(214 days)
Not Found
No
The summary describes a modification to an existing infusion pump system primarily involving the addition of a wireless remote accessory. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to provide "infusion therapy," which is a therapeutic intervention.
No
Explanation: The device is an infusion system designed to deliver medications and fluids during an MR procedure. It does not perform any diagnostic functions.
No
The device description explicitly states it is a "MEDRAD Continuum MR Infusion System" which is a physical infusion pump with a wireless remote accessory, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to provide infusion therapy (delivering medications and fluids) to patients during an MR procedure. This is a direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description reinforces that it's an infusion pump system that connects to the patient's administration line.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, not to administer substances into the body. This device falls under the category of a therapeutic device used in a clinical setting.
N/A
Intended Use / Indications for Use
The MEDRAD Continuum MR Infusion System with Wireless Remote Accessory is designed for patients who require medications and other 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 the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
The MEDRAD Continuum MR Infusion System with Wireless Remote Accessory is a modification of the MEDRAD Continuum MR Compatible Infusion System (3T Proximity) predicate device described in 510(k) submission K061128. Similar to the MEDRAD predicate device, the system is designed for patients requiring medications and other fluids during an MR imaging procedure. Both are designed for use in MR environments up to the 2000 Gauss line in magnet strengths up to and including 3T and are not intended to provide long-term patient care. Both systems connect to the existing patient administration line by the addition of a proprietary disposable and replace the bedside pump during the MR procedure. The proposed device and the predicate device are intended to be used by trained healthcare professionals, medical physicians, and critical care, emergency room, and radiology nursing staff. Neither is intended for the delivery of blood, blood products or nitroglycerine.
The Continuum MR Infusion System with Wireless Remote Accessory maintains the same intended use, similar operational parameters, and similar labeling (with the addition of a remote display specific operation manual) as the predicate device. The proposed device is used in a similar manner as both of the predicate devices described in the submission.
The MEDRAD Continuum MR Infusion System included in the proposed device has a similar design, similar materials of construction, similar components and similar infusion pump technology as the MEDRAD Continuum MR Compatible Infusion System (3T Proximity) predicate device. The primary difference between the two MEDRAD devices is the addition of the remote accessory and wireless radio technology. However, the proposed device and the Iradimed MRidium 3850 MRI Infusion Pump System with 3855 Optional Wireless Remote Control described in 510(k) submission K050301 have a similar intended use, similar wireless radio technology, and similar remote control functionality.
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 medical staff, primarily critical care, emergency room and radiology nursing staff.
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)
Testing of the MEDRAD Continuum MR Infusion System with Wireless Remote Accessory is being conducted against applicable standards including IEC 60601-2-24, IEC 60601-1, UL 60601- 1 and IEC 60601-1-2. These standards represent standardized testing for safety and These are the same standards used in the determination of substantial performance. equivalence for the MEDRAD predicate device. Testing to the standards will be completed by third party certified test labs for the MEDRAD Continuum MR Infusion System with Wireless Remote Accessory with satisfactory test results required prior to release of the product.
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
510(k) Summary of Safety and Effectiveness
| DATE PREPARED: | October 26, 2007 | MAY 30 200- | ||
|---|---|---|---|---|
| NAME OF SUBMITTER: | MEDRAD, Inc. | |||
| One MEDRAD Drive | ||||
| Indianola, PA 15051 | ||||
| OFFICIAL CONTACT: | Leslie S. O'Nan | |||
| Phone: 412-767-2400 ext. 3165 | ||||
| Fax: 412-767-2451 | ||||
| PROPRIETARY NAME: | MEDRAD Continuum MR Infusion System with Wireless Remote | |||
| Accessory | ||||
| CLASSIFICATION NAME: | Infusion Pump - Class II (see 21 CFR 880.5725) | |||
| COMMON NAME: | Peristaltic Pump | |||
| PRODUCT CODE: | FRN | |||
| PREDICATE DEVICES: | K061128, MEDRAD Continuum MR Compatible Infusion System | |||
| (3T Proximity) | ||||
| K050301, Iradimed MRidium 3850 MRI Infusion Pump System | ||||
| INDICATIONS FOR USE: | The MEDRAD Continuum MR Infusion System with Wireless | |||
| Remote Accessory is designed for patients who require | ||||
| medications and other 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 the MR environment. The system is to be | ||||
| used by trained medical staff, primarily critical care, emergency | ||||
| room and radiology nursing staff. |
DEVICE DESCRIPTION AND COMPARISON TO PREDICATE DEVICES
The MEDRAD Continuum MR Infusion System with Wireless Remote Accessory is a modification of the MEDRAD Continuum MR Compatible Infusion System (3T Proximity) predicate device described in 510(k) submission K061128. Similar to the MEDRAD predicate device, the system is designed for patients requiring medications and other fluids during an MR imaging procedure. Both are designed for use in MR environments up to the 2000 Gauss line in magnet strengths up to and including 3T and are not intended to provide long-term patient care. Both systems connect to the existing patient administration line by the addition of a proprietary disposable and replace the bedside pump during the MR procedure. The proposed device and the predicate device are intended to be used by trained healthcare professionals, medical physicians, and critical care, emergency room, and radiology nursing staff. Neither is intended for the delivery of blood, blood products or nitroglycerine.
