(127 days)
Not Found
No
The device description focuses on basic servo-controlled temperature regulation using thermistors and an analog safety circuit, with no mention of AI or ML technologies.
Yes
The device is intended to prevent and treat hypothermia, which is a therapeutic purpose.
No
The device is a convective warmer intended to prevent and treat hypothermia by delivering warmed air. Its function is therapeutic, not diagnostic.
No
The device description clearly details hardware components such as a convective warmer, air filter, heater, motor, thermistors, and disposable warming blankets. It is a physical medical device with integrated software for control and safety, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent and treat hypothermia and provide thermal comfort by warming the patient's body. This is a therapeutic and comfort-based application, not a diagnostic one.
- Device Description: The device works by warming and distributing air over the patient's body. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- No Mention of Diagnostic Testing: The text does not mention any form of diagnostic testing, analysis of biological samples, or providing information for medical diagnosis.
IVD devices are specifically designed to perform tests on samples from the human body to provide information about a person's health. This device's function is entirely external and focused on temperature regulation of the patient's body.
N/A
Intended Use / Indications for Use
The Equator® Convective Warmer is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warmer can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Equator® Convective Warmer can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments.
The Snuggle Warm® Convective Warming Blanket is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warming blanket can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Snuggle Warm® Convective Warming Blanket can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments
Product codes (comma separated list FDA assigned to the subject device)
DWJ
Device Description
Equator® Convective Warmer
The Equator® Convective Warmer (convective warmer) draws ambient- temperature air through a 0.2 micron particulate air filter. The filtered air is warmed to a selected temperature. The warmed air enters the convective warming blanket) through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the convective warming blanket gently disperse the warmed air over and around the patient.
The convective warmer has three outlet temperature settings, which provide flexibility in patient treatment: 36°C, 40°C, and 44°C. These temperature settings are servo-controlled by a thermistor placed at the end of hose where the hose connects to the blanket. A fourth temperature setting delivers ambient-temperature air. The temperature indicated on the control panel is the temperature of air being delivered to the blanket at the end of the hose. A control thermistor in the convective warmer adjusts the power applied to the heater to maintain the selected temperature. This enables the system to maintain the selected temperature under variations in ambient temperature.
A safety thermistor provides a signal to a separate high-temperature analog circuit. The safety thermistor activates and causes an alarm if the temperature exceeds the set point. The analog safety circuit provides an independent means of shutoff, which discontinues power to the heater and motor. This prevents patient exposure to excessive temperatures. Patient contact is not applicable to convective warmers, warmer accessories, or warmer spare parts, as there is no direct patient exposure.
Snuggle Warm® Convective Warming Blankets
All testing was conducted with currently marketed Snuggle Warm® Convective Warming Blankets identified as product numbers with the prefix "SW-" followed by a four digit identifier. The proposed convective warming blankets listed in this submission are identical in material, design, and manufacturing process to the blankets to which the testing has been conducted and only the Indications For Use are different. The proposed convective warming blankets listed in this submission have the product numbers with the prefix "SWU-" followed by the same four digit identifier as the currently marketed convective warming blankets. Because the proposed blankets are identical in every nature to the currently marketed blankets with the exception of the Indications For Use, additional testing of the proposed blankets was not repeated and any testing that was conducted on the currently marketed blankets would be applicable to the proposed blankets.
The proposed Snuggle Warm® convective warming blanket in this submission (SWU-2001, SWU-2002, SWU-2003, SWU-2004, SWU-2007, SWU-2009, SWU-2010, SWU-2011, SWU-2013, SWU-2014L, SWU-2014R, SWU-2016, SWU-2018, SWU-2019, and SWU-2113) is a single-use disposable blanket consisting of two layers of non-woven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket. The distribution of air is designed to minimize temperature differences throughout the blanket. The convective warming blankets are not sterilized with the exception of the Sterile Cardiac Convective Warming Blanket (SWU-2008) described below. The convective warming blankets are compatible with competitor warming units if used in conjunction with a Smiths Medical ASD, Inc. adapter as described in the Adapter section below.
Patient contact applies to the convective warming blankets as with any other standard blanket or sheet. Exposure is limited to intact skin and/or breached or compromised (closed surgical wounds) surfaces only.
No product in the convective warming family contains latex, DEHP or BPA.
