(198 days)
Not Found
No
The description focuses on the electro-mechanical function of a blower and heated air delivery, with no mention of AI or ML terms or functionalities.
Yes
Explanation: The device is intended for the "treatment of hypothermia," which directly indicates a therapeutic purpose.
No
The device is described as a "Convective Warming System" intended for the "prevention and treatment of hypothermia" and "management of appropriate normothermia." This indicates a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is an "electro-mechanical blower" and part of a system including a "warming unit and blanket," indicating it is a hardware device with software components, not a software-only 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 for the management of appropriate normothermia." This describes a therapeutic and patient-warming function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an "electro-mechanical blower that delivers heated air" to a blanket draped over the patient. This is a physical intervention applied to the patient's body, not a test performed on a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the WarmTouch Convective Warming System is a medical device used for patient warming, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The WarmTouch Convective Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, and for the management of appropriate normothermia.
The WarmTouch™ Convective Warming Unit is a portable device that is used in conjunction with a WarmTouch™ Blanket as a system that is intended for prescription use. The warming unit requlated the management of normothermia from pre-operative to post-operative, which aligns with the Intended Use of the currently cleared (predicate) device. There are no clinical implications, no new diagnostic or therapeutic information that is not normally associated with other general uses of the device, nor are there any additional outcomes that could influence patient management.
Product codes (comma separated list FDA assigned to the subject device)
DWJ
Device Description
The WarmTouch™ Convective Warming Unit is an electro-mechanical blower that delivers heated air. The WarmTouch™ Convective Warming Unit is part of the WarmTouch™ Convective Warming System that consists of the blower warming unit and Covidien's WarmTouch™ Blankets. The blower actively delivers heated air from the blower's flexible hose to a lightweight blanket. During this process, the blanket has already been draped over the patient's body, before the blanket begins distributing the heated air through numerous small perforations in the blanket, which allows the air to reach the targeted areas of the patient's body.
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
adult and pediatric patients
Intended User / Care Setting
clinical settings
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)
Design verification and validation testing was performed to confirm the blower unit's mechanical and software features met specified requirements. All verification and validation activities met product requirements.
Usability was evaluated with users in simulated operating environments. These studies consisted of formative and summative studies, which demonstrate the device provides adequate assurance of safety and performance (in regards to human factors/usability aspects) for the patient and operator.
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.
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).
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Image /page/0/Picture/1 description: The image contains the word COVIDIEN in bold, sans-serif font. To the left of the word is a black and white symbol that looks like a plus sign. The symbol is made up of a white plus sign on a black background.
APR 1 7 2013
510(k) Summary
Date Summary Prepared: 28-September-2012 Date Summary Revised: 20-November-2012
510(k) Submitter / Holder
Covidien IIc 6135 Gunbarrel Avenue Boulder, CO 80301
Contact
Name: Stacev A. Strand Title: Senior Regulatory Affairs Specialist Office Tel: 303.305.2631 720.539.9617 Mobile Tel: 303.305.2212 Fax: Email: Stacey. Strand@Covidien.com
Name of Device
WarmTouch™ Convective Warming Unit Trade Name: Cataloq Number: 5016000 Common Name: Thermal Requiating System Cardiovascular (21 CFR § 870.5900, Class II, DWJ) Classification Name:
Purpose of Submission
The purpose of this submission is to introduce the Covidien WarmTouch™ Convective Warming Unit which effectively provides a means for treating or preventing hypothermia in adult and pediatric patients in clinical settings. The design and intended use of the WarmTouch™ Convective Warming Unit Warming Unit is fundamentally similar to the predicate device. The new WarmTouch™ Convective Warming Unit includes modifications of the: hardware interface to a Graphic User Interface (GUI), blower's design for compliance with the IEC 80601-2-35:2009 (200 edition) standard, Printed Circuit Board Assembly (PCBA) to comply with the European Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU.
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This submission followed the "Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, 2005," the "Guidance for Industry on General / Specific Intended Use, 1998, " and the "Draft Guidance for Industry and FDA Staff. Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review, 2011."
Predicate Device
The WarmTouch™ Convective Warming Unit Warming Unit was compared and found to be substantially equivalent to the following product of comparable type in commercial distribution:
| Trade Name: | WarmTouch™ Model 5300A Patient Warming System |
|---|---|
| Device Common Name: | Thermal Regulating System |
| 510(k) Number: | K020604 (cleared April 2002) |
| Manufacturer: | Covidien, formerly Nellcor Puritan Bennett, |
| a division of Tyco Healthcare |
This WarmTouch™ Convective Warming Unit Warming Unit 510(k) submission is the only initial premarket notification for this new blower unit. There have not been any prior 510(k) premarket notification submissions, regarding this new blower unit, withdrawn or deleted.
Device Description
The WarmTouch™ Convective Warming Unit is an electro-mechanical blower that delivers heated air. The WarmTouch™ Convective Warming Unit is part of the WarmTouch™ Convective Warming System that consists of the blower warming unit and Covidien's WarmTouch™ Blankets. The blower actively delivers heated air from the blower's flexible hose to a lightweight blanket. During this process, the blanket has already been draped over the patient's body, before the blanket begins distributing the heated air through numerous small perforations in the blanket, which allows the air to reach the targeted areas of the patient's body.
Indications for Use
.
The WarmTouch Convective Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, and for the management of appropriate normothermia.
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Intended Use
The WarmTouch™ Convective Warming Unit is a portable device that is used in conjunction with a WarmTouch™ Blanket as a system that is intended for prescription use. The warming unit requlated the management of normothermia from pre-operative to post-operative, which aligns with the Intended Use of the currently cleared (predicate) device. There are no clinical implications, no new diagnostic or therapeutic information that is not normally associated with other general uses of the device, nor are there any additional outcomes that could influence patient management.
Technological and Performance Characteristics
The design technology of the proposed and predicate blower units have the same method of operation, power control, temperature sensor, materials, manufacturing method, and accessories. The main design technology differences between the proposed and predicate blower units are the control mechanism, motor, and user interface.
Performance Data
The design of the WarmTouch™ Convective Warming Unit features the same ambient blower operating range and air flow rate as the predicate device. The proposed blower unit alarms have improved accuracy, along with the improved performance of air temperature exiting the blower.
Design verification and validation testing was performed to confirm the blower unit's mechanical and software features met specified requirements. All verification and validation activities met product requirements.
Animal testing was not required to demonstrate that the proposed device met its design requirements.
Usability / Human Factors
Usability was evaluated with users in simulated operating environments. These studies consisted of formative and summative studies, which demonstrate the device provides adequate assurance of safety and performance (in regards to human factors/usability aspects) for the patient and operator.
Substantial Equivalence
In establishing substantial equivalence of the WarmTouch™ Convective Warming Unit with the predicate device, Covidien evaluated the intended use, indications for use, and technological characteristics. The use of the WarmTouch™ Convective Warming Unit in patient monitoring environments does not raise any new types of questions of safety and effectiveness compared with the predicate device that is currently in use.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2013
Covidien c/o Ms. Stacey Strand 6135 Gunbarrel Avenue Boulder, CO 80301
Re: K123083
Trade/Device Name: WarmTouch Convective Warming Unit Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: February 15, 2013 Received: February 19, 2013
Dear Ms. Strand:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
forth in the quality systems (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to '
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Matthew G. Hillebrenner
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K123083 510(k) Number (if known):
Device Name:
Covidien WarmTouch™ Convective Warming System
Indications for Use:
The WarmTouch Convective Warming System (warming unit and blanket) is intended for prevention and treatment of hypothermia, and for the management of appropriate normothermia.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
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