The CADD® -Solis Medication Safety Software - Administrator allows use of a computer to create therapy based protocol libraries to be used with the CADD®-Solis Ambulatory Infusion Pump or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

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

Device Description

The Smiths Medical MD, Inc. CADD® -Solis 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 -Solis Planorms such as lables, is designed for pains programming so managers infusion Pump (software revision H or higher) through a therapy-based protocol database defined by the user. The CADD®-Solis 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®-Solis Medication Safety Software does not allow duplicative Drug, Protocol or User identification entries.

The CADD®-Solis Medication Safety Software – Administrator module allows the user to create, cdit, and save therapy-based protocols and pump settings within user-defined protocol libraries. The Administrator user determines POC user access and library editing capabilities. Other Administrator module features include barcode printing, reports, and sending and receiving pump information.

The CADD®-Solis Medication Safety Software – Point of Care module allows the user to download therapy based protocols to the CADD® Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher) and send and receive pump settings via serial communication. Additional features include storing and printing pump program settings and reports, verifying pump settings to established protocols and viewing history logs in the easier view of a PC monitor.

AI/ML Overview

The provided documentation for the CADD®-Solis Medication Safety Software does not contain the detailed acceptance criteria and study information typically associated with AI/ML device evaluations. This submission is for a software that manages infusion pump protocols, essentially a data management and programming tool, not an AI/ML diagnostic or predictive device.

Therefore, many of the requested points are not applicable or cannot be answered from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified beyond "established specifications"	"Based upon the information provided, the CADD®-Solis Medication Safety Software is safe, effective and performs to established specifications."

Explanation: The document states that functional testing was performed ("Test plans associated with software validation, verification of software controlled programming functions and pump operation were performed.") and that the device "performs to established specifications." However, it does not explicitly list what those specifications or acceptance criteria were (e.g., specific error rates, performance metrics, or thresholds). This is common for software tools that are not performing diagnostic or analytical tasks with clearly defined output metrics.

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not applicable. The "study" was functional testing and software validation, not a test set of medical data in the way a diagnostic AI would use.
Data Provenance: Not applicable. The device processes therapy-based protocols and pump settings, not patient data in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. Ground truth, in the context of medical image interpretation or disease diagnosis, is not relevant here. The "ground truth" for this software would be the correctness of its programming functions and its ability to accurately manage and transfer drug protocols. This would typically be verified against design specifications and user requirements by software engineers and potentially clinical users, but it's not "expert-established ground truth" in the AI/ML sense.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication method: Not applicable. The software's performance was evaluated through functional testing and software validation processes, not through adjudication of medical interpretations or diagnoses.

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

MRMC Study: No. This device is a software tool for managing infusion pump protocols, not an AI-assisted diagnostic or interpretive system that would involve human readers. Clinical studies were "deemed not necessary to evaluate the safety or effectiveness."

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

Standalone Performance: The "functional testing" performed would generally evaluate the software's performance in isolation (standalone) against its design specifications. However, the nature of the device (protocol management for infusion pumps) inherently involves a human-in-the-loop for creating and applying these protocols to the physical pumps. It's not an algorithm that makes independent clinical decisions.

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

Ground Truth Type: Not applicable in the context of AI/ML evaluation. The "ground truth" for this software would be the correct execution of its programming functions and the accurate storage/retrieval/transfer of defined therapy protocols and pump settings, as per its design specifications. This is typically verified through software quality assurance processes.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This software is not an AI/ML model that undergoes training on a dataset. It is a deterministic software application.

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

Training Set Ground Truth: Not applicable. As it's not an AI/ML model, there is no training set or associated ground truth establishment process in that context.

Summary

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K082783

510(k) Premarket Notification 510(k) Summary

DEC 1 7 2008

GENERAL INFORMATION

Applicant's Name and Address:	Smiths Medical MD, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	Phil NeururerSr. Regulatory Affairs Specialist
Common/Usual Name:	Pump Communications System
Proprietary Name:	CADD®-Solis Medication Safety Software
Classification Name:	21 CFR 880.5725, Accessories, Pump, Infusion
Product Code	MRZ
Equivalence Device Comparison:	CADD®-Solis Medication Safety Software, andCADD-Sentry ProTM Medication SafetySoftware

DEVICE DESCRIPTION II.

CADD®-Solis Medication Safety Software

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510(k) Premarket Notification 510(k) Summary

INTENDED USE OF THE DEVICE III.

CADD®-Solis Medication Safety Software - Administrator

The CADD®-Solis Medication Safety Software - Administrator allows use of a computer to create therapy based protocol libraries to be used with the CADD®-Solis Ambulatory Infusion Pump or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

CADD®-Solis Medication Safety Software - Point of Care

The CADD®-Solis Medication Safety Software -- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD®-Solis Medication Safety Software - Administrator to the CADD®-Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

IV. DEVICE COMPARISON

CADD®-Solis Medication Safety Software

The CADD® -Solis Medication Safety Software was compared to and found to be substantially equivalent to the following commercially available predicate devices: CADD® Solis Medication Safety Software, and CADD-Sentry Pro™ Medication Safety Softwarc.

SUMMARY OF STUDIES V.

A. Functional Testing

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

B. Clinical Studies

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

C. Conclusions Drawn from the Studies

Based upon the information provided, the CADD®-Solis 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 consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is 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

Mr. Phil Neururer Senior Regulatory Affairs Specialist Smiths Medical MD, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

DEC 1 7 2008

Re: K082783

Trade/Device Name: CADD® - Solis Medication Safety Software - Administrator Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: December 11, 2008 Received: December 12, 2008

Dear Mr. Neururer:

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 vour 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. Neururer

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 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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® -Solis Medication Safety Software

Indications for Use

510(k) Number:

Device Name: CADD® -Solis Medication Safety Software - Administrator

Indications for Use:

"The CADD® -Solis Medication Safety Software - Administrator allows use of a computer to create therapy based protocol libraries to be used with the CADD®-Solis Ambulatory Infusion Pump or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher)."

OR Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The Counter Use

Per 21 CFR 801.109

Device Name: CADD® -Solis Medication Safety Software - Point of Care

Indications for Use:

"The CADD"-Solis Medication Safety Software -- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD® -Solis Medication Safety Software -Administrator to the CADD®-Solis Ambulatory Infusion Pump and 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)

Anton Bm

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

510(k) Number:

TAB 5 - Page 1 of 1

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).