Snuggle Warm® Sterile Cardiac Convective Warming Blanket
The Snuggle Warm® Sterile Cardiac Convective Warming Blanket (SWU-2008) is identical in material and construction to the convective warming blankets listed in the preceding section. The only difference between the Snuggle Warm® Sterile Cardiac Convective Warming Blanket all other Snuggle Warm® Convective Warming Blankets is that the Sterile Cardiac Convective Warming Blanket is sterilized using a routine Ethylene Oxide (EO) sterilization cycle developed to deliver a sterility assurance level of 10 ° and meets ISO standards for EO residuals prior to release for distribution.
Adapters
Snuggle Warm® Convective Warming Blankets have been designed to be used with all Smiths Medical ASD, Inc. warmers without requiring the use of any adapter. Snuggle Warm® Convective Warming Blankets are compatible with other convective warmers with the use of an adapter to ensure proper fit between the blanket and the warmer. The compatible warmers require the following for use with Snuggle Warm® convective warming blankets: (fpm=feet per minute, mpm = meters per minute).
The adapters are available from Smiths Medical ASD, Inc. are made from natural acetyl copolymer material and are designed to fit compatible warmer hose ends using the adapters (SWU-9001, SWU-9002, SWU-9003, SWU-9004). To ensure proper securement, a Level 1 elbow nozzle, included with each adapter, must be used to connect the convective warming blanket to the warmer. Adapters are designed to connect the Level 1 ° elbow nozzle to a compatible warming unit's hose. Each Snuggle Warm Convective Warming Blanket IFU describes which adapter to use for compatible warming units.
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 or pediatric patients
Intended User / Care Setting
appropriately trained healthcare professionals in clinical environments
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 tests and results for the Snuggle Warm® Convective Warming Blankets and the Equator® Convective Warmer are documented by Smiths Medical engineering test reports and independent test house reports. Human-factors engineering studies were also completed.
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.
K011907, K083336, K061513, K040632, K001149
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2014
Smith Medical ASD, Inc. Jim Johnson Regulatory Specialist 1265 Grey Fox Road St. Paul, Minnesota 55112
Re: K141686
Trade/Device Name: Equator Convective Warmer Snuggle Warm Adult Full Body Convective Warming Blanket Snuggle Warm Pediatric Full Body Convective Warming Blanket Snuggle Warm Upper Body Convective Warming Blanket Snuggle Warm Lower Body Convective Warming Blanket Snuggle Warm Tube Convective Warming Blanket Snuggle Warm Sterile Cardiac Convective Warming Blanket Snuggle Warm Pediatric Under Body Convective Warming Blanket Snuggle Warm Small Upper Body Convective Warming Blanket Snuggle Warm Large Pediatric Under Body Convective Warming Blanket Snuggle Warm Adult Under Body Convective Warming Blanket Snuggle Warm Left Lateral Access Convective Warming Blanket Snuggle Warm Right Lateral Access Convective Warming Blanket Snuggle Warm Full Body Split Access Convective Warming Blanket Snuggle Warm Multi-Access Convective Warming Blanket Snuggle Warm Poncho Blanket Convective Warming Blanket Snuggle Warm Adult Under Body Convective Warming Blanket with Arm Openings Regulation Number: 21 CFR 870.5900 Regulation Name: Convective Warming System Regulatory Class: Class II Product Code: DWJ Dated: June 20, 2014 Received: October 1, 2014
Dear Jim Johnson,
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.
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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/Safety/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillebrand
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141686
Device Name
Equator® Convective Warmer and Snuggle Warm® Convective Warming Blanket
Indications for Use (Describe)
The Equator® Convective Warmer is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warmer can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Equator® Convective Warmer can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments.
The Snuggle Warm® Convective Warming Blanket is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warming blanket can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Snuggle Warm® Convective Warming Blanket can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
smıths medıcal
bringing technology to life
Smiths Medical 1265 Grey Fox Road St. Paul, MN 55112 T: 651 633 2556 F: 651 628 7459 www.smiths-medical.com
510(k) Summary
510(k) _K141686 ______________________________________________________________________________________________________________________________________________________________
DATE PREPARED: September 22, 2014
I. GENERAL INFORMATION
| Applicant's Name and Address: | Smiths Medical ASD, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jim Johnson
Regulatory Affairs Specialist |
| Common/Usual Name: | 1) Convective Warming System |
| Trade Name: | 1) Equator® Convective Warmer
2) Snuggle Warm® Convective Warming Blanket |
| Equivalence Device Comparison: | 1) Snuggle Warm® 4000 Convective Warming System
2) Level 1® Snuggle Warm® Convective Warming Blankets
3) Level 1® Snuggle Warm® Pediatric Convective Warming Blanket
4) Level 1® Snuggle Warm® Sterile Cardiac Blanket (a component of
Snuggle Warm® 4000 Convective Warming System)
5) Bair Hugger® Temperature Management System |
II. DEVICE DESCRIPTION
Equator® Convective Warmer
The Equator® Convective Warmer (convective warmer) draws ambient- temperature air through a 0.2 micron particulate air filter. The filtered air is warmed to a selected temperature. The warmed air enters the convective warming blanket) through the hose and is distributed through delivery channels. Perforations on the patient side of the
4
air delivery channels in the convective warming blanket gently disperse the warmed air over and around the patient.
