(119 days)
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.
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.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) Summary for the MiniMed MMT-507 (Insulin Infusion Pump), which focuses on comparing the new device to a predicate device (MiniMed MMT-506) and outlining its technological features and intended use for regulatory submission purposes.
The document does not contain any details regarding:
- A table of acceptance criteria.
- Reported device performance against specific criteria.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for training sets.
- How ground truth for training sets was established.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using only the provided input.
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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
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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).