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. This update is only for the Alaris PC unit Module 8000 software correction and does not require any change to the associated modules, systems, or accessories of the Alaris System. The basic functionality and existing features as described in the original and subsequent 510(k) submissions for the Alaris System and associated modules will not change.

AI/ML Overview

The provided text is a 510(k) summary for a software correction to an existing infusion pump, the Alaris® PC unit Module 8000. It doesn't contain information about the device's acceptance criteria or a study proving that it meets specific performance metrics. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the administrative details of the submission.

Therefore, many of the requested categories related to performance studies and ground truth cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided input:

Section	Information from provided text
1. A table of acceptance criteria and the reported device performance	Not available. The document states: "The basic functionality and existing features as described in the original and subsequent 510(k) submissions for the Alaris System and associated modules will not change." This implies that the software correction did not alter the core performance characteristics that would typically have acceptance criteria. The submission is for a software correction, not a new device with new performance claims. Therefore, specific acceptance criteria and reported device performance metrics are not detailed in this 510(k) summary.
2. Sample size used for the test set and the data provenance	Not available. A test set or data provenance for performance evaluation is not mentioned. The submission is for a software correction to an existing device, and the focus is on maintaining equivalence rather than demonstrating new performance through a clinical or technical study with a specific test set.
3. Number of experts used to establish the ground truth for the test set and their qualifications	Not applicable/Not available. As there's no mention of a test set or ground truth establishment in the context of device performance in this document, expert involvement for this purpose is not discussed.
4. Adjudication method for the test set	Not applicable/Not available. No test set or related adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size	Not applicable. This submission is for a software correction to an infusion pump, which is a medical device that performs a specific function (infusion of fluids/medications) and not an imaging or diagnostic device typically evaluated with MRMC studies or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done	Not applicable. The device is an infusion pump with a software correction. Its performance is inherent to the machine's operation, not an "algorithm only" in the sense of AI for image analysis or diagnosis. The entire device, including its software, acts as a standalone system for its intended function (infusion). However, a specific "standalone performance study" in the context of AI evaluation is not applicable here as it's not an AI-driven diagnostic tool.
7. The type of ground truth used	Not applicable/Not available. The document does not describe performance metrics that would require external ground truth (e.g., pathology, outcomes data) to validate a diagnostic or predictive algorithm. The software correction's validity would likely be assessed through internal software validation, verification testing, and risk analysis, demonstrating that the correction resolves the identified issue without introducing new problems or altering the device's fundamental safe and effective operation.
8. The sample size for the training set	Not applicable/Not available. The software correction described is for an existing infusion pump. This is not an AI/ML device that typically involves a "training set" for model development. The software development process would involve various testing phases (e.g., unit testing, integration testing, system testing, regression testing) but not a "training set" in the context of machine learning.
9. How the ground truth for the training set was established	Not applicable/Not available. As there is no training set mentioned, there is no information on how its ground truth would be established. The "ground truth" for a software correction would relate to the correctness of the code's behavior against its specifications and requirements, as verified through standard software testing methodologies. This is different from the ground truth established for AI/ML performance evaluation (e.g., expert labels for images).

Summary

{0}------------------------------------------------

CAREFUSION, INC

MAR 2 6 2012

510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

Submitter Information
Name	CareFusion 303, Inc.
Address	10020 Pacific Mesa Blvd., San Diego, CA 92121
Phone number	(858) 617-5889
Fax number	(858) 617-5960
Establishment RegistrationNumber	2016493
Name of contact person	Gabriela Muranevici
Date prepared	February 22, 2011
Name of device
Trade or proprietary name	Alaris® PC unit Module 8000 with software correction
Common or usual name	Infusion Pump
Classification name	Pump, Infusion
Classification panel	Class II
Regulation	21 CFR 880.5725
Product Code(s)	FRN
Legally marketed device(s)to which equivalence isclaimed	Modification to the Alaris PC unit Module 8000
Reason for 510(k)submission	CareFusion 303, Inc. is submitting this Traditional 510(k) to informthe FDA of a correction to the Alaris PC unit Model 8000 software.
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 powersupply for the associated infusion and monitoring modules. Thisupdate is only for the Alaris PC unit Module 8000 softwarecorrection and does not require any change to the associatedmodules, systems, or accessories of the Alaris System.The basic functionality and existing features as described in theoriginal and subsequent 510(k) submissions for the Alaris Systemand associated modules will not change.

{1}------------------------------------------------

Intended use of the device	See Indications for Use statement
Indications for use	The Alaris® PC Unit is the main user interface unit and powersupply of the Alaris® System, a modular system to be used withAlaris® System modules (aka Medley™ System modules) intendedfor use in today's growing professional healthcare environment forfacilities that utilize infusion and/or monitoring devices. Thespecific intended use for each Alaris® System module is specifiedin its respective submission.

Intended use of the device

See Indications for Use statement

Indications for use

The Alaris® PC Unit is the main user interface unit and powersupply of the Alaris® System, a modular system to be used withAlaris® System modules (aka Medley™ System modules) intendedfor use in today's growing professional healthcare environment forfacilities that utilize infusion and/or monitoring devices. Thespecific intended use for each Alaris® System module is specifiedin its respective submission.

| Summary of the technological characteristics of the device compared to the predicate device

Characteristic	New Device	Predicate [Device Name]	[510(k) number]
With the exception of thesoftware correctionpresented in thissubmission, the Alaris PCunit is essentially the sameas the originally submittedpredicate device. Theintended use, principles ofoperation, fundamentalscientific technology,method of manufacture,and application areessentially the same.	Alaris PC unit Module 8000 withsoftware correction	Modification to the Alaris PC unit Module8000	K091308

・・

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR 2 6 2012

Ms. Gabriela Muranevici Principal Regulatory Affairs Specialist Carefusion, Incorporated 10020 Pacific Mesa Boulevard San Diego, California 92121

Re: K110535

Trade/Device Name: Alaris PC Unit Module 8000 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: March 21, 2012 Received: March 22, 2012

Dear Ms. Muranevici:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{3}------------------------------------------------

Page 2 - Ms. Muranevici

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

KII0535 510(k) Number (if known): ___

Device Name: Alaris® PC Unit

Indications for Use:

Prescription Use X ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ion Sign-Off)
ion of Anesthesiology, General Hospital
tion Control, Dental Devices

(k) Number:	K110535
-------------	---------

CONFIDENTIAL

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).