The convective warmer has three outlet temperature settings, which provide flexibility in patient treatment: 36°C, 40°C, and 44°C. These temperature settings are servo-controlled by a thermistor placed at the end of hose where the hose connects to the blanket. A fourth temperature setting delivers ambient-temperature air. The temperature indicated on the control panel is the temperature of air being delivered to the blanket at the end of the hose. A control thermistor in the convective warmer adjusts the power applied to the heater to maintain the selected temperature. This enables the system to maintain the selected temperature under variations in ambient temperature.
A safety thermistor provides a signal to a separate high-temperature analog circuit. The safety thermistor activates and causes an alarm if the temperature exceeds the set point. The analog safety circuit provides an independent means of shutoff, which discontinues power to the heater and motor. This prevents patient exposure to excessive temperatures. Patient contact is not applicable to convective warmers, warmer accessories, or warmer spare parts, as there is no direct patient exposure.
Snuggle Warm® Convective Warming Blankets
All testing was conducted with currently marketed Snuggle Warm® Convective Warming Blankets identified as product numbers with the prefix "SW-" followed by a four digit identifier. The proposed convective warming blankets listed in this submission are identical in material, design, and manufacturing process to the blankets to which the testing has been conducted and only the Indications For Use are different. The proposed convective warming blankets listed in this submission have the product numbers with the prefix "SWU-" followed by the same four digit identifier as the currently marketed convective warming blankets. Because the proposed blankets are identical in every nature to the currently marketed blankets with the exception of the Indications For Use, additional testing of the proposed blankets was not repeated and any testing that was conducted on the currently marketed blankets would be applicable to the proposed blankets.
5
The proposed Snuggle Warm® convective warming blanket in this submission (SWU-2001, SWU-2002, SWU-2003, SWU-2004, SWU-2007, SWU-2009, SWU-2010, SWU-2011, SWU-2013, SWU-2014L, SWU-2014R, SWU-2016, SWU-2018, SWU-2019, and SWU-2113) is a single-use disposable blanket consisting of two layers of non-woven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket. The distribution of air is designed to minimize temperature differences throughout the blanket. The convective warming blankets are not sterilized with the exception of the Sterile Cardiac Convective Warming Blanket (SWU-2008) described below. The convective warming blankets are compatible with competitor warming units if used in conjunction with a Smiths Medical ASD, Inc. adapter as described in the Adapter section below.
Patient contact applies to the convective warming blankets as with any other standard blanket or sheet. Exposure is limited to intact skin and/or breached or compromised (closed surgical wounds) surfaces only.
No product in the convective warming family contains latex, DEHP or BPA.
Snuggle Warm® Sterile Cardiac Convective Warming Blanket
The Snuggle Warm® Sterile Cardiac Convective Warming Blanket (SWU-2008) is identical in material and construction to the convective warming blankets listed in the preceding section. The only difference between the Snuggle Warm® Sterile Cardiac Convective Warming Blanket all other Snuggle Warm® Convective Warming Blankets is that the Sterile Cardiac Convective Warming Blanket is sterilized using a routine Ethylene Oxide (EO) sterilization cycle developed to deliver a sterility assurance level of 10 ° and meets ISO standards for EO residuals prior to release for distribution.
Adapters
Snuggle Warm® Convective Warming Blankets have been designed to be used with all Smiths Medical ASD, Inc. warmers without requiring the use of any adapter. Snuggle Warm® Convective Warming Blankets are compatible with other convective warmers
6
with the use of an adapter to ensure proper fit between the blanket and the warmer. The compatible warmers require the following for use with Snuggle Warm® convective warming blankets: (fpm=feet per minute, mpm = meters per minute).
| Minimum
Flow Rate | Maximum
Flow Rate | Minimum
Temp | Maximum
Temp | Minimum Hose
Diameter | Maximum Hose
Diameter |
|----------------------|----------------------|-----------------|-----------------|--------------------------|--------------------------|
| 1541 fpm | 2500 fpm | Ambient | 113°F | 2.625 inches | 3.125 inches |
| 470 mpm | 762 mpm | | 45°C | 66.675 mm | 79.375 mm |
Compatible Warmer Performance Requirements.