The Continuum MR Infusion System with Wireless Remote Accessory maintains the same intended use, similar operational parameters, and similar labeling (with the addition of a remote display specific operation manual) as the predicate device. The proposed device is used in a similar manner as both of the predicate devices described in the submission.
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· MEDRAD, Inc. · 510(k) Pre-market Submission● MEDRAD Continuum Wireless MR Infusion System ●
1
The MEDRAD Continuum MR Infusion System included in the proposed device has a similar design, similar materials of construction, similar components and similar infusion pump technology as the MEDRAD Continuum MR Compatible Infusion System (3T Proximity) predicate device. The primary difference between the two MEDRAD devices is the addition of the remote accessory and wireless radio technology. However, the proposed device and the Iradimed MRidium 3850 MRI Infusion Pump System with 3855 Optional Wireless Remote Control described in 510(k) submission K050301 have a similar intended use, similar wireless radio technology, and similar remote control functionality.
A tabular comparison of features and principles of operation for the MEDRAD Continuum MR Compatible Infusion System (3T Proximity) (Predicate) and MEDRAD Continuum MR Infusion System with Wireless Remote Accessory (Proposed) is contained in Table 2.
Table 2 Comparison of the MEDRAD Continuum MR Compatible Infusion System (3T Proximity) (Predicate) and MEDRAD Continuum MR Infusion System with Wireless Remote Accessory (Proposed)
| (Proposed)
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|---|---|---|
| Continuum MR Compatible | ||
| Infusion System - (3.0T | MEDRAD Continuum MR | |
| Infusion System with Wireless | ||
| Proximity) - K061128 | Remote Accessory | |
| Classification | CF | Same |
| Administration sets | Sterile, proprietary, single-use, | |
| standard PVC, free-flow protection | Same | |
| Intended Use | The MEDRAD Continuum MR | |
| Compatible Infusion System (3T | ||
| Proximity) 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 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 | |
| Infusion System with Wireless | ||
| Remote Accessory is designed for | ||
| patients who require medications | ||
| and other 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 the MR | ||
| environment. The system is to be | ||
| used by trained medical staff, | ||
| primarily critical care, emergency | ||
| room and radiology nursing staff. | ||
| Flow Rate | Continuous: 0.1 to 99.9 ml/h in 0.1 | |
| ml/h increments, | ||
| 100 to 1200 ml/h in 1 ml/h | ||
| increments | Same | |
| Housing | ABS | Same |
| Operating principle | Peristaltic Infusion Pump, | |
| Microprocessor controlled | Same | |
| KVO Infusion rate | 1 to 5 ml/h | 0 to 5 ml/h |
| KVO input limit was lowered from 1 | ||
| to 0 ml/h since last 510(k) clearance | ||
| System accuracy | +/- 10% | Same |
| Occlusion pressure | User selectable: Low - 0.3 bar (5 | |
| psi), Medium - 0.5 bar (7.5 psi), | ||
| High - 0.7 bar (10 psi) | Same | |
| PARAMETER | PREDICATE DEVICE | |
| Continuum MR Compatible | ||
| Infusion System - (3.0T | ||
| Proximity) - K061128 | PROPOSED DEVICE | |
| MEDRAD Continuum MR | ||
| Infusion System with Wireless | ||
| Remote Accessory | ||
| Pump Battery | ||
| Pump Battery | ||
| operation | Li-based rechargeable | |
| 4 hrs at 1200 ml/h | Same |
8 hrs at 125 ml/h
(> 5 hrs at 1200 ml/h) |
| | | Slightly higher battery life since last
510(k) clearance |
| Pump Battery
charging | ~6 hrs to 95% maximum battery
capacity | Same |
| Air-in-line detector | User selectable | Same |
| Total time setting | 100 hours | Same |
| Air sensor | Ultrasonic | Same |
| Prime rate | 1600 to 1800 ml/h | Same |
| Bolus flow rate | 0.1 to 1200 ml/h | Same |
| Bolus volume | 0.1 to 100 ml | Same |
| Alarm Conditions | ➤ Air in line
➤ Down occlusion
➤ Pump unattended
➤ Low battery
➤ End battery
➤ Fatal error
➤ End program
➤ Missing key
➤ Lock mode | ➤ Air in line
➤ Down occlusion
➤ Pump unattended
➤ Low battery
➤ End battery
➤ Fatal error
➤ End program
➤ Missing key
➤ Lock mode
➤ Program Nearing End
Addition of the Program Nearing
End alarm since last 510(k)
clearance |
| User Selectable
Alarm Volume | Yes | Same |
| Program modes | ➤ Continuous
➤ Dose
➤ Non-weight dose | Same |
| Integrated mounting
clamp for IV pole | Yes | Same |
| Built in Free Flow
Protection | Yes | Same |
| Automatic Bolus
