(115 days)
Not Found
Not Found
No
The provided text describes a patient warming system and does not mention any AI or ML capabilities.
Yes
The device is described as a "Patient Warming System," which suggests it is used to treat or manage a patient's body temperature, fitting the definition of a therapeutic device.
No
The device is described as a "Patient Warming System," which indicates a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "Patient Warming System" and a "System Thermal Regulating," which strongly implies hardware components for temperature 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, which would typically describe how the device is used to diagnose or monitor a condition using samples from the body, is "Not Found".
- Device Description: The description clearly states it's a "Patient Warming System". This indicates a therapeutic or supportive function, not a diagnostic one.
- Lack of IVD-related information: The document does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Bair Hugger® Total Temperature Management System®-Modification is a medical device used for patient warming, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
74 DWG
Device Description
The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management System®-Modification.
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.
Not Found
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
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
F: 510(k) Summary of Safety & Effectiveness
Safety
K963672
JAN 6, 1997
This 510(k) Summary of Safety & Effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management System®-Modification. The following summarizes safety issues related to the use of rolling stands and the measures to prevent these problems.
Summary of Safety: 1.
- A. Stability:
The Rolling Stand could be inadvertantly tipped over.
Prevention: The Rolling Stand has 5 legs to provide additional stability and meets the stability requirements of UL 2601-1 and IEC 601-1
- B. Use of stand with unapproved devices or products:
Use of the rolling stand with any device or product other than those provided by Augustine Medical, Inc. could result in damage to the stand, the attached product, or in the stand tipping over.
Prevention: Instructions packaged with the Model 90022 Rolling Stand include the statement "The Rolling Stand is not intended to be used with any device or product other than those provided by Augustine Medical, Inc."
2. Summary of Effectiveness
The Model 90022 Rolling Stand effectively supports the Bair Hugger Model 505 Warming Unit and provides effective transportation of the unit when used under normal operating conditions.
Contact: Scott D. Augustine, M.D., CEO Augustine Medical, Inc.