K Number
K110535
Device Name
ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
Date Cleared
2012-03-26

(395 days)

Product Code
Regulation Number
880.5725
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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.
More Information

Not Found

No
The document describes a software correction for an existing infusion system and explicitly states that the basic functionality and existing features will not change. There are no mentions of AI, ML, or related concepts.

No
The Alaris PC Unit is described as the "main user interface unit and power supply" for the Alaris® System, a "modular system to be used with Alaris® System modules... intended for use in today's growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices." It acts as a control and power hub for other modules, not directly providing therapy itself. The intended use also states that "The specific intended use for each Alaris® System module is specified in its respective submission," implying that the therapeutic function derives from the modules it powers, not the PC unit itself.

No

The provided text describes the Alaris® PC Unit as the main user interface and power supply for a modular system that utilizes infusion and/or monitoring devices. It does not mention that the device itself performs any diagnostic functions or provides diagnostic information.

No

The device description explicitly states it is a "point-of-care unit (PC unit) that provides the main user interface and power supply for the associated infusion and monitoring modules," indicating it is a hardware device with software, not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the Alaris PC Unit as the main user interface and power supply for a modular system used in a professional healthcare environment for infusion and/or monitoring devices. This relates to delivering substances to or monitoring patients, not performing tests on samples taken from the body.
  • Device Description: The description reinforces its role as a user interface and power supply for infusion and monitoring modules.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is clearly related to patient care through infusion and monitoring, which are not IVD activities.

N/A

Intended Use / 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.

Product codes

FRN

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

professional healthcare environment for facilities that utilize infusion and/or monitoring devices.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K091308

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

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
NameCareFusion 303, Inc.
Address10020 Pacific Mesa Blvd., San Diego, CA 92121
Phone number(858) 617-5889
Fax number(858) 617-5960
Establishment Registration
Number2016493
Name of contact personGabriela Muranevici
Date preparedFebruary 22, 2011
Name of device
Trade or proprietary nameAlaris® PC unit Module 8000 with software correction
Common or usual nameInfusion Pump
Classification namePump, Infusion
Classification panelClass II
Regulation21 CFR 880.5725
Product Code(s)FRN
Legally marketed device(s)
to which equivalence is
claimedModification to the Alaris PC unit Module 8000
Reason for 510(k)
submissionCareFusion 303, Inc. is submitting this Traditional 510(k) to inform
the FDA of a correction to the Alaris PC unit Model 8000 software.
Device descriptionThe 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.

1

Intended use of the deviceSee Indications for Use statement
Indications for useThe 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.

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

CharacteristicNew DevicePredicate [Device Name][510(k) number]
With the exception of the
software correction
presented in this
submission, the Alaris PC
unit is essentially the same
as the originally submitted
predicate device. The
intended use, principles of
operation, fundamental
scientific technology,
method of manufacture,
and application are
essentially the same.Alaris PC unit Module 8000 with
software correctionModification to the Alaris PC unit Module
8000K091308

・・

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:

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 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

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