The Extension Set with 0.2u filter and anti-siphon valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps.

The CADD® Administration Set with 0.2u filter and anti-siphon valve is intended for use with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps for the administration of fluids or medications.

Device Description

The purpose of this submission is to offer an alternate 0.2u filter, as a matter of customer preference, for use with the SIMS Deltec Extension Set with Anti-Siphon Valve and CADD® Administration Set with 0.2u Filter and Anti-Siphon Valve. The 0.2u filter is similar to the filter on the Abbott Laboratories' Filter Set with 0.22u Filter. An integral anti-siphon valve is included and is designed to protect against unregulated gravity infusion that may result from an improperly attached reservoir.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Extension Set with 0.2µ Filter and Anti-Siphon Valve and CADD® Administration Set with 0.2µ Filter and Anti-Siphon Valve). However, it describes the device and its intended use but does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document states that the purpose of the submission is to offer an alternate 0.2µ filter, similar to one on an existing Abbott Laboratories' product. It focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices, rather than presenting a detailed performance study with acceptance criteria.

Therefore, I cannot provide the requested table and detailed study information based on the given text. The provided document is a regulatory submission for premarket notification, not a performance study report.

No information is available in the provided text for the following requests:

A table of acceptance criteria and the reported device performance
Sample sized used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
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
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

Summary

{0}------------------------------------------------

K980 583

APR 27 1998 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

APR 2 7 1998 510(k) SUMMARY OF SAFETY AND with

Deltec Extension Set with Anti-Siphon Valve and CADD® Administration Set with 0.2µ Filter and Anti-Siphon Valve February 12, 1998

GENERAL INFORMATION I.

Applicant's Nameand Address:	SIMS Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	David H. ShortDirector, Regulatory and Clinical AffairsTel. (612) 628-7214
Common/Usual Name:	Extension Set Administration Set
Proprietary Name:	Extension Set with 0.2µ Filter and Anti-Siphon ValveCADD® Administration Set with 0.2µ Filter and Anti-Siphon Valve
Equivalence DeviceComparison:	Extension Set with Anti-Siphon Valve(manufactured by SIMS Deltec, Inc.)CADD® Administration Set with 0.2µ Filterand Anti-Siphon Valve(manufactured by SIMS Deltec, Inc.)Filter Set with 0.22µ Filter, y-Injection Site andOPTION-LOK®(manufactured by ABBOTT LABORATORIES)

II. DEVICE DESCRIPTION

{1}------------------------------------------------

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Alternate 0.2u Filter for use with Deltec Extension Set with Anti-Siphon Valve and CADD® Administration Set with 0.2μ Filter and Anti-Siphon Valve February 12, 1998

INTENDED USE OF DEVICE III.

The CADD® Administration Set with 0.2u filter and anti-siphon valve is intended for use with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps for the administration of fluids or medications.

{2}------------------------------------------------

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 eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 1998

Mr. David H. Short 'Director, Regulatory and Clinical Affairs SIMS Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

Re : K980583 Extension Set with 0.2μ Filter and Anti-Trade Name: Siphon Valve CADD® II Requlatory Class: Product Code: EPA Dated: February 13, 1998 February 17, 1998 Received:

Dear Mr. Short:

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 regulations affecting your device can be found in the Code of Federal Regulations, 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 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

{3}------------------------------------------------

Page 2 - Mr. Short

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.fda.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

{4}------------------------------------------------

Kg80583

510(k) Number (if known):

Device Name: CADD® Administration Set with 0.2µ Filter and Anti-Siphon Valve

Indications for Use:

"The CADD® Administration Set with 0.2µ filter and anti-siphon valve is intended for "The ORDD® Administration Des (CADD-PLUS®, CADD-Prizm® pumps for the administration of fluids or medications."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Caserite

on of Denni, Infection O and General Frispital Devices

510(k) Number K980583

Prescription Use

Over-The Counter Use

(Per 21 CFR 801:109) --

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.