(118 days)
Medtronic MiniMed Paradigm Model 511 Insulin Pump, BD Logic Glucose Monitor, Medtronic MiniMed Model 7304 ComLink
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No
The description focuses on continuous insulin delivery, blood glucose monitoring, and data transmission via radio frequency. There is no mention of AI or ML algorithms for decision-making, prediction, or pattern recognition. The "Bolus Wizard feature" uses a transmitted glucose value as a default, which is a simple data input, not an AI/ML function.
Yes
The Model 512 Insulin Pump is indicated for the continuous delivery of insulin for the management of diabetes mellitus, which is a therapeutic intervention.
Yes
The device explicitly states, "The BD Paradigm Link Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellius in the home as an aid to monitor the effectiveness of diabetes control." This measurement provides information about a physiological state, which is a key characteristic of a diagnostic device, even if it's not for initial diagnosis or screening. The description also labels the monitor as an "in-vitro diagnostic device."
No
The device description clearly details hardware components like an ambulatory, battery-operated, rate-programmable microinfusion pump with a drive motor and a blood glucose monitor. While it mentions software improvements and the ability to install upgraded software, the core device is a physical insulin pump and a physical glucose monitor.
Based on the provided text, yes, at least one component of this system is an IVD (In Vitro Diagnostic).
Here's why:
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BD Paradigm Link Glucose Monitor: The "Device Description" explicitly states, "The BD Paradigm Link Blood Glucose Monitor is an in-vitro diagnostic device for use in the quantitative measurement of glucose in capillary blood collected from fingertips." The "Intended Use / Indications for Use" also describes its purpose as the "quantitative measurement of glucose in whole blood," which is a classic function of an IVD.
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Model 512 Insulin Pump: The insulin pump itself is not an IVD. Its function is the delivery of insulin, which is a therapeutic action, not an in vitro diagnostic test.
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When used together: While the system integrates an IVD (the glucose monitor) with a therapeutic device (the insulin pump), the pump's use of the glucose value for the Bolus Wizard feature doesn't transform the pump into an IVD. It's using data generated by an IVD.
Therefore, the BD Paradigm Link Glucose Monitor is an IVD, making the overall system include an IVD component.
N/A
Intended Use / Indications for Use
Model 512 Insulin Pump:
The Medtronic MiniMed Paradigm Model 512 Insulin Pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
BD Paradigm Link Glucose Monitor:
The BD Paradigm Link Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The BD Paradigm Link Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip.
Model 512 Insulin Pump and BD Paradigm Link Glucose Monitor:
When used together, the BD Paradigm Link Glucose Monitor can automatically telemeter glucose values to the Model 512 Insulin Pump using radio frequency communication. The glucose value received by the Model 512 Insulin Pump is used as the default glucose value by the pump's Bolus Wizard feature if the Bolus Wizard is used within 12 minutes of the glucose value transmission.
The BD Link Glucose Monitor can also serve as a radio frequency interface to allow communication between the Model 512 Insulin Pump and a personal computer running the appropriate Medtronic MiniMed communications software.
Product codes
LZG, NBW
Device Description
The Paradigm Model 512 external insulin pump is an ambulatory, battery operated, rateprogrammable microinfusion pump, designed for continuous delivery of insulin. A reservoir is driven by a drive motor to deliver preset basal profiles and patient programmed bolus amounts of insulin through infusion sets into subcutaneous tissue. This pump incorporates new software improvements over the predicate model and is designed to allow installation of upgraded software with new features through radio frequency telemetry without the need to replace any pump components.
The BD Paradigm Link Blood Glucose Monitor is an in-vitro diagnostic device for use in the quantitative measurement of glucose in capillary blood collected from fingertips. The BD Paradigm Link™ is designed to be simple and easy to use. It provides accurate blood glucose test results in 5 seconds while requiring a very small (0.3 µL) sample.
When the BD Paradigm Link Glucose Monitor is used together with the Medtronic MiniMed 512 External Insulin Pump, blood glucose test values obtained using the BD Paradigm Link Glucose Monitor can be automatically transmitted to the insulin pump for use in the pump's Bolus Wizard feature. Consumers or healthcare practitioners may also use the meter as a communication device to facilitate transfer of information between the pump and a personal computer.
The Paradigm Model 512 pump is restricted to sale by, or on the order of, a physician. The Paradigm Link Glucose Monitor is intended for over-the-counter use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Model 512 Insulin Pump: restricted to sale by, or on the order of, a physician
BD Paradigm Link Blood Glucose Monitor: people with diabetes mellitus in the home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Medtronic MiniMed Paradigm Model 511 Insulin Pump, BD Logic Glucose Monitor and Medtronic MiniMed Model 7304 ComLink
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K03053/
510(k) Summary
In accordance with the requirements of SMDA 1990, and 21 CFR 807.92, this 510(k) Summary is provided:
Submitter: Medtronic MiniMed 18000 Devonshire St., Northridge, CA 91325
Contact: Mark Faillace (818) 576-5616
Name of Devices: Medtronic MiniMed Paradigm Model 512 Insulin Pump and BD Paradigm Link Glucose Monitor
Predicate Devices: Medtronic MiniMed Paradigm Model 511 Insulin Pump, BD Logic Glucose Monitor and Medtronic MiniMed Model 7304 ComLink
Description of the Devices:
The Paradigm Model 512 external insulin pump is an ambulatory, battery operated, rateprogrammable microinfusion pump, designed for continuous delivery of insulin. A reservoir is driven by a drive motor to deliver preset basal profiles and patient programmed bolus amounts of insulin through infusion sets into subcutaneous tissue. This pump incorporates new software improvements over the predicate model and is designed to allow installation of upgraded software with new features through radio frequency telemetry without the need to replace any pump components.
