The purpose of this submission is to offer an alternate injection site ("Luer Activated Needleless Injection Site") for use with various Deltec administration sets. The injection site is a valve and is accessed using needleless syringes or IV administration sets.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (a Luer Activated Needleless Injection Site). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a medical claim for an AI/ML device. Therefore, the requested information geared towards AI/ML device studies (such as the number of experts used for ground truth, adjudication methods, MRMC studies, training set size, etc.) is not applicable to this document.

However, I can extract the information that is relevant to the functional and biocompatibility testing mentioned in the summary.

Acceptance Criteria and Device Performance (Based on available information):

Acceptance Criteria Category	Reported Device Performance
Functional Specifications	"Functions according to specification"
Biocompatibility	"Meets the biocompatibility requirements"

Study Details (as per the provided document):

Sample size used for the test set and data provenance:
- The document does not specify sample sizes for either functional or biocompatibility testing.
- Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These tests typically involve laboratory testing rather than patient data.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth, in the context of AI/ML, refers to clinically verified labels. For functional and biocompatibility testing of a physical medical device, "ground truth" is established by adherence to predefined engineering specifications and regulatory standards.
Adjudication method for the test set: Not applicable. This concept pertains to resolving discrepancies in expert labeling, which is not relevant for functional and biocompatibility testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical component, not an AI/ML diagnostic or assistive tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) study was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML context. For this device, "ground truth" for functional testing refers to meeting predefined engineering performance parameters, and for biocompatibility, it refers to compliance with established biological safety standards.
The sample size for the training set: Not applicable. This device does not involve machine learning; therefore, a "training set" is not relevant.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device submission.

Summary of Studies from the Document:

Functional Testing: "Functional specification testing was performed on the alternate injection site."
Biocompatibility Testing: "Biocompatibility testing was conducted."
Clinical Studies: "Clinical studies were not deemed necessary regarding the alternate injection site due to its similarity in materials, design and function to current commercially available injection sites."

The conclusion states: "The results of the testing indicated that the alternate injection site functions according to specification and it meets the biocompatibility requirements. Therefore, the alternate injection site is considered acceptable for human use."

Summary

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K991599

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Luer Activated Needleless Injection Site for use with Various Deltec Administration Sets

May 6, 1999

GENERAL INFORMATION I.

Applicant's Name and Address:	SIMS Deltec, Inc.
	1265 Grey Fox Road
	St. Paul, MN 55112
Contact Person:	Edward W. Numainville
	Vice President, Regulatory Affairs andQuality Systems
Common/Usual Name:	Administration Set with Injection Site
Proprietary Name:	For example: CADD-Prizm® High VolumeAdministration Set with 0.2 µ filter, Add-OnAnti-Siphon Valve, bag spike, lueractivated needleless injection site, male luer,and clamp
Equivalence Device Comparison:	ULTRASITE™ Needle-free IV System

II. DEVICE DESCRIPTION

INTENDED USE OF THE DEVICE III.

The alternate injection site is designed for use with various SIMS Deltec administration sets or syringes for fluid delivery.

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DEVICE COMPARISON IV.

	Alternate Injection Site foruse with Various DeltecAdministration Sets	Standard Injection Siteused on the CADD-Prizm®High VolumeAdministration Set	ULTRASITE™ Needle-free IV System
MANUFACTURER	SIMS Deltec, Inc.	SIMS Deltec, Inc.	B. Braun Medical Inc.
510(K) NUMBER	Subject Device	K943310	Unknown
INDICATIONS FOR USE	Designed for use withvarious SIMS Deltecadministration sets orsyringes for fluid delivery.	Designed for use withvarious SIMS Deltecadministration sets for fluiddelivery.	The ULTRASITE™ Valveis a specially designed valvefor use on intravenous lines.It allows you to use asyringe or IV administrationset without a needle.
NEEDLE-FREE VALVE	YES	NO	YES
INTEGRAL TOADMINISTRATION SET	YES	YES	NO

V. SUMMARY OF STUDIES

A. Functional testing

Functional specification testing was performed on the alternate injection site.

Biocompatibility testing was conducted.

Clinical Studies B.

Clinical studies were not deemed necessary regarding the alternate injection site due to its similarity in materials, design and function to current commercially available injection sites.

C. Conclusions Drawn from the Studies

The results of the testing indicated that the alternate injection site functions according to specification and it meets the biocompatibility requirements. Therefore, the alternate injection site is considered acceptable for human use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck, with three wavy lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 15 1999

Mr. Edward W. Numainville Vice President Requlatory Affairs and Quality Systems SIMS Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

K991599 Re: CADD® Administration Set Trade Name: Requlatory Class: II Product Code: FPA Dated: May 6, 1999 May 10, 1999 Received:

Dear Mr. Numainville:

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 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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will Failure to comply with the GMP verify such assumptions. regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Numainville

Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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" (21 CFR 807.97). Other general 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.fdg.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 991599

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Luer Activated Needleless Injection Site

Indications for Use:

The luer activated needleless injection site is designed for use with various SIMS Deltec, Inc. administration sets or syringes for fluid delivery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR Over-the-Counter Use __

Palica Cucente
(Division Sign-Off)

510(k) Nun

EN99038

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.