(66 days)
Not Found
No
The summary describes a modular infusion system with an updated user interface and processor, but makes no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
No.
The Alaris® PC Unit is described as the main user interface unit and power supply for a modular system designed for infusion and/or monitoring devices, not as a device that directly provides therapy itself.
No
The Alaris® PC Unit is described as the main user interface and power supply for a modular system of infusion and monitoring devices. It facilitates the use of these devices but does not itself perform diagnostic functions by analyzing patient data to identify conditions or diseases.
No
The device description explicitly states it is a "point-of-care unit (PC Unit)" which provides the "main user interface and power supply" for associated modules. This indicates a physical hardware component, not a software-only device.
Based on the provided information, the Alaris® PC Unit is not an In Vitro Diagnostic (IVD) device.
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 professional healthcare environments for infusion and monitoring. This does not involve the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing, which is the core definition of an IVD.
- Device Description: The description focuses on the hardware components (processor, memory, screen) and its function as a control unit for other modules. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Reagents or assays
- Diagnostic information
- Laboratory setting
The Alaris® PC Unit is clearly described as a component of a system used for delivering fluids (infusion) and potentially monitoring physiological parameters, which falls under the category of medical devices used for treatment and monitoring, not in vitro diagnosis.
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 Alario® 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. 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.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
CARDINAL HEALTH
KC09/308
SPECIAL 510/k ALARIS® PC UNIT
ATTACHMENT D
SUMMARY OF SAFETY AND EFFECTIVENESS
Cardinal Health 303, Inc.
Alaris® PC Unit
Models 8000 and 8015
JUL - 9 2009
| SUBMITTER'S NAME: | Cardinal Health 303, Inc. |
|---|---|
| 10020 Pacific Mesa Blvd. | |
| San Diego, CA 92121 | |
| (858) 617-5925 | |
| (858) 617-5977 FAX | |
| CONTACT PERSON: | Michelle J. Badal, RAC |
| Vice President, Regulatory Affairs | |
| DATE PREPARED: | May 1, 2009 |
| DEVICE NAME: | Proprietary Name: Alaris® PC Unit |
| Common Name: Infusion Pump | |
| Classification Name: Pump, Infusion, FRN (880.5725) | |
| PREDICATE DEVICE: | Alaris® PC Unit (K051641, October 20, 2005) |
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.
1
SUMMARY OF SAFETY AND EFFECTIVENESS Page 2 of 2
SUBSTANTIAL EQUIVALENCE
With the exception of the device modification 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.
INTENDED USE
The intended use of this device has not changed from the original submissions in terms of content or intent:
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
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Alaris® PC Unit and the predicate devices has been performed. The results of this comparison demonstrate that the modified Alaris® PC Unit is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered.
.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 2009
Ms. Michelle J. Badal Vice President Regulatory Affairs Cardinal Health 303, Incorporated 10020 Pacific Mesa Boulevard San Diego, California 92121
Re: K091308
Trade/Device Name: Alaris® PC Unit Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: June 26, 2009 Received: July 1, 2009
Dear Ms. Badal:
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 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. Badal
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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Anthony D. Watson
Susan Runner, D.D.S., M.A.
Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment B INDICATIONS FOR USE
K091308 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 Alario® System module is specified in its respective submission.
X Prescription Use (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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K091308
00069