CADD MEDICATION CASSETTE RESERVOIR

K081156 · Smiths Medical MD, Inc. · FPA · Jul 18, 2008 · General Hospital

Device Facts

• Record ID: K081156
• Device Name: CADD MEDICATION CASSETTE RESERVOIR
• Applicant: Smiths Medical MD, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jul 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CADD™ Medication Cassette reservoirs are intended for the delivery of medications and fluids for subcutaneous, intramuscular, intravenous, intra-arterial, intraperitoneal, or intraspinal infusion.

Device Story

CADD™ Medication Cassette Reservoir is a fluid delivery component for use with CADD® pumps. The device consists of a 250 mL medication bag, pump tube, extension tube, and a two-part housing assembly featuring a pressure plate with a Flow Stop mechanism. The two-part housing allows clinicians to manipulate the medication bag to remove air bubbles before snapping the housing together for permanent assembly. The device is used in clinical settings to facilitate medication infusion. It functions as a reservoir and delivery interface, ensuring controlled fluid flow through the pump system. The primary benefit is the inclusion of the Flow Stop feature and the ability to prime the reservoir by removing air prior to pump attachment.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing demonstrated that the device meets all safety and performance requirements.

Technological Characteristics

Two-part snap-together housing assembly; 250 mL reservoir capacity; includes medication bag, pump tube, extension tube, and pressure plate with Flow Stop feature. Non-electronic, mechanical fluid delivery component.

Indications for Use

Indicated for patients requiring subcutaneous, intramuscular, intravenous, intra-arterial, intraperitoneal, or intraspinal infusion of medications and fluids via CADD 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™ Medication Cassette Reservoir with Flow Stop (K040636)

Submission Summary (Full Text)

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K∅81156

Page 1 of 2

### 510(k) SUMMARY

# JUL 1 8 2008

# CADD™ Medication Cassette Reservoir

#### I. GENERAL INFORMATION

| Applicant's Name and Address: | Smiths Medical MD, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
|--------------------------------|----------------------------------------------------------------------------------------|
| Contact Person: | David H. Short<br>Director Regulatory Affairs and<br>Design Assurance |
| Common/Usual Name: | Medication Cassette Reservoir |
| Proprietary Name: | CADD™ Medication Cassette Reservoir |
| Equivalence Device Comparison: | CADD™ Medication Cassette Reservoir<br>with Flow Stop<br>Flexible Medication Reservoir |

#### II. DEVICE DESCRIPTION

The CADD™ Medication Cassette Reservoir with Flow Stop feature is a modification to the current CADD™ Medication Cassette Reservoir with Flow Stop. The modification incorporates a 250 mL reservoir and a two-part housing assembly. It is provided with a medication bag and pump tube, extension tube, pressure plate with Flow Stop feature, rear housing, clamp and leur assembled with the cover set into the rear housing assembly but not snapped together. This two-part housing design is intended to allow manipulation of the medication bag for removal of air bubbles prior to permanently snapping the housing together.

#### III. INTENDED USE OF THE DEVICE

The CADD™ Medication Reservoirs are designed for use with the CADD® pumps (except CADD® Micro, CADD-MSTM 3, and CADD TPN®) for medication delivery.

#### IV. DEVICE COMPARISON

The CADD™ Medication Cassette Rescrvoir with Flow Stop is similar in design, function, and intended use to the predecessor CADD™ Medication Cassette Reservoir with Flow Stop, K040636. These sets are identical except for size and

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assembly method of the housing prior to use with the pump. The reservoir housing for the predecessor device, 50 mL and 100 mL capacity, is ultrasonically welded to the pressure plate, whereas the 250 mL reservoir housing is a two-piece design that is snapped together by the clinician prior to attachment to the pump.

#### V. SUMMARY OF STUDIES

#### Functional Testing A.

The CADD™ Medication Cassette Reservoir with Flow Stop was subjected to verification and validation testing. All tests performed demonstrate that the CADD™ Medication Cassette Reservoir with Flow Stop meets the acceptance criteria for the safety and performance requirements set by the CADD™ Medication Cassette Reservoir with Flow Stop specifications.

#### B. Clinical Studies

Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the CADD™ Medication Cassette Reservoir with Flow Stop.

#### C. Conclusions Drawn from the Studies

Based upon the information provided, CADD " Medication Cassette Reservoir with Flow Stop is safe, effective and performs to established specifications

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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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2008

Mr. David H Short Director Regulatory Affairs and Design Assurance Smiths Medical Md. Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

Re: K081156

Trade/Device Name: CADD Medication Cassette Reservoir Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 22, 2008 Received: April 23, 2008

Dear Mr. Short:

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 predicate 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) 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 either 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 - Mr. Short

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 80) ); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the 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) 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division 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/industry/support/index.html.

Sincerely yours,
TKlamrelk Ludi. my for/ch

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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K081156

## SMITHS MEDICAL MD, INC. 510(k) Premarket Notification CADD™ Medication Cassette Reservoir

### Indications for Use

510(k) Number:

### Device Name: CADD™ Medication Cassette Reservoir

Indications for Use:

"The CADD™ Medication Cassette reservoirs are intended for the delivery of medications and fluids for subcutaneous, intramuscular, intravenous, intra-arterial, intraperitoneal, or intraspinal infusion."

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for now 7/18/08
(Division Sign-Off)

(Division Sig Division of Anesthesiology, General Hospital Infection Control, Dental Devices

OR

510(k) Number. _ KO 8/1/5 ماك