(25 days)
Not Found
No
The device description and performance studies focus on the physical and material properties of a central venous catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
A device that delivers chemotherapy is not necessarily a therapeutic device itself. The central venous catheter facilitates the administration of therapeutic agents (chemotherapy, nutrients, fluids) but is not directly therapeutic; its primary function is as an access pathway.
No.
The device is a central venous catheter used for administering fluids, drugs, and for blood sampling and delivery, but it does not perform any diagnostic functions. Its purpose is therapeutic and for monitoring venous pressure, not for diagnosing conditions.
No
The device description clearly describes a physical central venous catheter, a hardware device, and details performance studies related to its physical properties (tensile strength, flexibility, flow rate, etc.). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body for administering substances, sampling blood, and monitoring pressure. This is an in vivo application.
- Device Description: The description details a catheter designed to be inserted into the vasculature, again indicating an in vivo use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease.
IVD devices are used to test samples like blood, urine, or tissue in a laboratory setting to diagnose or monitor conditions. This device is a therapeutic and monitoring tool used directly on the patient.
N/A
Intended Use / Indications for Use
The Spectrum™ Five Lumen Central Venous Catheter Set is indicated for the intravenous administration of nutrient fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The Spectrum Five Lumen Central Venous Catheter Set is a central venous catheter designed to intravenously administer nutrients, fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring through the vasculature. The Spectrum Five Lumen Central Venous Catheter will be 10 Fr. available in lengths of 15, 20, 25, and 30 cm. The Spectrum Five Lumen Catheter will be impregnated with an average of 683.3 ug/cm minocycline and 564.1 ug/cm rifampin. This device will be supplied sterile and is intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access
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 Spectrum Five Lumen Central Venous Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
- Tensile Testing
- Shaft Flexibility Testing
- Shaft Flexural Fatigue Tolerance Testing
- Gravity Flow Rate Testing
- Air Leakage Testing
- Collapsibility under Vacuum Testing
- Liquid Leakage Testing
- Burst Pressure Testing
- Biocompatibility Testing
- Tensile Testing after Aging
- Amount of Minocycline and Rifampin Impregnated
The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a central venous catheter.
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.
K032274, K033843, K962577, K010021
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
Ko60174
33
510(k) Summary
Submitted By:
FEB 1 7 2006
Evangeline D. Loh, Ph.D., RAC Regulatory Affairs Scientist Cook Incorporated 750 Daniels Way (PO Box 489) Bloomington, IN 47404 (47402) 812-339-2235 January 23, 2006
Device:
| Trade Name: | Cook Incorporated Spectrum Five Lumen Central Venous
Catheter Set |
|--------------------------|----------------------------------------------------------------------|
| Proposed Classification: | Intravascular Catheter
FOZ (21 CFR§880.5200) |
Indications for Use
Indicated for use in vascular access to intravenously administer nutrients, fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring.
Predicate Devices:
The Spectrum Five Lumen Central Venous Catheter Set is similar in terms of intended use, principles of operation, materials of construction and technological characteristics to predicate devices reviewed as devices for venous access to intravenously administer solutions needed in medical treatment.
Device Description:
The Spectrum Five Lumen Central Venous Catheter Set is a central venous catheter designed to intravenously administer nutrients, fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring through the vasculature. The Spectrum Five Lumen Central Venous Catheter will be 10 Fr. available in lengths of 15, 20, 25, and 30 cm. The Spectrum Five Lumen Catheter will be impregnated with an average of 683.3 ug/cm minocycline and 564.1 ug/cm rifampin. This device will be supplied sterile and is intended for one-time use.
1
K060174 34
Substantial Equivalence:
The Spectrum Five Lumen Central Venous Catheter is similar to many devices in commercial distribution for venous access. These devices include the Cook Incorporated Five Lumen Central Venous Catheter Set (D.C. # K032274), Cook Incorporated Spectrum and Spectrum Glide Central Venous Catheter Set (D.C. #K033843), the Arrow International Arrowgard Blue Quad-Lumen Central Venous Catheter (D.C. #K962577), and the Medical Components Medcomp Quad Lumen (D.C.#K010021).
The similar indications for use, principles of operation, technological characteristics, and performance testing results of the Spectrum Five Lumen Central Venous Catheter as compared to the predicate devices support a determination of substantial equivalence.
Test Data:
The Spectrum Five Lumen Central Venous Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
- 1 . Tensile Testing
- Shaft Flexibility Testing in
- Shaft Flexural Fatigue Tolerance Testing ﻢ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ
-
- Gravity Flow Rate Testing
- న్, Air Leakage Testing
- Collapsibility under Vacuum Testing ().
- Liquid Leakage Testing 7.
- Burst Pressure Testing oc
- Biocompatibility Testing ().
- Tensile Testing after Aging 】().
- Amount of Minocycline and Rifampin Impregnated | | .
The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a central venous catheter.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2006
Evangeline D. Loh, Ph.D., RAC Regulatory Affairs Scientist Cook, Incorporated 750 Daniels Way Bloomington, Indian 47404
Re: K060174
K000174
Trade/Device Name: Cook Incorporated Spectrum® Five Lumen Central Venous Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: January 23, 2006 Received: January 24, 2006
Dear Dr. Loh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed your sected by 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 mendments, 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 approvial appressions of the Act. The general controls provisions of the Act include controls provisions of 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 (1 WA), it har ob subject in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device to rear roublish further announcements concerning your device in the Ecderal Register.
3
Page 2 - Dr. Loh
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issualice of a substantials with other requirements
mean that FDA has made a determination that your device Fodard assessios mean that FDA has made a decemination until Josefinistered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by posignity of the Act of any Federal statutes and registerents, including, but not limited to: registration You must comply with an the Act 3 requirement 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Rat 800); and i and listing (21 CFR Fall 807), labeling (21 CFR Pat 820), and if and 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act);
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 5 10(k) I his letter will anow you to begin marketing your alence of your device to a premarket notification. The PDA miding of babbaan of 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), a If you desire specific advice for your device of your device Also, please note the regulation please contact the Other or Comphanes and in (21CFR Part 807.97). You entitled, "Misoranding by reserved to problems on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Binas 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely wours,
Susan Yunae
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
4
510(k) Number (if known):
Device Name:
Cook Incorporated Spectrum™ Five Lumen Central Venous Catheter Set
The Spectrum™ Five Lumen Central Venous Catheter Set is Indications for Use: indicated for the intravenous administration of nutrient fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring.
Prescription Use X (Per 21 CFR 801 Subpart D) ાર
Over-the-Counter Use (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)
Anton Viny
They, General Hospital,