CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER

K990083 · Sims Deltec, Inc. · FPA · Feb 12, 1999 · General Hospital

Device Facts

• Record ID: K990083
• Device Name: CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER
• Applicant: Sims Deltec, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Feb 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CADD® Administration Set is designed to be used with Deltec CADD® Pumps to allow fluid delivery from a flexible remote bag with female luer connector.

Device Story

Device consists of CADD® Administration Set, 250 ml Flexible Medication Reservoir, Modified Security Shell, and Security Shell Adapter. Used with Deltec CADD® ambulatory infusion pumps for fluid delivery. Modified Security Shell and Adapter create locked compartment for reservoir to prevent unauthorized access. Includes add-on anti-siphon valve to prevent unregulated gravity infusion. Operated by clinicians or patients in ambulatory settings. Output is controlled fluid delivery; device ensures secure medication containment and flow regulation.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing conducted on fluid path components confirmed safety for human use.

Technological Characteristics

Fluid path components tested for biocompatibility. Includes add-on anti-siphon valve. Dimensions: 69 in. length, 0.040 in. I.D., 0.105 in. O.D., 2 ml priming volume. Mechanical locking mechanism for medication security.

Indications for Use

Indicated for patients requiring fluid delivery via Deltec CADD® ambulatory infusion pumps from a flexible remote bag with a female luer connector.

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® Administration Set (SIMS Deltec, Inc.)
• SabrasetTM 560500-100 Administration Set (Sabratek)

Submission Summary (Full Text)

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2/12/99

K990083

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### CADD® Administration Set and Accessories

January 6, 1999

#### GENERAL INFORMATION I.

| 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: | Administration Set and Accessories |
| Proprietary Name: | CADD® Administration Set<br>CADD® 250 ml Flexible Medication Reservoir<br>Modified Security Shell<br>Security Shell Adapter |
| Equivalence Device<br>Comparison: | CADD® Administration Set<br>(manufactured by SIMS Deltec, Inc.)<br>SabrasetTM 560500-100 Administration Set with 100 ml<br>Bag and Cassette<br>(manufactured by Sabratek) |

#### II. DEVICE DESCRIPTION

The purpose of this submission is to offer an additional CADD® Administration Set that can be used with three new accessories; i.e. a 250 ml Flexible Medication Reservoir, a Modified Security Shell, and a Security Shell Adapter; for the delivery of fluids with SIMS Deltec CADD® ambulatory infusion pumps. The Modified Security Shell and Security Shell Adapter provide a "locked" compartment for the 250 ml Flexible Medication Reservoir to deter unauthorized access to its contents. An add-on antisiphon valve is included with the set. This valve is designed to protect against unregulated gravity infusion that can result from an improperly attached reservoir.

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#### ロ. INTENDED USE OF DEVICE

The CADD® Administration Set is designed to be used with Deltec CADD® Pumps to allow fluid delivery from a flexible remote bag with female luer connector.

#### DEVICE COMPARISON IV.

| | SIMS Deltec CADD® | Sabratek Sabraset™<br>560500-100 | |
|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Administration Set with<br>Accessories | Administration Set with<br>100 ml Bag & Cassette | SIMS Deltec CADD®<br>Administration Set |
| INTENDED USE | The CADD® Admin-<br>istration Set is designed to<br>be used with Deltec<br>CADD® Pumps to allow<br>fluid delivery from a<br>flexible remote bag with<br>female luer connector. | For use with the Sabratek<br>6060 Homerun® pump. | The CADD® Admin-<br>istration Set is designed to<br>be used with a variety of<br>Deltec CADD® Pumps to<br>allow fluid delivery from a<br>remote bag. |
| CAN BE USED WITH<br>REMOTE FLEXIBLE<br>RESERVOIR | YES | YES | YES |
| CAN BE USED WITH<br>AN ENCLOSURE AND<br>REMOTE FLEXIBLE<br>RESERVOIR TO<br>LIMIT ACCESS TO<br>MEDICATION | YES<br>(Modified Security Shell,<br>Security Shell Adapter,<br>and 250 ml Flexible<br>Medication Reservoir)<br>Subject of this submission. | YES | YES |
| FREE FLOW<br>PROTECTION<br>MECHANISM | YES<br>(Add-on anti-siphon<br>valve) | UNKNOWN | YES<br>(Add-on anti-siphon<br>valve) |
| DIMENSIONS<br>(NOMINAL) | | | |
| LENGTH | 69 in. | 56 in. | 77 in. |
| TUBING I.D. | 0.040 in. | UNKNOWN | 0.040 in. |
| TUBING O.D. | 0.105 in. | UNKNOWN | 0.105 in. |
| PRIMING VOLUME | 2 ml | 3 ml | 2.3 ml |

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510(k) Summary of Safety and Effectiveness Page 3 of 3

#### V. SUMMARY OF STUDIES

#### Functional Testing A.

Biocompatibility testing was conducted on the set's fluid path components.

#### Clinical Studies B.

Clinical studies were not deemed necessary regarding the CADD® Administration Set and Accessories due to their similarity in materials, design and function to other SIMS Deltec products and the Sabratek Set and Accessories.

#### C. Conclusions Drawn from the Studies

The results of the testing indicated that the fluid path materials used in the CADD® Administration Set and Accessories are biocompatible. Therefore, these products are considered acceptable for human use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1999

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

Re : K990083 Trade Name: CADD® Administration Set, and Accessories Regulatory Class: II Product Code: FPA Dated: January 6, 1999 Received: January 11, 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 of the Act. The general controls provisions 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. ਰੈ 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 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. Numainville

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 marketed produces or mits 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

Directør Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K990083

510(k) Number (if known): _

Device Name: CADD Administration Set with Accessories

Indications for Use:

"The CADD® Administration Set is designed to be used with Deltec CADD® Pumps to allow fluid delivery from a flexible remote bag with female luer connector."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

Over-The Counter Use _________________

Palacios Crescenti
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _