(15 days)
The Medrad Continuum MR Compatible Infusion System is designed for patients who require maintenance medications and fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during, and immediately after the MR procedure, functioning while either stationary or mobile. It is not intended to provide long-term patient care outside of the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
The Medrad Continuum MR Compatible Infusion System has been modified to include two new programming options, and to remove two previous programming options. None of the modifications required changes to the system hardware, labeling, or disposable administration sets. The following two programs have been added as features to the Continuum MR Infusion System:
- Dose Program The Dose Program enables the administration of a weight-based dose in either micrograms/kg/min or milligrams/kg/min. This program is designed for use in procedures that require special dosing and infusion based on the patient's weight. The program calculates a flow rate in ml/hr based on the input parameters programmed by the user. The require parameters are:
Patient Weight (kg) t
Drug Concentration (mg/ml) ●
Dose (ug/kg/min or mg/kg/min) ●
. Volume (ml) - Bolus Program The Bolus Program chables the Continuum MR Infusion System to administer a bolus to the patient. This program removes the need for an cxternal syringe connection to the Continuum Administration Set for a bolus administration. The Bolus Program feature is available in both the Dose program and the Rate Over Volume mode of the Continuous Program. The Bolus Program prompts the user for the bolus volume and then administers the bolus at the user's command. The following parameters are available for the Bolus Program:
Bolus Flow Rate (programmable in the Adjust Settings Menu) .
a. 10 99.9 ml/hr in 0.1 ml increments
b. 100 500 ml/hr in 1.0 ml increments
Bolus Volume (0.1 100 ml in 0.1 ml increments)
In addition to the inclusion of the two programs above, two of the existing programs, the Intermittent Program and the 25-steps Protocol, have been removed from the modified Continuum MR Infusion System.
The Medrad Continuum MR Infusion System is a peristaltic pump system designed for administering maintenance medications and fluids to patients during MR procedures. The system has been modified to include new "Dose Program" and "Bolus Program" options while removing the existing "Intermittent Program" and "25-steps Protocol". The modifications did not require changes to the system hardware, labeling, or disposable administration sets.
Acceptance Criteria and Device Performance
The provided document does not explicitly state acceptance criteria in a quantitative format for the new Dose and Bolus programs, nor does it detail a specific study that quantitatively proves the device meets such criteria. However, the submission is a Special 510(k) for device modifications, implying that the modified device's performance is considered substantially equivalent to the predicate device (Medrad Continuum MR Infusion System, K021988), particularly since no hardware changes were made. The "System Accuracy" for flow rate remains the same as the predicate device: ± 10%. This can be inferred as the primary performance criterion for fluid delivery.
The comparison table provided in the document highlights the parameters that are "Same" as the predicate device, implying that their performance and safety characteristics remain unchanged and meet the previously established standards for the predicate device.
Table 1: Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate) | Reported Device Performance (Modified) |
|---|---|---|
| System Accuracy (Flow Rate) | ± 10% | Same as predicate (implied ± 10%) |
| Bolus Rate | N/A (for predicate) | 10 - 99.9 ml/hr in 0.1 ml increments |
| 100 - 500 ml/hr in 1 ml increments | ||
| Bolus Volume | N/A (for predicate) | 0.1 - 100 ml in 0.1 ml increments |
| Alarms (e.g., Air-in-line) | Yes | Same |
| MRI Compatible | Yes | Same |
| Other Parameters (Flow Rate, | Same as predicate | Same |
| KVO Rate, Battery Life, etc.) |
Note: The document is a 510(k) summary, which typically presents a high-level overview. Detailed test reports with specific acceptance criteria and performance data for the new software functions (Dose and Bolus Programs) are not included in this summary but would have been part of the full 510(k) submission. The "Same" entries in the performance column imply that the modified device's performance for those parameters continues to meet the predicate device's established performance.
Study Details and Ground Truth Establishment
The provided document does not describe a detailed "study" in the sense of a clinical trial or a formal quantitative performance study tailored to prove the device meets specific acceptance criteria for the new features. Instead, this is a Special 510(k) submission for device modifications. This type of submission relies on the concept of substantial equivalence to a predicate device, particularly when the modifications do not affect fundamental safety or effectiveness.
Given the nature of a Special 510(k), the "study" would primarily involve verification and validation (V&V) testing to ensure the new software functionality (Dose and Bolus Programs) operates as intended and does not negatively impact existing safety and performance features. This V&V testing would compare the modified device's performance against its own design specifications and the predicate device's established performance characteristics.
