(52 days)
No
The document describes a system for automating infusion parameter programming and adding wireless communication capabilities to an existing infusion device. There is no mention of AI or ML technologies being used for data analysis, decision-making, or any other function. The focus is on communication and automation of manual steps.
Yes
The device is an infusion system intended for the delivery of fluids, medications, blood, and blood products for therapeutic purposes.
No
The device is described as an infusion and monitoring system intended for the delivery of fluids, medications, blood, and blood products, and for automating the programming of infusion parameters. It does not mention any function for diagnosis of a disease or condition.
No
The device is described as a modular infusion and monitoring system consisting of a Programming Module and attachable/detachable modules (Pump Module, Syringe Module, Pulse Oximetry modules). While it adds wireless communication capability (software functionality), it is clearly built upon and integrated with existing hardware components.
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 "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 performing tests on samples taken from the body.
- Device Description: The description details a modular infusion and monitoring system with components like pump modules, syringe modules, and pulse oximetry. These are all related to patient care and administration, not in vitro testing.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Reagents or test kits
The device is an infusion system designed to improve the safety and efficiency of administering medications and fluids to patients.
N/A
Intended Use / Indications for Use
The ALARIS Medical Systems, Inc., Medley" System with Medication Management System (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 Medley™ 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
The Medley *** System (K950419) is a currently marketed modular infusion and monitoring system that consists of a Programming Module (PM) and attachable/detachable modules. Current infusion modules available are a Pump Module (K950419) and a Syringe Module (K023264). Monitoring modules currently include Pulse Oximetry (SpO2) using Nellcor (K022677) and Masimo (K010966) technology.
This traditional 510(k) Premarket Notification is being submitted to assist our customers in reducing the number of manual steps needed to program an infusion by allowing wireless communication capability to the currently marketed device, the Medley" Medication Safety System (Medley System) K950419. This Medication Management System (MMS) adds communication capability to the Medley" System thereby providing our customers with a "safety net" at the bedside to help reduce the number of programming errors at the point of care. This product will be called the Medley System with MMS.
As with the predicate device (B. Braun Medical Inc., Horizon™ Outlook with DoseCom™) this submission adds wireless communication to a server and to an existing infusion device. The Medley System was originally cleared with the capability of wired or wireless communication to include receiving infusion protocol information, uploading/downloading system configuration information and reporting infusion or system status. However, this capability was not well defined and did not include communication with a Server. It was also not clear about the local retrieval of data using optical laser scanning (bar-coding) or RF detection of information contained in documents, labels, RF ID Chips, etc. Adding MMS to the Medley System is simply an expansion of the original 510(k) indications for use for the Medley System. This submission will allow the Medley 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
trained healthcare professional / hospital network infrastructure, bedside
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)
The performance data indicate that the Medley™ System with MMS meets specified requirements and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K950419, K023264, K022677, K010966
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
APR 0 4 2003
ORIGINAL PREMARKET NOTIFICATION MEDLEY SYSTEM WITH MMS
SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems, Inc. Medley System with MMS
SUBMITTER INFORMATION
| A. | Company Name: | ALARIS Medical Systems, Inc. |
|---|---|---|
| B. | Company Address: | 10221 Wateridge Circle |
| San Diego, CA 92121-2733 | ||
| C. | Company Phone: | |
| Company Fax: | (858) 458-7563 | |
| (858) 458-6114 | ||
| D. | Contact Person: | Renée L. Fluet |
| Principal Regulatory Affairs Specialist | ||
| ALARIS Medical Systems, Inc. | ||
| E. | Date Summary Prepared: | February 3, 2003 |
| VICE IDENTIFICATION | ||
| A. | Generic Device Name: | Pump, Infusion |
| B. | Trade/Proprietary Name: | Medley™ System with Medication |
| Management System (Medley™ System with |
MMS)
Class II C. Classification:
FRN, Infusion Pump Product Code:
DEVICE DESCRIPTION
D.
The Medley *** System (K950419) is a currently marketed modular infusion and monitoring system that consists of a Programming Module (PM) and attachable/detachable modules. Current infusion modules available are a Pump Module (K950419) and a Syringe Module (K023264). Monitoring modules currently include Pulse Oximetry (SpO2) using Nellcor (K022677) and Masimo (K010966) technology.
DEV
1
SUMMARY OF SAFETY AND EFFECTIVENESS DEVICE DESCRIPTION, Continued
This traditional 510(k) Premarket Notification is being submitted to assist our customers in reducing the number of manual steps needed to program an infusion by allowing wireless communication capability to the currently marketed device, the Medley" Medication Safety System (Medley System) K950419. This Medication Management System (MMS) adds communication capability to the Medley" System thereby providing our customers with a "safety net" at the bedside to help reduce the number of programming errors at the point of care. This product will be called the Medley System with MMS.
As with the predicate device (B. Braun Medical Inc., Horizon™ Outlook with DoseCom™) this submission adds wireless communication to a server and to an existing infusion device. The Medley System was originally cleared with the capability of wired or wireless communication to include receiving infusion protocol information, uploading/downloading system configuration information and reporting infusion or system status. However, this capability was not well defined and did not include communication with a Server. It was also not clear about the local retrieval of data using optical laser scanning (bar-coding) or RF detection of information contained in documents, labels, RF ID Chips, etc. Adding MMS to the Medley System is simply an expansion of the original 510(k) indications for use for the Medley System. This submission will allow the Medley 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).
2
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
SUBSTANTIAL EQUIVALENCE
The ALARIS Medical Systems Inc., Medley™ System with MMS is substantially equivalent to the following predicate device:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Horizon OutlookTM | |||
| with Dose ComTM | B. Braun Medical, Inc. | K011975 | 09/19/01 |
In further support of a substantial equivalence determination, Section 9.2 provides a comparison chart of the Medley" System with MMS and the predicate device.
INTENDED USE
The incorporation of the Medication Management System (MMS) with the ALARIS Medley Medication Safety System provides wired or wireless communication between the Medley 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 Medley System with MMS is integrated into an existing hospital network infrastructure and allows communications to and from external devices, including personal computers (PC's), 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 Medley 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.
.
3
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
TECHNOLOGICIAL CHARACTERISTICS
A comparison of the technological characteristics of the Medley" System with MMS and the predicate device has been performed. The results of this comparison demonstrate that the Medley™ System with MMS is equivalent to the marketed predicate device in technological characteristics.
PERFORMANCE DATA
The performance data indicate that the Medley™ System with MMS meets specified requirements and is substantially equivalent to the predicate device.
4
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APR 0 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Renée L. Fluet Principal Regulatory Affairs Specialist ALARIS, Medical Systems, Incorporated 10221 Wateridge Circle San Diego, California 92121-2733
Re: K030459
Trade/Device Name: Medley™ System with Medication Management System (Medley™ System with MMS) Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: February 3, 2003 Received: February 11, 2003
Dear Ms. Fluet:
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.
5
Page 2 - Ms. Fluet
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 (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.
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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runner, DDS, M/A
Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
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INDICATIONS FOR USE
| 510(k) Number: | K 030459 (To Be Assigned By FDA) |
|---|---|
| ---------------- | ----------------------------------------- |
Device Trade Name: Medley" System with Medication Management System (Medley" System with MMS)
Indications For Use: The ALARIS Medical Systems, Inc., Medley" System with Medication Management System (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 Medley™ 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.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number: _
Prescription Use _
OR
Over-The-Counter Use _
(Per 21 CFR 801.109) /ellua Cucente
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: 403045-9
0034