The adapters are available from Smiths Medical ASD, Inc. are made from natural acetyl copolymer material and are designed to fit compatible warmer hose ends using the adapters (SWU-9001, SWU-9002, SWU-9003, SWU-9004). To ensure proper securement, a Level 1 elbow nozzle, included with each adapter, must be used to connect the convective warming blanket to the warmer. Adapters are designed to connect the Level 1 ° elbow nozzle to a compatible warming unit's hose. Each Snuggle Warm Convective Warming Blanket IFU describes which adapter to use for compatible warming units.
III. DEVICE INTENDED USE
Equator® Convective Warmer
The Equator® Convective Warmer is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warmer can also be used to provide thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Equator® Convective Warmer can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments.
Snuggle Warm® Convective Warming Blanket
The Snuggle Warm® Convective Warming Blanket is intended to prevent and treat hypothermia when temperature therapy is clinically indicated. The warming blanket can also be used to provide thermal comfort when conditions exist that may cause patients to
7
become too warm or too cold. The Snuggle Warm® Convective Warming Blanket can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments.
IV. SUMMARY OF STUDIES
Performance Testing
Performance tests and results for the Snuggle Warm® Convective Warming Blankets and the Equator® Convective Warmer are documented by Smiths Medical engineering test reports and independent test house reports. Human-factors engineering studies were also completed.
Clinical Studies
Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the Equator® Convective Warmer and Snuggle Warm® Convective Warming Blankets.
Testing Conclusion
All testing met pre-established specifications, and successfully demonstrated that the devices performed as intended. The testing results allowed for a conclusion to be made that the Equator® Convective Warmer and Snuggle Warm® Convective Warming Blankets were as safe and effective as the predicate devices.
V. STATEMENT OF EQUIVALENCE
The Equator® Convective Warmer and Snuggle Warm® Convective Warming Blankets are substantially equivalent to the predicate devices, based on comparisons of the device classifications, intended use, and technological characteristics. Verification and validation tests confirmed the suitability of the devices for their intended uses. The test results did not raise new safety or performance questions, and confirmed that the Equator® Convective Warmer and Snuggle Warm® Convective Warming Blankets devices are substantially equivalent to the predicate devices.
8
VI. Subject and Predicate Device Comparison Tables
| Parameters | Predicate devices
Snuggle Warm Convective
Warming Blankets
(models SW-2001, SW-2002, SW-
2003, SW-2004)
Per 510(k) K011907 | Predicate devices
Snuggle Warm Convective Warming Blankets
(models SW-2013, SW-2014L, SW-2014R,
SW-2016, SW-2018, SW-2019)
Per 510(k) K083336 | Proposed devices
Snuggle Warm Convective Warming
Blankets
(models SWU-2001, SWU-2002, SWU-
2003, SWU-2004, SWU-2007, SWU-
2010, SWU-2013, SWU-2014L, SWU-
2014R, SWU-2016, SWU-2018, SWU-
2019, SWU-2113) |
|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE
INDICATIONS FOR
USE | Convective warming system for
thermal regulation of a patient's
body temperature in a clinical
environment.
The Convective Warming System
is intended for thermal regulating
a patient's temperature to prevent
hypothermia by a warm air heated
blanket system to reduce cold
discomfort during and after
surgical procedures. It is intended
for use by appropriately trained
healthcare professionals in clinical
environments. | Convective warming system for thermal
regulation of a patient's body temperature in a
clinical environment.
The Convective Warming System is intended
for thermal regulating a patient's temperature to
prevent hypothermia by a warm air heated
blanket system to reduce cold discomfort during
and after surgical procedures. It is intended for
use by appropriately trained healthcare
professionals in clinical environments. | Convective warming system for thermal
regulation of a patient's body temperature
in a clinical environment.
