The CADD® Administration Set is designed to be used with Deltec CADD® Pumps to allow fluid delivery from a flexible remote bag with female luer connector.

Device Description

The purpose of this submission is to offer an additional CADD® Administration Set that can be used with three new accessories; i.e. a 250 ml Flexible Medication Reservoir, a Modified Security Shell, and a Security Shell Adapter; for the delivery of fluids with SIMS Deltec CADD® ambulatory infusion pumps. The Modified Security Shell and Security Shell Adapter provide a "locked" compartment for the 250 ml Flexible Medication Reservoir to deter unauthorized access to its contents. An add-on antisiphon valve is included with the set. This valve is designed to protect against unregulated gravity infusion that can result from an improperly attached reservoir.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the CADD® Administration Set and Accessories. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through extensive studies.

Therefore, the typical structure for reporting acceptance criteria and study details for an entirely new device (including metrics like sensitivity, specificity, or reader performance improvement) is not directly applicable here. Instead, the "acceptance criteria" can be inferred as demonstration of "substantial equivalence" to the predicate device, supported by functional testing and comparisons.

Here's how the information can be organized based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Comparison with Predicate Device)
Intended Use Equivalence: Designed for fluid delivery with Deltec CADD® Pumps from a flexible remote bag with female luer connector.	Matches: "The CADD® Administration Set is designed to be used with Deltec CADD® Pumps to allow fluid delivery from a flexible remote bag with female luer connector." (Identical to predicate CADD® Admin Set, and similar to Sabratek)
Compatibility with Remote Flexible Reservoir: Capable of being used with a remote flexible reservoir.	Matches: YES (for both the new device with accessories and all predicate devices)
Compatibility with Enclosure for Medication Access Limitation: Capable of being used with an enclosure and remote flexible reservoir to limit access to medication.	Matches: YES (Modified Security Shell, Security Shell Adapter, and 250 ml Flexible Medication Reservoir included as part of this submission; similar to predicate Sabratek and CADD® Admin Set)
Free Flow Protection Mechanism: Includes a mechanism to protect against unregulated gravity infusion.	Matches: YES (Add-on anti-siphon valve) (Similar to predicate CADD® Admin Set, Sabratek status unknown)
Biocompatibility: Fluid path components must be biocompatible.	Meets: Biocompatibility testing was conducted on the set's fluid path components, and results indicated that the fluid path materials are biocompatible.
Physical Dimensions (Nominal): Dimensions of the administration set.	Similar:- Length: 69 in. (Predicate CADD®: 77 in., Sabratek: 56 in.)- Tubing I.D.: 0.040 in. (Predicate CADD®: 0.040 in., Sabratek: Unknown)- Tubing O.D.: 0.105 in. (Predicate CADD®: 0.105 in., Sabratek: Unknown)
Priming Volume: Priming volume of the administration set.	Similar: 2 ml (Predicate CADD®: 2.3 ml, Sabratek: 3 ml)

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

Sample Size: Not explicitly stated as a numerical sample size for "test sets" in the typical sense of clinical trials. The evaluation was primarily based on comparative analysis of design specifications and functional testing (biocompatibility).
Data Provenance: The biocompatibility testing would have been conducted in a laboratory setting, likely in the US (as the applicant is SIMS Deltec, Inc. in St. Paul, MN). The comparison data for predicate devices is based on their known specifications.
Retrospective or Prospective: Primarily retrospective comparison to predicate device specifications and prospective laboratory testing for biocompatibility.

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

This information is not applicable to this type of submission. "Ground truth" in the context of clinical device performance, expert consensus, or pathology is not established for this 510(k). The evaluation relies on engineering and material science principles, and comparison to existing, legally marketed devices.

4. Adjudication Method for the Test Set

Not applicable. No clinical adjudication process involving human reviewers or experts for specific cases is mentioned.

5. 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

No. This is a medical device for fluid administration, not an imaging or diagnostic AI-powered device that would involve human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is a physical medical device. There is no "algorithm" or AI component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the comparison of functional and design specifications is the published specifications and documented performance of the legally marketed predicate devices.
For biocompatibility, the "ground truth" is established by biocompatibility testing standards and protocols.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set."

Summary of the Study:

The "study" presented here is a functional and comparative analysis rather than a clinical trial.

