(343 days)
The Gibeck, Inc. Warmbag Reusable Convective Warming Blanket is a thermal regulation system as described in 21 CFR 870.5900.
The Gibeck, Inc. Warmbag Reusable Convective Warming Blanket is a thermal regulation system as described in 21 CFR 870.5900.
The provided text is a 510(k) summary for a medical device called the "Gibeck, Inc. Warmbag Reusable Convective Warming Blanket." This document primarily focuses on establishing substantial equivalence to a predicate device, the "TropicAir Reusable Convective Warming Blankets." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any details typically found in a clinical study report for assessing device performance.
Therefore, I cannot provide the requested information based on the input text. The document's purpose is to satisfy regulatory requirements for market approval based on equivalence, not to detail a specific performance study against defined acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the date January 13, 1997. The month is abbreviated as JAN. The day is 13 and the year is 1997. The text is in a simple, sans-serif font.
Image /page/0/Picture/1 description: The image shows the word "Gibeck" in a bold, sans-serif font. To the left of the word is a circular logo with a horizontal line through the middle and a vertical line extending from the top to the horizontal line. The logo and the word "Gibeck" are both in black.
K,960511
510(k) Summary of Safety and Effectiveness Subiect:
Gibeck, Inc. Warmbag Reusable Convective Product: Warming Blanket
Summary:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Gibeck, Inc. Warmbag Reusable Convective Warming Blanket is a thermal regulation system as described in 21 CFR 870.5900. These products are substantially equivalent to the TropicAir Reusable Convective Warming Blankets distributed by Seabrook Medical, Inc.
The Gibeck, Inc. Warmbag Reusable Convective Blanket is similar in design, operation and function to the Seabrook Medical, Inc. TropicAir Reusable Convective Warming Blanket.
The principal differences between the Gibeck, Inc. Warmbag Reusable Convective Warming Blanket and the Seabrook Medical, Inc. TropicAir Reusable Convective Warming Blanket are the manufacturing processes, materials and labeling. These differences are not considered to be critical to the intended therapeutic, prosthetic or surgical use of the device nor should these differences significantly affect the safety or effectiveness of the device when used as labeled.
B. Shigh
Submitter/Contact Person
1/31/96
Date
Gibeck, Inc. 10640 East 59th Street · P.O. Box 36430 · Indianapolis, IN 46236 Telephone: (317) 823-6866 · Telefax: (317) 823-1662 A Member of the Gibeck Group
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).