The Snuggle Warm® Convective Warming
Blanket is intended to prevent and treat
hypothermia when temperature therapy is
clinically indicated. The warming blanket
can also be used to provide thermal
comfort when conditions exist that may
cause patients to become too warm or too
cold. The Snuggle Warm® Convective
Warming Blanket can be used with adult
or pediatric patients and is intended for
use by appropriately trained healthcare
professionals in clinical environments. |
| Parameters | Predicate devices
Snuggle Warm Convective
Warming Blankets
(models SW-2001, SW-2002, SW-
2003, SW-2004)
Per 510(k) K011907 | Predicate devices
Snuggle Warm Convective Warming Blankets
(models SW-2013, SW-2014L, SW-2014R,
SW-2016, SW-2018, SW-2019)
Per 510(k) K083336 | Proposed devices
Snuggle Warm Convective Warming
Blankets
(models SWU-2001, SWU-2002, SWU-
2003, SWU-2004, SWU-2007, SWU-
2010, SWU-2013, SWU-2014L, SWU-
2014R, SWU-2016, SWU-2018, SWU-
2019, SWU-2113) |
| MATERIAL/DESIGN | Consists of two layers of non-woven polypropylene fabric bonded to a fusion layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels The warm air is distributed around the patient's body through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side layer of the blanket. The distribution of air is designed to minimize temperature differences of delivered air at different blanket locations. Two (2) hose ports for models SW-2001, SW-2003, and SW-2004. The hose entry retainer material is 240# bleached white skin board un-laminated with high porosity and is 0.024" thick. | Consists of two layers of non-woven polypropylene fabric bonded to a fusion layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels The warm air is distributed around the patient's body through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side layer of the blanket. The distribution of air is designed to minimize temperature differences of delivered air at different blanket locations. Three (3) hose ports for model SW-2013. The hose entry retainer material is 240# bleached white skin board un-laminated with high porosity and is 0.024" thick. | Identical
Identical
Identical
Identical
Identical
Identical |
| Parameters | Predicate devices
Snuggle Warm Convective
Warming Blankets
(models SW-2001, SW-2002, SW-
2003, SW-2004)
Per 510(k) K011907 | Predicate devices
Snuggle Warm Convective Warming Blankets
(models SW-2013, SW-2014L, SW-2014R,
SW-2016, SW-2018, SW-2019)
Per 510(k) K083336 | Proposed devices
Snuggle Warm Convective Warming
Blankets
(models SWU-2001, SWU-2002, SWU-
2003, SWU-2004, SWU-2007, SWU-
2010, SWU-2013, SWU-2014L, SWU-
2014R, SWU-2016, SWU-2018, SWU-
2019, SWU-2113) |
| Packaging | Box and polybag | Box and polybag | Identical |
| Shelf Life | 3 years | 3 years | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
| SAFETY
SPECIFICATION | | | |
| Blanket material
conforms to
16CFR1610 | Pass | Pass | Pass |
| Average Contact
Surface
Temperature of
blanket shall not
exceed 46°C in
Normal
Condition | Pass | Pass | Pass |
| Maximum
Contact Surface
Temperature of
blanket shall not
exceed 48°C in
Normal
Condition | Pass | Pass | Pass |
Table 3.6.1: Comparison between Snuggle Warm® Convective Warming Blankets and predicate devices.
9
10
11
| Parameters | Predicate devices
Snuggle Warm Convective
Warming Blankets
(models SW-2001, SW-2002, SW-
2003, SW-2004)
Per 510(k) K011907 | Predicate devices
Snuggle Warm Convective Warming Blankets
(models SW-2013, SW-2014L, SW-2014R,
SW-2016, SW-2018, SW-2019)
Per 510(k) K083336 | Proposed devices
Snuggle Warm Convective Warming
Blankets
(models SWU-2001, SWU-2002, SWU-
2003, SWU-2004, SWU-2007, SWU-
2010, SWU-2013, SWU-2014L, SWU-
2014R, SWU-2016, SWU-2018, SWU-
2019, SWU-2113) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| For connectors
intended to
accept Hoses,
means shall be
provided to
prevent Hoses
from
disengaging
unintentionally
from connectors | Pass | Pass | Pass |
| PHYSICAL
SPECIFICATIONS | | | |
| Material/design | • No Level 1 logo
• Drape included (SW-2003, SW-
2010, and SW-2013) | • Preprinted Level 1 logo on the top layer
• Drape included (SW-2018) | • Preprinted logo on the top layer of all
blankets
• Drape included (SWU-2003, SWU-
2010, SWU-2013, SWU-2018, and
SW-2113)
• SWU-2113 includes arm slots |
12
| Parameters | Predicate devices
