(150 days)
Not Found
No
The document describes a system for automating infusion programming and communication, but there is no mention of AI or ML technologies being used for data analysis, decision support, or any other function. The focus is on wireless communication and data transfer.
No
The device delivers fluids, medications, blood, and blood products, which are therapeutic actions, but the device itself is an infusion system that automates programming and reduces manual steps, acting as a delivery mechanism rather than a direct therapeutic agent.
No
The device is an infusion device for delivering fluids, medications, blood, and blood products, and helps automate programming and reduce errors in infusion parameters. Its purpose is treatment delivery, not diagnosis.
No
The device description explicitly states it includes wireless communication capability to an existing infusion device (the Alaris® System), which is a hardware component. The software component facilitates communication and automation but is integrated with and relies on this hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "delivery of fluids, medications, blood and blood products" and to "automate the programming of infusion parameters." This describes a device used for administering substances to a patient, not for testing samples taken from the body.
- Device Description: The description focuses on wireless communication for programming and reducing errors in infusion delivery. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Using reagents or assays
The device described is an infusion system designed to manage and deliver substances to a patient, which falls under the category of therapeutic or drug delivery devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Alaris® System with Medication Management System (also known as the Medley™ System with MMS and the Alaris® System with MMS) is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.
The Alaris® System with MMS is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
Product codes
FRN
Device Description
As with the predicate device, the Alaris® System with MMS assists our customers in reducing the number of manual steps needed to program an infusion by allowing wireless communication capability to a server and an existing infusion device (the Alaris® System). The wireless communication capability provides a "safety net" at the bedside to help reduce the number of programming errors at the point of care. It allows the Alaris® System to transmit and receive messages with the Alaris® Server which in turn allows communication capability with external devices, including personal computers, Personal Digital Assistants (PDA;s), hospital monitoring systems and Hospital Information Management Systems (HIMS).
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
"The Alaris® System with MMS is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products." and "All data entry and validation of infusion parameters using MMS is performed by the trained healthcare professional."
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
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
SPECIAL 510(K) ALARIS® SYSTEM WITH MMS
ATTACHMENT D
SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health 303, Inc. Alaris® System with MMS
| SUBMITTER'S NAME: | Cardinal Health 303, Inc.
d.b.a. Cardinal Health
10221 Wateridge Circle
San Diego, CA 92121-2772
(858) 458-7830
(858) 458-6114 FAX | DEC 2 8 2007 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Stacy L. Lewis
Principal Regulatory Affairs Specialist | |
| DATE PREPARED: | July 27, 2007 | |
| DEVICE NAME: | Proprietary Name
Alaris® System with MMS | |
| | Common Name
Infusion Pump | |
| | Classification Name
Pump, Infusion and accessories, FRN (880.5725) | |
| PREDICATE DEVICE: | Alaris® System with MMS (a.k.a. Medley™ System with
MMS) K030459 | |
DEVICE DESCRIPTION
As with the predicate device, the Alaris® System with MMS assists our customers in reducing the number of manual steps needed to program an infusion by allowing wireless communication capability to a server and an existing infusion device (the Alaris® System). The wireless communication capability provides a "safety net" at the bedside to help reduce the number of programming errors at the point of care. It allows the Alaris® System to transmit and receive messages with the Alaris® Server which in turn allows communication capability with external devices, including personal computers, Personal Digital Assistants (PDA;s), hospital monitoring systems and Hospital Information Management Systems (HIMS).
1
ALARIS® SYSTEM WITH MMS SUMMARY OF SAFETY AND EFFECTIVENESS Page 2 of 2
SUBSTANTIAL EQUIVALENCE
The Alaris® System with MMS is essentially the same as the predicate device in that they have the same intended use, operating principles, method of operation, technology, materials and manufacturing processes. The changes as described in this Special 510(k) pose no new issues of safety or efficacy. The Alaris® System with MMS as described in this submission is substantially equivalent to the predicate device.
INTENDED USE
The incorporation of the Medication Management System (MMS) with the Alaris® System (a.k.a. Medley™ System) provides wired or wireless communication between the Alaris® System and external devices. This is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps to enter infusion data. All data entry and validation of infusion parameters using MMS is performed by the trained healthcare professional.
The Alaris System with MMS is integrated into an existing hospital network infrastructure and allows communications to and from external devices, including personal computers, Personal Digital Assistants (PDAs), hospital monitoring systems and Hospital Information Management Systems (HIMS). Bi-directional communication of data includes infusion parameters, system configuration, history, events, trending, alarms and status. In addition the Alaris System with MMS has the capability to transmit, receive and/or store: features, calibration data, datasets, and libraries from external components or devices to the pump.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Alaris® System with MMS and the predicate device has been performed. The results of this comparison demonstrate that the Alaris® System with MMS is equivalent in technological characteristics and the fundamental scientific technology of the predicate device has not been altered.
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00768
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the serpent winding around the staff.
DEC 2 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Stacey L. Lewis Principal Regulatory Affairs Specialist Cardinal Health 303, Incorporated 10221 Wateridge Circle San Diego, California 92121
Re: K072105
Trade/Device Name: Alaris System with MMS Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: December 3, 2006 Received: December 4, 2006
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 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 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.
3
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 (OS) 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 device 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Shiela A Murphy, MD for Chu Lin, Ph D
Chu Lin, Ph D
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
4
CARDINAL HEALTH
Attachment B
INDICATIONS FOR USE
510(k) Number:
- 05
(To Be Assigned By FDA)
Device Trade Name:
Alaris® System with MMS
Indications For Use:
The Alaris® System with Medication Management System (also known as the Medley™ System with MMS and the Alaris® System with MMS) is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.
The Alaris® System with MMS is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
Prescription Use X
Over-Th
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
Clint Damer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K472145
00763