Based on the information provided, here's an analysis of the requested points:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in terms of patient data or clinical cases. The V&V testing would likely involve bench testing using a representative number of infusion scenarios and parameters for the Dose and Bolus programs to confirm accurate calculation and delivery. The data provenance would be from internal Medrad, Inc. testing. The testing would be prospective in the sense that the new software features are tested against their design specifications. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable in this context. For an infusion pump, "ground truth" relates to the accurate delivery of fluids based on programmed parameters, which is verified through physical measurements and engineering standards, not expert consensus on interpretations. The "experts" would be the engineers and quality assurance personnel conducting the V&V testing, ensuring the device performs according to its design and regulatory requirements. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in studies involving subjective interpretations (e.g., image analysis by multiple radiologists) to establish a consensus ground truth. For an infusion pump, performance is objectively measured. -
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, not an AI-powered diagnostic tool. MRMC studies are used for evaluating AI performance in diagnostic imaging. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The "standalone" performance for the infusion pump refers to its ability to accurately deliver fluids as programmed. The V&V testing for the new Dose and Bolus programs would assess this. For example, testing would confirm that if a user programs a specific dose (micrograms/kg/min) and concentration, the pump correctly calculates and delivers the corresponding flow rate (ml/hr) with the specified accuracy (± 10%). Similarly, for the Bolus program, the accuracy of delivering the programmed bolus volume and rate would be tested. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For an infusion pump, the "ground truth" for V&V testing is based on engineering specifications and metrology. For instance, the ground truth for flow rate accuracy would be the precisely measured volume of fluid delivered over time, compared to the calculated and programmed rate. This is established using calibration equipment and standard test methods for infusion devices. -
The sample size for the training set:
Not applicable. Infusion pumps are not typically developed using machine learning or AI models that require "training sets." The device's functionality is based on deterministic algorithms and software logic. -
How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the context of this device.
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SEP 2 3 2003
Special 510(k) Summary - Medrad Continuum MR Infusion System
| OFFICIAL CONTACT: | Andrew P. ZeltwangerRegulatory Affairs AnalystMcdrad, Inc.One Medrad DriveIndianola, PA 15051(412) 767-2400 ext. 3005 |
|---|---|
| CLASSIFICATION NAME: | Infusion Pump & Accessories [21 CFR 880.5725] |
| COMMON NAME(s): | Peristaltic Pump System |
| PROPRIETARY NAME(s): | Medrad Continuum MR Infusion System |
| PREDICATE DEVICE(s): | Medrad Continuum MR Infusion System(K021988) |
| INTENDED USE: | The Medrad Continuum MR Compatible InfusionSystem is designed for patients who requiremaintenance medications and fluids during an MRprocedure. It is intended to provide infusiontherapy directly prior to, during, and immediatelyafter the MR procedure, functioning while eitherstationary or mobile. It is not intended to providelong-term patient care outside of the MRenvironment. The system is to be used by trainedmedical staff, primarily critical care, emergencyroom and radiology nursing staff. |
DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE:
The Medrad Continuum MR Compatible Infusion System has been modified to include two new programming options, and to remove two previous programming options. None of the modifications required changes to the system hardware, labeling, or disposable administration sets. The following two programs have been added as features to the Continuum MR Infusion System:
-
- Dose Program The Dose Program enables the administration of a weight-based dose in either micrograms/kg/min or milligrams/kg/min. This program is designed for use in procedures that require special dosing and infusion based on the patient's weight. The program calculates a flow rate in ml/hr based on the input parameters programmed by the user. The require parameters are:
- Patient Weight (kg) t
- Drug Concentration (mg/ml) ●
- · Medrad, Inc. · Special 510(k) Device Modification ·
- · Continuum MR Compatible Infusion System ·
- · Medrad, Inc. · Special 510(k) Device Modification ·
{1}------------------------------------------------
- Dose (ug/kg/min or mg/kg/min) ●
- . Volume (ml)
-
- Bolus Program The Bolus Program chables the Continuum MR Infusion System to administer a bolus to the patient. This program removes the need for an cxternal syringe connection to the Continuum Administration Set for a bolus administration. The Bolus Program feature is available in both the Dose program and the Rate Over Volume mode of the Continuous Program. The Bolus Program prompts the user for the bolus volume and then administers the bolus at the user's command. The following parameters are available for the Bolus Program:
- Bolus Flow Rate (programmable in the Adjust Settings Menu) .