Snuggle Warm Convective
Warming Blankets
(models SW-2001, SW-2002, SW-
2003, SW-2004)
Per 510(k) K011907 | Predicate devices
Snuggle Warm Convective Warming Blankets
(models SW-2013, SW-2014L, SW-2014R,
SW-2016, SW-2018, SW-2019)
Per 510(k) K083336 | Proposed devices
Snuggle Warm Convective Warming
Blankets
(models SWU-2001, SWU-2002, SWU-
2003, SWU-2004, SWU-2007, SWU-
2010, SWU-2013, SWU-2014L, SWU-
2014R, SWU-2016, SWU-2018, SWU-
2019, SWU-2113) |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Blanket
Dimensions
Width X Length
(approximate) | SW-2001: 40.00" X 78.75"
SW-2002: 40.00" X 57.5"
SW-2003: 80.0" X 40.0"
SW-2004: 40.00" X 64.50" | SW-2013: 40.00: X 80.00"
SW-2014L: 40.00" X 79.50"
SW-2014R: 40.00" X 79.50"
SW-2016: 40.00" X 80.00"
SW-2018: 40.00" X 80.00"
SW-2019: 40.00" X 80.00" | SWU-2001: 40.00" X 78.75"
SWU-2002: 40.00" X 57.5"
SWU-2003: 80.0" X 40.0"
SWU-2004: 40.00" X 64.50"
SWU-2007: 28.0" X 70.0"
SWU-2010: 78.00" X 30.70"
SWU-2013: 40.00: X 80.00"
SWU-2014L: 40.00" X 79.50"
SWU-2014R: 40.00" X 79.50"
SWU-2016: 40.00" X 80.00"
SWU-2018: 40.00" X 80.00"
SWU-2019: 40.00" X 80.00"
SWU-2113: 40.00" X 80.00" |
13
| Parameters | Predicate devices | Proposed devices |
|---|---|---|
| Snuggle Warm Pediatric Convective Warming Blankets | Snuggle Warm Pediatric Convective Warming Blankets | |
| (models SW-2009, SW-2011) | (models SWU-2009, SWU-2011) | |
| Per 510(k) K061513 | ||
| INTENDED USE | Thermal regulation of a patient's temperature in a | |
| clinical environment. | Convective warming system for thermal regulation of a | |
| patient's body temperature in a clinical environment. | ||
| INDICATIONS FOR USE | ||
| (Refer to Appendix A below) | For thermal regulation of a patient's temperature to | |
| prevent hypothermia and/or reduce cold discomfort | ||
| during and after surgical procedures. It is intended for | ||
| use by appropriately trained healthcare professionals in | ||
| clinical environments. | The Snuggle Warm® Convective Warming Blanket is intended | |
| to prevent and treat hypothermia when temperature therapy is | ||
| clinically indicated. The warming blanket can also be used to | ||
| provide thermal comfort when conditions exist that may cause | ||
| patients to become too warm or too cold. The Snuggle Warm® | ||
| Convective Warming Blanket can be used with adult or | ||
| pediatric patients and is intended for use by appropriately | ||
| trained healthcare professionals in clinical environments. | ||
| MATERIAL/DESIGN | • Consists of two layers of non-woven polypropylene | |
| fabric bonded to a fusion layer of polyethylene. | ||
| • The layers are bonded together to form a distribution | ||
| network of air delivery channels | ||
| • The warm air is distributed around the patient's body | ||
| through the delivery channels and exits the blanket | ||
| through a specially designed series of perforations in | ||
| the patient side layer of the blanket. | ||
| • The distribution of air is designed to minimize | ||
| temperature differences of delivered air at different | ||
| blanket locations. | ||
| • The blanket is designed to be placed under the | ||
| patient. | ||
| • The hose entry retainer material is 240# bleached | ||
| white skin board un-laminated with high porosity and | ||
| is 0.024" thick. | Identical | |
| Packaging | Box and polybag | Identical |
| Shelf Life | 3 years | Identical |
| Sterility | Non-sterile | Identical |
| Parameters | Predicate devices | |
| Snuggle Warm Pediatric Convective Warming Blankets | ||
| (models SW-2009, SW-2011) | ||
| Per 510(k) K061513 | Proposed devices | |
| Snuggle Warm Pediatric Convective Warming Blankets | ||
| (models SWU-2009, SWU-2011) | ||
| SAFETY SPECIFICATION | ||
| Blanket material conforms to | ||
| 16CFR1610 | Pass | Pass |
| Average Contact Surface | ||
| Temperature of blanket shall | ||
| not exceed 46°C in Normal | ||
| Condition | Pass | Pass |
| Maximum Contact Surface | ||
| Temperature of blanket shall | ||
| not exceed 48°C in Normal | ||
| Condition | Pass | Pass |
| For connectors intended to | ||
| accept Hoses, means shall be | ||
| provided to prevent Hoses | ||
| from disengaging | ||
| unintentionally from | ||
| connectors | Pass | Pass |
| PHYSICAL SPECIFICATIONS | ||
| Material/design | • The blanket includes absorbent pads | |
