(127 days)
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.
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: 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).
Snuggle Warm® Sterile Cardiac Convective Warming Blanket: identical in material and construction to the convective warming blankets listed in the preceding section. The only difference is that it is sterilized using a routine Ethylene Oxide (EO) sterilization cycle developed to deliver a sterility assurance level of 10-6 and meets ISO standards for EO residuals prior to release for distribution.
Adapters: 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.
The provided text describes the acceptance criteria and a summary of studies for the Equator Convective Warmer and Snuggle Warm Convective Warming Blanket. However, it does not contain information about a study proving the device meets the acceptance criteria in the format requested, particularly for AI-related performance metrics. This document is a 510(k) premarket notification for a medical device (convective warmer and blankets), primarily focusing on demonstrating substantial equivalence to predicate devices rather than the detailed performance evaluation of an AI-powered system.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides tables (Table 3.6.1, 3.6.2, 3.6.3, and 3.6.4) comparing the proposed devices to predicate devices. The "Acceptance Criteria" for the proposed devices are implicitly that they "Pass" the safety and performance specifications, or are "Identical" to predicate devices, which themselves were accepted. The reported device performance is indicated as "Pass" or "Identical".
For Snuggle Warm® Convective Warming Blankets (Various models):
| Acceptance Criteria (Implicit for Proposed Devices) | Reported Device Performance (Proposed Devices) |
|---|---|
| Blanket material conforms to 16CFR1610 | Pass |
| Average Contact Surface Temperature of blanket shall not exceed 46°C in Normal Condition | Pass |
| Maximum Contact Surface Temperature of blanket shall not exceed 48°C in Normal Condition | Pass |
| For connectors intended to accept Hoses, means shall be provided to prevent Hoses from disengaging unintentionally from connectors | Pass |
| Material/design (e.g., layers, air distribution, hose ports) | Identical (to predicate devices) |
| Packaging | Identical (to predicate devices) |
| Shelf Life | Identical (to predicate devices - 3 years) |
| Sterility (Non-sterile or Sterile for specific model) | Identical (to predicate devices) |
| Blanket Dimensions | Identical (to predicate devices) |
For Equator® Convective Warmer (models EQ-5000, EQ-5000HF):
| Acceptance Criteria (Implicit for Proposed Devices) | Reported Device Performance (Proposed Devices) |
|---|---|
| Air Velocity | 1650-2500 ft/minute (8.4-12.7 m/sec) |
| Air Temperature (Hose End, 4 selections: 44°C, 40°C, 36°C, Ambient) | 44°C +/- 1.0°C, 40°C +/- 1.0°C, 36°C +/- 1.0°C, Ambient |
| System Power Requirements | 115 VAC, 50/60 Hz; 8.05 Amps |
| Heater Power Requirement | 800W |
| Dimensions | 11.75" X 9.5" X 7.5" |
| Weight | 15 lbs |
| Materials | Plastic/Metal |
| EMI/EMC Compliant (to IEC 60601-1, EN 60601-1-2) | Yes |
| Forced air Over Temperature Protection (44°C setting) - Electrical Heater safety relay opens at 47.0°C +/- 1.0°C | Electrical Heater safety relay opens at 47.0°C +/- 1.0°C |
| Alternate provisions (Warning light & audible alarm activated) | Warning light & audible alarm activated |
| Hose with Secure Locking Mechanism | Yes |
| Hose Support Arm/Handle | Yes |
| Air Filter (Replaceable 0.2 micron) | Replaceable 0.2 micron |
| Temperature Display (Front panel digital display) | Front panel digital display |
2. Sample size used for the test set and the data provenance:
The document states: "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."
However, specific sample sizes for testing and data provenance (e.g., country of origin, retrospective/prospective) are not provided in this summary. The testing appears to be primarily engineering verification and validation, likely conducted in-house or by a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The device is a convective warming system, not an AI diagnostic device requiring expert consensus for ground truth. Technical specifications and safety parameters are evaluated against engineering standards and design requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. As mentioned above, this is not an AI diagnostic device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI versus without AI assistance:
No MRMC study was done, and this information is not applicable. This document pertains to a physical medical device (convective warmer), not an AI-assisted diagnostic tool. No AI component is described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance was done, and this information is not applicable. The device described is a physical warming system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device would be established through engineering specifications, international standards (e.g., IEC, ISO for safety and performance), and established physical principles of heat transfer and materials science. For example, temperature measurements are verified against calibrated instrumentation, and material conformity is checked against regulatory standards (e.g., 16CFR1610 for flammability).