- a. 10 99.9 ml/hr in 0.1 ml increments
- b. 100 500 ml/hr in 1.0 ml increments
- Bolus Volume (0.1 100 ml in 0.1 ml increments) �
In addition to the inclusion of the two programs above, two of the existing programs, the Intermittent Program and the 25-steps Protocol, have been removed from the modified Continuum MR Infusion System.
The following table shows a comparison between the device components of the modified and unmodified Continuum MR Infusion System.
| Parameters | Predicate Device | Modified Device |
|---|---|---|
| Medrad ContinuumMR Infusion Pump(K021988) | Medrad Continuum MRInfusion Pump | |
| Classification | Peristaltic InfusionSystem | Same |
| Compatible IV AdministrationSet | Standard PVCSingle UseY Site SetFree Flow Protection | Same Administration Set |
| Flow Rate | 0.1 – 100 ml/hr in 0.1ml increments100 – 500 ml/hr in 1.0ml increments | Same |
| Housing | ABS | Same |
| Microprocessor Controlled | Yes | Same Hardware |
| KVO Infusion Rate | Configurable 1-5 ml/hr | Same |
| System Accuracy | $\pm$ 10% | Same |
| Occlusion Pressure | User Selectable | Same |
| Battery | Li-Ion, Rechargeable | Same Battery |
| Battery Life | 4 hr (at 500 ml/hr) | Same |
| Battery Charging | ~ 6 hr to 95% max.battery capacity | Same |
| Air in Line Detector | User Adjustable | Same |
| Total Time Setting | 100 hours | Same |
· Medrad, Inc. · Special 510(k) Device Modification ·
- · Continuum MR Compatible Infusion System ·
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| Air Sensor | Ultrasonic | Same Sensor |
|---|---|---|
| Bolus Rate | N/A | 10 - 99.9 ml/hr in .1 mlincrements100 - 500 ml/hr in 1 mlincrements |
| Alarm Conditions | ||
| 1. Air-in-line | 1. Yes | 1. Same |
| 2. Down Occlusion | 2. Yes | 2. Same |
| 3. Pump Unattended | 3. Yes | 3. Same |
| 4. Low Battery | 4. Yes | 4. Same |
| 5. End Battery | 5. Yes | 5. Same |
| 6. Fatal Error | 6. Yes | 6. Same |
| 7. End Program | 7. Yes | 7. Same |
| 8. Missing Key | 8. Yes | 8. Same |
| 9. Lock Mode | 9. Yes | 9. Same |
| Multi-Programs | ||
| 1. Continuous Program | 1. Yes | 1. Same |
| 2. Intermittent Program | 2. Yes | 2. Removed |
| 3. 25-Steps Protocol | 3. Yes | 3. Removed |
| 4. Dose Program | 4. No | 4. Yes |
| 5. Bolus Program | 5. No | 5. Yes |
| Integrated Mounting for IV Pole | Yes | Same |
| Built-in Free Flow Protection | Yes | Same |
| User-selectable OcclusionPressures | Yes | Same |
| Rate/Volume and Volume/TimeProgramming | Yes | Same |
| Bolus Capability | Manual, Syringe-induced boluscapability foradministration set. | Programmable BolusFunction |
| User Selectable Alarm/Volume | Yes | Same |
| MRI Compatible | Yes | Same |
:
:
.
• Continuum MR Compatible Infusion System •
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 2003
Mr. Andrew P. Zeltwanger Regulatory Affairs Analyst Medrad, Incorporated One Medrad Drive Indianola, Pennsylvania 15051-0780
Re: K032771
Trade/Device Name: Medrad Continuum MR Infusion System Regulation Number: 880.5725 Regulation Name: Infusion Pump & Accessories Regulatory Class: II Product Code: FRN Dated: September 4, 2003 Received: September 8, 2003
Dear Mr. Zeltwanger:
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.
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Page 2 - Mr. Zeltwanger
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 Runno
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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Intended Use
There has been no change to the indications for use as a result of the proposed modifications described in this submission.
Indications for Use Statement
2022711 510(k) Number:
Device Name: Medrad Continuum MR Infusion System
Indications for Use:
The Medrad Continuum MR Compatible Infusion System is designed for patients who require maintenance medications and fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during, and immediately after the MR procedure, functioning while either stationary or mobile. It is not intended to provide long-term patient care outside of the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
Patricia Cucurite
Anesthesiology, General Hospital, ontrol, Dental De
510(k) Number. K032771
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
Or
Over-the-Counter Use
· Medrad, Inc. · Special 510(k) Device Modification ·
· Continuum MR Compatible Infusion System ·
§ 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).