| • Preprinted logo on top layer is the Snuggle Warm logo SnuggleRoo® | ||
| • Ink for logo is Pantone 266 (Purple) | ||
| • Two (2) hose inlets | ||
| • Drape included | ||
| • Full body is placed onto blanket | • The blanket includes absorbent pads | |
| • Preprinted logo on top layer is the Snuggle Warm logo SnuggleRoo® | ||
| • Ink for logo is Pantone 266 (Purple) | ||
| • Two (2) hose inlets | ||
| • Drape included | ||
| • Full body is placed onto blanket | ||
| Blanket Dimensions | ||
| Width X Length | ||
| (approximate) | SW-2009: 37.0" X 26.0" | |
| SW-2011: 53.75" X 40.25" | SWU-2009: 37.0" X 26.0" | |
| SWU-2011: 53.75" X 40.25" | ||
| Parameters | Predicate devices | |
| Snuggle Warm Convective Warming Blankets | ||
| (models SW-2008) | ||
| Per 510(k) K040632 | Proposed devices | |
| Snuggle Warm Convective Warming Blankets | ||
| (models SWU-2008) | ||
| INTENDED USE | Convective warming system for thermal regulation of a | |
| patient's body temperature in a clinical environment. | Convective warming system for thermal regulation of a | |
| patient's body temperature in a clinical environment. | ||
| INDICATIONS FOR USE | ||
| (Refer to Appendix A below) | The device is intended for thermal regulating a patient's | |
| temperature to prevent hypothermia by a warm air | ||
| heated blanket to reduce cold discomfort during and | ||
| after surgical procedures. | The Snuggle Warm® Convective Warming Blanket is intended | |
| to prevent and treat hypothermia when temperature therapy is | ||
| clinically indicated. The warming blanket can also be used to | ||
| provide thermal comfort when conditions exist that may cause | ||
| patients to become too warm or too cold. The Snuggle Warm® | ||
| Convective Warming Blanket can be used with adult or | ||
| pediatric patients and is intended for use by appropriately | ||
| trained healthcare professionals in clinical environments. | ||
| MATERIAL/DESIGN | • Consists of two layers of non-woven polypropylene | |
| fabric bonded to a fusion layer of polyethylene. | ||
| • The layers are bonded together to form a distribution | ||
| network of air delivery channels | ||
| • The warm air is distributed around the patient's body | ||
| through the delivery channels and exits the blanket | ||
| through a specially designed series of perforations in | ||
| the patient side layer of the blanket. | ||
| • The distribution of air is designed to minimize | ||
| temperature differences of delivered air at different | ||
| blanket locations. | Identical | |
| Identical | ||
| Identical | ||
| Identical | ||
| Packaging | Box and polybag | Identical |
| Shelf Life | 3 years | Identical |
| Sterility | Sterile | Identical |
| SAFETY SPECIFICATION | ||
| Blanket material | ||
| conforms to 16CFR1610 | Pass | Pass |
| Parameters | Predicate devices | Proposed devices |
| Snuggle Warm Convective Warming Blankets | ||
| (models SW-2008) | ||
| Per 510(k) K040632 | Snuggle Warm Convective Warming Blankets | |
| (models SWU-2008) | ||
| Average Contact Surface | ||
| Temperature of blanket shall | ||
| not exceed 46°C in Normal | ||
| Condition | Pass | Pass |
| Maximum Contact Surface | ||
| Temperature of blanket | ||
| shall not exceed 48°C in | ||
| Normal Condition | Pass | Pass |
| For connectors intended to | ||
| accept Hoses, means shall | ||
| be provided to prevent | ||
| Hoses from disengaging | ||
| unintentionally from | ||
| connectors | Pass | Pass |
| PHYSICAL SPECIFICATIONS | ||
| Material/design | • Packaging for sterile cardiac blanket consists of the | |
| Sterile Cardiac Blanket, Instructions for Use, and a | ||
| Convective Warming Hose | ||
| • All contents are packaged together in a sealed | ||
| polybag | ||
| • Package is Ethylene Oxide Sterilized to 10-6 SAL. | • Packaging for sterile cardiac blanket consists of the Sterile | |
| Cardiac Blanket, Instructions for Use, and a Convective | ||
| Warming Hose | ||
| • All contents are packaged together in a sealed polybag | ||
| • Package is Ethylene Oxide Sterilized to 10-6 SAL. | ||
| Blanket Dimensions | ||
| Width X | ||
| Length(approximate) | SW-2008: 40.0" X 64." | SWU-2008: 40.0" X 64.5" |
Table 3.6.2: Comparison between Snuggle Warm® Pediatric Convective Warming Blankets and predicate devices.
