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 Description

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.

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.

AI/ML Overview

The provided 510(k) summary for the CADD-Sentry Pro™ Medication Safety Software does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving device performance in the manner typically expected for AI/ML-based medical devices.

This document describes a software-only device used for programming infusion pumps, and its validation appears to be centered on functional and software verification testing rather than performance metrics against a medical condition or diagnostic task. Therefore, many of the requested fields, particularly those related to clinical performance, ground truth, experts, and comparative effectiveness, are not applicable in this context.

Here's an analysis of the available information:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Software Validation (e.g., proper functioning, no critical errors)	"Test plans associated with software validation... were performed."
Verification of Software Controlled Programming Functions	"verification of software controlled programming functions... were performed."
Proper Software and Pump Operation	"software related to proper software and pump operation were performed."
Safety and Effectiveness	"Based upon the information provided, the CADD-Sentry Pro™ Medication Safety Software is safe, effective and performs to established specifications."
Substantial Equivalence to Predicate Devices	"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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document only states that "Test plans" were performed for "software validation, verification of software controlled programming functions, and software related to proper software and pump operation." It does not specify a "test set" in the sense of patient data or clinical samples that would have a sample size or provenance. These appear to be internal functional tests of the software.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. Ground truth, in the context of medical image analysis or diagnostic AI, refers to a definitive correct answer for a medical condition. This device is a software utility for programming an infusion pump, not a diagnostic tool requiring expert interpretation of medical data to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are typically used in studies where multiple human readers or algorithms interpret data, and their findings need to be reconciled. This is a functional software validation, not a reader study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the CADD-Sentry Pro™ Medication Safety Software." This type of study is focused on the impact of the software on human performance or diagnostic accuracy, which is not relevant for this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is essentially a "standalone algorithm" in the sense that it performs its function of programming the pump automatically based on user input. The "functional testing" performed would be considered the standalone evaluation of the software's performance, ensuring it correctly implements the defined protocols and communicates with the pump. Performance is assessed against its functional specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device would be its own functional specifications and the correct operation of the infusion pump. For example, if the software is designed to program the pump with a specific flow rate and volume, the ground truth would be that the pump is indeed programmed with that exact flow rate and volume after the software transmits the data. This would be verified through system testing rather than clinical ground truth like pathology.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML system that learns from a training set of data. It is a deterministic software program that performs predefined functions.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of software.

Summary

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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.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	Melanie Hess RN, BSNSr. Regulatory and Clinical Affairs Associate
Common/Usual Name:	Pump Communications System
Proprietary Name:	CADD-Sentry ProTM Medication SafetySoftware
Equivalence Device Comparison:	CADD-Diplomat® PC Communications System,MedleyTM Medication Safety System andMcdleyTM System with Bar Code Module
Date Summary Prepared:	August 31, 2006

II. DEVICE DESCRIPTION

CADD-Sentry Pro™ Medication Safety Software

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510(k) Summary

K00592

Sola

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

August 31, 2006

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
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.(b)
Classification. Class II (performance standards).