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 user-defined 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 text describes the CADD-Sentry Pro™ Medication Safety Software. However, it does not contain specific acceptance criteria, a detailed study proving performance against those criteria, or the typical elements of a performance study for AI/machine learning medical devices.

Instead, the document focuses on:

Device Description: What the software does (Administrator module for creating protocols, Point-of-Care module for sending protocols to a pump).
Intended Use: How the software is meant to be used.
Device Comparison: Stating equivalence to a predicate device (itself, indicating a modification or re-submission).
Summary of Studies: A very brief mention of "Functional Testing" related to software validation and "verification of software controlled programming functions," and a statement that "Human clinical studies were deemed not necessary."
Conclusion: The software is "safe, effective and performs to established specifications."

Given the information, I can only provide a general response based on the limited details regarding testing.

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or measurable device performance metrics in the typical sense of a diagnostic or an AI-driven device. The "acceptance criteria" appear to be met through successful completion of "Functional Testing" and "verification of software controlled programming functions."

Acceptance Criteria (Implied)	Reported Device Performance
Proper software and pump operation	"performed" (successfully completed functional testing)
Verification of software-controlled programming functions	"performed" (successfully completed verification)
Software validation	"performed" (successfully completed software validation)
Safety and Effectiveness (overall regulatory requirement)	"safe, effective and performs to established specifications" (conclusion)

Study Details

Sample size used for the test set and data provenance:
- Test Set Sample Size: Not specified. The document only mentions "Test plans associated with software validation, verification of software controlled programming functions, and software related to proper software and pump operation were performed." This implies internal software testing rather than a dataset of patient cases.
- Data Provenance: Not applicable, as no external data set (e.g., patient data, images, clinical records) was used in the described testing suitable for AI/ML performance evaluation. The testing would have involved the software interacting with the infusion pump.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" in this context would likely be the expected correct behavior of the software and pump based on engineering specifications and design, rather than expert interpretation of clinical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication method is used for clinical data where human expert disagreement needs resolution. The testing described is functional software testing.
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. 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 software is a pump communication and programming system, not an AI diagnostic or decision support tool for human readers/clinicians, so an MRMC study is not relevant here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The "functional testing" performed would be considered standalone in the sense that it evaluated the software's ability to perform its programmed functions (sending/receiving data, managing protocols) without a human interpreting outputs for diagnostic purposes. However, it's not "standalone" in the typical AI sense of providing a clinical assessment without human oversight. The software's function is to facilitate human programming of a pump.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's functional testing would be the pre-defined functional specifications and expected behavior of the software and the CADD-Prizm pump as determined by its design and engineering requirements.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set of data. The software's logic is explicitly programmed.
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) Premarket Notification 510(k) Summary

	GENERAL INFORMATION	K472955 (P.1242)
Applicant's Name and Address:	Smiths Medical MD, Inc.1265 Grey Fox RoadSt. Paul, MN 55112	FEB 13 2008
Contact Person:	David H. ShortDirector Regulatory Affairs and DesignAssurance
Common/Usual Name:	Pump Communications System
Proprietary Name:	CADD-Sentry Pro™ Medication Safety Software
Classification Name:	21 CFR 880.5725, Accessories, Pump, Infusion
Product Code	MRZ
Equivalence Device Comparison:	CADD-Sentry Pro™ Medication Safety Software
Date Prepared	February 7, 2008

II. DEVICE DESCRIPTION

CADD-Sentry Pro™ Medication Safety Software

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510(k) Premarket Notification 510(k) Summary

K47a155 (P.202a)

INTENDED USE OF THE DEVICE III.

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 device: CADD-Sentry Pro " Medication Safety Software 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

FEB 13 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K072955

Trade/Device Name: CADD-Sentry Pro™ Medication Safety Software – Administrator CADD-Sentry Pro™ Medication Safety Software – Point of Care Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: January 17, 2008 Received: January 18, 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 (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,

Ches. Lins, 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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510(k) Premarket Notification 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)."

Prescription Use	X
OR
Over-The Counter Use
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)."

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cinton Vrant

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

510(k) Number:__ Ko7295S

CADD-Sentry Pro™ Medication Safety Software Smiths Medical MD, Inc.

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).