8. The sample size for the training set:
This information is not applicable. There is no AI or machine learning component described that would require a training set.
9. How the ground truth for the training set was established:
This information is not applicable. There is no AI or machine learning component described that would require a training set.
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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.
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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
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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)
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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 RoadSt. Paul, MN 55112 |
|---|---|
| Contact Person: | Jim JohnsonRegulatory Affairs Specialist |
| Common/Usual Name: | 1) Convective Warming System |
| Trade Name: | 1) Equator® Convective Warmer2) Snuggle Warm® Convective Warming Blanket |
| Equivalence Device Comparison: | 1) Snuggle Warm® 4000 Convective Warming System2) Level 1® Snuggle Warm® Convective Warming Blankets3) Level 1® Snuggle Warm® Pediatric Convective Warming Blanket4) Level 1® Snuggle Warm® Sterile Cardiac Blanket (a component ofSnuggle 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
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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.
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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
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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).
| MinimumFlow Rate | MaximumFlow Rate | MinimumTemp | MaximumTemp | Minimum HoseDiameter | Maximum HoseDiameter |
|---|---|---|---|---|---|
| 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
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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.
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VI. Subject and Predicate Device Comparison Tables
| Parameters | Predicate devicesSnuggle Warm ConvectiveWarming Blankets(models SW-2001, SW-2002, SW-2003, SW-2004)Per 510(k) K011907 | Predicate devicesSnuggle Warm Convective Warming Blankets(models SW-2013, SW-2014L, SW-2014R,SW-2016, SW-2018, SW-2019)Per 510(k) K083336 | Proposed devicesSnuggle Warm Convective WarmingBlankets(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 USEINDICATIONS FORUSE | Convective warming system forthermal regulation of a patient'sbody temperature in a clinicalenvironment.The Convective Warming Systemis intended for thermal regulatinga patient's temperature to preventhypothermia by a warm air heatedblanket system to reduce colddiscomfort during and aftersurgical procedures. It is intendedfor use by appropriately trainedhealthcare professionals in clinicalenvironments. | Convective warming system for thermalregulation of a patient's body temperature in aclinical environment.The Convective Warming System is intendedfor thermal regulating a patient's temperature toprevent hypothermia by a warm air heatedblanket system to reduce cold discomfort duringand after surgical procedures. It is intended foruse by appropriately trained healthcareprofessionals in clinical environments. | Convective warming system for thermalregulation of a patient's body temperaturein a clinical environment.The Snuggle Warm® Convective WarmingBlanket is intended to prevent and treathypothermia when temperature therapy isclinically indicated. The warming blanketcan also be used to provide thermalcomfort when conditions exist that maycause patients to become too warm or toocold. The Snuggle Warm® ConvectiveWarming Blanket can be used with adultor pediatric patients and is intended foruse by appropriately trained healthcareprofessionals in clinical environments. |
| Parameters | Predicate devicesSnuggle Warm ConvectiveWarming Blankets(models SW-2001, SW-2002, SW-2003, SW-2004)Per 510(k) K011907 | Predicate devicesSnuggle Warm Convective Warming Blankets(models SW-2013, SW-2014L, SW-2014R,SW-2016, SW-2018, SW-2019)Per 510(k) K083336 | Proposed devicesSnuggle Warm Convective WarmingBlankets(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. | IdenticalIdenticalIdenticalIdenticalIdenticalIdentical |
| Parameters | Predicate devicesSnuggle Warm ConvectiveWarming Blankets(models SW-2001, SW-2002, SW-2003, SW-2004)Per 510(k) K011907 | Predicate devicesSnuggle Warm Convective Warming Blankets(models SW-2013, SW-2014L, SW-2014R,SW-2016, SW-2018, SW-2019)Per 510(k) K083336 | Proposed devicesSnuggle Warm Convective WarmingBlankets(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 |
| SAFETYSPECIFICATION | |||
| Blanket materialconforms to16CFR1610 | Pass | Pass | Pass |
| Average ContactSurfaceTemperature ofblanket shall notexceed 46°C inNormalCondition | Pass | Pass | Pass |
| MaximumContact SurfaceTemperature ofblanket shall notexceed 48°C inNormalCondition | Pass | Pass | Pass |
Table 3.6.1: Comparison between Snuggle Warm® Convective Warming Blankets and predicate devices.
