LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP

K080743 · Smiths Medical MD, Inc. · FRN · Apr 25, 2008 · General Hospital

Device Facts

• Record ID: K080743
• Device Name: LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP
• Applicant: Smiths Medical MD, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Apr 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Indications for Use

The LockBox is intended to hold the CADD®-Solis infusion pump and provide reasonably secure access to the medication reservoir or syringe contained within.

Device Story

LockBox is a plastic enclosure accessory for CADD®-Solis ambulatory infusion pumps; provides physical security for medication reservoirs (IV bags up to 500 mL or syringes up to 60 mL). Device attaches to CADD-Prizm polemount brackets. Used in clinical or ambulatory settings to prevent unauthorized access to medication. Operated by clinicians or patients. No electronic components; purely mechanical housing.

Clinical Evidence

No clinical data. Bench testing, verification, validation, and human factors usability testing performed to confirm safety and performance specifications.

Technological Characteristics

Plastic enclosure; mechanical design; compatible with CADD-Solis infusion pumps and CADD-Prizm polemount brackets. No energy source, software, or electronic connectivity.

Indications for Use

Indicated for use as a protective enclosure for the CADD®-Solis ambulatory infusion pump and associated medication reservoirs (up to 500 mL IV bags or 60 mL syringes).

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

• LockBox with Syringe Holder

Submission Summary (Full Text)

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# Ko80743

# 510(k) Summary

### 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 of Regulatory Affairs and Design Assurance |
| Common/Usual Name: | Lockbox |
| Proprietary Name: | LockBox for CADD®-Solis Ambulatory Infusion Pump |
| Equivalence Device Comparison: | LockBox with Syringe Holder |

#### II. DEVICE DESCRIPTION

The LockBox is an accessory to the CADD® -Solis ambulatory infusion pump. It is a plastic enclosure for the CADD®-Solis ambulatory infusion pump when it is attached to commercially available medication rescrvoir. The reservoir may be a flexible IV bag up to 500 mL in size or a syringe up to 60 mL. The Lockbox may be attached to a CADD-Prizm Polcmount Bracket.

### INTENDED USE OF THE DEVICE III.

The LockBox is intended to hold the CADD®-Solis infusion pump and provide reasonably secure access to the medication reservoir or syringe contained within.

#### SUMMARY OF STUDIES V.

### A. Functional Testing

The LockBox was subjected to verification and validation testing as well as human factors usability testing. All tests performed demonstrate the LockBox meets the acceptance criteria for the safety and performance requirements set by the LockBox specifications.

# B. Clinical Studies

Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the LockBox.

### C. Conclusions Drawn from the Studies

Based upon the information provided, LockBox is safe, effective and performs to established specifications.

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Image /page/1/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, facing left. The eagle is composed of thick, black lines. Surrounding the eagle is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 5 2008

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

Re: K080743

Trade/Device Name: LockBox for CADD® -Solis Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ, FRN Dated: April 18, 2008 Received: April 21, 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) 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,

Sutte y. Michin Dns.

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. 510(k) Premarket Notification LockBox for CADD®-Solis Infusion Pump

# Indications for Use

510(k) Number: k060778

# Device Name: LockBox for CADD®-Solis Infusion Pump

Indications for Use:

"The LockBox is a plastic enclosure designed to hold a CADD®-Solis infusion pump and a medication reservoir or syringe."

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR 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)

Antron D. Nume

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

510(k) Number: K�8�743