EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE

K974013 · Sims Deltec, Inc. · FPA · Dec 17, 1997 · General Hospital

Device Facts

• Record ID: K974013
• Device Name: EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE
• Applicant: Sims Deltec, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Dec 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Extension Set with Anti-Siphon Valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD® pumps. The Extension Set with microbore tubing attaches to the Micro Medication Reservoir for the administration of fluids or medications with the CADD-Micro® pump.

Device Story

Extension sets with microbore tubing designed for use with CADD-Micro® and CADD® infusion pumps; facilitate fluid/medication delivery from reservoirs to patients. Variants include microbore tubing, 0.2 micron air-eliminating filters, and anti-siphon valves. Anti-siphon valve protects against unregulated gravity infusion caused by improperly attached reservoirs. Used in clinical or home settings; operated by healthcare professionals or patients. Device acts as a fluid path conduit; filter removes air; valve provides mechanical flow regulation. Benefits include precise micro-infusion delivery and enhanced safety against free-flow events.

Clinical Evidence

No clinical data. Bench testing only, including functional performance testing and biocompatibility assessment of materials.

Technological Characteristics

Microbore tubing (0.020 inch I.D., 0.088 inch O.D.); 0.2 micron air-eliminating filter; anti-siphon valve. Mechanical fluid delivery accessory. Non-electronic, passive device.

Indications for Use

Indicated for patients requiring fluid or medication administration via CADD® or CADD-Micro® infusion pumps. The anti-siphon valve variant is indicated for use with MEDICATION CASSETTE™ reservoirs to prevent unregulated gravity infusion in vulnerable patients.

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 (K942046)
• Micro-Volume Extension Set with 0.22 µ Filter (K811463)

Submission Summary (Full Text)

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K974013

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

DEC 1 7 1997

## Extension Sets with Microbore Tubing

October 20, 1997

#### GENERAL INFORMATION L

| Applicant's Name<br>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 Quality Systems<br>Tel. [phone] |
| Common/Usual Name: | Extension Set |
| Proprietary Name: | Extension Set with Microbore Tubing |
| Equivalence Device<br>Comparison: | Extension Set with Anti-Siphon Valve<br>(manufactured by SIMS Deltec, Inc.)<br><br>Micro-Volume Extension Set with 0.22 µ Filter<br>(manufactured by Baxter Healthcare Corp.) |

#### II. DEVICE DESCRIPTION

The purpose of this submission is to offer an alternative, as a matter of customer preference, to the current commercially available SIMS Deltec Extension Sets. The Extension Sets have been modified to include microbore tubing for use in microinfusions and a new compatible female luer on two of the sets. A 0.2 micron filter has been included on two of the sets and is an air eliminating filter similar to the filter on the Baxter Extension Set. An anti-siphon valve is included on one of the sets and is designed to protect against unregulated gravity infusion that can result from an improperly attached reservoir.

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### INTENDED USE OF DEVICE Ш.

The Extension Set with microbore tubing attaches to the Micro Medication Reservoir for use with the CADD-Micro® pump.

The Extension Set with Anti-Siphon Valve must be used with the MEDICATION CASSETTE™ reservoir to protect against unregulated gravity infusion that can result from an improperly attached reservoir.

| | Extension Set with<br>microbore tubing | Extension Set with<br>microbore tubing and<br>0.2 μ filter | Extension Set with<br>microbore tubing, 0.2<br>μ filter, and anti-<br>siphon valve | Extension Set with<br>anti-siphon valve<br>K942046 | Micro-Volume<br>Extension Set with<br>0.22 μ Filter<br>K811463 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Baxter Healthcare<br>Corporation |
| INTENDED USE | The Extension Set with<br>microbore tubing<br>attaches to the Micro<br>Medication Reservoir for<br>use with the CADD-<br>Micro® pump. | The Extension Set with<br>microbore tubing<br>attaches to the Micro<br>Medication Reservoir for<br>use with the CADD-<br>Micro® pump. | The Extension Set with<br>Anti-Siphon Valve must<br>be used with the<br>MEDICA-TION<br>CASSETTE™ reservoir<br>to protect against<br>unregulated gravity<br>infusion that can result<br>from an improperly<br>attached reservoir. | The Extension Set with<br>Anti-Siphon Valve is an<br>accessory for fluid<br>delivery devices. It is<br>design-ed to protect<br>against unregulated<br>gravity infusion from<br>improperly attached<br>administration sets used<br>with mechanical infusion<br>pumps in vulnerable<br>patients. | |
| DIMENSIONS<br>(Nominal) | | | | | |
| LENGTH | 45 inches | 60 inches | 60 inches | 4 inches or 60 inches | 60 inches |
| TUBING LD. | 0.020 inches | 0.020 inches | 0.020 inches | 0.040 inches | |
| TUBING O.D. | 0.088 inches | 0.088 inches | 0.088 inches | 0.105 inches | |
| FILTER | NO | YES | YES | NO | YES |
| ANTI-SIPHON<br>VALVE | NO | NO | YES | YES | NO |

### IV. DEVICE COMPARISON

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### SUMMARY OF STUDIES V.

#### A. Functional Testing

Functional testing performed on the sets to establish their operating parameters.

Biocompatibility testing was conducted on the set components.

#### B. Clinical Studies

Clinical studies were not deemed necessary regarding the Extension Sets with Microbore Tubing due to their similarity in materials, design and function to current SIMS Deltec commercially available extension sets.

#### C. Conclusions Drawn from the Studies

The results of the testing indicated that the Extension Sets with Microbore Tubing function according to specification and the materials used in the sets are biocompatible. Therefore, these sets 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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 17 1997

Mr. Edward W. Numainville Mr. Baward W. Ramatillatory Affairs and Quality Systems Sims Deltec, Incorporated 1265 Grey Fox Road 55112 St. Paul, Minnesota

K974013 Re : Extension Set with Microbore Tubing, Trade Name: Extension Set with Microbore Tubing and 0.2 µ Filter Requlatory Class: II Product Code: FPA Dated: October 20, 1997 Received: October 22, 1997

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. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Numainville

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 requlations.

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 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
premarket notification" (21 CFR 807.97). Other gener 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timot hy 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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K974013

510(k) Number (if known):

Device Name: Extension Set with Microbore Tubing, 0.2 u Filter, and Anti-Siphon Valve

Indications for Use:

" The Extension Set with Anti-Siphon Valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD® pumps. "

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Litera Cucente

(Division Sign-Off) Division of Dental, Infection Control, and General Flospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

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K974013

. . . . . . . .

510(k) Number (if known):

Device Name: Extension Set with Microbore Tubing, or Extension Set with Microbore Tubing and 0.2 u Filter

Indications for Use:

"The Extension Set with microbore tubing attaches to the Micro Medication Reservoir for the administration of fluids or medications with the CADD-Micro® pump."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Fabian Cusati

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital B r : ^/k) Number _

Prescription Use レ (Per 21 CFR 801.109)

OR

Over-The Counter Use -------