The CADD -Solis ambulatory infusion pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both (such as patientcontrolled analgesia).

The CADD®-Solis Medication Safety Software consists of the Administrator and the Point of Care software applications. This software allows you to create a set of standard pump Protocols to be used with the CADD®-Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump. The Point of Care software application is used for the CADD-Prizm® PCS II Ambulatory Infusion pump (with software revision H or higher) only.

Device Description

The CADD® -Solis ambulatory infusion pump ("Solis Pump") provides measured drug therapy to patients in the hospital setting. The pump can be programmed to deliver medication at a continuous rate, patient controlled analgesia (PCA), clinician bolus, continuous rate plus PCA, and continuous rate plus clinician bolus.

The Smiths Medical MD, Inc. CADD® -Solis Medication Safety Software -Administrator ("Solis Safety Software - Administrator"), a server based software program that operates on commercially available computers, is designed to establish user defined therapy based protocols for use by the Solis Pump or for use by use CADD®-Solis Medication Safety Software – Point of Care (POC) to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher). The Solis Safety Software - Administrator does not allow duplicative Drug, Protocol or User identification entries.

AI/ML Overview

The provided text describes two devices: the CADD®-Solis Ambulatory Infusion Pump and the CADD®-Solis Medication Safety Software – Administrator. The information primarily focuses on the regulatory submission (510(k) summary) and does not contain detailed acceptance criteria and a study that proves the device meets those criteria in the typical format of clinical performance evaluation studies (e.g., with metrics like sensitivity, specificity, or accuracy).

Instead, the submission indicates that:

For both devices: "The Solis Pump and Solis Safety Software – Administrator were subjected to verification and validation testing. The verification and validation testing performed demonstrate the devices function as intended and perform to specification."
For the Medication Safety Software: "Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the CADD-Sentry Pro™ Medication Safety Software." (Note: The document inconsistently refers to "CADD-Sentry Pro™ Medication Safety Software" here, but the 510(k) is for "CADD®-Solis Medication Safety Software - Administrator").
Conclusion: "Based upon the information provided, the CADD-Sentry Pro™ Medication Safety Software is safe, effective and performs to established specifications."

Given this, I cannot provide a table of acceptance criteria and reported device performance with quantitative metrics, nor can I answer many of the specific questions about clinical study design (sample size, ground truth, expert qualifications, etc.) because such a clinical study, as typically understood for AI/diagnostic devices, was explicitly deemed "not necessary."

However, I can extract the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
CADD®-Solis Ambulatory Infusion Pump:
Functions as intended	"demonstrate the devices function as intended"
Performs to specification	"perform to specification"
CADD®-Solis Medication Safety Software – Administrator:
Functions as intended	"demonstrate the devices function as intended"
Performs to specification	"perform to specification"
Safe and effective	"is safe, effective and performs to established specifications."
No human clinical studies necessary to evaluate safety/effectiveness	Deemed not necessary

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

No specific sample size for a test set is mentioned.
Data provenance is not specified. The studies mentioned are "verification and validation testing," which typically involves engineering and functional testing rather than clinical data sets.

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

Not applicable/Not provided. The document states clinical studies were "deemed not necessary."

4. Adjudication method for the test set

Not applicable/Not provided. Clinical studies with adjudication methods were not conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. A multi-reader multi-case study was not conducted as clinical studies were "deemed not necessary."

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

The "verification and validation testing" performed for the CADD®-Solis Medication Safety Software – Administrator can be considered a form of standalone testing, as it evaluates the software's functional performance against its specifications. However, this is not a standalone clinical performance study.

7. The type of ground truth used

For the "verification and validation testing," the ground truth would be based on the established engineering specifications and intended functional behavior of the infusion pump and the software. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable/Not provided. As no AI/ML algorithm requiring a training set is explicitly discussed in the clinical study context, this information is not relevant to the described studies. The software is described as a "server based software program" designed to "establish user defined therapy based protocols."

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

Not applicable/Not provided. No training set is mentioned.

Summary: The provided document is a 510(k) summary for medical devices (an infusion pump and its associated medication safety software). It describes "verification and validation testing" to show that the devices function as intended and perform to specification. Crucially, it states that "Human clinical studies were deemed not necessary" for the medication safety software. Therefore, the questions related to clinical study design, patient data, expert evaluation, and AI algorithm training sets are not addressed in this document. The "acceptance criteria" appear to be met through these internal functional and validation tests, rather than through a comparative clinical performance study.

Summary

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510(k) Summary

MAR - 7 ZUUn

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:	Ambulatory Infusion PumpPump Communications System
Proprietary Name:	CADD®-Solis Ambulatory Infusion PumpCADD®-Solis Medication Safety Software
Equivalence Device Comparison:	CADD-Prizm® PCS II Model 6101 Ambulatory InfusionSystemCADD-Sentry Pro® Medication Safety

II. DEVICE DESCRIPTION

CADD®-Solis Ambulatory Infusion Pump

CADD®-Solis Medication Safety Software – Administrator

072144

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INTENDED USE OF THE DEVICE III.

CADD®-Solis Ambulatory Infusion Pump

The CADD® Solis ambulatory infusion pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion, patient controlled PCA doses, or both.

CADD®-Solis Medication Safety Software – Administrator

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

SUMMARY OF STUDIES V.

A. Functional Testing

The Solis Pump and Solis Safety Software – Administrator were subjected to verification and validation testing. The verification and validation testing performed demonstrate the devices function as intended and perform to specification.

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 consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 7 2008

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

Re: K072144

Trade/Device Name: CADD® -Solis Ambulatory Infusion Pump CADD® - Solis Medication Safety Software - Administrator Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA Dated: February 20, 2008 Received: February 21, 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 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. 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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chih Lin, Ph.D.

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 Ambulatory Infusion Pump CADD®-Solis Medication Safety Software

Indications for Use

510(k) Number: K072144

Device Name: CADD®-Solis Ambulatory Infusion Pump

Indications for Use:

"The CADD -Solis ambulatory infusion pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both (such as patientcontrolled analgesia)."

Prescription Use

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

Per 21 CFR 801.109)

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

Indications for Use:

"The CADD®-Solis Medication Safety Software consists of the Administrator and the Point of Care software applications. This software allows you to create a set of standard pump Protocols to be used with the CADD®-Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump. The Point of Care software application is used for the CADD-Prizm® PCS II Ambulatory Infusion pump (with software revision H or higher) only."

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony D. Morton

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

510(k) Number: K$\phi$7a,44

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).