(67 days)
Not Found
No
The document describes a standard insulin pump with no mention of AI or ML capabilities in its function or description.
Yes.
The device delivers insulin for the management of diabetes, which is a therapeutic intervention.
No
The device is an insulin pump designed for the continuous delivery of insulin, which is a treatment, not a diagnostic, function. Its purpose is to deliver medication for the management of diabetes, not to identify or monitor a disease state for diagnostic purposes.
No
The device description explicitly states it is an "external, portable insulin pump," which is a hardware device designed for the physical delivery of insulin.
Based on the provided information, the Medtronic MiniMed Paradigm Model MMT-515/715 Insulin Pumps are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is the delivery of insulin for the management of diabetes. This is a therapeutic action, not a diagnostic one. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the mechanical function of delivering insulin at set rates. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information.
- Using reagents or assays.
Therefore, the Medtronic MiniMed Paradigm Model MMT-515/715 Insulin Pumps are a therapeutic device, specifically an insulin pump, and not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
LZG
Device Description
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.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic MiniMed Paradigm Model 712 Insulin Pump
Reference Device(s)
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
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
1
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.
2
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
3
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