The purpose of this submission is to offer an alternate 1.2 µ Filter for manufacturing standardization and use with the current SIMS Deltec Administration Sets. The Administration Sets are made up of the following components: bag spike, tubing, housing, 1.2 µ filter, tubing clamp, injection site (found on the CADD-Prizm® High Volume Administration Set only), male luer connector with protective cap, and antisiphon valve.

AI/ML Overview

The provided 510(k) summary for the CADD-Prizm® High Volume Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve and the CADD® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve does not contain information related to a study proving the device meets acceptance criteria.

This document is a 510(k) summary of safety and effectiveness aiming to demonstrate substantial equivalence to previously marketed devices, not a report of a study specifically designed to prove acceptance criteria for a new, unique device.

However, based on the provided text, we can infer some information about acceptance criteria and the "study" conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission, the "acceptance criteria" are implied by the functional and biocompatibility requirements. The "device performance" is a statement that these criteria were met.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Specification	Filter functions according to specification.
Biocompatibility	Set meets biocompatibility requirements.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document states "Functional specification testing was performed on the alternate filter when used with the anti-siphon valve" and "Biocompatibility testing was conducted" but does not give sample sizes for these tests.
Data Provenance: The testing was implicitly performed by SIMS Deltec, Inc. (the manufacturer). No country of origin is specified, but given the company's US address, it's likely US-based. The testing is retrospective in the sense that it's reported after completion as part of the submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic or image-analysis AI devices. For an administration set, "ground truth" is determined by objective functional and material testing against established standards or specifications.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical evaluations, particularly for diagnostic accuracy. For functional and biocompatibility testing of a medical device like an administration set, the results are typically objectively measured and do not require expert adjudication in this manner.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The device in question is a medical administration set, not an AI or diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study of an algorithm was not done. This device is a physical administration set, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation was based on functional specifications and biocompatibility requirements. These are objective, technical standards and tests, rather than expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical administration set, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no "training set" for this type of device.

Summary

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K991301

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

CADD-Prizm® High Volume Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve

CADD® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve

April 15, 1999

I. GENERAL INFORMATION

Applicant's Name and Address:	SIMS Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	Edward W. NumainvilleVice President, Regulatory Affairs andQuality Systems
Common/Usual Name:	Administration Set
Proprietary Name:	CADD-Prizm® High Volume Administration Setwith 1.2 $\mu$ Filter and Add-on Anti-siphon ValveCADD® Administration Set with 1.2 $\mu$ Filter andAdd-on Anti-siphon ValveHereafter, collectively referred to as"Administration Sets".
Equivalence Device Comparison:	CADD-Prizm® High Volume Administration Setwith 1.2 $\mu$ Filter and Add-on Anti-siphon ValveCADD® Administration Set with 1.2 $\mu$ Filter andAdd-on Anti-siphon Valve

II. DEVICE DESCRIPTION

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INTENDED USE OF THE DEVICE III.

The CADD-Prizm High Volume Administration Set is designed for use with the CADD-Prizm® pump to allow fluid delivery from an IV bag.

The CADD® Administration Set is designed to be used with a variety of CADD® pumps to allow fluid delivery from an IV bag.

IV. DEVICE COMPARISON

	CADD-Prizm HighVolume AdministrationSet with 1.2 µ Filter andAdd-on Anti-siphon Valve	CADD-Prizm® HighVolume AdministrationSet with 1.2 µ Filter andAdd-on Anti-siphon Valve	CADD® AdministrationSet with 1.2 µ Filter andAdd-on Anti-siphon Valve	CADD® AdministrationSet with 1.2 µ Filter andAdd-on Anti-siphon Valve
MANUFACTURER	SIMS Deltec, Inc.	SIMS Deltec, Inc.	SIMS Deltec, Inc.	SIMS Deltec, Inc.
510(K) NUMBER	Subject Device	K943310	Subject Device	K933390 K954870
INDICATIONS FORUSE	The CADD-Prizm® HighVolume Administration Setis designed for use with theCADD-Prizm® pump toallow fluid delivery froman IV bag.	The CADD-Prizm® HighVolume Administration Setis designed for use with theCADD-Prizm® pump toallow fluid delivery froman IV bag.	The CADD®Administration Set isdesigned to be used with avariety of CADD® pumpsto allow fluid delivery froman IV bag.	The CADD®Administration Set isdesigned to be used with avariety of CADD® pumpsto allow fluid delivery froman IV bag.
DIMENSIONS(Nominal)
LENGTH	120 in.	120 in.	94 in.	94 in.
I.D.	0.100	0.100	0.060 in. (coiled tubing)	0.060 in. (coiled tubing)
O.D.	0.164	0.164	0.105 in. (coiled tubing)	0.105 in. (coiled tubing)
FILTER	YES	YES	YES	YES
ANTI-SIPHONVALVE	YES	YES	YES	YES

V. SUMMARY OF STUDIES

A. Functional Testing

Functional specification testing was performed on the alternate filter when used with the anti-siphon valve.

Biocompatibility testing was conducted.

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Clinical Studies B.

Clinical studies were not deemed necessary regarding the new Administration Sets due to their similarity in materials, design and function to current commercially available SIMS Deltec Administration Sets.

Conclusions Drawn from the Studies C.

The results of the testing indicated that the filter functions according to specification and the set meets the biocompatibility requirements. Therefore, the Administration Sets are considered acceptable for human use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 9 1999

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

Re : K991301 Trade Name: CADD-Prizm® High Volume Administration Set with 1.2 μ Filter and Add-on Anti-siphon Valve Requlatory Class: II Product Code: FPA Dated: April 15, 1999 Received: April 16, 1999

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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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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 asborizon in four and 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 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 one royalation" (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.fdag.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

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

Enclosure

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K991301

510(k) Number (if known):

Device Name: CADD-Prizm® High Volume Administration Set with 1.2 u Filter and Add-on Anti-siphon Valve

Indications for Use:

"The CADD-Prizm® High Volume Administration Set is designed for use with the CADD-Prizm® pump to allow fluid delivery from an IV bag."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Palanca Cassonte

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 1199

) Prescription Use (Per 21 CFR 801.109) Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

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K991301

510(k) Number (if known): _

Device Name: CADD® Administration Set with 1.2 u Filter and Add-on Anti-siphon Valve

Indications for Use:

"The CADD® Administration Set is designed to be used with a variety of CADD® pumps to allow fluid delivery from an IV bag."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cuende

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 49

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The Counter Use

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.