CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE

K062592 · Smiths Medical MD, Inc. · FRN · Nov 29, 2006 · General Hospital

Device Facts

• Record ID: K062592
• Device Name: CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE
• Applicant: Smiths Medical MD, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Nov 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The CADD-Sentry Pro™ Medication Safety Software – Administrator allows you to establish a therapy-based protocol library that will be used by the CADD-Sentry Pro Medication Safety Software - Point of Care to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher). The CADD-Sentry Pro™ Medication Safety Software – Point of Care allows use of a personal computer to send CADD-Sentry Pro™ Medication Safety Software -Administrator established therapy-based protocols to the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

Device Story

CADD-Sentry Pro™ Medication Safety Software is a PC-based application for programming CADD-Prizm® PCS II Ambulatory Infusion Pumps. It consists of an Administrator module for creating/editing therapy-based protocol libraries and a Point-of-Care (POC) module for transferring these protocols to pumps via serial communication. The system supports barcode scanners for data entry (up to 20 alphanumeric characters). Clinicians use the Administrator module to define pump settings and access rights, while the POC module verifies pump settings against established protocols and logs history. The software prevents duplicate entries for drugs, protocols, or users. By standardizing infusion parameters through protocol libraries, the device aims to improve medication safety and programming accuracy. It is intended for clinical environments where infusion pumps are managed.

Clinical Evidence

No clinical data. Bench testing only. Software validation and verification of software-controlled programming functions were performed to ensure proper operation of the software and the infusion pump.

Technological Characteristics

Software-based system operating on standard PCs or tablets. Employs serial communication for data transfer to CADD-Prizm® PCS II pumps. Supports barcode scanner integration. Features include protocol library management, barcode printing, and history logging. Software architecture consists of Administrator and Point-of-Care modules. No specific hardware materials or energy sources defined beyond standard PC requirements.

Indications for Use

Indicated for use by clinicians to manage and program therapy-based protocols for the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher) via a personal computer. Prescription use only.

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-Diplomat® PC Communications System
• Medley™ Medication Safety System
• Medley™ System with Bar Code Module

Submission Summary (Full Text)

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510(k) Summary

K062592
1 of 2

## GENERAL INFORMATION

| | NOV 2 9 2006 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Applicant's Name and Address: | Smiths Medical MD, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
| Contact Person: | Melanie Hess RN, BSN<br>Sr. Regulatory and Clinical Affairs Associate |
| Common/Usual Name: | Pump Communications System |
| Proprietary Name: | CADD-Sentry ProTM Medication Safety<br>Software |
| Equivalence Device Comparison: | CADD-Diplomat® PC Communications System,<br>MedleyTM Medication Safety System and<br>McdleyTM System with Bar Code Module |
| Date Summary Prepared: | August 31, 2006 |

#### II. DEVICE DESCRIPTION

# CADD-Sentry Pro™ Medication Safety Software

The Smiths Medical MD, Inc. CADD-Sentry Pro™ Medication Safety Software, a software program that operates on commercially available personal computers or similar hardware platforms such as tablets, is designed for pump programming of the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher) through a therapy-based protocol database defined by the user. The CADD-Sentry Pro™ Medication Safety Software consists of an Administrator and a Point-of-Care (POC) software module that employs serial communications to send and receive pump information. Both modules are compatible with barcode scanners (or similar input devices) through various PC connections. Barcode format is determined by the user; but is limited to 20 alphanumerical characters. The CADD-Sentry Pro™ Medication Safety Software does not allow duplicative Drug, Protocol or User identification entries .

The CADD-Sentry Pro™ Medication Safety Software - Administrator module allows the user to create and save therapy-based protocols, including pump settings. The Administrator module allows therapy-based protocols to be stored and edited within userdefined protocol libraries. The Administrator user determines POC user access and editing capabilities of these libraries. Other Administrator module features include barcode printing, reports, and sending and receiving pump identification.

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### 510(k) Summary

K00592

Sola

The CADD-Sentry Pro™ Medication Safety Software – Point-of-Care module allows the user to send and receive pump settings via serial communication sourced from protocol libraries established using the Administrator module. Additional features include storing and printing pump programs and reports, verifying pump settings to established protocols and viewing history logs in the easier view of the PC monitor.

#### III. INTENDED USE OF THE DEVICE

## CADD-Sentry Pro™ Medication Safety Software

The CADD-Sentry Pro" Medication Safety Software -- Administrator allows you to establish a therapy-based protocol library that will be used by the CADD-Sentry Pro Medication Safety Software - Point of Care to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The CADD-Sentry Pro™ Medication Safety Software – Point of Care allows use of a personal computer to send CADD-Sentry Pro" Medication Safety Software -Administrator established therapy-based protocols to the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

#### IV. DEVICE COMPARISON

### CADD-Sentry Pro™ Medication Safety Software

The CADD-Sentry Pro" Medication Safety Software was compared to and found to be substantially equivalent to the following commercially available predicate devices: CADD-Diplomat® PC Communications System, Medication Safety System and Medley" System with Bar Code Module 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 software and pump operation were performed.

### B. Clinical Studies

Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the CADD-Sentry Pro" Medication Safety Software.

### C. Conclusions Drawn from the Studies

Based upon the information provided, the CADD-Sentry Pro™ Medication Safety Software 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 features a stylized eagle with three overlapping wings, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2006

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

Re: K062592

Trade/Device Name: CADD-Sentry Pro" Medication Safety Software-Administrator & Point of Care Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: August 31, 2006 Received: September 1, 2006

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 complics 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,

Cures

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

## CADD-Sentry Pro™ Medication Safety Software Indications for Use

510(k) Number: TBD

## Device Name: CADD-Sentry Pro " Medication Safety Software -- Administrator

Indications for Use:

"The CADD-Sentry Pro" Medication Safety Software – Administrator allows you to establish a therapy-based protocol library that will be used by the CADD-Sentry Pro Medication Safety Software - Point of Care to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher)."

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use OR Per 21 CFR 801.109

# Device Name: CADD-Sentry Pro " Medication Safety Software - Point of Care

Indications for Use:

"The CADD-Sentry Pro" Medication Safety Software – Point of Care allows use of a personal computer to send CADD-Sentry Pro " Medication Safety Software -Administrator established therapy-based protocols to the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher)."

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)

Schal Fur Aow

Anesthesiology, General Hosp.
Control, Dental Devices

K062592

Confidential

Confidential

August 31, 2006