(62 days)
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No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses solely on the function of an insulin pump.
Yes
The device is indicated for the "management of diabetes mellitus," which is a medical condition, making it a therapeutic device.
No
Explanation: The device is an insulin pump, which delivers insulin for the management of diabetes. Its function is to administer therapy, not to diagnose a condition.
No
The intended use clearly describes an "Insulin Pump," which is a hardware device for delivering insulin. The summary does not mention any software-only component or function.
Based on the provided information, the Medtronic MiniMed Paradigm Model 511 Insulin Pump is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "continuous delivery of insulin... for the management of diabetes mellitus in persons requiring insulin." This describes a device that delivers a therapeutic substance directly to the patient's body.
- Definition of IVD: IVDs are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The provided information does not mention any analysis of biological specimens, diagnostic testing, or any of the typical functions of an IVD.
Therefore, the Medtronic MiniMed Paradigm Model 511 Insulin Pump is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medtronic MiniMed Paradigm Model 511 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.
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.
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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.
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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).
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of a caduceus, a symbol often associated with healthcare. The caduceus consists of a staff with two snakes coiled around it and wings at the top.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2004
Ms. Gerda P. Resch, MT, RAC Manager, Regulatory Affairs Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325-1219
Re: K041318
Trade/Device Name: Medtronic MiniMed Paradigm Model 511 Insulin Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: July 8, 2004 Received: July 12, 2004
Dear Ms. Resch:
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. Resch
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,
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) Numbers:
| Device Names: | Medtronic MiniMed Paradigm Model 511 Insulin Pump |
|---|---|
| Indications for Use: | The Medtronic MiniMed Paradigm Model 511 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. |
Prescription Use X (Per 21 CFR 80 Subpart D) AND/OR
Over-the-Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ar Vm
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: _ Kuy 13/8
Confidential 10