CADD-MS 3 AMBULATORY INFUSION PUMP

K051568 · Smiths Medical MD, Inc. · FRN · Nov 17, 2005 · General Hospital

Device Facts

• Record ID: K051568
• Device Name: CADD-MS 3 AMBULATORY INFUSION PUMP
• Applicant: Smiths Medical MD, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Nov 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CADD-MS™ 3 Ambulatory Infusion Pump is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medication. The Smiths Medical MD, Inc. 3-ml Cartridge Reservoir is designed for use with the CADD-MS™ 3 for delivering medication.

Device Story

Microprocessor-based electronic syringe pump; 3-ml cartridge reservoir; delivers medication via subcutaneous, intravenous, epidural, or intrathecal routes. User programs basal (continuous), bolus (demand), and automatic dosing profiles via front keypad and LCD based on internal real-time clock. Features include cartridge sensor, downstream occlusion sensor, audible/vibratory alarms, and waterproof housing. Powered by one AAA battery. Used in ambulatory settings; operated by clinicians or patients. Output provides controlled medication delivery; assists in managing infusion therapy; enables precise low-volume dosing.

Clinical Evidence

No clinical data. Safety and effectiveness established through bench testing, including software validation, verification of programming functions, and biocompatibility testing of the 3-ml cartridge.

Technological Characteristics

Microprocessor-based electronic syringe pump; 3-ml cartridge reservoir; AAA alkaline battery power; backlit LCD; 4-key keypad; cartridge and downstream occlusion sensors; waterproof; software-controlled programming.

Indications for Use

Indicated for subcutaneous, intravenous, epidural, and intrathecal infusion of medication in patients requiring low-volume syringe-based therapy.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• CADD-Micro® Ambulatory Infusion Pump

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS CADD-MSTM 3 Ambulatory Infusion Pump June 13, 2005 K051568

### GENERAL INFORMATION

# NOV 1 7 2005

| Applicant's Name and Address: | Smiths Medical MD, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
|--------------------------------|---------------------------------------------------------------------|
| Contact Person: | Melanie Hess<br>Regulatory and Clinical Affairs Associate |
| Common/Usual Name: | Ambulatory Syringe Pump |
| Proprietary Name: | CADD-MS™ 3 Ambulatory Infusion Pump |
| Equivalence Device Comparison: | CADD-Micro® Ambulatory Infusion Pump |

#### II. DEVICE DESCRIPTION

The Smiths Medical MD, Inc. CADD-MS™ 3 Ambulatory Infusion Pump, a microprocessor based electronic syringe pump with a 3-ml cartridge reservoir, is designed for low volume syringe-based infusion therapy allowing continuous, automatic dose and demand dose delivery profiles for subcutaneous, intravenous, epidural and intrathecal delivery.

The pump operates on one (1) AAA alkaline battery. The user-interface of hardware features include a backlit liquid crystal display, 4-key front keypad, separate bolus button, audible or vibratory alarm, battery cap and cartridge cap. The pump is waterproof and features a cartridge sensor and downstream occlusion sensor.

Based on user code-entry and an internal real-time clock, a user will be able to program multiple basal (continuous), bolus (demand) dosing and automatic dosing delivery profiles within programmed maximum limits.

The pump accommodates the Smiths Medical MD, Inc. 3ml cartridge reservoir.

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### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS CADD-MS™ 3 Ambulatory Infusion Pump

June 13, 2005

# KOS1568

#### INTENDED USE OF THE DEVICE III.

The CADD-MS™ 3 is a syringe infusion pump designed for subcutaneous, intravenous, intrathecal and epidural delivery of medication.

The Smiths Medical MD, Inc. 3ml Cartridge is designed for use with the CADD-MS™ 3 for delivering medication

#### IV. DEVICE COMPARISON

The CADD-MS™ 3 Ambulatory Infusion Pump was compared to and found to be substantially equivalent to the following commercially available predicate device: CADD-Micro® Ambulatory Infusion Pump.

The CADD-MS™ 3 Ambulatory Infusion Pump is substantially equivalent to the CADD-Micro Ambulatory Infusion Pump with respect to indications for use and performance features

#### V. SUMMARY OF STUDIES

### A. Functional Testing

Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were performed.

Biocompatibility testing for the 3-ml Cartridge was performed and found to be biocompatible

### B. Clinical Studies

Human clinical studies were not deemed necessary to evaluate the safety or effectiveness of the CADD-MS™ 3 Ambulatory Infusion Pump.

### C. Conclusions Drawn from the Studies

Based upon the information provided through verification and validation test reports, the CADD-MS™ 3 Ambulatory Infusion Pump is safe, effective and performs to established specifications.

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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features a stylized image of an eagle with three wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. The text is in a sans-serif font and is oriented to follow the curve of the circle.

Public Health Service

NOV 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Melanie Hess Regulatory and Clinical Affairs Associate Smith Medical MD, Incorporated 1265 Grev Fox Road St. Paul. Minnesota 55112

Re: K051568

Trade/Device Name: CADD-MS™ 3 Ambulatory Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 31, 2005 Received: November 1, 2005

Dear Ms. Hess:

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 - Ms. Hess

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 801); 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 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 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,

Smette y. Michin ons.

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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Smiths Medical MD, Inc. Indications for Use Statement 510(k) Number: K051568

# Device Name: CADD-MS'" 3 Ambulatory Infusion Pump

Indications for Use:

"The CADD-MS™ 3 Ambulatory Infusion Pump is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medication."

Prescription Use x 21 CFR 801.109)

OR

OR

Over-The Counter Use Per

### Device Name: Smiths Medical MD, Inc. 3-ml Cartridge Reservoir

Indications for Use:

"The Smiths Medical MD, Inc. 3-ml Cartridge Reservoir is designed for use with the CADD-MS™ 3 for delivering medication."

Prescription Use _____________________________________________________________________________________________________________________________________________________________ 21 CFR 801 109)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton Wang

Siston (Sign-Off) Division of Anesthesiology, General Hospital, Intection Control, Dental Devices

510(k) Number. k051568