Functional Testing: Biocompatibility testing was performed on the fluid path components of the new CADD® Administration Set and Accessories.
Comparative Analysis: The new device was compared to two predicate devices: an existing CADD® Administration Set (manufactured by SIMS Deltec, Inc.) and the Sabraset™ 560500-100 Administration Set (manufactured by Sabratek). This comparison covered intended use, compatibility with remote reservoirs and security enclosures, free-flow protection, and physical dimensions (length, tubing diameter, priming volume).

Conclusion:

The results of the biocompatibility testing indicated that the materials were acceptable for human use. The comparison demonstrated that the new CADD® Administration Set and Accessories are substantially equivalent to the predicate devices in terms of materials, design, and function, thereby meeting the requirements for 510(k) clearance. Clinical studies were not deemed necessary due to this demonstrated similarity.

Summary

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2/12/99

K990083

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

CADD® Administration Set and Accessories

January 6, 1999

GENERAL INFORMATION I.

Applicant's Nameand Address:	SIMS Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	Edward W. NumainvilleVice President, Regulatory Affairs and Quality SystemsTel. (651) 628-7166
Common/Usual Name:	Administration Set and Accessories
Proprietary Name:	CADD® Administration SetCADD® 250 ml Flexible Medication ReservoirModified Security ShellSecurity Shell Adapter
Equivalence DeviceComparison:	CADD® Administration Set(manufactured by SIMS Deltec, Inc.)SabrasetTM 560500-100 Administration Set with 100 mlBag and Cassette(manufactured by Sabratek)

II. DEVICE DESCRIPTION

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ロ. INTENDED USE OF DEVICE

The CADD® Administration Set is designed to be used with Deltec CADD® Pumps to allow fluid delivery from a flexible remote bag with female luer connector.

DEVICE COMPARISON IV.

	SIMS Deltec CADD®	Sabratek Sabraset™560500-100
	Administration Set withAccessories	Administration Set with100 ml Bag & Cassette	SIMS Deltec CADD®Administration Set
INTENDED USE	The CADD® Admin-istration Set is designed tobe used with DeltecCADD® Pumps to allowfluid delivery from aflexible remote bag withfemale luer connector.	For use with the Sabratek6060 Homerun® pump.	The CADD® Admin-istration Set is designed tobe used with a variety ofDeltec CADD® Pumps toallow fluid delivery from aremote bag.
CAN BE USED WITHREMOTE FLEXIBLERESERVOIR	YES	YES	YES
CAN BE USED WITHAN ENCLOSURE ANDREMOTE FLEXIBLERESERVOIR TOLIMIT ACCESS TOMEDICATION	YES(Modified Security Shell,Security Shell Adapter,and 250 ml FlexibleMedication Reservoir)Subject of this submission.	YES	YES
FREE FLOWPROTECTIONMECHANISM	YES(Add-on anti-siphonvalve)	UNKNOWN	YES(Add-on anti-siphonvalve)
DIMENSIONS(NOMINAL)
LENGTH	69 in.	56 in.	77 in.
TUBING I.D.	0.040 in.	UNKNOWN	0.040 in.
TUBING O.D.	0.105 in.	UNKNOWN	0.105 in.
PRIMING VOLUME	2 ml	3 ml	2.3 ml

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510(k) Summary of Safety and Effectiveness Page 3 of 3

V. SUMMARY OF STUDIES

Functional Testing A.

Biocompatibility testing was conducted on the set's fluid path components.

Clinical Studies B.

Clinical studies were not deemed necessary regarding the CADD® Administration Set and Accessories due to their similarity in materials, design and function to other SIMS Deltec products and the Sabratek Set and Accessories.

C. Conclusions Drawn from the Studies

The results of the testing indicated that the fluid path materials used in the CADD® Administration Set and Accessories are biocompatible. Therefore, these products 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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1999

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

Re : K990083 Trade Name: CADD® Administration Set, and Accessories Regulatory Class: II Product Code: FPA Dated: January 6, 1999 Received: January 11, 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 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 (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. ਰੈ 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Numainville

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 marketed produces or mits 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

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

Enclosure

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K990083

510(k) Number (if known): _

Device Name: CADD Administration Set with Accessories

Indications for Use:

"The CADD® Administration Set is designed to be used with Deltec CADD® Pumps to allow fluid delivery from a flexible remote bag with female luer connector."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

Over-The Counter Use _________________

Palacios Crescenti
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 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.