(78 days)
The Medtronic MiniMed Paradigm Model 712E Insulin Pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The Paradigm Model MMT-712E is an external, portable insulin pump, designed for continuous delivery of insulin. It is designed to deliver 000 to 35.00 units of U100 insulin per hour in basal rates and up to 25.00 units of U100 insults per meal bolus. The insulin programming step size allows users to program insulin delivery in steps of 0.1 units for boluses and 0.05 units/hour for basal dclivery. The Model 712F accommodates a proprietary 3.0 ml reservoir. This reservoir mates with the existing and future Paradigm infusion sets.
The provided text is a 510(k) summary for the Medtronic MiniMed Paradigm Model MMT-712E Insulin Pump. This document is primarily focused on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving device performance against those criteria in the way one might expect for a novel AI/software device.
Based on the provided text, there is no information available regarding acceptance criteria, device performance metrics, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance studies, or ground truth details relevant to an AI/software device.
The 510(k) summary explicitly states:
- "The new and predicate devices have identical materials and design. The new device, MMT 712E, is a derivative of the MMT-712. Both pumps are mechanically identical. Software modifications only were made to the MMT-712E to disable certain features thereby simplifying its use."
This indicates that the device is a modified version of an existing, already cleared device, with software modifications solely to simplify its use by disabling certain features. Therefore, the primary "study" proving its acceptance would have been focused on demonstrating that these software changes did not introduce new safety or effectiveness concerns, and that the simplified device still performed its intended function within the expected parameters of the predicate device. This is a much different type of evaluation than what is typically performed for AI/ML-driven diagnostics or decision support systems.
Given this context, I cannot fulfill the request as presented, because the necessary information is not within the provided text. The questions posed are targeted at the evaluation of AI/ML-driven devices, which is not what the Medtronic MiniMed Paradigm Model MMT-712E Insulin Pump represents based on this 510(k) summary.
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JAN 3 1 2006
Kq53177
SECTION D. 510(k) Summary
In accordance with the requirements of SMDA 1990, and 21 CFR 807.92, this 510(k) Summary is provided:
Submitter: Medtronic MiniMcd, 18000 Devonshire St., Northridge. CA 91325
Contact: Staci Ellis (818) 576-5959.
Name of Device: Medtronic MiniMed Paradigm Model MMT-712E Insulin Pump
Predicate Device: Medtronic MiniMcd Paradigm Model MMT-712 Insulin Pump
Description of the Device: The Paradigm Model MMT-712E is an external, portable insulin pump, designed for continuous delivery of insulin. It is designed to deliver 000 to 35.00 units of U100 insulin per hour in basal rates and up to 25.00 units of U100 insults per meal bolus. The insulin programming step size allows users to program insulin delivery in steps of 0.1 units for boluses and 0.05 units/hour for basal dclivery.
The Model 712F accommodates a proprietary 3.0 ml reservoir. This reservoir mates with the existing and future Paradigm infusion sets.
Intended Use of the Device: The Medtronic MiniMed Paradigm Model 712E Insulin Pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Comparison of the Technological Features of the New Device and Predicate Device: The new and predicate devices have identical materials and design. The new device, MMT 712E, is a derivative of the MMT-712. Both pumps are mechanically identical. Software modifications only were made to the MMT-712E to disable certain features therehy simplifying its use.
Mark Faillace
11/10/05
Date
Senior Director, Regulatory Affairs and Product Reporting Medtronic MiniMed
1 M Paradigm Model 712E insulin pump is a Trademark of Medtronic MiniMed
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2006
Ms. Staci Ellis Senior Regulatory Affairs Specialist Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325
Re: K053177
Trade/Device Name: Medtronic MiniMed Paradigm Model MMT-712E Insulin Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: November 14, 2005 Received: November 15, 2005
Dear Ms. Ellis:
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 – Ms. Ellis
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 yours,
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 (if known):
Device Name:__________________________________________________________________________________________________________________________________________________________________ Medtronic MiniMed Paradigm Model MMT-712E Insulin Pump
Indications For Use: The Medtronic MiniMed Paradigm Model 712E Insulin Pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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K+S3177
§ 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).