The CADD-TPN® Administration Set is designed for use with the CADD-TPN® pump for the administration of nutritional and other solutions or fluids intravenously from an IV bag.

Device Description

The purpose of this submission is to offer an alternate CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve. The set is made up of the following components: bag spike, tubing, set plate, 1.2 u filter, tubing clamp, injection site, male luer connector with protective cap, and anti-siphon valve. The anti-siphon valve is designed to protect against unregulated gravity infusion that can result from an improperly attached set plate to the CADD-TPN® Ambulatory Infusion Pump.

AI/ML Overview

The provided 510(k) summary for the CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve indicates that this is a Class II medical device. For such devices, the primary demonstration of safety and effectiveness often relies on substantial equivalence to a predicate device, supported by functional testing rather than extensive clinical studies.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Functional specifications for the filter	The filter functions according to specification.
Biocompatibility requirements	The set meets the biocompatibility requirements.
Performance similar to predicate devices in materials, design, and function	Not explicitly detailed as a separate criterion, but assumed as the basis for not requiring clinical studies. The new device's dimensions (length, I.D., O.D.), filter presence, and anti-siphon valve presence are comparable to predicate devices, particularly the CADD-TPN® Administration Set with 1.2 µ Filter and the CADD® Extension Set with Anti-siphon Valve, addressing the "add-on anti-siphon valve" feature.

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 and antisiphon valve" and "Biocompatibility testing was conducted." The exact number of units or tests performed is not mentioned.
Data Provenance: Not specified. It's internal testing conducted by SIMS Deltec, Inc. There is no indication of country of origin for the data or whether it was retrospective or prospective. It is implied to be prospective testing for regulatory submission.

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

Not applicable. The ground truth for functional and biocompatibility testing is established by technical specifications and standardized testing protocols, not by expert consensus in the clinical sense.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or patient outcomes. For functional and biocompatibility testing, results are determined by adherence to pre-defined technical thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. The document explicitly states: "Clinical studies were not deemed necessary regarding the new set due to its similarity in materials, design and function to current commercially available CADD® Administration Sets and Extension Sets."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is an administration set, not an algorithm. Performance is assessed through physical and biological testing, not through algorithmic evaluation.

7. The Type of Ground Truth Used:

Functional Testing: The ground truth for functional testing is the adherence to the device's technical specifications and intended performance (e.g., filter efficacy, anti-siphon valve operation). These specifications would be derived from engineering requirements and industry standards.
Biocompatibility Testing: The ground truth for biocompatibility is compliance with established biological safety standards (e.g., ISO 10993 series) for medical devices, demonstrated through a battery of tests (e.g., cytotoxicity, irritation, sensitization).

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "design and function" similarity to existing devices serves as the basis for demonstrating safety and effectiveness, leveraging the established performance of the predicate devices.

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

Not applicable, as there is no training set for this type of device.

Summary of the Study:

The study proving the device meets acceptance criteria primarily consisted of functional testing and biocompatibility testing.

Functional Testing: This testing assessed whether the "alternate filter and antisiphon valve" performed according to their designed specifications. The conclusion was that "the filter functions according to specification." While specific parameters or pass/fail criteria are not detailed in this summary, it implies that the device achieved its intended functional performance for these key components.
Biocompatibility Testing: This testing evaluated the materials of the device to ensure they are safe for human contact and use without causing adverse biological reactions. The conclusion was that "the set meets the biocompatibility requirements," suggesting compliance with relevant biological safety standards.

The 510(k) submission relied heavily on substantial equivalence to predicate devices. The justification for not conducting clinical studies explicitly states it was "due to its similarity in materials, design and function to current commercially available CADD® Administration Sets and Extension Sets." This means the historical safety and effectiveness data of the predicate devices implicitly served as a basis for the new device's acceptance, supplemented by the targeted functional and biocompatibility tests on the new features (the specific filter and the added anti-siphon valve).

Summary

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K991255

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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

April 9, 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 SystemsTel. (651) 628-7166
Common/Usual Name:	Administration Set
Proprietary Name:	CADD-TPN® Administration Set with 1.2 μFilter and Add-on Anti-siphon Valve
Equivalence Device Comparison:	CADD-TPN® Administration Set with 1.2 μFilterCADD® Extension Set with Anti-siphon ValveCADD® Administration Set with TOTMPlasticized Tubing

II. DEVICE DESCRIPTION

III. INTENDED USE OF THE DEVICE

The CADD-TPN® Administration Set is designed for use with the CADD-TPN® pump for the administration of nutritional and other solutions or fluids intravenously from an IV bag.

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DEVICE COMPARISON IV.

	CADD-TPN®Administration Setwith 1.2 µ Filter andAdd-on Anti-siphonValve	CADD-TPN®Administration Setwith 1.2 µ Filter	CADD® Extension Setwith Anti-siphonValve	CADD®Administration Setwith TOTMPlasticized Tubing
MANUFACTURER	SIMS Deltec, Inc.	SIMS Deltec, Inc.	SIMS Deltec, Inc.	SIMS Deltec, Inc.
510(K) NUMBER	Subject Device	K902374	K942046	K933390
INDICATIONS FORUSE	The CADD-TPN®Administration Set isdesigned for use withthe CADD-TPN® pumpfor the administrationof nutritional and othersolutions or fluidsintravenously from anIV bag.	The CADD-TPN®Administration Set isdesigned for use withthe CADD-TPN® pumpfor the administrationof nutritional and othersolutions or fluidsintravenously from anIV bag.	For use with theMEDICATIONCASSETTE™Reservoir.	The CADD®Administration Set isdesigned to be usedwith a variety of DeltecCADD® Pumps toallow fluid deliveryfrom a remote bag.
DIMENSIONS(Nominal)
LENGTH	114 in.	100 in.	30, 45, or 60 in.	77 in.
I.D.	0.100 in.	0.100 in.	0.039 in.	0.100 in.
O.D.	0.164 in.	0.164 in.	0.106 in	0.164 in.
FILTER	YES	YES	NO	NO
ANTI-SIPHONVALVE	YES	NO	YES	YES

V. SUMMARY OF STUDIES

Functional Testing A.

Functional specification testing was performed on the alternate filter and antisiphon valve.

Biocompatibility testing was conducted.

B. Clinical Studies

Clinical studies were not deemed necessary regarding the new set due to its similarity in materials, design and function to current commercially available CADD® Administration Sets and Extension Sets.

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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 CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve is 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 features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted with three stylized lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ਰ 1999 JUN

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

Re : K991255 Trade Name: CADD-TPN® Administration Set with 1.2 μ Filter and Add-on Anti-siphon Valve Regulatory Class: II Product Code: FPA Dated: April 9, 1999 Received: April 13, 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, qood 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. ਬੇ 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Paqe 2 - Mr. Numainville

this response to your premarket notification Please note: rease 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 described in your sie wir privalence 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
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.fdaygov/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 991255

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

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

Indications for Use:

"The CADD-TPN® Administration Set is designed for use with the CADD-TPN® "The CADD-1111" "Xunimistration of nutritional and other solutions or fluids intravenously 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)

Prescription Use(Per 21 CFR 801.109)	✓
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Over-The Counter UseDivision of Dental, Infection Control, and General Hospital I 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.