(10 days)
Not Found
No
The description focuses on pre-configured, hospital-defined protocols and monitoring limits, not adaptive or learning algorithms. The "Protocol" is a safety net based on specified parameters, not AI/ML.
Yes
The device is described as an infusion device used for the delivery of medications or fluids, specifically for PCA pain management therapy with opioid medications, which are therapeutic interventions.
No
Explanation: The device is an infusion device for delivering medications and fluids, specifically for PCA pain management therapy, and while it includes monitoring capabilities, its primary intended use is not diagnosis. The monitoring function is described as providing an "additional safety net" and does not replace clinician assessment or therapy decision-making, which are hallmarks of a diagnostic device.
No
The device description explicitly states it is a "Medley PCA Module" and integrates with "monitoring module(s) (EtCO2 Module and/or SpO2 module)" and a "Medley Point of Care Unit (PCU)". These are hardware components, making the device a combination of hardware and software, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Medley PCA Module is an infusion device used to deliver medications or fluids to a patient. While it can be used in conjunction with monitoring modules that might measure physiological parameters (like EtCO2 and SpO2), its primary function is drug delivery and patient monitoring based on those measurements, not analyzing samples in vitro.
- Intended Use: The intended use clearly describes the delivery of medications and fluids and the monitoring of patient response, not the analysis of biological samples.
Therefore, the Medley PCA Module falls under the category of a therapeutic and monitoring device, not an in vitro diagnostic device.
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 infusion devices 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.
The addition of the PCA/Monitoring Protocol provides an optional and hospitalconfigurable feature that is intended to align with healthcare facilities' current protocols that require monitoring of patients while on PCA therapy. All device programming, data entry and validation of PCA/Monitoring Protocol parameters is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order.
Product codes (comma separated list FDA assigned to the subject device)
MEA
Device Description
Due to the potential for opioid-induced respiratory depression, hospitals require regular monitoring and assessment of patients prescribed opioid medications. By allowing for the combination of a PCA Module and monitoring module (EtCO2 Module and/or SpO2 module) on the same platform, the Medley System provides a readily available way for the clinician to continuously monitor the patient's respiratory response while receiving opioid infusion therapy.
This submission will utilize the current system modularity to add a new hospitalconfigured Guardrails parameter (PCA/ Monitoring Protocol) to the Medley PCA Module. This Protocol is designed to help ensure patient safety when administering opioid medications. This Protocol will be available for use when a PCA Module and monitoring module(s) are attached to the same Medley Point of Care Unit (PCU). The PCA/Monitoring Protocol will be part of the Guardrails data set and will consist of a specified list of opioid medications and hospital-specified pre-configured monitoring limits. The Protocol will activate only when hospital-specified protocol indicates an unsafe state of respiratory depression is detected.
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 infusion devices 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 with PCA/Monitoring Protocol meets specified requirements, and is substantially equivalent to the predicate device.
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/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus-like symbol, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
APR 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Stacy L. Lewis Senior Regulatory Affairs Specialist ALARIS Medical Systems, Incorporated 10221 Wateridge Circle San Diego, California 92121-2733
Re: K043299
Trade/Device Name: Medley™ PCA Module with PCA/Monitoring Protocol Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA Dated: November 29,2004 Received: November 30,2004
Dear Ms. Lewis:
This letter corrects our substantially equivalent letter of December 10, 2004.
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 (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.
1
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 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Suitte Michael Jmd
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
2
INDICATIONS FOR USE
| 510(k) Number: | K043299 |
|---|---|
| Device Trade Name: | Medley TM PCA Module with PCA/Monitoring Protocol |
Indications For Use: The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices 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.
The addition of the PCA/Monitoring Protocol provides an optional and hospitalconfigurable feature that is intended to align with healthcare facilities' current protocols that require monitoring of patients while on PCA therapy. All device programming, data entry and validation of PCA/Monitoring Protocol parameters is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order.
OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Am
n of Anesthesiolor Intection Control. Denta
510(k) Number: K943214
Confidential
3
DEC 1 0 2004 SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley™ PCA Module with PCA/Monitoring Protocol
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: | November 29, 2004 |
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
Due to the potential for opioid-induced respiratory depression, hospitals require regular monitoring and assessment of patients prescribed opioid medications. By allowing for the combination of a PCA Module and monitoring module (EtCO2 Module and/or SpO2 module) on the same platform, the Medley System provides a readily available way for the clinician to continuously monitor the patient's respiratory response while receiving opioid infusion therapy.
4
SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley" PCA Module with PCA/Monitoring Protocol Page 2 of 3
This submission will utilize the current system modularity to add a new hospitalconfigured Guardrails parameter (PCA/ Monitoring Protocol) to the Medley PCA Module. This Protocol is designed to help ensure patient safety when administering opioid medications. This Protocol will be available for use when a PCA Module and monitoring module(s) are attached to the same Medley Point of Care Unit (PCU). The PCA/Monitoring Protocol will be part of the Guardrails data set and will consist of a specified list of opioid medications and hospital-specified pre-configured monitoring limits. The Protocol will activate only when hospital-specified protocol indicates an unsafe state of respiratory depression is detected.
SUBSTANTIAL EQUIVALENCE
The ALARIS Medical Systems Medley" PCA Module with PCA/Monitoring Protocol is of comparable type and is substantially equivalent to the following predicate device:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Medley PCA Module | ALARIS Medical | ||
| Systems, Inc. | K032233 | Sept. 9, 2003 |
INTENDED USE
The Medley PCA Module with PCA/Monitoring Protocol is intended for use with patients that are prescribed PCA pain management therapy with opioid medications, specifically: Fentanyl, Demerol, Morphine, and Hydromorphone. The Medley PCA Module with PCA/Monitoring Protocol is intended for use by healthcare professionals in clinical environments. The Protocol does not replace clinician assessment or therapy decision making, but adds an additional safety net for the clinician at the point of care. All device programming, data entry and validation of the Medley PCA Module with PCA/Monitoring Protocol is performed by the trained healthcare professional according
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SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley" PCA Module with PCA/Monitoring Protocol Page 3 of 3
INTENDED USE (continued)
to hospital-defined protocol or a physician's order. A separate Indications for Use page is located in Section 6.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Medley™ PCA Module with PCA/Monitoring Protocol and the predicate device has been performed. The results of this comparison demonstrate that the Medley™ PCA Module with PCA/Monitoring Protocol is equivalent to the marketed predicate device in technological characteristics.
PERFORMANCE DATA
The performance data indicate that the Medley™ PCA Module with PCA/Monitoring Protocol meets specified requirements, and is substantially equivalent to the predicate device.