(10 days)
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.
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 to hospital-defined protocol or a physician's order.
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.
The provided document discusses the Medley™ PCA Module with PCA/Monitoring Protocol and its substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria and performance data in the typical sense for a diagnostic or AI-powered device.
This clearance is for a medical device (an infusion pump with a specific protocol feature), which undergoes different types of validation than, for example, an AI diagnostic tool. The "performance data" mentioned in the document refers to engineering and functional testing to ensure the device operates as intended and is safe, rather than clinical performance metrics like sensitivity, specificity, or AUC against a ground truth.
Therefore, many of the requested categories (like sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance with metrics like AUC/sensitivity/specificity) are not applicable or not detailed in this type of 510(k) summary for an infusion pump.
However, I can extract what is available from the document regarding the "acceptance criteria" (implied functional requirements) and what the document states about "performance data".
Here's an attempt to answer based on the provided text, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied / Functional Requirements) | Reported Device Performance |
|---|---|
| Functional Safety & Performance: - Ability to deliver continuous or intermittent medications/fluids. - Compatibility with various routes of administration (IV, subcutaneous, epidural). - Integration of a PCA Module and monitoring module (EtCO2 Module and/or SpO2 module) on the Medley System platform. - Activation of PCA/Monitoring Protocol based on hospital-specified parameters and detection of an "unsafe state of respiratory depression." - All device programming, data entry, and validation of parameters performed by trained healthcare professionals according to protocol/physician's order. - The Protocol acts as an "additional safety net" for clinicians without replacing assessment or decision-making. - The device must meet specified requirements for safety and effectiveness. | The document states: "The Medley PCA Module is intended for use... for continuous or intermittent delivery through clinically acceptable routes of administration; such as intravenous (IV), subcutaneous, or epidural." "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..." "This Protocol is designed to help ensure patient safety when administering opioid medications... The Protocol will activate only when hospital-specified protocol indicates an unsafe state of respiratory depression is detected." "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." "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." "The performance data indicate that the Medley™ PCA Module with PCA/Monitoring Protocol meets specified requirements, and is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance
- Not explicitly stated in the document. The "performance data" mentioned would typically refer to engineering and functional testing of the device's hardware and software, rather than clinical trials with patient data. This is common for a 510(k) medical device clearance where substantial equivalence to a legally marketed predicate is established.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/not explicitly stated. For a medical device like an infusion pump, "ground truth" in the diagnostic sense is not typically established by experts reviewing cases. Performance is usually assessed against engineering specifications and functional output.
4. Adjudication method for the test set
- Not applicable/not explicitly stated. Clinical adjudication, as seen in diagnostic studies, is not typically part of the clearance for an infusion pump's functional performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an infusion pump with a safety protocol (not an AI diagnostic tool for image or data interpretation by human readers). Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially applicable, but for device function, not diagnostic performance. The "algorithm" here refers to the PCA/Monitoring Protocol. Its standalone functionality (i.e., whether it correctly detects 'unsafe states' based on its programming and triggers alerts) would have been tested as part of the "performance data." However, its "performance" is not measured in terms of diagnostic metrics like AUC, sensitivity, or specificity against a clinical ground truth, but rather its adherence to design specifications and safety requirements. The document states it is "intended to align with healthcare facilities' current protocols."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated/not applicable in the traditional sense. For this device, the "ground truth" for validation would be its adherence to engineering specifications, safety standards, and its ability to correctly implement the defined "PCA/Monitoring Protocol" logic (e.g., detecting specified physiological parameters (EtCO2, SpO2) and acting in accordance with pre-configured monitoring limits). These are validated through functional and performance testing, not against clinical outcomes or expert consensus on patient cases.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML model that requires a training set in the conventional sense. Its "protocol" is programmed logic, not learned from data.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of the Study (as described in the 510(k) submission):
The document describes the Medley™ PCA Module with PCA/Monitoring Protocol and references a "performance data" section, which is typical for 510(k) submissions. This "performance data" is designed to demonstrate that the device meets its specified requirements and is substantially equivalent to its predicate device (Medley PCA Module, K032233).
The study that proves the device meets the acceptance criteria (i.e., functional requirements and safety) is implicitly described as the "Performance Data" section of the 510(k) submission. This data would have involved:
- Bench testing: Verifying the accuracy of fluid delivery, the functionality of the monitoring module integration (EtCO2, SpO2), and the correct execution of the PCA/Monitoring Protocol logic (e.g., proper activation in response to simulated "unsafe states" and adherence to pre-configured monitoring limits).
- Software validation: Ensuring the software correctly implements the protocol and user interface.
- Electrical safety and EMC testing: Adherence to relevant standards.
The primary goal of this submission was to demonstrate Substantial Equivalence to a previously cleared device (Medley PCA Module, K032233) due to the addition of a new hospital-configurable Guardrails parameter (the PCA/Monitoring Protocol). The document states, "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." and "The performance data indicate that the Medley™ PCA Module with PCA/Monitoring Protocol meets specified requirements, and is substantially equivalent to the predicate device."
This means the "study" involved comparing the new device's functional and safety performance against the established requirements and the predicate device's performance, ensuring the added protocol feature did not introduce new safety concerns or compromise existing functionality.
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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.
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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
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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
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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 CircleSan Diego, CA 92121-2733 |
| C. | Company Phone:Company Fax: | (858) 458-7830(858) 458-6114 |
| D. | Contact Person: | Stacy L. LewisSr. Regulatory Affairs SpecialistALARIS 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.
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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 MedicalSystems, 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.
§ 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).