(119 days)
None
No
The summary describes a standard insulin pump with a microprocessor and programmable rates, with no mention of AI or ML capabilities.
Yes
The device is intended for the management of diabetes mellitus by continuously delivering insulin, which is a therapeutic intervention for a medical condition.
No
Explanation: This device is described as an external insulin pump designed for the continuous delivery of insulin, which indicates it is a therapeutic device for managing diabetes, not a diagnostic one.
No
The device description explicitly lists hardware components such as an external case, microprocessor, LCD, syringe compartment, lead screw, and motor, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the MMT-507 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the delivery of insulin for the management of diabetes. This is a therapeutic action, not a diagnostic one.
- Device Description: The description details a pump designed to deliver fluid (insulin) into the body. It does not mention any components or functions related to analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
The MMT-507 is clearly described as an external insulin pump, which is a medical device used for drug delivery.
No
Explanation: There is no mention of a Predetermined Change Control Plan (PCCP) in the provided clearance letter. PCCP authorization is a specific FDA designation that allows for pre-defined modifications to a device without needing a new 510(k) clearance, and it would be explicitly stated if applicable.
Intended Use / Indications for Use
The MMT-507 is intended for continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Product codes
Not Found
Device Description
The MMT-507 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 MMT-507 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 MMT-507 consists of an external case, a microprocessor, a Liquid Crystal Display (LCD), a syringe compartment with a lead screw connecting to a motor. None of these components contact the fluid pathway.
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
prescribed by the user's physician.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
MiniMed MMT-506 (cleared: 510(k) K901588)
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
Image /page/0/Picture/1 description: The image shows the logo for MiniMed Technologies. The logo consists of the words "MiniMed" stacked on top of the word "TECHNOLOGIES". To the right of the words is a graphic that appears to be a stylized integrated circuit with the letter "M" in the center.
12744 San Fernando Road Sylmar, California 91342 Tel. (818) 362-5958 . (800) 933-3322 FAX (818) 364-2246
MiniMed Technolog Premarket Notification MMT-507
510(k) Summary
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990, and 21 CFR 807.92:
A. Submitter: MiniMed Technologies, 12744 San Fernando Road, Sylmar, California 91342. Contact: Terrance H. Gregg (818) 362-5958, ext. 2569. FAX: (818) 362-6928.
B. Name of Device: MiniMed MMT-507 (Insulin Infusion Pump).
C. Predicate Device: MiniMed MMT-506 (cleared: 510(k) K901588).
D. Description of the Device: The MMT-507 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 MMT-507 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 MMT-507 consists of an external case, a microprocessor, a Liquid Crystal Display (LCD), a syringe compartment with a lead screw connecting to a motor. None of these components contact the fluid pathway.
E. Intended Use of the New Device: The MMT-507 is intended for continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
F. Comparison of the Technological Features of the New Device and Predicate Device: The principal differences between the new device and the predicate device include a back-light for the LCD display, software changes to allow link to a personal computer for in-house evaluations, a user self-test, the addition of audible tones, an increase in memory capacity relative to bolus programing and bolus recalls, the display of the 24 hour basal rate profile following programming, an increase in the temporary basal rate duration, and a time-delay feature for bolus delivery. These modifications do not negatively affect the safety or effectiveness of the device.
Signed,
Hs Russ
Terrence H. Gregg
12/29/95
Date
Terrance H. Gregg Vice President Regulatory Affairs and Clinical Research
CONFIDENTIAL
Image /page/0/Picture/18 description: The image shows the number 853 written in a handwritten style. The numbers are written in black ink and are slightly distorted. The number 8 is written with a large loop at the top and a smaller loop at the bottom. The number 5 is written with a curved line at the top and a straight line at the bottom. The number 3 is written with two curved lines, one on top of the other.