EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE

K980583 · Sims Deltec, Inc. · FPA · Apr 27, 1998 · General Hospital

Device Facts

• Record ID: K980583
• Device Name: EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE
• Applicant: Sims Deltec, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Apr 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Extension Set with 0.2u filter and anti-siphon valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps. The CADD® Administration Set with 0.2u filter and anti-siphon valve is intended for use with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps for the administration of fluids or medications.

Device Story

Extension and administration sets designed for use with CADD infusion pumps; incorporates 0.2µ filter and anti-siphon valve. Anti-siphon valve prevents unregulated gravity infusion from improperly attached reservoirs. Used in clinical or home settings by patients or healthcare providers to deliver fluids/medications. Device acts as a fluid path component between medication reservoir and patient access site.

Clinical Evidence

Bench testing only.

Technological Characteristics

Fluid administration set featuring an integrated anti-siphon valve and a 0.2µ filter. Designed for compatibility with CADD-series infusion pumps. Materials and construction are consistent with previously cleared SIMS Deltec administration sets.

Indications for Use

Indicated for patients requiring administration of fluids or medications via CADD-1, CADD-PCA, CADD-PLUS, or CADD-Prizm infusion 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

• Extension Set with Anti-Siphon Valve (SIMS Deltec, Inc.)
• CADD® Administration Set with 0.2µ Filter and Anti-Siphon Valve (SIMS Deltec, Inc.)
• Filter Set with 0.22µ Filter, y-Injection Site and OPTION-LOK® (Abbott Laboratories)

Submission Summary (Full Text)

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K980 583

# APR 27 1998 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
APR 2 7 1998 510(k) SUMMARY OF SAFETY AND with

Deltec Extension Set with Anti-Siphon Valve and CADD® Administration Set with 0.2µ Filter and Anti-Siphon Valve February 12, 1998

### GENERAL INFORMATION I.

| Applicant's Name<br>and Address: | SIMS Deltec, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David H. Short<br>Director, Regulatory and Clinical Affairs<br>Tel. [phone] |
| Common/Usual Name: | Extension Set Administration Set |
| Proprietary Name: | Extension Set with 0.2µ Filter and Anti-Siphon Valve<br>CADD® Administration Set with 0.2µ Filter and Anti-<br>Siphon Valve |
| Equivalence Device<br>Comparison: | Extension Set with Anti-Siphon Valve<br>(manufactured by SIMS Deltec, Inc.)<br>CADD® Administration Set with 0.2µ Filter<br>and Anti-Siphon Valve<br>(manufactured by SIMS Deltec, Inc.)<br>Filter Set with 0.22µ Filter, y-Injection Site and<br>OPTION-LOK®<br>(manufactured by ABBOTT LABORATORIES) |

#### II. DEVICE DESCRIPTION

The purpose of this submission is to offer an alternate 0.2u filter, as a matter of customer preference, for use with the SIMS Deltec Extension Set with Anti-Siphon Valve and CADD® Administration Set with 0.2u Filter and Anti-Siphon Valve. The 0.2u filter is similar to the filter on the Abbott Laboratories' Filter Set with 0.22u Filter. An integral anti-siphon valve is included and is designed to protect against unregulated gravity infusion that may result from an improperly attached reservoir.

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Alternate 0.2u Filter for use with Deltec Extension Set with Anti-Siphon Valve and CADD® Administration Set with 0.2μ Filter and Anti-Siphon Valve February 12, 1998

## INTENDED USE OF DEVICE III.

The Extension Set with 0.2u filter and anti-siphon valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps.

The CADD® Administration Set with 0.2u filter and anti-siphon valve is intended for use with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps for the administration of fluids or medications.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 1998

Mr. David H. Short 'Director, Regulatory and Clinical Affairs SIMS Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

Re : K980583 Extension Set with 0.2μ Filter and Anti-Trade Name: Siphon Valve CADD® II Requlatory Class: Product Code: EPA Dated: February 13, 1998 February 17, 1998 Received:

Dear Mr. Short:

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 Regulations, 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 verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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. Short

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.fda.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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Kg80583

510(k) Number (if known):

Device Name: CADD® Administration Set with 0.2µ Filter and Anti-Siphon Valve

Indications for Use:

"The CADD® Administration Set with 0.2µ filter and anti-siphon valve is intended for "The ORDD® Administration Des (CADD-PLUS®, CADD-Prizm® pumps for the administration of fluids or medications."

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Caserite

on of Denni, Infection O and General Frispital Devices

510(k) Number K980583

Prescription Use

OR

Over-The Counter Use

(Per 21 CFR 801:109) --