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| Parameters | Predicate devicesSnuggle Warm ConvectiveWarming Blankets(models SW-2001, SW-2002, SW-2003, SW-2004)Per 510(k) K011907 | Predicate devicesSnuggle Warm Convective Warming Blankets(models SW-2013, SW-2014L, SW-2014R,SW-2016, SW-2018, SW-2019)Per 510(k) K083336 | Proposed devicesSnuggle Warm Convective WarmingBlankets(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 connectorsintended toaccept Hoses,means shall beprovided toprevent Hosesfromdisengagingunintentionallyfrom connectors | Pass | Pass | Pass |
| PHYSICALSPECIFICATIONS | |||
| 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 allblankets• Drape included (SWU-2003, SWU-2010, SWU-2013, SWU-2018, andSW-2113)• SWU-2113 includes arm slots |
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| Parameters | Predicate devicesSnuggle Warm ConvectiveWarming Blankets(models SW-2001, SW-2002, SW-2003, SW-2004)Per 510(k) K011907 | Predicate devicesSnuggle Warm Convective Warming Blankets(models SW-2013, SW-2014L, SW-2014R,SW-2016, SW-2018, SW-2019)Per 510(k) K083336 | Proposed devicesSnuggle Warm Convective WarmingBlankets(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) |
|---|---|---|---|
| BlanketDimensionsWidth 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" |
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| 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 aclinical environment. | Convective warming system for thermal regulation of apatient's body temperature in a clinical environment. |
| INDICATIONS FOR USE(Refer to Appendix A below) | For thermal regulation of a patient's temperature toprevent hypothermia and/or reduce cold discomfortduring and after surgical procedures. It is intended foruse by appropriately trained healthcare professionals inclinical environments. | The Snuggle Warm® Convective Warming Blanket is intendedto prevent and treat hypothermia when temperature therapy isclinically indicated. The warming blanket can also be used toprovide thermal comfort when conditions exist that may causepatients to become too warm or too cold. The Snuggle Warm®Convective Warming Blanket can be used with adult orpediatric patients and is intended for use by appropriatelytrained healthcare professionals in clinical environments. |
| MATERIAL/DESIGN | • Consists of two layers of non-woven polypropylenefabric bonded to a fusion layer of polyethylene.• The layers are bonded together to form a distributionnetwork of air delivery channels• The warm air is distributed around the patient's bodythrough the delivery channels and exits the blanketthrough a specially designed series of perforations inthe patient side layer of the blanket.• The distribution of air is designed to minimizetemperature differences of delivered air at differentblanket locations.• The blanket is designed to be placed under thepatient.• The hose entry retainer material is 240# bleachedwhite skin board un-laminated with high porosity andis 0.024" thick. | Identical |
| Packaging | Box and polybag | Identical |
| Shelf Life | 3 years | Identical |
| Sterility | Non-sterile | Identical |
| Parameters | Predicate devicesSnuggle Warm Pediatric Convective Warming Blankets(models SW-2009, SW-2011)Per 510(k) K061513 | Proposed devicesSnuggle Warm Pediatric Convective Warming Blankets(models SWU-2009, SWU-2011) |
| SAFETY SPECIFICATION | ||
| Blanket material conforms to16CFR1610 | Pass | Pass |
| Average Contact SurfaceTemperature of blanket shallnot exceed 46°C in NormalCondition | Pass | Pass |
| Maximum Contact SurfaceTemperature of blanket shallnot exceed 48°C in NormalCondition | Pass | Pass |
| For connectors intended toaccept Hoses, means shall beprovided to prevent Hosesfrom disengagingunintentionally fromconnectors | 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 DimensionsWidth 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 devicesSnuggle Warm Convective Warming Blankets(models SW-2008)Per 510(k) K040632 | Proposed devicesSnuggle Warm Convective Warming Blankets(models SWU-2008) |
| INTENDED USE | Convective warming system for thermal regulation of apatient's body temperature in a clinical environment. | Convective warming system for thermal regulation of apatient's body temperature in a clinical environment. |
| INDICATIONS FOR USE(Refer to Appendix A below) | The device is intended for thermal regulating a patient'stemperature to prevent hypothermia by a warm airheated blanket to reduce cold discomfort during andafter surgical procedures. | The Snuggle Warm® Convective Warming Blanket is intendedto prevent and treat hypothermia when temperature therapy isclinically indicated. The warming blanket can also be used toprovide thermal comfort when conditions exist that may causepatients to become too warm or too cold. The Snuggle Warm®Convective Warming Blanket can be used with adult orpediatric patients and is intended for use by appropriatelytrained healthcare professionals in clinical environments. |
