(90 days)
Not Found
No
The description focuses on basic programming features, memory, and alarms, with no mention of AI or ML.
Yes
The device is indicated for the management of diabetes mellitus by continuously delivering insulin, which is a therapeutic intervention.
No
The device, an insulin pump, is designed for the continuous delivery of insulin for the management of diabetes, not for diagnosing medical conditions. Its features are related to insulin delivery and device convenience, not diagnostic functions.
No
The device description explicitly states it is an "external insulin pump" and details hardware components like a keypad, LCD screen, and flash memory, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, the MiniMed insulin pump, model 508, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is the continuous delivery of insulin for the management of diabetes. This is a therapeutic action, not a diagnostic one.
- Device Description: The description focuses on the pump's function in delivering insulin at set and variable rates. It describes features related to programming, alarms, and convenience for insulin delivery.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status based on such testing. IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
The MiniMed insulin pump is a medical device used for the treatment of diabetes by delivering insulin. It does not perform diagnostic testing.
N/A
Intended Use / Indications for Use
The 508 is intended for continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It is not intended for use with blood or blood products.
The MiniMed insulin pump, model 508, 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
The 508 external insulin pump is a rate-programmable syringe infusion pump, designed for continuous delivery of insulin, at set and variable rates, as prescribed by the user's physician. The 508 is restricted to sale by, or on the order of, a physician. It is not intended or indicated for the delivery of blood or blood products. The principal modifications described in this submission are intended to allow the pump user more options for programming, and to enhance the convenience of the device.
Convenience features include a vibrating and escalating audible alarm; a low insulin alert; new keypad; and a new LCD screen. New programming features include the addition of two personal delivery patterns to enhance delivery options; the ability to program a bolus on square wave to enable the user to program a bolus while an extended (or square wave) bolus is being administered; child block to help prevent reprogramming by younger users; and limited remote programming by radio frequency (RF), which allows users to deliver an audio bolus, suspend or restart the pump.
The new device also has a flash memory instead of a read only memory, which holds data in the pump batteries are removed for more than two hours.
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)
MiniMed Model 507C Insulin Pump
Reference Device(s)
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
MiniMed Inc. Premarket Notification - 510(k) 508 Insulin Pump
JUN 8 10000
Image /page/0/Picture/2 description: The image shows the logo for MiniMed. The logo consists of a black square with white wavy lines inside, followed by the word "MiniMed" in a serif font. Below the word "MiniMed" is the text "K990801" in a handwritten style.
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: MiniMed® Inc. 12744 San Fernando Rd., Sylmar, California 91342.
Contact: Don Selvey, Department of Clinical Research and Regulatory Affairs (818) 362-5958, 3011; (520) 527-0107 (v/f).
Name of Device: MiniMed Model 508 Insulin Pump
Predicate Device: MiniMed Model 507C Insulin Pump
Description of the Device: The 508 external insulin pump is a rate-programmable syringe infusion pump, designed for continuous delivery of insulin, at set and variable rates, as prescribed by the user's physician. The 508 is restricted to sale by, or on the order of, a physician. It is not intended or indicated for the delivery of blood or blood products. The principal modifications described in this submission are intended to allow the pump user more options for programming, and to enhance the convenience of the device.
Convenience features include a vibrating and escalating audible alarm; a low insulin alert; new keypad; and a new LCD screen. New programming features include the addition of two personal delivery patterns to enhance delivery options; the ability to program a bolus on square wave to enable the user to program a bolus while an extended (or square wave) bolus is being administered; child block to help prevent reprogramming by younger users; and limited remote programming by radio frequency (RF), which allows users to deliver an audio bolus, suspend or restart the pump.
The new device also has a flash memory instead of a read only memory, which holds data in the pump batteries are removed for more than two hours.
Intended Use of the Device: The 508 is intended for continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It is not intended for use with blood or blood products.
Comparison of the Technological Features of the New Device and Predicate Device: The technological features of the new device do not differ significantly from the predicate devices have similar materials, product design, and energy source.
Don Selvey and the date is 3-5-99
Senior Regulatory Affairs Specialist Department of Clinical and Regulatory Affairs MiniMed Inc.
1
Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight. The overall design is simple and conveys a sense of government authority and purpose.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 8
Mr. Don Selvey Senior Regulatory Affairs Specialist Department of Clinical and Regulatory Affairs MiniMed® Incorporated 12744 San Fernando Road Sylmar, California 91342
K990801 Re: Trade Name: MiniMed® 508 Insulin Pump Regulatory Class: II Product Code: LZG March 9, 1999 Dated: March 10, 1999 Received:
Dear Mr. Selvey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marker one as acreatially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Selvey
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638f2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
MiniMed Inc. Premarket Notification - 510(k) 508 Insulin Pump
INDICATIONS FOR USE
510(k) Number:
Device Name: MiniMed Model 508 Insulin Pump
The MiniMed insulin pump, model 508, is indicated for the continuous Indications for Use: delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Patrice Cairente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510/k) Number _