(218 days)
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.
The 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.
The provided document is a 510(k) summary for a medical device, the Cook Five Lumen Central Venous Catheter. It describes the device, its intended use, and states that it has undergone testing to provide reasonable assurance of safety and effectiveness.
However, the document does not contain the detailed acceptance criteria and a specific study report proving the device meets those criteria in the format requested. It only broadly states "Testing includes Biocompatibility, Tensile, Vacuum and Pressure, Leakage and Flow Rate." It does not provide:
- A table of specific acceptance criteria values and reported performance values.
- Information on sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details for a diagnostic or AI-enabled device study. This is because the device is a physical medical device (a catheter), not a diagnostic tool or an AI algorithm.
Therefore, I cannot fulfill your request for a table of acceptance criteria and the study that proves the device meets them, nor the other requested details, as this information is not present in the provided text. The document is a regulatory submission for a physical medical product, not a software or AI-driven diagnostic.
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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 Incorporated750 Daniels Way, P.O. Box 489Bloomington, IN 47402 |
|---|---|
| Contact Person: | Jennifer Bosley, MBA, RACPh: (812) 339-2235Fax: (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 Days21 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.
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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
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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
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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)
§ 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).