(25 days)
503-0830, 503-0810
Not Found
No
The summary describes a patient warming system and blanket, focusing on temperature control and physical characteristics. There is no mention of AI or ML.
Yes
The device is intended for the prevention and treatment of hypothermia and shivering, which are medical conditions, thus qualifying it as therapeutic.
No
The device is a patient warming system intended for the prevention and treatment of hypothermia and shivering. It does not perform any diagnostic function.
No
The device description clearly details physical components (warming unit and blanket) and performance studies related to physical properties (temperature, burst pressure, tape strength), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "prevention and treatment of hypothermia and/or shivering in the critical care environment." This describes a therapeutic intervention applied directly to the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "Patient Warming System (warming unit and blanket)." This is a physical device used to regulate body temperature externally.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device's function is to provide external warming to the patient, which is a therapeutic action, not a diagnostic test.
N/A
Intended Use / Indications for Use
The WarmTouch Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia and/or shivering in the critical care environment.
Product codes
DWJ
Device Description
The Warm Touch® CareDrape™ Cardiac Blanket is similar to the CareDrape™ Lower Body Blanket in use, as both are used in the operating room to help manage the patient's body temperature. The WarmTouch® CareDrape™ Cardiac Blanket is similar to the CareQuilt™ Full Body/ Multi-Access Warming Blanket, as both are equipped with slits, which can be opened for access to the patient through the blanket. The kev difference between the Cardiac Blanket and all earlier WarmTouch® blankets is that the Cardiac Blanket is sterile permitting use of the blanket within the sterile field.
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
critical care environment.
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
Maximum Temperature delivered to the patient – The blankets were tested according to the draft ASTM standard Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices. This testing vertfied that the blanket maintained a maximum temperature of 40.5℃. This maximum temperature is located immediately in front of the nozzle tube. Temperature range. The blankets were tested according to the Temperature Management Devices. This testing showed a temperature difference of
§ 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
JAN 1 1 2002
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter's Name: Nellcor Puritan Bennett, Inc.
Submitter's Address: 4280 Hacienda Drive Pleasanton, CA 94588-8604
Contact Person: Anthony Mullin Phone Number: 314-654-3049 FAX Number: 314-654-3344 Summary Date: December 5, 2001
Device Trade Name: WarmTouch® CareQuilt™ Cardiac Blanket
Common Name: Convective Air Warming Blanket
- Device Classification Names: The FDA has classified Thermal Regulation Systems as Class II devices under CFR Title 21, Section 870-5900. The product code is DWJ
- Predicate Devices: CareDrape™ Lower Body Blanket, Cat #503-0830 CareQuilt™ Full Body/ Multi-Access Warming Blanket, Cat #503-0810.
Device Description: The Warm Touch® CareDrape™ Cardiac Blanket is similar to the CareDrape™ Lower Body Blanket in use, as both are used in the operating room to help manage the patient's body temperature. The WarmTouch® CareDrape™ Cardiac Blanket is similar to the CareQuilt™ Full Body/ Multi-Access Warming Blanket, as both are equipped with slits, which can be opened for access to the patient through the blanket. The kev difference between the Cardiac Blanket and all earlier WarmTouch® blankets is that the Cardiac Blanket is sterile permitting use of the blanket within the sterile field.
- Indications For Use: The WarmTouch Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia and/or shivering in the critical care environment.
Contraindications: There are no contraindications for the use of this device
Summary of Performance Testing:
Maximum Temperature delivered to the patient �
The blankets were tested according to the draft ASTM standard Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices. This testing vertfied that the blanket maintained a maximum temperature of 40.5℃. This maximum temperature is located immediately in front of the nozzle tube.
1
Temperature range .
i emperature range The blankels were tosted docoraing to the nemerature Management Devices. This testing Cilculaung Liquid and I olecu Air Patche Formprature difference of