(134 days)
V1424, V1515-15
BAXTER McGaw V 1424, McGaw V1515-15
No
The device description focuses on the use of colored tubing for identification and tracking of IV lines, with no mention of AI or ML technologies.
No.
The device is used for administering fluids, not for treating a disease or condition directly. Its purpose is to facilitate the delivery of already prepared medications/solutions.
No
The device is used to administer fluids and aid in identification of tubing, not to diagnose a condition or disease.
No
The device description explicitly states it is manufactured using "colored tubes," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer fluids to a patient's vascular system. This is a therapeutic or delivery function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of the tubing (colored) to aid in identification during administration. It does not mention any analysis of biological samples or diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample for diagnostic purposes.
- Anatomical Site: The anatomical site is the patient's vascular system, which is the site of administration, not typically the site of in vitro diagnostic testing.
In vitro diagnostics are devices used to examine specimens from the human body, such as blood, tissue, or urine, to detect diseases, conditions, or infections. This device's function is purely for the delivery of substances into the body.
N/A
Intended Use / Indications for Use
colorVees Intravascular Administration Set will be used to administer fluids from a container to a patient's vascular system through a needle or catheter. The proposed device will enable the practitioner to identify and follow the colored multiple lines during the administration of intravenous solutions/medicaments.
Product codes
FPA
Device Description
colorVees Intravascular Administration Set will be used to administer fluids from t a container to a patient's vascular system through a needle or catheter. The proposed device will enable the practitioner to identify and follow the colored multiple lines during the administration of intravenous solutions/medicaments. This device is manufactured using different colored tubes. Its difference from predicated legally marked devices relies in this multiplicity of colored tubing. These colored tubes assist the practitioner to instantaneously identify and follow the delivery tubing when there is a need to run a plurality of intravascular administration sets to the same patient. The fundamental value added concept is to enlist color as an additional means of identification of tubing. This will greatly aid in preventing a practitioner from failing to make the proper identification of an IV tube from point of source (the IV solution itself) to point of delivery (venipuncture site on patient's body).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BAXTER McGaw V 1424 McGaw V1515-15
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Re: K983411, colrVees IV Sets
510K Summary
| Company Name: | VALNET Medical Corp. |
|---|---|
| Address: | Felicia Industrial Park (Playa) |
| Street B Lot 16 | |
| PO Box 859 | |
| Santa Isabel, Puerto Rico | |
| 00757-0859 | |
| Telephone: | (787) 845-2727 |
| Contact Person: | Víctor Ortíz, Vice-President and General Manager |
| Date: | 09/18/98 |
| Name of Device: | Intravascular Administration Set |
| Trade Name: | colorVees IV Set 20 drops/ml 105" |
| colorVees IV Set 60 drops/ml 105" | |
| colorVees IV Set Vented 20 drops/ml 105" | |
| colorVees IV Set Vented 60 drops/ml 105" | |
| Usual Name: | Intravascular Administration Set |
| Classification: | FPA Class II Device |
| For discussion only | |
| Solo para discutirse | |
| Predicate on legally marked device: |
2C5435s BAXTER McGaw V 1424 McGaw V1515-15
Description of the device:
Function:
colorVees Intravascular Administration Set will be used to administer fluids from t a container to a patient's vascular system through a needle or catheter. The
. .
colorVees Intravascular Administration Set Section E-R2.doc, 2/3/99
1
Re: K983411, colrVees IV Sets
proposed device will enable the practitioner to identify and follow the colored multiple lines during the administration of intravenous solutions/medicaments. Basic Scientific Concept:
This device is manufactured using different colored tubes. Its difference from predicated legally marked devices relies in this multiplicity of colored tubing. These colored tubes assist the practitioner to instantaneously identify and follow the delivery tubing when there is a need to run a plurality of intravascular administration sets to the same patient. The fundamental value added concept is to enlist color as an additional means of identification of tubing. This will greatly aid in preventing a practitioner from failing to make the proper identification of an IV tube from point of source (the IV solution itself) to point of delivery (venipuncture site on patient's body).
Significant Physical and Performance Characteristics:
There are no significant physical differences or performance characteristics from predicated devices. The only difference from predicated legally marked devices relies in its coloring. These colored tubes comply with biocompatibility requirements of FDA Blue Book Memorandum #G95-1 ISO 10993-1.
Statement of how the technological characteristics compare to predicate or legally marked devices:
The colorVees Intravascular Administration Set's technological characteristics are similar or compare to those of predicated devices. The only difference between the colorVees Intravascular Administration Sets and predicated legally marked devices relies in its coloring.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 1999
Mr. Victor Ortiz Vice-President and General Manager VALNET Medical Corporation Felicia Industrial Park (Playa) Street B Lot 16 P.O. Box 859 Santa Isabel, Puerto Rico 00757-0859
Re : K983411 ColorVees IV Sets Trade Name: Requlatory Class: II Product Code: FPA October 27, 1998 Dated: Received: November 16, 1998
Dear Mr. Ortiz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਮ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Paqe 2 - Mr. Ortiz
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Re: K983411. colorVoes IV Sets
Ver/3 - 4/24/96
Applicant: VALNET Medical Corp.
510 (k) Number (if known):
Device Name: colorVees Intravascular Administration Set
Indications for Use:
colorVees Intravascular Administration Set will be used to administer fluids from a container to a patient's vascular system through a needle or catheter. The proposed device will enable the practitioner to identify and follow the colored multiple lines during the administration of intravenous solutions/medicaments.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-The-Counter_ Prescription Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Patricia Crescenti
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
K 983411 510(k) Number _