CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1

K991301 · Sims Deltec, Inc. · FPA · Jun 9, 1999 · General Hospital

Device Facts

• Record ID: K991301
• Device Name: CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1
• Applicant: Sims Deltec, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jun 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

Administration sets for use with CADD-Prizm® and CADD® infusion pumps; components include bag spike, tubing, 1.2 µ filter, tubing clamp, injection site (Prizm model only), male luer connector, and anti-siphon valve. Device facilitates fluid delivery from IV bags to patients. Used in clinical settings by healthcare providers. Design incorporates an alternate 1.2 µ filter for manufacturing standardization. Output is controlled fluid infusion; clinical benefit is safe, filtered delivery of fluids via pump.

Clinical Evidence

No clinical data. Bench testing only. Functional specification testing performed on the alternate filter with the anti-siphon valve; biocompatibility testing conducted. Results confirmed the filter functions to specification and meets biocompatibility requirements.

Technological Characteristics

Components: bag spike, tubing, housing, 1.2 µ filter, tubing clamp, injection site, male luer connector, anti-siphon valve. Dimensions: 120 in. length (Prizm), 94 in. length (CADD). Tubing ID: 0.100 in. (Prizm), 0.060 in. (CADD). Connectivity: mechanical interface with CADD pumps. Sterilization: not specified.

Indications for Use

Indicated for patients requiring fluid delivery from an IV bag via CADD-Prizm® or CADD® pumps.

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

• CADD-Prizm® High Volume Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve (K943310)
• CADD® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve (K933390)
• CADD® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve (K954870)

Submission Summary (Full Text)

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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.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 | | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Edward W. Numainville<br>Vice President, Regulatory Affairs and<br>Quality Systems | | |
| Common/Usual Name: | Administration Set | | |
| Proprietary Name: | CADD-Prizm® High Volume Administration Set<br>with 1.2 \$\mu\$ Filter and Add-on Anti-siphon Valve<br><br>CADD® Administration Set with 1.2 \$\mu\$ Filter and<br>Add-on Anti-siphon Valve<br><br>Hereafter, collectively referred to as<br>"Administration Sets". | | |
| Equivalence Device Comparison: | CADD-Prizm® High Volume Administration Set<br>with 1.2 \$\mu\$ Filter and Add-on Anti-siphon Valve<br><br>CADD® Administration Set with 1.2 \$\mu\$ Filter and<br>Add-on Anti-siphon Valve | | |

#### II. DEVICE DESCRIPTION

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.

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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 High<br>Volume Administration<br>Set with 1.2 µ Filter and<br>Add-on Anti-siphon Valve | CADD-Prizm® High<br>Volume Administration<br>Set with 1.2 µ Filter and<br>Add-on Anti-siphon Valve | CADD® Administration<br>Set with 1.2 µ Filter and<br>Add-on Anti-siphon Valve | CADD® Administration<br>Set with 1.2 µ Filter and<br>Add-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<br>K954870 |
| INDICATIONS FOR<br>USE | The CADD-Prizm® High<br>Volume Administration Set<br>is designed for use with the<br>CADD-Prizm® pump to<br>allow fluid delivery from<br>an IV bag. | The CADD-Prizm® High<br>Volume Administration Set<br>is designed for use with the<br>CADD-Prizm® pump to<br>allow fluid delivery from<br>an IV bag. | The CADD®<br>Administration Set is<br>designed to be used with a<br>variety of CADD® pumps<br>to allow fluid delivery from<br>an IV bag. | The CADD®<br>Administration Set is<br>designed to be used with a<br>variety of CADD® pumps<br>to allow fluid delivery from<br>an IV bag. |
| DIMENSIONS<br>(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-SIPHON<br>VALVE | 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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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 [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 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 [phone] or [phone] 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)

OR

Over-The Counter Use