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.

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).

AI/ML Overview

This document is a 510(k) summary for the VALNET Medical Corp. colorVees IV Sets. It describes the device, its function, and states that its technological characteristics are similar to predicate devices, with the only difference being the colored tubing.

Based on the provided text, the device is considered substantially equivalent to predicate devices, largely due to its similarity in physical and performance characteristics, with the addition of colored tubing as a differentiating feature.

Here's an analysis of the provided information against your requested criteria:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence	The device must administer fluids from a container to a patient's vascular system through a needle or catheter effectively.	The proposed `colorVees Intravascular Administration Set` "will be used to administer fluids from a container to a patient's vascular system through a needle or catheter." This aligns directly with the functional requirement.
Safety - Biocompatibility	The materials used in the device must be biocompatible.	The colored tubes used in the device "comply with biocompatibility requirements of FDA Blue Book Memorandum #G95-1 ISO 10993-1." This directly addresses the biocompatibility criteria.
Performance Characteristics	The device should have no significant physical or performance differences from legally marketed predicate devices, other than the added color.	"There are no significant physical differences or performance characteristics from predicated devices. The only difference from predicated legally marked devices relies in its coloring." This statement confirms the device meets the performance criteria by being equivalent to existing predicate devices.
Identification Aid	The colored tubing should assist practitioners in identifying and following multiple IV lines to prevent errors.	The device "will enable the practitioner to identify and follow the colored multiple lines during the administration of intravenous solutions/medicaments." 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... to point of delivery." This describes the intended positive impact of the differentiating feature.
Substantial Equivalence	Should be substantially equivalent to legally marketed predicate devices.	The FDA reviewed the 510(k) and "determined the device is substantially equivalent... to legally marketed predicate devices." This is the ultimate acceptance criterion for a 510(k) submission and was met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided document does not detail any specific test set or clinical study data for this device. The basis for substantial equivalence is primarily a comparison of the technological characteristics to predicate devices. The biocompatibility compliance is noted as per FDA Blue Book Memorandum #G95-1 ISO 10993-1, which implies material testing, but no specific sample size or provenance is given for this.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The substantial equivalence determination is based on a comparison to predicate devices and compliance with existing standards, rather than expert evaluation of a test set for this specific device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there is no described test set or clinical study requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC or comparative effectiveness study is mentioned in the document. This device is a physical medical device (IV Set) and not an AI-powered diagnostic or assistive tool, so such a study would not be applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable as the device is an IV Set, not an algorithm or AI system.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" in this context is the established performance and safety profiles of the predicate devices and adherence to recognized biocompatibility standards (ISO 10993-1). The device's "sameness" in function and physical characteristics (except color) to these predicates, combined with standard compliance, forms the basis of its acceptance.

8. The sample size for the training set

This information is not provided as there is no training set in the context of this type of device submission.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set. The substantial equivalence is established by direct comparison to predicate devices and adherence to relevant standards.

Summary

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Re: K983411, colrVees IV Sets

K983411

510K Summary

Company Name:	VALNET Medical Corp.
Address:	Felicia Industrial Park (Playa)Street B Lot 16PO Box 859Santa Isabel, Puerto Rico00757-0859
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 DeviceFor discussion onlySolo 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

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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.

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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

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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

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K983411

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:

(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 _

Regulation Number and Section

§ 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.