(246 days)
Not Found
No
The summary describes a physical medical device (a central venous catheter) with antimicrobial impregnation and a hydrophilic coating. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
No
The device is used for administration of drugs and fluids, blood sampling, and monitoring, and while it has antimicrobial impregnation to prevent infections, it is explicitly stated "It is not intended to be used as a treatment for existing infections," which would be a primary function of a therapeutic device.
No
Explanation: The device is described as a catheter for intravenous administration, blood sampling, blood delivery, and venous pressure monitoring, and is impregnated with antimicrobials. Its primary functions are therapeutic delivery and monitoring, not diagnosis. The text explicitly states "It is not intended to be used as a treatment for existing infections," which further clarifies its non-diagnostic role.
No
The device description clearly describes a physical catheter made of polyurethane with lumens and coatings, 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 as a catheter for the intravenous administration of fluids and drugs, blood sampling and delivery, and venous pressure monitoring. These are all direct interactions with the patient's circulatory system for therapeutic and monitoring purposes.
- Device Description: The description details a physical catheter designed for insertion into a vein.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to test blood, urine, tissue, etc., outside of the body.
The device is a medical device used for direct patient care and treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Spectrum® 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 impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections. The device is a short-term use catheter, supplied sterile and intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The nominal 7-French Triple Lumen Spectrum® Central Venous Catheter with Hydrophilic Coating is a polyurethane catheter with three non-communicating vascular access lumens. The cothing is impregnated with the antimicrobials minocycline and rifamping (avg. concentration 520 ug/clin and 470 ug/cm respectively) and has a hydrophilic coating consisting of polyacrylamide and polyvinylpyridone to enhance insertion.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device has undergone testing that provides reasonable assurance of safety and effectiveness for its intended use. Testing includes: biocompatibility, tensile, vacuum and pressure, flow rate, HPLC and zone of inhibition.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AUG 1 2 2004
COOK®
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 J. Bosley, MBA, RAC
Ph: (812) 339-2235
Fax: (812) 332-0281 |
| Date Prepared: | August 5, 2004 |
| 510(k) #: | K033843 |
| Device: | |
| Trade Name: | Spectrum® Central Venous Catheter with or without Hydrophilic Coating |
| Common/Usual Name: | Central Venous Catheter |
| Proposed Classification: | Intravascular Catheter, 21 CFR Part 880.5200 (80 FOZ) Class II |
Device Description:
The nominal 7-French Triple Lumen Spectrum® Central Venous Catheter with Hydrophilic Coating is a polyurethane catheter with three non-communicating vascular access lumens. The cothing is impregnated with the antimicrobials minocycline and rifamping (avg. concentration 520 ug/clin and 470 ug/cm respectively) and has a hydrophilic coating consisting of polyacrylamide and polyvinylpyridone to enhance insertion.
Intended Use;
The Spectrum® 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 impregnated with the animorobials minocycline and relieves to help provide protection against catheter-related bloodstream infections (CRBSI). II is not intended to be used as a treatment for existing infections. The device is a short-term use catherer, supplied to and intended for one-time use.
Substantial Equivalence:
| Manufacturer | Device |
|---|---|
| the consideration of the program and the first of the first of the first of the first | And Property of Concession, |
| Cook Incorporated | ABRM Central Venous Catheter |
510(k) Number K950118
In terms of section 510(k) substantial equivalence, the device is identical in terms of design, intended use and technological characteristics to the predicate Cook ABRM Catheter except for the addition of the hydrophilic coating.
Test Data:
The device has undergone testing that provides reasonable assurance of safety and effectiveness for its intended use. Testing includes: biocompatibility, tensile, vacuum and pressure, flow rate, HPLC and zone of inhibition.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2004
Ms. Jennifer Bosley, MBA, RAC Regulatory Affairs Coordinator Cook, Incorporated 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402-0489
Re: K033843
Trade/Device Name: Spectrum® Central Venous Catheter with or without Hydrophilic Coating Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: June 22, 2004 Received: June 23, 2004
Dear Ms. Bosley:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your ed your extermined the device is substantially equivalent (for the itsienced above and nave acteringlosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmisered pror to that have been reclassified in accordance with the provisions of Allendinents, or to devroos that in tic Act (Act) that do not require approval of a premarket the rodelar F ood, Drag, and Comments , therefore, market the device, subject to the general approval application (1 Million ) . The general controls provisions of the Act include condors provisions of an 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 If your device is classified (see associety) in a controls. Existing major regulations affecting g (FMA), it may of Subject to Bach ademic and Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.
2
Page 2 - Ms. Bosley
Please be advised that FDA's issuance of a substantial equivalence determination does not Frease be advisod that I Dri o issualites on that your device complies with other requirements mean that I DA nas made a decemmand regulations administered by other Federal agencies. of the Act of ary I outhal bates requirements, including, but not limited to: registration You must comply with an me Hee s roq 21 CFR Part 801); good manufacturing practice allo listing (21 CF RT att 007), laoulity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are qt 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) ITILS felt will anow you to objall finding of substantial equivalence of your device to a premarket notified.com - The PDF 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), If you desire specific at no for your as (301) 594-4618. 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 may obtain 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,
Clus
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
K033843 510(k) Number:
Spectrum® Central Venous Catheter with or without Hydrophilic Coating Device Name:
Indications for Use:
The Spectrum Central Venous Catheter is used for the intravenous administration of nutrient The Spectrum® Central Venous Catheter is used for therapy, blood sampling, blood delivery, and
fluids, chemothers in the sether is impremated with the animicrobials minorobia fluids, chemotherapeutic and other drigs intressmed with the antipics of the open to the courses of the opening the minocyclines (CRBS).
Venous pressure monities and stimes venous pressure monitoring. The extention against catherer-related bloodstream forctions (CRBS).
and rifampin to help provide protection against catheter-related bloodstream and rifampin to help provide protection against cated blooders. The device is a short-term use
It is not intended to be used as treatment for existing use It is not intended to be used as a creading.
catheter, supplied sterile and intended for one-time use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arata V. nxt
Oivision Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: Ky3384)