or 130 centimeters (cm). The EquaFlow Multivalve Infusion Catheter is manufactured with distal and proximal platinum/iridium radiopaque markers, indicating the location of the side-valves' infusion segment. The infusion segments are in lengths of 5, 10, 15, 20, 30, 40, 50, and 60 cm. The number of side-valves is directly related to the length of the infusion segment, with holes 0.10 inches apart at the distal end and 0.25 inches apart as you move toward the proximal end. The distal tip of the EquaFlow Multivalve Infusion Catheter is straight and tapered. The catheter is manufactured with a nylon hub and strain relief at the proximal end.
The EquaFlow Multivalve Infusion Catheter is a single lumen catheter intended for delivering controlled infusions of intravascular therapeutic solutions. The catheter tip is designed with a tip valve, which allows occlusion of the catheter end hole without the use of a wire guide. The EquaFlow Multivalve Infusion Catheter is designed with side-valves spiraling along the specified infusion segment length of the distal portion of the catheter, providing a more even distribution of therapeutic solutions to the targeted location.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general vasculature
Indicated Patient Age Range
Not intended for pediatric or neonatal use.
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 proposed EquaFlow Multivalve Infusion Catheter was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance:
- Tensile
- Flow Restriction
- Flow Rate
- Burst Pressure
- Liquid/Air Leakage
- Biocompatibility
The results of these tests support a conclusion that the proposed Equaflow Multivalve Infusion Catheter and the predicate devices are substantially equivalent.
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
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Cook Incorporated EquaFlow™ MultiValve Infusion Catheter 11 January 2013
5. 510(k) Summary
K123235 Poge 2 of
23
FEB 1 4 2013
EquaFlow™ Multivalve Infusion Catheter 510(k) Summary 21 CFR §807.92
1. Submitter Information:
Applicant: Address:
Phone Number: Fax Number:
Contact: Contact Address:
Email Contact Phone Number: Contact Fax Number:
2. Device Information:
Trade name: Common name: Classification: Regulation: Product Code:
Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (800) 468-1379 (812) 332-0281
Amber Brown Cook Incorporated 750 Daniels Way Bloomington, IN 47404 amber.brown@cookmedical.com 812-339-2235 Ext. 2234 812-332-0281
EquaFlow™ Multivalve Infusion Catheter Continuous flush catheter Class II 21 CFR 870.1210 KRA
3. Predicate Device:
The EquaFlow Multivalve Infusion Catheter is substantially equivalent to the Cragg-McNamara" Valved Infusion Catheters, manufactured by Micro Therapeutics Incorporated, which are cleared under 510(k) number K964868. The EquaFlow Multivalve Infusion Catheter is also substantially equivalent to the Pulse*Spray® Infusion System, manufactured by AngioDynamics Incorporated, which is cleared under 510(k) number K961763.
4. Comparison to Predicates:
The proposed device is substantially equivalent to the predicates in terms of intended use, duration of use, principles of operation, technological characteristics, insertion method, anatomical location, and method of sterilization. The proposed devices will be manufactured
1
Cook Incorporated EquaFlow™ MultiValve Infusion Catheter 11 January 2013
according to Cook Incorporated's specified process controls, sterilization, and packaging procedures.
K12323
24
5. Device Description:
The EquaFlow Multivalve Infusion Catheter (MIC) is manufactured as a 4.0 or 5.0 French catheter, available in lengths of 40, 65, 100, or 130 centimeters (cm). The EquaFlow Multivalve Infusion Catheter is manufactured with distal and proximal platinum/iridium radiopaque markers, indicating the location of the side-valves' infusion segment. The infusion segments are in lengths of 5, 10, 15, 20, 30, 40, 50, and 60 cm. The number of side-valves is directly related to the length of the infusion segment, with holes 0.10 inches apart at the distal end and 0.25 inches apart as you move toward the proximal end. The distal tip of the EquaFlow Multivalve Infusion Catheter is straight and tapered. The catheter is manufactured with a nylon hub and strain relief at the proximal end.
6. Intended Use:
The EquaFlow Multivalve Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents into the general vasculature. It is not intended for coronary, pediatric or neonatal use.
7. Technological Characteristics:
The proposed device is substantially equivalent to the predicates in terms of intended use, duration of use, principles of operation, technological characteristics, insertion method, anatomical location, and method of sterilization.
The EquaFlow Multivalve Infusion Catheter is a single lumen catheter intended for delivering controlled infusions of intravascular therapeutic solutions. The catheter tip is designed with a tip valve, which allows occlusion of the catheter end hole without the use of a wire guide. The EquaFlow Multivalve Infusion Catheter is designed with side-valves spiraling along the specified infusion segment length of the distal portion of the catheter, providing a more even distribution of therapeutic solutions to the targeted location.
The proposed EquaFlow Multivalve Infusion Catheter was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance:
- Tensile
- Flow Restriction
- Flow Rate
- Burst Pressure .
- Liquid/Air Leakage
- Biocompatibility
2
25
Cook Incorporated
EquaFlow™ MultiValve Infusion Catheter
11 January 2013
The results of these tests support a conclusion that the proposed Equaflow Multivalve Infusion Catheter and the predicate devices are substantially equivalent.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
FEB 1 4 2013
Cook Incorporated Amber Brown, Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K123235
Trade/Device Name: EquaFlow Multivalve Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: DYB Dated: January 11, 2013 Received: January 14, 2013
Dear Ms. Brown:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Matthew G. Hillebrenner
for Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Cook Incorporated EquaFlow™ MultiValve Infusion Catheter 11 January 2013
4. Indications for Use Statement
510(k) Number (if known):
Device Name:
EquaFlow™ Multivalve Infusion Catheter
Intended Use:
The EquaFlow™ Multivalve Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents into the general vasculature. It is not intended for coronary, pediatric or neonatal use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE | MAWTex |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K123235 |