(67 days)
The Medtronic MiniMed Paradigm Model MMT-515/715 Insulin Pumps are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The Paradigm Model 515 and 715 are external, portable insulin pumps, designed for continuous delivery of insulin. They are designed to deliver 0.00 to 35.00 units of U100 insulin per hour in basal rates and up to 25.00 units of U100 insulin per meal bolus. The difference between the MMT-515 and 715 pumps is the reservoir size. The MMT-515 will be compatible with a 1.5 ml reservoir and MMT-715 can be used with both the 3.0 and the 1.5 ml reservoirs.
This 510(k) summary for the Medtronic MiniMed Paradigm Model 515 and 715 Insulin Pumps does not contain the detailed information required to fill out all requested sections regarding acceptance criteria and a definitive study proving the device meets them.
The document primarily focuses on:
- Identifying the device and its predicate.
- Describing its intended use and basic functionality.
- Stating that the device has "similar materials and basic design" to the predicate and includes "hardware as well as software modifications including the Bolus Wizard upgrades and other user improvements."
- Concluding with a substantial equivalence determination by the FDA.
There is no mention of specific acceptance criteria, performance metrics, a dedicated study, sample sizes, expert involvement, or any form of ground truth establishment. This type of information is usually found in a separate section detailing performance data, often titled "Performance Data" or "Non-Clinical and Clinical Tests."
Therefore, I have to state that the requested information is largely not available in the provided document.
However, I can extract the available information and indicate what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document. Typically would include accuracy of insulin delivery (basal rates, bolus), safety features, alarm functionality, battery life, etc. | Not specified in document. The document states "similar materials and basic design" and "hardware as well as software modifications," implying performance is at least equivalent to the predicate, but no specific metrics are given. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document.
- Data Provenance: Not specified in the document. (e.g., country of origin, retrospective/prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified in the document.
- Qualifications of Experts: Not specified in the document.
4. Adjudication method for the test set
- Not specified in the document.
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/Not mentioned. This device is an insulin pump, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable in the typical sense for this type of medical device where "standalone performance" usually refers to the device's functional operation (e.g., pumping accuracy, alarm activation). While the device operates "standalone," specific performance metrics from such a test are not detailed in this summary.
7. The type of ground truth used
- Not specified in the document. For an insulin pump, ground truth would typically relate to the accuracy of insulin delivery against a calibrated standard, the reliability of its components, and its safety features' performance.
8. The sample size for the training set
- Not specified in the document. (If any software modifications involved machine learning, this would be relevant, but it's not clear from the text that AI/ML was used, and no training data is mentioned).
9. How the ground truth for the training set was established
- Not specified in the document.
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MAY 2 1 2004
510(k) Summary SECTION D.
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: Mirielle Mengotto (818) 576-4112
| Name of Device: | Medtronic MiniMed Paradigm Model 515 Insulin Pump |
|---|---|
| Medtronic MiniMed Paradigm Model 715 Insulin Pump |
- Modtronic MiniMed Paradigm Model 512 Insulin Pump Predicate Device: Medtronic MiniMed Paradigm Model 712 Insulin Pump
Description of the Device: The Paradigm Model 515 and 715 are external, portable insulin purrips, designed for continuous delivery of insulin. They are designed to deliver 0.00 to 35.00 units of U100 insulin per hour in basal rates and up to 25.00) units of U100 insulin per meal bolus.
The difference between the MMT-515 and 715 pumps is the reservoir size. The MMT-515 will be compatible with a 1.5 ml reservoir and MMT-715 can be used with both the 3.0 and the 1.5 ml reservoirs.
Intended Use of the Device: The Medtronic MiniMed Paradigm Model 515 and Model 715 Insulin Pumps are 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 prodicate devices have similar materials and basic design. The new devices will have hardware as well as software modifications including the Bolus Wizard upgrades and other user improvements.
s software modifications including
9/12 Date
Gerda Resch Manager, Regulatory Affairs Medtronic MiniMod
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 2004
Ms. Mirielle Mengotto Senior Regulatory Affairs Specialist Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325-1219
Re: K040676
Trade/Device Name: Medtronic MiniMed Paradigm MMT-515/715 Insulin Pumps Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: March 11, 2004 Received: March 15, 2004
Dear Ms. Mengotto:
We have reviewed your Section 510(k) promarket 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. Mengotto
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease to acribed that made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of all - Pourier and stills requirements, including, but not limited to: registration r od linest comply wart 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 er reas on the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form 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) This feter "hiffication. The FDA finding of substantial equivalence of your device to a premainer nemreans and 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), 11 you desire specific advise 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 may other 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,
Rreps
Chiu Lin, Ph.D Director Division of Anesthesiology, Gencral 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:
Indications For Use:
Medtronic MiniMed Paradigm MMT-515/715 Insulin Pumps
The Medtronic MiniMed Paradigm Model MMT-515/715 Insulin Pumps are indicated for the continuous delivery of insulin, at set r anips are harvs, for the management of diabetes mellitus in persons requiring insulin.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRII, Office of Device Evaluation (ODE)
Kola Hubbard for Britton Watson
(Division-City or Town)
ision of Anesthesiolog y, General Hospital, Infection Control, Denta
Page 1 of
510(k) Number: K040676
§ 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).