(57 days)
Not Found
No
The summary describes a forced-air patient warming system with temperature setting modifications and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the "treatment of hypothermia," which is a medical condition, making it a therapeutic device.
No
The device is a patient warming system intended for prevention and treatment of hypothermia, which is a therapeutic function, not a diagnostic one. It actively delivers warm air to the patient rather than collecting or interpreting data for diagnosis.
No
The device description explicitly states it is a "Patient Warming System (warming unit and blanket)" and describes the physical components and how they function to warm the patient. It also mentions electrical safety and EMC testing, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for warming a patient's body externally to prevent and treat hypothermia. This is a direct interaction with the patient's body, not the examination of specimens derived from the human body.
- Device Description: The description details a system that delivers warm air to a blanket placed on or under the patient. This is a physical warming mechanism, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The WarmTouch Model 5300 Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, for example, with the surgical patient, the patient in the pre-operative holding area, the pregnant woman who shivers during epidural anesthesia due to hypothermia, or any patient who is uncomfortable anywhere in the cold critical care environment.
Product codes
DWJ,DNJ
Device Description
The WarmTouch Model 5300 Patient Warming System surrounds the patient with warm air and convectively transfers heat across the skin. With the WarmTouch Model 5300 Patient Warming System, air is warmed and delivered into a lightweight blanket (CareQuilt or CareDrape Blanket) that rests over or under the patient.
The modification to the WarmTouch Patient Warming Unit consists of design changes relating to temperature settings.
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)
Performance testing of the WarmTouch Model 5300 with the CareQuilt and CareDrape Blankets demonstrated safe maximum temperature compliance.
Testing of the WarmTouch Model 5300 Patient Warming System for electrical safety and EMC testing demonstrated compliance to applicable sections in the November 1993 FDA Review Guidance document, UL544 Standard for Safety for Medical and Dental Equipment, IEC 60601-1-2:1993 1st Edition requirements, IEC 60601-2-35 Particular Standard for Patient Warming Systems, and CAN/CSA C22.2 No. 125 for Electromedical Equipment. Performance testing demonstrated conformity to the draft ASTM Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K62004
280 Hacienda Dri Pleasanton, CA 9458
Tele: 925 463-4000 Fax: 925 463-4020
tuco Healthcare
Nellcor
510(k) Summary
APR 2 3 2002
| Submitted by: | Nellcor Puritan Bennett Incorporated
(A business unit of Mallinckrodt Inc.,
a division of Tyco Healthcare Group LP)
4280 Hacienda Drive
Pleasanton, CA 94588 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Gina To
Senior Regulatory Affairs Project Manager
(925) 463-4427
(925) 463-4020 - FAX |
| Date Summary Prepared: | February 22, 2002 |
| Trade Name: | WarmTouch Model 5300 Patient Warming System |
| Common/Usual Name: | Convective Air Warming System |
| Classification Name: | Thermal Regulating System per 21 CFR §870.5900 |
| Product Code: | DWJ |
| Legally Marketed Predicate
Device (Unmodified): | WarmTouch, Advanced Warming Systems, Inc.,
510(k) #K913016 |
Device Description
The WarmTouch Model 5300 Patient Warming System surrounds the patient with warm air and convectively transfers heat across the skin. With the WarmTouch Model 5300 Patient Warming System, air is warmed and delivered into a lightweight blanket (CareQuilt or CareDrape Blanket) that rests over or under the patient.
The modification to the WarmTouch Patient Warming Unit consists of design changes relating to temperature settings.
Intended Use
The WarmTouch Model 5300 Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, for example, with the surgical patient, the patient in the pre-operative holding area, the pregnant woman who shivers during epidural anesthesia due to hypothermia, or any patient who is uncomfortable anywhere in the cold critical care environment.
NPB CONFIDENTIAL
1
Summary of Technological Characteristics of the Device Compared to the Legally Marketed (Unmodified) Device
The WarmTouch Model 5300 Patient Warming System has the same technological characteristics as the above referenced predicate device. The only changes relate to temperature settings.
Testing
Performance testing of the WarmTouch Model 5300 with the CareQuilt and CareDrape Blankets demonstrated safe maximum temperature compliance.
Testing of the WarmTouch Model 5300 Patient Warming System for electrical safety and EMC testing demonstrated compliance to applicable sections in the November 1993 FDA Review Guidance document, UL544 Standard for Safety for Medical and Dental Equipment, IEC 60601-1-2:1993 1st Edition requirements, IEC 60601-2-35 Particular Standard for Patient Warming Systems, and CAN/CSA C22.2 No. 125 for Electromedical Equipment. Performance testing demonstrated conformity to the draft ASTM Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices.
Conclusions
The WarmTouch Model 5300 Patient Warming System and the results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2002
Ms. Gina To Senior Regulatory Affairs Project Manager Nellcor Puritan Bennett Incorporated 4280 Hacienda Drive Pleasanton, CA 94588
Re: K020604
Trade Name: WarmTouch Model 5300 Patient Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (two) Product Code: DNJ Dated: March 27, 2002 Received: March 28, 2002
Dear Ms. To:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Gina To
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of acrease a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or unf I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 6077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and in your e FDA finding of substantial equivalence of your device to a legally promance motification " results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the O invision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Qarla Tull
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
WarmTouch Model 5300 Patient Warming System Device Name:
Indications For Use:
The WarmTouch Model 5300 Patient Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, for example, with the surgical patient, the patient in the pre-operative holding area, the pregnant woman who shivers during epidural anesthesia due to hypothermia, or any patient who is uncomfortable anywhere in the cold critical care environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)