(343 days)
Not Found
Not Found
No
The summary describes a thermal regulation system (warming blanket) and makes no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The predicate device is also a warming blanket.
No
The device is described as a "thermal regulation system" and there is no mention of treating or preventing a disease, nor restoring, modifying, or correcting body function. The predicate device is also a "Warming Blanket," further supporting its classification as a general purpose device rather than a therapeutic one.
No
The device is described as a "thermal regulation system" and a "convective warming blanket," which indicates a therapeutic rather than diagnostic function. It is classified under 21 CFR 870.5900, "Thermal Regulating System," which generally refers to devices used to control body temperature, not to diagnose medical conditions.
No
The device description explicitly states it is a "Warmbag Reusable Convective Warming Blanket," which is a physical hardware component used for thermal regulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: This section is "Not Found," which is a key indicator for IVDs. IVDs have specific intended uses related to diagnosing diseases or conditions using samples from the human body.
- Device Description: The description states it's a "thermal regulation system as described in 21 CFR 870.5900." This CFR section pertains to thermal regulating systems, which are devices used to control a patient's body temperature, not for in vitro diagnostic testing.
- Lack of IVD-related information: There is no mention of analyzing samples, diagnostic purposes, or any other characteristics typically associated with IVDs.
Therefore, the Gibeck, Inc. Warmbag Reusable Convective Warming Blanket is a medical device for thermal regulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Gibeck, Inc. Warmbag Reusable Convective Warming Blanket is a thermal regulation system as described in 21 CFR 870.5900.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Gibeck, Inc. Warmbag Reusable Convective Warming Blanket is a thermal regulation system. The Gibeck, Inc. Warmbag Reusable Convective Blanket is similar in design, operation and function to the Seabrook Medical, Inc. TropicAir Reusable Convective Warming Blanket.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
TropicAir Reusable Convective Warming Blankets
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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