The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules (aka Medley System modules) intended for use in today's growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Alaris System module is specified in its respective submission.

Device Description

The Alaris System is a modular system that consists of a point-of-care unit (PC Unit) that provides the main user interface and power supply for the associated infusion and monitoring modules. The Enhanced PC Unit will include a faster processor, increased memory, and a color screen. This update is only for the Alaris PC Unit and does not require any change to the associated modules, systems, or accessories of the Alaris System.

AI/ML Overview

This document describes the Alaris System with Enhanced PC Unit, which is an infusion pump. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed performance study with acceptance criteria in the typical sense for a novel AI/software device.

Therefore, many of the requested categories for AI/software device performance studies (like sample size for test/training sets, ground truth establishment methods, MRMC studies, or standalone performance) are not applicable here as this is a medical device hardware upgrade focusing on equivalence to an existing device.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in the way one would for an AI algorithm (e.g., "sensitivity > 90%"). Instead, it focuses on functional equivalence and meeting "specified requirements" through verification and validation activities.

Acceptance Criteria (Implied)	Reported Device Performance
Substantially equivalent to predicate device (Alaris System K950419) in technological characteristics.	The comparison of technological characteristics demonstrates that the Alaris System with Enhanced PC Unit is equivalent to the marketed predicate device.
Meets "specified requirements."	The performance information provided indicates that the Alaris System with Enhanced PC Unit meets specified requirements.
Functionality as a main user interface unit and power supply for Alaris System modules.	The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, intended for use with Alaris System modules.

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

Sample Size for Test Set: Not applicable / Not provided. The evaluation appears to be based on engineering verification and validation activities comparing the upgraded unit to the predicate, rather than a clinical study with a "test set" of patient data.
Data Provenance: Not applicable. This is not a data-driven device; it's a hardware upgrade.

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

Not applicable. Ground truth in the context of expert consensus on medical images or clinical outcomes is not relevant here. The "ground truth" for this device would be its adherence to design specifications and safety/performance standards, verified through testing.

4. Adjudication method for the test set:

Not applicable. There is no mention of an adjudication process for a "test set" in the context of clinical evaluation or expert review. Testing would likely follow a pre-defined protocol for hardware and software verification.

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. This is not an AI-assisted diagnostic or therapeutic device. It is an infusion pump with an upgraded user interface and processor.

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

Not applicable. This device is a hardware system, not an algorithm. Performance testing would be for the entire system, including its user interface.

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

Not applicable in the typical sense. The "ground truth" for this device would be its conformance to engineering specifications, safety standards, and functional requirements, likely demonstrated through:
- Design verification testing: Ensuring the device manufactured meets the design specifications.
- Design validation testing: Ensuring the device meets user needs and intended use, likely involving usability and functional tests.
- Comparison to predicate device: Demonstrating that the upgraded features (faster processor, increased memory, color screen) do not negatively impact the safety and effectiveness established by the predicate device.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As above, no training set is involved.

Summary of the Study (Implied):

The "study" or rather, the basis for substantial equivalence, was a comparison of technological characteristics of the Alaris System with Enhanced PC Unit against its predicate device (Alaris System, K950419). It involved demonstrating that the upgrades (faster processor, increased memory, color screen) did not introduce new safety or effectiveness concerns and that the device continued to meet its "specified requirements." This would typically involve:

Engineering bench testing: To verify the performance of the new processor, memory, and display.
Software verification and validation: To ensure the upgraded software running on the new hardware functions correctly and consistently.
Usability testing (implied): To ensure the color screen and faster interface maintain or improve usability without introducing errors.

The document states, "The performance information provided indicates that the Alaris System with Enhanced PC Unit meets specified requirements, and is substantially equivalent to the predicate device." This indicates that adequate testing was conducted to support these claims, though the specific details of those tests are not elaborated in this summary.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products® Alaris System with Enhanced PC Unit

SUBMITTER INFORMATION

A.	Company Name:	Cardinal Health, Alaris Products
B.	Company Address:	10221 Wateridge CircleSan Diego, CA 92121-2733
C.	Company Phone:Company Fax:	(858) 458-7830(858) 458-6114
D.	Contact Person:	Stacy L. LewisSr. Regulatory Affairs SpecialistCardinal Health, Alaris Products
E.	Date Summary Prepared:	June 15, 2004

DEVICE IDENTIFICATION

A.	Generic Device Name:	Infusion Pump
B.	Trade/Proprietary Name:	Alaris System PC Unit
C.	Classification:	Class II
D.	Product Code:	FRN, Infusion Pump

DEVICE DESCRIPTION

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SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products® Alaris System with Enhanced PC Unit Page 2 of 3

SUBSTANTIAL EQUIVALENCE

The Cardinal Health, Alaris Products Alaris System with Enhanced PC Unit is substantially equivalent to the following predicate device:

Predicate Device	Manufacturer	510(k) No.	Date Cleared
Alaris System(originally submitted asIMED Orion InfusionSystem)	Cardinal Health, AlarisProducts	K950419	June 21, 1995

INTENDED USE

The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules (aka Medley System modules) intended for use in today's growing professional healtheare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Afaris System module is specified in it's respective submission,

TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Alaris System with Enhanced PC Unit and the predicate device has been performed. The results of this comparison demonstrate that the Alaris System with Enhanced PC Unit is equivalent to the marketed predicate device in technological characteristics.

PERFORMANCE INFORMATION

The performance information provided indicates that the Alaris System with Enhanced PC Unit meets specified requirements, and is substantially equivalent to the predicate device.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Public Health Service

OCT 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stacy L. Lewis Senior Regulatory Affairs Associate Cardinal Health, Alaris Products 10221 Wateridge Circle San Diego, California 92121-2772

Re: K051641

Trade/Device Name: ALARIS SYSTEM PC UNIT, MODEL 8001 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 22, 2005 Received: September 23, 2005

Dear Ms. Lewis:

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 Devicc 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 cither 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. Lewis

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 dcvice 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,

Suette Y. Michie MD

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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INDICATIONS FOR USE

510(k) Number:

K051641 (To Be Assigned By FDA)

Device Trade Name:

Alaris System PC Unit

Indications For Use: The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules (aka Medley System modules) intended for use in today's growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Alaris System module is specified in its respective submission.

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)

Cisa Vur

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

510(k) Number ._

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).