ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION

K110535 · Carefusion 303, Inc. · FRN · Mar 26, 2012 · General Hospital

Device Facts

• Record ID: K110535
• Device Name: ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
• Applicant: Carefusion 303, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Mar 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Alaris PC Unit Module 8000 serves as the central user interface and power supply for the Alaris System (Medley System) modular infusion and monitoring platform. Device operates in professional healthcare environments; provides power and control interface for attached infusion/monitoring modules. This submission represents a software correction to the existing PC unit. Device does not change fundamental functionality, intended use, or technological characteristics of the previously cleared Alaris System. Healthcare providers interact with the unit to manage infusion parameters and monitor patient data via the integrated interface. Output facilitates clinical decision-making regarding fluid/medication delivery and patient monitoring.

Clinical Evidence

No clinical data provided. The submission is a software correction to an existing, legally marketed device; substantial equivalence is supported by the unchanged fundamental technology and intended use.

Technological Characteristics

Modular infusion/monitoring system PC unit. Provides power and user interface for attached modules. Software-controlled. No changes to materials, dimensions, or energy source compared to predicate. Connectivity remains consistent with existing Alaris System architecture.

Indications for Use

Indicated for use in professional healthcare facilities utilizing infusion and/or monitoring devices. Used as the primary user interface and power supply for the Alaris System modular infusion/monitoring platform.

Regulatory Classification

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.

Predicate Devices

• Modification to the Alaris PC unit Module 8000 (K091308)

Submission Summary (Full Text)

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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 | [phone] |
| Fax number | [phone] |
| Establishment Registration<br>Number | 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)<br>to which equivalence is<br>claimed | Modification to the Alaris PC unit Module 8000 |
| Reason for 510(k)<br>submission | CareFusion 303, Inc. is submitting this Traditional 510(k) to inform<br>the 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-<br>care unit (PC unit) that provides the main user interface and power<br>supply for the associated infusion and monitoring modules. This<br>update is only for the Alaris PC unit Module 8000 software<br>correction and does not require any change to the associated<br>modules, systems, or accessories of the Alaris System.<br>The basic functionality and existing features as described in the<br>original and subsequent 510(k) submissions for the Alaris System<br>and associated modules will not change. |

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| Intended use of the device | See Indications for Use statement |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Alaris® PC Unit is the main user interface unit and power<br>supply of the Alaris® System, a modular system to be used with<br>Alaris® System modules (aka Medley™ System modules) intended<br>for use in today's growing professional healthcare environment for<br>facilities that utilize infusion and/or monitoring devices. The<br>specific intended use for each Alaris® System module is specified<br>in 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 the<br>software correction<br>presented in this<br>submission, the Alaris PC<br>unit is essentially the same<br>as the originally submitted<br>predicate device. The<br>intended use, principles of<br>operation, fundamental<br>scientific technology,<br>method of manufacture,<br>and application are<br>essentially the same. | Alaris PC unit Module 8000 with<br>software correction | Modification to the Alaris PC unit Module<br>8000 | K091308 |

・・

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### 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.

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### 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 [phone] or [phone] 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

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# 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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