CADD-TPN ADMINISTRATION SET, MODEL 21-7071

K991255 · Sims Deltec, Inc. · FPA · Jun 9, 1999 · General Hospital

Device Facts

• Record ID: K991255
• Device Name: CADD-TPN ADMINISTRATION SET, MODEL 21-7071
• 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-TPN® Administration Set is designed for use with the CADD-TPN® pump for the administration of nutritional and other solutions or fluids intravenously from an IV bag.

Device Story

Administration set for CADD-TPN® ambulatory infusion pumps; facilitates intravenous delivery of nutritional solutions or fluids from IV bags. Components include bag spike, tubing, set plate, 1.2 µ filter, tubing clamp, injection site, male luer connector, and add-on anti-siphon valve. Anti-siphon valve prevents unregulated gravity infusion if set plate is improperly attached to pump. Used in clinical or home settings; operated by healthcare providers or patients. Output is controlled fluid delivery; enables safe, ambulatory nutritional therapy.

Clinical Evidence

No clinical data. Bench testing only. Functional specification testing confirmed filter performance and anti-siphon valve operation. Biocompatibility testing confirmed material safety.

Technological Characteristics

Administration set comprising bag spike, tubing, set plate, 1.2 µ filter, and anti-siphon valve. Materials are consistent with existing CADD® sets. Mechanical flow control via anti-siphon valve. Dimensions: 114 in length, 0.100 in ID, 0.164 in OD. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring intravenous administration of nutritional solutions or fluids via CADD-TPN® ambulatory 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

• CADD-TPN® Administration Set with 1.2 µ Filter (K902374)
• CADD® Extension Set with Anti-siphon Valve (K942046)
• CADD® Administration Set with TOTM Plasticized Tubing (K933390)

Submission Summary (Full Text)

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K991255

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

# CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve

April 9, 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<br>Tel. [phone] |
| Common/Usual Name: | Administration Set |
| Proprietary Name: | CADD-TPN® Administration Set with 1.2 μ<br>Filter and Add-on Anti-siphon Valve |
| Equivalence Device Comparison: | CADD-TPN® Administration Set with 1.2 μ<br>Filter<br>CADD® Extension Set with Anti-siphon Valve<br>CADD® Administration Set with TOTM<br>Plasticized Tubing |

#### II. DEVICE DESCRIPTION

The purpose of this submission is to offer an alternate CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve. The set is made up of the following components: bag spike, tubing, set plate, 1.2 u filter, tubing clamp, injection site, male luer connector with protective cap, and anti-siphon valve. The anti-siphon valve is designed to protect against unregulated gravity infusion that can result from an improperly attached set plate to the CADD-TPN® Ambulatory Infusion Pump.

#### III. INTENDED USE OF THE DEVICE

The CADD-TPN® Administration Set is designed for use with the CADD-TPN® pump for the administration of nutritional and other solutions or fluids intravenously from an IV bag.

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#### DEVICE COMPARISON IV.

| | CADD-TPN®<br>Administration Set<br>with 1.2 µ Filter and<br>Add-on Anti-siphon<br>Valve | CADD-TPN®<br>Administration Set<br>with 1.2 µ Filter | CADD® Extension Set<br>with Anti-siphon<br>Valve | CADD®<br>Administration Set<br>with TOTM<br>Plasticized Tubing |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. |
| 510(K) NUMBER | Subject Device | K902374 | K942046 | K933390 |
| INDICATIONS FOR<br>USE | The CADD-TPN®<br>Administration Set is<br>designed for use with<br>the CADD-TPN® pump<br>for the administration<br>of nutritional and other<br>solutions or fluids<br>intravenously from an<br>IV bag. | The CADD-TPN®<br>Administration Set is<br>designed for use with<br>the CADD-TPN® pump<br>for the administration<br>of nutritional and other<br>solutions or fluids<br>intravenously from an<br>IV bag. | For use with the<br>MEDICATION<br>CASSETTE™<br>Reservoir. | The CADD®<br>Administration Set is<br>designed to be used<br>with a variety of Deltec<br>CADD® Pumps to<br>allow fluid delivery<br>from a remote bag. |
| DIMENSIONS<br>(Nominal) | | | | |
| LENGTH | 114 in. | 100 in. | 30, 45, or 60 in. | 77 in. |
| I.D. | 0.100 in. | 0.100 in. | 0.039 in. | 0.100 in. |
| O.D. | 0.164 in. | 0.164 in. | 0.106 in | 0.164 in. |
| FILTER | YES | YES | NO | NO |
| ANTI-SIPHON<br>VALVE | YES | NO | YES | YES |

#### V. SUMMARY OF STUDIES

#### Functional Testing A.

Functional specification testing was performed on the alternate filter and antisiphon valve.

Biocompatibility testing was conducted.

### B. Clinical Studies

Clinical studies were not deemed necessary regarding the new set due to its similarity in materials, design and function to current commercially available CADD® Administration Sets and Extension Sets.

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## 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 CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve is considered acceptable for human use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ਰ 1999 JUN

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

Re : K991255 Trade Name: CADD-TPN® Administration Set with 1.2 μ Filter and Add-on Anti-siphon Valve Regulatory Class: II Product Code: FPA Dated: April 9, 1999 Received: April 13, 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, qood 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. ਬੇ 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Paqe 2 - Mr. Numainville

this response to your premarket notification Please note: rease 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 described in your sie wir privalence 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 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.fdaygov/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 991255

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CADD-TPN® Administration Set with 1.2 u Filter and Add-on Anti-siphon Valve

Indications for Use:

"The CADD-TPN® Administration Set is designed for use with the CADD-TPN® "The CADD-1111" "Xunimistration of nutritional and other solutions or fluids intravenously from an IV bag."

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <span style="text-decoration: overline;">✓</span> |
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Over-The Counter UseDivision of Dental, Infection Control, and General Hospital I 510(k) Number ..