(50 days)
Not Found
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description focuses on standard syringe pump functionality.
Yes
The device is a PCA Module that delivers medications or fluids intravenously, subcutaneously, or epidurally, which are therapeutic interventions.
No
The device delivers medications or fluids and functions as a PCA pump, which are therapeutic rather than diagnostic functions.
No
The device description explicitly states that the Medley PCA Module functions as part of a system and uses standard non-dedicated, single-use, administration sets and syringes. This indicates the presence of hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the delivery of medications or fluids to patients through various routes (IV, subcutaneous, epidural). This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the mechanical function of delivering fluids using syringes and administration sets. This aligns with a drug delivery device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Medley PCA Module's function is to administer substances into the body, not to analyze substances from the body.
N/A
Intended Use / Indications for Use
The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids.
The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), subcutaneous, or epidural.
Product codes (comma separated list FDA assigned to the subject device)
MEA, FRN
Device Description
The Medley PCA Module functions as part of the Medley™ Medication Safety System. In combination with the Medley" Programming Module (PM), the PCA Module will deliver fluids in a manner similar to current PCA pumps on the market. The Medley" PCA Module uses standard non-dedicated, single-use, administration sets and syringes with luer-lock connectors, of type designed for use on syringe-type PCA pumps.
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
adults, pediatrics, and neonates
Intended User / Care Setting
professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids.
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" PCA Module meets specified requirements, and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/3 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K', 'O', '3', '2', '2', '3', and '3'. The characters are written in a casual, cursive style.
SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley™ PCA 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 |
| Regulatory Affairs Associate | ||
| ALARIS Medical Systems, Inc. | ||
| E. | Date Summary Prepared: | July 17, 2003 |
DEVICE IDENTIFICATION
| A. | Generic Device Name: | PCA Infusion Pump |
|---|---|---|
| B. | Trade/Proprietary Name: | MedleyTM PCA Module |
| C. | Classification: | Class II |
| D. | Product Code: | MEA, PCA Infusion Pump |
DEVICE DESCRIPTION
The Medley PCA Module functions as part of the Medley™ Medication Safety System. In combination with the Medley" Programming Module (PM), the PCA Module will deliver fluids in a manner similar to current PCA pumps on the market. The Medley" PCA Module uses standard non-dedicated, single-use, administration sets and syringes with luer-lock connectors, of type designed for use on syringe-type PCA pumps.
1
SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley™ PCA Module Page 2 of 2
SUBSTANTIAL EQUIVALENCE
The ALARIS Medical Systems® Medley" PCA Module is of comparable type and is substantially equivalent to the following predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Medley Syringe Module | ALARIS Medical | ||
| Systems, Inc. | K023264 | 12/19/02 | |
| Baxter PCA II Pump | Baxter Healthcare | ||
| Corporation | K921994 | 8/3/92 |
INTENDED USE
The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids.
The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), subcutaneous, or epidural.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Medley" PCA Module and the predicate devices has been performed. The results of this comparison demonstrate that the Medley" PCA Module is equivalent to the marketed predicate devices in technological characteristics.
PERFORMANCE DATA
The performance data indicate that the Medley" PCA Module meets specified requirements, and is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
SEP - 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Stacy L. Lewis Regulatory Affairs Associate Alaris Medical System, Incorporated 10221 Wateridge Circle San Diego, California 92121-2772
Re: K032233
Trade/Device Name: PCA Infusion Pump Regulation Number: 880.5275 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA, FRN Dated: July 17, 2003 Received: July 21, 2003
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 (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
Susan Runner, DDS, MA Interim 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
510(k) Number:
K032233 (To Be Assigned By FDA)
Device Trade Name:
Medley™ PCA Module
Indications For Use: The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids.
The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), subcutaneous, or epidural.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use __
(Per 21 CFR 801.109)
Patricio Cucenite
ivision Sian-Off ion of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
0002