CADD ADMINISTRATION SET

K991599 · Sims Deltec, Inc. · FPA · Jun 15, 1999 · General Hospital

Device Facts

• Record ID: K991599
• Device Name: CADD ADMINISTRATION SET
• Applicant: Sims Deltec, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jun 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Luer activated needleless injection site; valve mechanism integrated into SIMS Deltec administration sets; accessed via needleless syringes or IV sets; enables needle-free fluid delivery; used in clinical settings; replaces standard injection sites to reduce needle-stick risk; provides secure fluid path for medication/fluid administration.

Clinical Evidence

No clinical data. Functional and biocompatibility testing performed to demonstrate safety and performance.

Technological Characteristics

Needle-free valve injection site; integrated into administration sets; materials biocompatible; mechanical actuation via luer connection.

Indications for Use

Indicated for use with SIMS Deltec administration sets or syringes for fluid delivery in patients requiring intravenous therapy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ULTRASITE™ Needle-free IV System (Unknown)

Reference Devices

• CADD-Prizm® High Volume Administration Set (K943310)

Submission Summary (Full Text)

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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 and<br>Quality Systems |
| Common/Usual Name: | Administration Set with Injection Site |
| Proprietary Name: | For example: CADD-Prizm® High Volume<br>Administration Set with 0.2 µ filter, Add-On<br>Anti-Siphon Valve, bag spike, luer<br>activated needleless injection site, male luer,<br>and clamp |
| Equivalence Device Comparison: | ULTRASITE™ Needle-free IV System |

#### II. DEVICE DESCRIPTION

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.

#### 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 for<br>use with Various Deltec<br>Administration Sets | Standard Injection Site<br>used on the CADD-Prizm®<br>High Volume<br>Administration Set | ULTRASITE™ Needle-<br>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 with<br>various SIMS Deltec<br>administration sets or<br>syringes for fluid delivery. | Designed for use with<br>various SIMS Deltec<br>administration sets for fluid<br>delivery. | The ULTRASITE™ Valve<br>is a specially designed valve<br>for use on intravenous lines.<br>It allows you to use a<br>syringe or IV administration<br>set without a needle. |
| NEEDLE-FREE VALVE | YES | NO | YES |
| INTEGRAL TO<br>ADMINISTRATION 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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