CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET

K040636 · Smiths Medical MD, Inc. · FPA · May 19, 2004 · General Hospital

Device Facts

• Record ID: K040636
• Device Name: CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET
• Applicant: Smiths Medical MD, Inc.
• Product Code: FPA · General Hospital
• Decision Date: May 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CADD® Medication Cassette Reservoir with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids. The CADD® Administration Set with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids.

Device Story

CADD® Medication Cassette Reservoir and Administration Set with Flow Stop are modifications to existing infusion delivery components. Primary function: fluid/medication delivery from flexible containers via CADD® pumps. Key modification: integration of a mechanical 'Flow Stop' component on the reservoir/set housing. Flow Stop mechanism: occludes tubing automatically if the reservoir/set is incorrectly placed on the pump or becomes detached, preventing free-flow. Operation: user removes a blue 'CLIP' to activate Flow Stop before attachment; Flow Stop can be manually held open for priming. Replaces previous integral anti-siphon valve. Used in clinical settings where CADD® pumps are deployed. Benefits: enhanced safety against accidental free-flow during pump setup or detachment.

Clinical Evidence

No clinical data. Substantial equivalence established via in-vitro functional testing and biocompatibility testing of the Flow Stop component. Devices demonstrated to function according to specifications.

Technological Characteristics

Mechanical infusion delivery components (reservoir/set) with integrated Flow Stop mechanism. Materials: biocompatible components. Connectivity: physical attachment to CADD® pumps. Sterilization: not specified. Software: none.

Indications for Use

Indicated for delivery of medications and fluids using CADD® pumps (excluding CADD-Micro® and CADD-TPN®) in patients requiring infusion therapy.

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® Medication Cassette Reservoir
• CADD® Administration Set

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## CADD® Medication Cassette Reservoir with Flow Stop

### March 9, 2004

### GENERAL INFORMATION I.

| Applicant's Name and Address: | Smiths Medical MD, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
|--------------------------------|---------------------------------------------------------------------|
| Contact Person: | Patricia A. LaForte<br>Regulatory Affairs Associate |
| Common/Usual Name: | Medication Cassette Reservoir |
| Proprietary Name: | CADD® Medication Cassette Reservoir with<br>Flow Stop |
| Equivalence Device Comparison: | CADD® Medication Cassette Reservoir |

### DEVICE DESCRIPTION II.

The CADD® Medication Cassette Reservoirs with Flow Stop are a modification to the current CADD® Medication Cassette Reservoirs. The reservoirs will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the reservoirs are accidentally placed onto the pump incorrectly or become detached from the pump.

The Flow Stop will be located on the reservoir housing, which is attached to the pump. The reservoir will be provided to the user in an open state. Before the reservoir can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the reservoir to the pump, the user can still remove the reservoir from the pump and prime it by holding the Flow Stop in the open position.

### INTENDED USE OF THE DEVICE III.

The CADD® Medication Reservoirs are designed for use with the CADD® pumps (except CADD® Micro) to allow fluid delivery from a flexible container.

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### IV. DEVICE COMPARISON

The CADD® Medication Cassette Reservoirs with Flow Stop are similar in design, function, and intended use to the current CADD® Medication Cassette Reservoirs. These sets are identical except for the addition of the Flow Stop.

The sets will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the reservoir is accidentally placed onto the pump incorrectly or becomes detached from the pump.

### SUMMARY OF STUDIES V.

### A. Functional Testing

In-vitro testing was conducted on the CADD® Medication Cassette Reservoirs with Flow Stop.

Biocompatibility testing was performed on the new Flow Stop components.

### B. Clinical Studies

Clinical studies were not deemed necessary regarding the CADD® Medication Cassette Reservoirs with Flow Stop due to their similarity in materials, design and function to the current CADD® Medication Cassette Reservoirs.

### C. Conclusions Drawn from the Studies

The results of the testing indicated that the CADD® Medication Cassette Reservoirs with Flow Stop function according to specifications and the materials used in the device are biocompatible. Therefore, the product is considered acceptable for human use.

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### CADD® Administration Set with Flow Stop

March 9, 2004

### II. GENERAL INFORMATION

| Applicant's Name and Address: | Smiths Medical MD, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
|--------------------------------|---------------------------------------------------------------------|
| Contact Person: | Patricia A. LaForte<br>Regulatory Affairs Associate |
| Common/Usual Name: | Administration Set |
| Proprietary Name: | CADD® Administration Set with Flow Stop |
| Equivalence Device Comparison: | CADD® Administration Set |

### DEVICE DESCRIPTION II.

The CADD® Administration Sets with Flow Stop is a modification to the current CADD® Administration Sets. The sets will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump.

The Flow Stop will be located on the set housing, which is attached to the pump. The set will be provided to the user in an open state. Before the set can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the set to the pump, the user can still remove the set from the pump and prime it by holding the Flow Stop in the open position.

The Add-on Integral Anti-siphon Valve, which is included with current sets will not be provided with the new sets. This valve is no longer necessary because of the addition of the Flow Stop.

### INTENDED USE OF THE DEVICE III.

The CADD® Administration Set is designed for use with the CADD® pumps (except CADD®-Micro) to allow medication delivery from a flexible container.

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### DEVICE COMPARISON IV.

The CADD® Administration Sets with Flow Stop are similar in design, function, and intended use to the current CADD® Administration Sets. These sets are identical except for the addition of the Flow Stop and the removal of the Integral Anti-siphon Valve.

The sets will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump.

### V. SUMMARY OF STUDIES

### Functional Testing A.

In-vitro testing was conducted on the CADD® Administration Set with Flow Stop.

Biocompatibility testing was performed on the new Flow Stop components.

### D. Clinical Studies

Clinical studies were not deemed necessary regarding the CADD® Administration Sets with Flow Stop due to their similarity in materials, design and function to the current CADD® Administration Sets.

### Conclusions Drawn from the Studies E.

The results of the testing indicated that the CADD® Administration Sets with Flow Stop function according to specifications and the materials used in the device are biocompatible. Therefore, the product is considered acceptable for human use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2004

Ms. Patricia A. LaForte Regulatory Affairs Associate Smiths Medical MD, Incorporated 1265 Grey Fox Road St Paul, Minnesota 55112

Re: K040636

Trade/Device Name: CADD® Administration Sct with Flow Stop CADD® Medication Cassette Reservoir with Flow Stop Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Codc: FPA Dated: March 9, 2004 Received: March 10, 2004

Dear Ms. LaForte:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed prodicate devices marketed in interstate commerce prior to May 23, 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) that do not require approval of a premarket approval application (PMA). 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 cither class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Ms. LaForte

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the rever mily with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and if the (2 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - requirents as electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) rins reter notification. The FDA finding of substantial equivalence of your device to a promative methous aredicate 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), r you deents the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the misjon of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Chris Lim, Ph.D.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):_K040636

Device Name: CADD® Medication Cassette Reservoir with Flow Stop

CADD® Administration Set with Flow Stop

Indications For Use:

"The CADD® Medication Cassette Reservoir with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids."

"The CADD® Administration Set with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids."

Prescription Use × AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton D, mnc

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Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. k944636