(382 days)
Not Found
No
The summary describes a catheter with antimicrobial properties and clinical trial results related to infection reduction. There is no mention of AI or ML technology.
No
The device is primarily used for drug administration and monitoring. While it helps protect against infections, the text explicitly states it's "not intended to be used as a treatment for existing infections," which would be a characteristic of a therapeutic device. Its function regarding CRBSI is preventative.
No
The device is described as a catheter used for the administration of fluids and drugs, blood sampling, blood delivery, and venous pressure monitoring, and it is impregnated with antimicrobials to prevent infections. These are therapeutic and monitoring functions, not diagnostic ones.
No
The device description clearly states it is a physical catheter made of silicone, impregnated with antimicrobials, and available in various sizes and lumen configurations. It is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the intravenous administration of fluids and drugs, blood sampling, blood delivery, and venous pressure monitoring. These are all procedures performed on the patient's body, not on samples outside the body for diagnostic purposes.
- Device Description: The description details a catheter designed for insertion into veins.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, etc.) to diagnose a condition or provide information about a patient's health status. The antimicrobial impregnation is for preventing infection in the patient, not for testing a sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is therapeutic and procedural, not diagnostic.
N/A
Intended Use / Indications for Use
The COOK Spectrum® Silicone 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. Catheters are available in single and double lumen PICC, and single, double and triple lumen CVC.
Product codes (comma separated list FDA assigned to the subject device)
FOZ, LJS
Device Description
The COOK Spectrum® Silicone Catheters are single, double or triple lumen central venous catheters; and single and double lumen peripherally inserted central catheters available in sizes ranging from 4Fr single lumen to 12Fr double lumen. including an 8Fr triple lumen device. Catheter lengths range from 8 to 60 cm. The catheter is impregnated with an antimicrobial combination of minocycline and rifampin. The device is supplied sterile and intended for one-time use.
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)
In this prospective, randomized clinical trial with well matched treatment and control cohorts, results indicate that the COOK Spectrum® Silicone Catheter can significantly reduce the rate of catheter-related bloodstream infection (CRBSI). Clinical safety was evaluated by comparing rates of each complication (other than CRBSI) for the treatment cohort versus the control cohort. To determine effectiveness, the occurrence of definite CRBSI was evaluated as the primary outcome measure. When available, catheters were evaluated after removal from patients by zone of inhibition testing against MRSA (CI4371). Determination of catheter colonization was based on results of any culture from the subcutaneous and tip segment of the catheter using roll plate and sonication culture techniques. Performance was evaluated by comparing the incidence of catheter removal due to catheter leak, bleeding around the catheter thrombosis between the two study groups and by comparing the incidence of catheter repositioning.
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.
A137605, K992198, K010034, K950118, K011812, K000251, K993691
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
Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489 Phone: 800 468-1379 www.cookgroup.com
MAY 3 0 2003
510(k) Summary
Page 1 of 2
| Submitted by: | Cook Incorporated |
|---|---|
| Contact Person: | Jennifer Bosley, MBA |
| Ph: (812) 339-2235 x2093 | |
| Fax: (812) 332-0281 | |
| Date Prepared: | March 26, 2003 |
| 510(k) #: | K021557 |
| Device: | COOK Spectrum® Silicone Catheter |
| Trade Name: | Intravascular Catheter, Central Venous Catheter |
| Common/Usual Name: | Intravascular Catheter, Therapeutic, Long-term and Short-term |
| Proposed Classification: | 21 CFR Part 880.5970 (80 LJS), Class II |
| 21 CFR Part 880.5200 (80 FOZ), Class II |
Device Description:
The COOK Spectrum® Silicone Catheters are single, double or triple lumen central venous catheters; and single and double lumen peripherally inserted central catheters available in sizes ranging from 4Fr single lumen to 12Fr double lumen. including an 8Fr triple lumen device. Catheter lengths range from 8 to 60 cm. The catheter is impregnated with an antimicrobial combination of minocycline and rifampin. The device is supplied sterile and intended for one-time use.
Intended Use:
The COOK Spectrum® Silicone 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. Catheters are available in single and double lumen PICC, and single, double and triple lumen CVC.
1
Predicate Devices:
The COOK Spectrum® Silicone Catheter is comparable in terms of intended use and technological characteristics to predicate intravascular catheters used to sample blood, administer fluids intravenously, and to monitor venous pressure.
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| COOK Incorporated | Silicone Catheter | A137605 |
| COOK Incorporated | Single Lumen Urethane PICC | K992198 |
| COOK Incorporated | Double Lumen Urethane PICC | K010034 |
| COOK Incorporated | Spectrum® Catheter | K950118 |
| COOK Incorporated | Spectrum® Ventricular Catheter | K011812 |
| COOK Urological/OB/GYN | Spectrum® Silicone Foley Catheter | K000251 |
| Arrow International, Inc. | ARROWgard Blue PlusTM Multi-Lumen CVC | K993691 |
Substantial Equivalence:
The device will be manufactured according to specified process controls, adhering to Good Manufacturing Practices and Quality System Regulations, undergoing processing, sterilization and packaging procedures similar to devices currently manufactured and marketed by Cook Incorporated. This device is similar with respect to indications for use and design to predicate devices in terms of section 510(k) substantial equivalence.
Test Data:
The COOK Spectrum® Silicone Catheter has undergone biocompatibility, performance, and clinical testing which provide reasonable assurance of safety and effectiveness for its intended use. Testing includes:
- Biocompatibility
- . Tensile Testing
- Vacuum and Pressure Testing
- HPLC and Zone of Inhibition Testing ●
- Flow Testing .
- Shelf-Life Testing .
Clinical Evaluation:
In this prospective, randomized clinical trial with well matched treatment and control cohorts, results indicate that the COOK Spectrum® Silicone Catheter can significantly reduce the rate of catheter-related bloodstream infection (CRBSI). Clinical safety was evaluated by comparing rates of each complication (other than CRBSI) for the treatment cohort versus the control cohort. To determine effectiveness, the occurrence of definite CRBSI was evaluated as the primary outcome measure. When available, catheters were evaluated after removal from patients by zone of inhibition testing against MRSA (CI4371). Determination of catheter colonization was based on results of any culture from the subcutaneous and tip segment of the catheter using roll plate and sonication culture techniques. Performance was evaluated by comparing the incidence of catheter removal due to catheter leak, bleeding around the catheter thrombosis between the two study groups and by comparing the incidence of catheter repositioning.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wing-like shapes, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2003
Ms. Jennifer Bosley, MBA Regulatory Affairs Coordinator Cook. Incorporated 925 South Curry Pike P.O. Box 489 Bloomington, Indiana 47402-0489
Re: K021557
Trade/Device Name: COOK Spectrum® Silicone Catheter Regulation Number: 880.5200, 880.5970 Regulation Name: Intravascular Catheter, Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: FOZ, LJS Dated: March 26, 2003 Received: March 27, 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 vour 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.
3
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 vour 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) 594-4618. 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 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
Susan Runse
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name:
COOK Spectrum® Silicone Catheter
Indications for Use:
The COOK Spectrum® Silicone 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 catheterrelated bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections. Catheters are available in single and double lumen PICC: and single, double and triple lumen CVC. The device is supplied sterile and intended for one-time use.
PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Salvatore Cucenti
Division Sian-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: K021557
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)