14
15
Table 3.6.3: Comparison between Snuggle Warm® Cardiac Convective Warming Blankets and predicate devices.
16
17
| Parameters | Predicate device
Bair Hugger Model 750
Temperature Management Unit
Per 510(k) K001149 | Predicate device
Snuggle Warm® 4000
Temperature Management System
(model SW-4000)
Per 510(k) K011907 | Proposed device
Equator® Convective Warmer
(model EQ-5000) | Proposed device
Equator® Convective Warmer
(model EQ-5000HF) |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| INTENDED USE | Convective warming system
for thermal regulation of a
patient's body temperature in a
clinical environment. | Convective warming system for
thermal regulation of a patient's
body temperature in a clinical
environment. | Convective warming system for
thermal regulation of a patient's
body temperature in a clinical
environment. | Convective warming system for
thermal regulation of a patient's
body temperature in a clinical
environment. |
| PERFORMANCE | | | | |
| Air Velocity | Up to 48 cfm or 23Lps (2233
ft/minute) | 1800-2500 ft/minute (9.1-12.7
m/sec) | 1650-2500 ft/minute (8.4-12.7
m/sec) | 1650-2500 ft/minute (8.4-12.7
m/sec) |
| Air Temperature
Four (4) selections: | Hose End Temperature | Hose End Temperature | Hose End Temperature | Hose End Temperature |
| 1. High
2. Medium
3. Low
4. Ambient | 43°C +/- 1.5°C
38°C +/- 4.5°C
32°C +/- 1.5°C
Ambient | 44°C +/- 1.0°C
40°C +/- 1.0°C
36°C +/- 1.0°C
Ambient | 44°C +/- 1.0°C
40°C +/- 1.0°C
36°C +/- 1.0°C
Ambient | 44°C +/- 1.0°C
40°C +/- 1.0°C
36°C +/- 1.0°C
Ambient |
| System Power
Requirements | 110-120 VAC 50/60 Hz
11.7 Amps | 120 VAC 60 Hz
8.9 Amps | 115 VAC, 50/60 Hz
8.05 Amps | 115 VAC, 50/60 Hz
8.05 Amps |
| Heater Power
Requirement | 1600 Watts | 980 Watts | 800W | 800 W |
| PHYSICAL SPECIFICATIONS | | | | |
| Dimensions | 13.5" X 9.5" X 10.5" | 20" X 13" X 16.5" | 11.75" X 9.5" X 7.5" | 11.75" X 9.5" X 7.5" |
| Weight | 16.3 lbs | 45 lbs | 15 lbs | 15 lbs |
| Materials | Plastic/metal | Plastic/metal | Plastic/Metal | Plastic/Metal |
| SAFETY | | | | |
| EMI/EMC Compliant | Yes, IEC 60601-1, EN 60601-1 | Yes, EN 60601-1, EN 60601-1-2 | Yes, IEC 60601-1, EN 60601-1-2 | Yes, IEC 60601-1, EN 60601-1-2 |
| Forced air Over
Temperature
Protection (44°C
setting) | Thermal cutoff shuts heater off
at 47°C +/- 2°C | Electrical Heater safety relay
opens at 47.0°C +/- 1.0°C | Electrical Heater safety relay
opens at 47.0°C +/- 1.0°C | Electrical Heater safety relay
opens at 47.0°C +/- 1.0°C |
| Parameters | Predicate device
Bair Hugger Model 750
Temperature Management Unit
Per 510(k) K001149 | Predicate device
Snuggle Warm® 4000
Temperature Management System
(model SW-4000)
Per 510(k) K011907 | Proposed device
Equator® Convective Warmer
(model EQ-5000) | Proposed device
Equator® Convective Warmer
(model EQ-5000HF) |
| Alternate provisions | Flashing amber light & audible
alarm activated | Warning light & audible alarm
activated | Warning light & audible alarm
activated | Warning light & audible alarm
activated |
| FEATURES | | | | |
| Hose with Secure
Locking Mechanism | Yes | Yes | Yes | Yes |
| Hose Support
Arm/Handle | No | Yes | Yes | Yes |
| Air Filter | Replaceable 0.2 micron | Replaceable 0.2 micron | Replaceable 0.2 micron | Replaceable 0.2 micron |
| Temperature Display | Front panel LCD display | Front panel digital display | Front panel digital display | Front panel digital display |
Table 3.6.4: Comparison between Equator® Convective Warmer and predicate devices.
18