The FLOSTAR Needleless Connector device is sterile, disposable, needle-less I.V. access valve for use in intravenous administration of fluids to a patient's vascular system. The FLOSTAR Needleless Connector device may aid in the prevention of needle stick injuries.

Device Description

The FLOSTAR Needleless Connector is a sterile, disposable, needle-less I.V. access valve for use in general intravenous administration of fluids.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria related to device performance (e.g., accuracy, sensitivity, specificity) for an AI/device, nor does it describe a study (including sample sizes, expert ground truth, adjudication methods, or MRMC studies) designed to prove the device meets such criteria.

Instead, the document is a 510(k) premarket notification for the "FLOSTAR Needleless Connector," a medical device, with a focus on demonstrating "substantial equivalence" to a predicate device.

Here's a breakdown of what the document does provide, and what is missing based on your request:

What is present in the document:

Device Type: FLOSTAR Needleless Connector (not an AI-driven diagnostic or image analysis device).
Intended Use: Sterile, disposable, needle-less I.V. access valve for intravenous fluid administration and aid in preventing needle stick injuries.
Predicate Device: Safe-Connect Valve.
Demonstration of Substantial Equivalence: The document states the FLOSTAR Needleless Connector is substantially equivalent to the Safe-Connect Valve because they:
- have the same intended use.
- use the same operating principle.
- incorporate the same final design configuration.
- are both labeled as single patient use.
- are packaged and labeled using the same materials and processes.
Summary of Testing (General): "All materials used in the fabrication of this FLOSTAR Needleless Connector were evaluated with the original design through physical testing and biocompatibility testing." This is a general statement about material and design testing, not performance metrics based on clinical data or AI evaluation.

What is missing from the document (as it pertains to your request for AI/device performance criteria and studies):

A table of acceptance criteria and the reported device performance: This document does not provide specific performance metrics (like accuracy, sensitivity, specificity, etc.) with corresponding acceptance criteria. It primarily focuses on equivalence to a predicate device in terms of design and material.
Sample size used for the test set and the data provenance: Not applicable, as no such performance study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided document is a 510(k) notification demonstrating substantial equivalence for a physical medical device (a needleless connector), not an AI-driven device requiring performance evaluation based on clinical data, ground truth establishment, or specific diagnostic metrics as envisioned by your detailed request. Therefore, it does not contain the information needed to fill out the requested table regarding acceptance criteria and study details for an AI-enabled device.

Summary

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NOV 2 1 2002

K023585

10.0 SUMMARY OF SAFETY AND EFFECTIVENESS

Manufacturer:	IntraVascular Incorporated3600 Bur Wood DriveWaukegan, Illinois 60085
Contact:	Steve AperavichPresident, IntraVascular Incorporated
Telephone Number:Fax Number:	847-596-7700847-596-7710
Date Summary Prepared:	November 18, 2002
Product Trade Name:	FLOSTAR Needleless Connector
Common Name:	Needle-less I.V. Access Valve
	Classification: Set, Administration, Intravascular21 CFR 880.5440
Predicate Devices:	Safe-Connect Valve

Description:

The FLOSTAR Needleless Connector is a sterile, disposable, needle-less I.V. access valve for use in general intravenous administration of fluids.

Intended Uses/Indications:

Substantial Equivalence:

The FLOSTAR Needleless Connector is substantially equivalent to the current Safe-Connect Valve in that:

have the same intended use, .
use the same operating principle, ●
incorporate the same final design configuration .
are both labeled as single patient use .
are packaged and labeled using the same materials and processes ●

Intra Vascular Incorporated FLOSTAR Needleless Connector Special 510(k) Notification

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Summary of Testing:

All materials used in the fabrication of this FLOSTAR Needleless Connector were evaluated with the original design through physical testing and biocompatibility testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

Rockville MD 20850

NOV 21 2002

Mr. Steve Aperavich President IntraVascular Incorporated 3600 Bur Wood Drive Waukegan, Illinois 60085

Re: K023585

Trade/Device Name: FLOSTAR Needleless Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 22, 2002 Received: October 25, 2002

Dear Mr. Aperavich:

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 your 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.

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Page 2 – Mr. Aperavich

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 (OS) 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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K0235585

Page 1 of 1

K023585 510(k) Number (if known):

FLOSTAR Needleless Connector Device Name:

Indications For Usc:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use (Per 21 CFR 801.109)

Over -The-Counter Use

Patricio Caicedo

(Division Sign-Off) Division of Dental, Infection Control, And General Hospital Devices

5109(k) Number KC23585

Intra Vascular Incorporate FLOSTAR Needleless Connector Special 510(k) Notification

113

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.