The BD Paradigm Link Blood Glucose Monitor is an in-vitro diagnostic device for use in the quantitative measurement of glucose in capillary blood collected from fingertips. The BD Paradigm Link™ is designed to be simple and easy to use. It provides accurate blood glucose test results in 5 seconds while requiring a very small (0.3 µL) sample.
When the BD Paradigm Link Glucose Monitor is used together with the Medtronic MiniMed 512 External Insulin Pump, blood glucose test values obtained using the BD Paradigm Link Glucose Monitor can be automatically transmitted to the insulin pump for use in the pump's Bolus Wizard feature. Consumers or healthcare practitioners may also use the meter as a communication device to facilitate transfer of information between the pump and a personal computer.
The Paradigm Model 512 pump is restricted to sale by, or on the order of, a physician. The Paradigm Link Glucose Monitor is intended for over-the-counter use.
1
510(k) Summary (Continued)
Intended Use of the Devices:
Model 512 Insulin Pump:
The Medtronic MiniMed Paradigm Model 512 Insulin Pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
BD Paradigm Link Glucose Monitor:
The BD Paradigm Link Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The BD Paradigm Link Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip.
Model 512 Insulin Pump and BD Paradigm Link Glucose Monitor:
When used together, the BD Paradigm Link Glucose Monitor can automatically telemeter glucose values to the Model 512 Insulin Pump using radio frequency communication. The glucose value received by the Model 512 Insulin Pump is used as the default glucose value by the pump's Bolus Wizard feature if the Bolus Wizard is used within 12 minutes of the glucose value transmission.
The BD Paradigm Link Glucose Monitor can also serve as a radio frequency interface to allow communication between the Model 512 Insulin Pump and a personal computer running the appropriate Medtronic MiniMed communications software.
Comparison of the Technological Features of the New Devices and Predicate Devices:
The Model 512 and Model 511 have similar materials and basic design. The new device contains additional features compared to the predicate device. These additional features include a Bolus Wizard function and the ability to receive glucose values transmitted by the BD Paradigm Link Glucose Monitor.
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510(k) Summary (Continued)
The BD Paradigm Link and BD Logic Glucose Monitors also have similar materials and basic design. The new device has additional circuitry and software modifications that allow it to transmit glucose values to the Model 512 Insulin Pump and to facilitate transfer of data between the Model 512 Insulin Pump and a personal computer running the appropriate Medtronic MiniMed communications software.
Arnold Faillace
5/12/03
Date
Mark Faillace Senior Director, Device Regulatory Affairs and Quality Assurance Medtronic MiniMed
TM Paradigm 512 is a Trademark of Medtronic MiniMed
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark J. Faillace Senior Director, Device RA/QA Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325
Re: K030531
Trade/Device Name: Medtronic MiniMed Paradigm Model 512 Insulin Pump and the BD Paradigm Link™ Glucose Meter Regulation Number: 880.5725, 862.1345 Regulation Name: Infusion Pump, Glucose Test System Regulatory Class: II Product Code: LZG, NBW Dated: May 13, 2003 Received: May 14, 2003
Dear Mr. Mark J. Faillace:
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.
JUN 1 7 2003
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Page 2 - Mr. Mark J. Faillace
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 vour 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,
Suser Runos
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:
Device Names:
Medtronic MiniMed Paradigm Model 512 Insulin Pump and BD Paradigm Link Glucose Monitor
Indications for Use:
Model 512 Insulin Pump:
The Medtronic MiniMed Paradigm Model 512 Insulin Pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
or
Prescription Use V (Per 21 CFR 801.109)
Over-the-Counter Use ------
d
BD Paradigm Link Glucose Monitor:
The BD Paradigm Link Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellius in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The BD Paradigm Link Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertin.
Prescription Use (Per 21 CFR 801.109) or
Over-the-Counter Use
Model 512 Insulin Pump and BD Paradigm Link Glucose Monitor:
When used together, the BD Paradigm Link Glucose Monitor can automatically telemeter glucose values to the Model 512 Insulin Pump using radio frequency communication, The glucose value received by the Model 512 Insulin Pump is used as the default glucose value by the pump's Bolus Wizard feature if the Bolus Wizard is used within 12 minutes of the glucose value transmission.
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INDICATIONS FOR USE (CONTINUED)
.. .. : "
The BD Link Glucose Monitor can also serve as a radio frequency interface to allow communication between the Model 512 Insulin Pump and a personal computer running the appropriate Medtronic MiniMed communications software.
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| or | |
| Over-the-Counter Use |
Concurrence of CDRH, Office of Device Evaluation (ODE)
1
Patrizia Quenti
(Division Sign-Off) Division of Anesthesiology, General Ho Infection Control, Dental De
510(k) Number. K030537