Function (Safety
Feature) | Yes | Same |
| MR compatible | Yes (up to 2000 Gauss) | Same |
| Usability software
features | Yes | ➤ Bolus Review Screen
➤ Screen dimming
➤ Reset behavior for the "Total
Volume Infused"
➤ Dose Rate Units setting
Addition of new usability software |
| PARAMETER | PREDICATE DEVICE
Iradimed MRidium 3850 MRI
Infusion Pump System with
MRidium 3855 Wireless Remote
Control | PROPOSED DEVICE
MEDRAD Continuum MR
Infusion System with Wireless
Remote Accessory |
| Optional Wireless
Remote Accessory | Yes | Same |
| Infusion
Management
Features | Status of the pump operation,
battery level, flow rate parameters
and alarms | Same |
| Control Features | Start, stop, titrate, bolus | Same |
| RF Wireless
Technology | Operates at 2.4 GHz | Same
IEEE 802.11b/g |
Page 2
● MEDRAD, Inc. ● 510(k) Pre-market Submission● MEDRAD Continuum Wireless MR Infusion System ●
2
Page 3
:
● MEDRAD, Inc. ● 510(k) Pre-market Submission● MEDRAD Continuum Wireless MR Infusion System ●
3
A tabular comparison of features and principles of operation for the Iradimed MRidium 3850 MRI Infusion Pump System with MRidium 3855 Wireless Remote Control (Predicate) and MEDRAD Continuum MR Infusion System with Wireless Remote Accessory (Proposed) is contained in Table 3.
Table 3 Comparison of the Iradimed MRidium 3850 MRI Infusion Pump System with MRidium 3855 Wireless Remote Control (Predicate) and MEDRAD Continuum MR Infusion System with Wireless Remote Accessory (Proposed)
SUMMARY OF PERFORMANCE TESTING
Testing of the MEDRAD Continuum MR Infusion System with Wireless Remote Accessory is being conducted against applicable standards including IEC 60601-2-24, IEC 60601-1, UL 60601- 1 and IEC 60601-1-2. These standards represent standardized testing for safety and These are the same standards used in the determination of substantial performance. equivalence for the MEDRAD predicate device. Testing to the standards will be completed by third party certified test labs for the MEDRAD Continuum MR Infusion System with Wireless Remote Accessory with satisfactory test results required prior to release of the product.
STATEMENT OF SUBSTANTIAL EQUIVALENCE
The substantial equivalence comparisons demonstrate that the MEDRAD Continuum MR Infusion System with Wireless Remote Accessory contain technological features that do not differ significantly from currently marketed devices.
Verification and validation will be completed according to the Verification and Validation Test Plan to confirm that the design specifications for the MEDRAD Continuum MR Infusion System with Wireless Remote Accessory have been met and that the device meets the applicable requirements of the safety and performance standards cited.
Therefore, it has been determined that the Continuum MR Infusion System with Wireless Remote Accessory is substantially equivalent to the predicate devices described in the submission for its intended use when used as prescribed in the User Operation Manual.
● MEDRAD, Inc. ● 510(k) Pre-market Submission● MEDRAD Continuum Wireless MR Infusion System ●
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2008
Ms. Leslie S. O'Nan Regulatory Affairs Specialist MEDRAD, Incorporated One Medrad Drive Indianola, Pennsylvania 15051
Re: K073051
Trade/Device Name: MEDRAD Continuum MR Infusion System with Wireless Remote Accessory Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 9, 2008 Received: May 12, 2008
Dear Ms. O'Nan:
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.
5
Page 2 - O'Nan
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 (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/industry/support/index.html.
Sincerely vours,
Chiu Lin, Ph.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
6
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MEDRAD Continuum MR Infusion System with Wireless Remote Accessory
Indications for Use:
The MEDRAD Continuum MR Infusion System with Wireless Remote Accessory is designed for patients who require medications and other 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 the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (Part 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)
Charles Beard
Division of Oil & Gas
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KD73051
Page 1 of 1
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· MEDRAD, Inc. · Abbreviated 510(k) Pre-market Submission · Confidential · MEDRAD Continuum MR Infusion System with Wireless Remote Accessory ●