(148 days)
Not Found
No
The 510(k) summary describes insulin infusion pumps and does not mention any AI or ML capabilities. The predicate devices are also older models of insulin pumps.
Yes
The device is an insulin infusion pump indicated for the continuous delivery of insulin for the management of diabetes mellitus, which is a therapeutic intervention.
No
The device is an insulin infusion pump, which is used for the delivery of a substance for therapeutic management of diabetes, not for diagnosing a condition.
No
The intended use clearly describes insulin infusion pumps, which are hardware devices. The summary does not mention any software-only component or function.
Based on the provided information, the Medtronic MiniMed Paradigm insulin infusion pumps are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is for the continuous delivery of insulin for the management of diabetes. This is a therapeutic function, not a diagnostic one. IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description (though not found): Insulin pumps are mechanical devices that deliver medication. They do not perform tests on biological samples.
- Lack of IVD-related information: The provided text does not mention any activities typical of IVD devices, such as analyzing blood, urine, or other bodily fluids, or providing diagnostic results.
Therefore, these insulin pumps are considered medical devices for drug delivery, not IVD devices.
N/A
Intended Use / Indications for Use
The Medtronic MiniMed Paradigm Model MMT-512, MMT-712, MMT-515 and MMT-715 insulin infusion pumps are indicated 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
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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
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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): 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
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark J. Faillace Senior Director, Regulatory Affairs and Product Reporting Medtronic MiniMed, Incorporated 18000 Devonshire Street Northridge, California 91325
APR 2 5 2008
Re: K073356
Trade/Device Name: Medtronic-MiniMed Paradigm Model: MMT-512, MMT-712, MMT-515 and MMT-715 Insulin Infusion Pumps
Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: April 1, 2008 Received: April 2, 2008
Dear Mr. 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.
1
Page 2 - Mr. Faillace
Please be advised that FDA's issuance of a substantial equivalence determination docs 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) 276-0120. 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,
Smythe y. Nickens MD.
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
2
INDICATIONS FOR USE
| 510(k) Numbers: | K030531 (MMT-512) K031390 (MMT-712) K040676 (MMT-515/MMT-715) |
|---|---|
| Device Names: | Medtronic MiniMed Paradigm Model MMT-512, MMT- 712, MMT-515 and MMT-715 insulin infusion pumps |
| Indications for Use: | The Medtronic MiniMed Paradigm Model MMT-512, MMT-712, MMT-515 and MMT-715 insulin infusion pumps are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. |
Prescription Use _ X (Per 21 CFR 80 Subpart D)
AND/OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
Charle Bady for Alw
(Division Sign-Off) Division of Anesthesiology, General Hospital intection Control, Dental Devices
510(k) Number: K673356