| MATERIAL/DESIGN | • Consists of two layers of non-woven polypropylenefabric bonded to a fusion layer of polyethylene.• The layers are bonded together to form a distributionnetwork of air delivery channels• The warm air is distributed around the patient's bodythrough the delivery channels and exits the blanketthrough a specially designed series of perforations inthe patient side layer of the blanket.• The distribution of air is designed to minimizetemperature differences of delivered air at differentblanket locations. | IdenticalIdenticalIdenticalIdentical |
| Packaging | Box and polybag | Identical |
| Shelf Life | 3 years | Identical |
| Sterility | Sterile | Identical |
| SAFETY SPECIFICATION | ||
| Blanket materialconforms 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 SurfaceTemperature of blanket shallnot exceed 46°C in NormalCondition | Pass | Pass |
| Maximum Contact SurfaceTemperature of blanketshall not exceed 48°C inNormal Condition | Pass | Pass |
| For connectors intended toaccept Hoses, means shallbe provided to preventHoses from disengagingunintentionally fromconnectors | Pass | Pass |
| PHYSICAL SPECIFICATIONS | ||
| Material/design | • Packaging for sterile cardiac blanket consists of theSterile Cardiac Blanket, Instructions for Use, and aConvective Warming Hose• All contents are packaged together in a sealedpolybag• Package is Ethylene Oxide Sterilized to 10-6 SAL. | • Packaging for sterile cardiac blanket consists of the SterileCardiac Blanket, Instructions for Use, and a ConvectiveWarming Hose• All contents are packaged together in a sealed polybag• Package is Ethylene Oxide Sterilized to 10-6 SAL. |
| Blanket DimensionsWidth XLength(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.
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Table 3.6.3: Comparison between Snuggle Warm® Cardiac Convective Warming Blankets and predicate devices.
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| Parameters | Predicate deviceBair Hugger Model 750Temperature Management UnitPer 510(k) K001149 | Predicate deviceSnuggle Warm® 4000Temperature Management System(model SW-4000)Per 510(k) K011907 | Proposed deviceEquator® Convective Warmer(model EQ-5000) | Proposed deviceEquator® Convective Warmer(model EQ-5000HF) |
|---|---|---|---|---|
| INTENDED USE | Convective warming systemfor thermal regulation of apatient's body temperature in aclinical environment. | Convective warming system forthermal regulation of a patient'sbody temperature in a clinicalenvironment. | Convective warming system forthermal regulation of a patient'sbody temperature in a clinicalenvironment. | Convective warming system forthermal regulation of a patient'sbody temperature in a clinicalenvironment. |
| PERFORMANCE | ||||
| Air Velocity | Up to 48 cfm or 23Lps (2233ft/minute) | 1800-2500 ft/minute (9.1-12.7m/sec) | 1650-2500 ft/minute (8.4-12.7m/sec) | 1650-2500 ft/minute (8.4-12.7m/sec) |
| Air TemperatureFour (4) selections: | Hose End Temperature | Hose End Temperature | Hose End Temperature | Hose End Temperature |
| 1. High2. Medium3. Low4. Ambient | 43°C +/- 1.5°C38°C +/- 4.5°C32°C +/- 1.5°CAmbient | 44°C +/- 1.0°C40°C +/- 1.0°C36°C +/- 1.0°CAmbient | 44°C +/- 1.0°C40°C +/- 1.0°C36°C +/- 1.0°CAmbient | 44°C +/- 1.0°C40°C +/- 1.0°C36°C +/- 1.0°CAmbient |
| System PowerRequirements | 110-120 VAC 50/60 Hz11.7 Amps | 120 VAC 60 Hz8.9 Amps | 115 VAC, 50/60 Hz8.05 Amps | 115 VAC, 50/60 Hz8.05 Amps |
| Heater PowerRequirement | 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 OverTemperatureProtection (44°Csetting) | Thermal cutoff shuts heater offat 47°C +/- 2°C | Electrical Heater safety relayopens at 47.0°C +/- 1.0°C | Electrical Heater safety relayopens at 47.0°C +/- 1.0°C | Electrical Heater safety relayopens at 47.0°C +/- 1.0°C |
| Parameters | Predicate deviceBair Hugger Model 750Temperature Management UnitPer 510(k) K001149 | Predicate deviceSnuggle Warm® 4000Temperature Management System(model SW-4000)Per 510(k) K011907 | Proposed deviceEquator® Convective Warmer(model EQ-5000) | Proposed deviceEquator® Convective Warmer(model EQ-5000HF) |
| Alternate provisions | Flashing amber light & audiblealarm activated | Warning light & audible alarmactivated | Warning light & audible alarmactivated | Warning light & audible alarmactivated |
| FEATURES | ||||
| Hose with SecureLocking Mechanism | Yes | Yes | Yes | Yes |
| Hose SupportArm/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.
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§ 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).