(56 days)
Not Found
No
The description focuses on bar code scanning and data exchange for automating infusion parameter entry, with no mention of AI or ML technologies.
No.
The device automates the programming of infusion parameters and exchanges information, but it does not directly administer treatment or affect the operation of the infusion system. It acts as an auxiliary component to infusion devices rather than a therapeutic device itself.
No
The device is an infusion system that automates the programming of infusion parameters and aids in data entry and verification, not in diagnosing medical conditions.
No
The device description explicitly states that the Medley Bar Code Module is a physical module that attaches to and receives power from the Medley System. It also mentions an attachable/detachable handheld scanner as an accessory. These are hardware components, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to automate the programming of infusion parameters for delivering fluids, medications, blood, and blood products. This is a function related to drug delivery and patient care, not the diagnosis of diseases or conditions based on in vitro examination of specimens.
- Device Description: The device description focuses on how the bar code module integrates with the infusion system to acquire and exchange data for programming. It does not mention any interaction with biological specimens or performing tests on them.
- Lack of IVD Characteristics: 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 biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The device's function is to improve the accuracy and efficiency of administering substances to a patient, which falls under the category of medical devices used for treatment or management, not diagnosis.
N/A
Intended Use / Indications for Use
The Medley System with Bar Code Module 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 Bar Code Module 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 Bar Code Module functions as part of the Medley System and can operate as a fifth module (when all four infusion and/or monitoring positions are in use). The Medley Bar Code Module attaches to and receives its power from the Medley System consistent with the modular design. The Bar Code Module does not directly interface with the Medley System; all communications are routed using a separate and dedicated communications interface channel resident in the Medley System.
Through the dedicated communications channel, the Medley Bar Code Module exchanges information between itself and other sources, such as the patient wristband, medication or device packaging, Medley, or MMS System components such as the ALARIS Server and Hospital Information Management Systems. As with the Medley System with MMS, there is an information protocol for proprietary data exchange and a method to verify the integrity of the information sent or received prior to programming a Medley System infusion module. The software incorporates error checking to ensure the correct acquisition, exchange, and integrity of acquired bar coded data.
All data entry and verification of infusion parameters using the Medley System with Bar Code Module is performed by trained healthcare professionals prior to administration of medication(s). The Medley Bar Code Module does not affect the operation of the Medley System. All Medley System functionality and performance specifications remain unchanged.
An attachable/detachable handheld scanner will be provided as an accessory to the Medley System with Bar Code Modulc as alternative way to acquire bar code data.
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 caregivers
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" Bar Code Module meets specified requirements, and is substantially equivalent to the predicate devices.
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
JUL - 6 2004
ORIGINAL PREMARKET 510(K) NOTIFIC MEDLEY SYSTEM w/BAR CODE MODULE
SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley" System with Bar Code Module
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) 458-7830 | ||
| (858) 458-6114 | |||
| D. | Contact Person: | Stacy L. Lewis | |
| Sr. Regulatory Affairs Specialist | |||
| ALARIS Medical Systems, Inc. | |||
| E. | Date Summary Prepared: | May 10, 2004 |
DEVICE IDENTIFICATION
| A. | Generic Device Name: | Infusion Pump | |
|---|---|---|---|
| B. | Trade/Proprietary Name: | MedleyTM System with Bar Code Module | |
| C. | Classification: | Class II | |
| D. | Product Code: | FRN, Infusion Pump |
DEVICE DESCRIPTION
The Medley Bar Code Module functions as part of the Medley System and can operate as a fifth module (when all four infusion and/or monitoring positions are in use). The Medley Bar Code Module attaches to and receives its power from the Medley System consistent with the modular design. The Bar Code Module does not directly interface with the Medley System; all communications are routed using a separate and dedicated communications interface channel resident in the Medley System.
1
SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley" System with Bar Code Module Page 2 of 3
Through the dedicated communications channel, the Medley Bar Code Module exchanges information between itself and other sources, such as the patient wristband, medication or device packaging, Medley, or MMS System components such as the ALARIS Server and Hospital Information Management Systems. As with the Medley System with MMS, there is an information protocol for proprietary data exchange and a method to verify the integrity of the information sent or received prior to programming a Medley System infusion module. The software incorporates error checking to ensure the correct acquisition, exchange, and integrity of acquired bar coded data.
All data entry and verification of infusion parameters using the Medley System with Bar Code Module is performed by trained healthcare professionals prior to administration of medication(s). The Medley Bar Code Module does not affect the operation of the Medlev System. All Medley System functionality and performance specifications remain unchanged.
An attachable/detachable handheld scanner will be provided as an accessory to the Medley System with Bar Code Modulc as alternative way to acquire bar code data.
SUBSTANTIAL EQUIVALENCE
The ALARIS Medical Systems® Medley" Bar Code Module is of comparable type and is substantially equivalent to the following predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Medley System w/ MMS | ALARIS Medical | ||
| Systems, Inc. | K030459 | April 4, 2003 | |
| Horizon Outlook 200 | B. Braun | K011975 | Sept. 19, 2001 |
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SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley™ System with Bar Code Module Page 3 of 3
INTENDED USE
The Medley System with Bar Code Module 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 Bar Code Module 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.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Medley " Bar Code Module and the predicate devices has been performed. The results of this comparison demonstrate that the Medley" Bar Code Module is equivalent to the marketed predicate devices in technological characteristics.
PERFORMANCE DATA
The performance data indicate that the Medley" Bar Code Module meets specified requirements, and is substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and is composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 2004
Ms. Stacy L. Lewis Senior Regulatory Affairs Specialist ALARIS Medical Systems, Incorporated 10221 Wateridge Circle San Diego, California 92121-2772
Re: K041241
Trade/Device Name: Medley™ System with Bar Code Module Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 10, 2004 Received: May 11, 2004
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.
4
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 (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
Sincerely yours,
Shih-Liang P1.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
5
Indications for Use
510(k) Number (if known):
Medley™ System with Bar Code Module Device Name:
Indications For Use:
The Medley System with Bar Code Module 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 Bar Code Module 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 × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anta V.m.
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K041241
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