(218 days)
Not Found
No
The summary describes a physical medical device (a catheter) and its intended use and physical characteristics. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies listed are related to the physical properties of the catheter.
Yes
The device is used for the administration of nutrient fluids, chemotherapeutic agents, and other drugs for therapy, indicating its role in medical treatment.
No
The device is a Five Lumen Central Venous Catheter used for administering fluids and drugs, blood sampling/delivery, and venous pressure monitoring, which are therapeutic and monitoring functions, not diagnostic ones.
No
The device description clearly describes a physical catheter made of polyurethane with multiple lumens and hubs, 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 describes the device's function as a tool for administering fluids, drugs, blood, and monitoring venous pressure within the patient's body. This is a direct interaction with the patient's circulatory system.
- Device Description: The description details a physical catheter designed for insertion into a vein.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide information about a patient's health. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, the Five Lumen Central Venous Catheter is a medical device used for direct patient care and intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Five Lumen Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is intended for short-term vascular access.
Product codes
FOZ
Device Description
Doe Five Lumen Central Venous Catheter is a 10-French radiopaque polyurethane coaxial catheter for short-term use. The catheter is available in lengths of 15 to 30 cm incorporating five round noncommunicating vascular access lumens with numbered, colored-coded hubs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The Five Lumen Central Venous Catheter has undergone testing which provide reasonable assurance of safety and effectiveness for its intended use. Testing includes Biocompatibility, Tensile, Vacuum and Pressure, Leakage and Flow Rate.
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)
Pre-Amendment, K984189, K010021, K904404
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
FEB 2 € 2004
Image /page/0/Picture/1 description: The image shows the word "COOK" in a bold, serif font. A small registered trademark symbol is located to the upper right of the letter "K". The letters are black and the background is white.
Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489 Phone: 800 468-1379 www.cookgroup.com
510(k) Summary
| Submitted by: | Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington, IN 47402 |
|--------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Bosley, MBA, RAC
Ph: (812) 339-2235
Fax: (812) 332-0281 |
| Date Prepared: | February 13, 2004 |
| 510(k) #: | K032274 |
| Device:
Trade Name: | Five Lumen Central Venous Catheter |
| Common/Usual Name: | Central Venous Catheter |
| Proposed Classification: | Intravascular Catheter, Therapeutic, Short-Term, Less than 30 Days
21 CFR Part 880.5200 (80 FOZ) Class II |
Device Description:
Doe Five Lumen Central Venous Catheter is a 10-French radiopaque polyurethane coaxial catheter for short-term use. The catheter is available in lengths of 15 to 30 cm incorporating five round noncommunicating vascular access lumens with numbered, colored-coded hubs.
Intended Use:
The Five Lumen Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is intended for short-term vascular access.
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Cook Incorporated | Central Venous Catheter | Pre-Amendment |
| Maxxim Medical | Argon Multi-Lumen CVC | K984189 |
| Medical Components | Medcomp Quad Lumen CVC | K010021 |
| Arrow International | Multi-Lumen Central Venous Catheter | K904404 |
In terms of section 510(k) substantial equivalence, the Five Lumen Central Venous Catheter is similar in terms of materials, design, intended use and technological characteristics to predicate multi-lumen intravascular catheters used to sample blood, administer fluids intravenously, and to monitor venous pressure.
Test Data:
The Five Lumen Central Venous Catheter has undergone testing which provide reasonable assurance of safety and effectiveness for its intended use. Testing includes Biocompatibility, Tensile, Vacuum and Pressure, Leakage and Flow Rate.
1
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer Bosley, MBA, RAC Regulatory Affairs Coordinator Cook, Incorporated 750 Daniels Way P.O. Box 489
Bloomington, Indiana 47402
Re: K032274
Trade/Device Name: Cook Five Lumen Central Venous Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: December 12, 2003 Received: December 15, 2003
Dear Ms. Bosley:
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.
FEB 2 € 2004
2
Page 2 - Ms. Bosley
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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Cls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use Statement
510(k) Number (if known):
Device Name: Five Lumen Central Venous Catheter
Indications for Use:
The Five Lumen Central Venous Catheter is used for the intravenous administration of nutrien: fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is intended for short-term vascular access.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
free for William Burslick
Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 032274
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use (Optional Format 1-2-96)