(188 days)
The 505 insulin pump is intended for continuous delivery of insulin for the management of diabetes mellitus in persons requiring exogenous insulin. It is not intended or indicated for the delivery of blood or blood products
The 505 insulin pump is a rate-programmable syringe infusion pump, designed for continuous delivery of insulin, as prescribed by the user's physician. The 50% is restricted to sale by or on the order of a physician. It is not intended or indicated for the delivery of blood products.
The 505 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.
This document is a 510(k) summary for a medical device, the MiniMed Insulin Pump, model 505. It focuses on demonstrating substantial equivalence to a predicate device and does not contain the detailed information typically found in a clinical study report regarding acceptance criteria, device performance, sample sizes, expert involvement, or ground truth establishment.
Therefore, I cannot extract the requested information from the provided text. The document primarily serves as a regulatory filing to introduce a new version of an existing device based on minor modifications. It does not describe a study involving specific performance metrics against defined acceptance criteria in the manner you've outlined.
The document states: "The modification described [does] not negatively affect the safety or effectiveness of the device." This is the general claim, but no specific study design or results are provided to quantitatively support this claim in the context of your questions.
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APR - 8 1997
Image /page/0/Picture/1 description: The image shows the logo for MiniMed. The logo consists of a black square with white lines inside, followed by the word "MiniMed" in a bold, sans-serif font. Below the word "MiniMed" is the number "K963948" in a handwritten font.
Part I. 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 Inc. 12744 San Fernando Road, Sylmar, CA 91342 Contact: Don Selvey, Senior Regulatory Affairs Specialist 818 362-5958, ext. 3011 (v); 818 364-7947 (f); 520 527-0107 (v/f).
B. Name of Device: MiniMed Insulin Pump, model 505.
C. Predicate Device: MiniMed Insulin Pump, model 506 (cleared: 510(k) K901588).
D. Description of Device: The 505 insulin pump is a rate-programmable syringe infusion pump, designed for continuous delivery of insulin, as prescribed by the user's physician. The 50% is restricted to sale by or on the order of a physician. It is not intended or indicated for the delivery of blood products.
The 505 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 505 insulin pump is intended for continuous delivery of insulin for the management of diabetes mellitus in persons requiring exogenous insulin. It is not intended or indicated for the delivery of blood or blood products
F. Comparison of the Technological Features of the New Device and Predicate Device: The 505 insulin pump is identical to the 506 insulin pump in nearly every way, except that the software has been simplified, i.e., the new device has a single rate profile, instead of the six rates programmable with the predicate device, and the memory retains fewer values. Both devices use the same case and drive mechanism, same microprocessor, same reservoir and infusion sets, and are programmed the same way by the user. The indications, contraindications, warnings, precautions, and adverse reaction statements in the User's Guide are not substantially different, if at all. The intended use of the devices is nearly the same.
The modification described docs not negatively affect the safety or effectiveness of the device.
Signed,
Signature
Terrance H. Gregg Executive Vice President, Operations MiniMed, Inc.
5 Sep 16
Date
§ 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).