(29 days)
Not Found
No
The description focuses on forced air thermal regulation and standard safety/performance testing, with no mention of AI or ML capabilities.
Yes
The device is intended to "prevent and treat hypothermia when temperature therapy is clinically indicated" and "provide thermal comfort", indicating a direct therapeutic action on the patient's body temperature.
No
The device, a convective warmer, is intended to prevent and treat hypothermia and provide thermal comfort by regulating body temperature. It does not identify or diagnose a disease or condition.
No
The device description clearly states it is a "forced air thermal regulating system" and includes physical components like a "connection hose" and is used with "Snuggle Warm® Convective Warming Blankets". The performance studies also describe testing of the "system, including the subject device, connection hose and Snuggle Warm® Convective Warming Blanket," and include electrical safety, particular safety, and IP rating testing, all of which are related to hardware.
Based on the provided information, 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 is a forced air thermal regulating system that connects to warming blankets. This describes a physical therapy/comfort device, not something used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Level 1® 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 Level 1® Convective Warmer can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments.
Product codes
DWJ
Device Description
The Level 1® Convective Warmer, is a forced air thermal regulating systems which includes a connection hose to attach to the Snuggle Warm® Convective Warming Blankets for patients requiring body temperature requlation in clinical environments which are provided non-sterile and intended to be reused. In order to accommodate various clinical environments, the Level 1® Convective Warmer is able to be placed on the floor, placed on a floor cart, or mounted on an I.V. pole to allow flexible portability. The Level 1® Convective Warmer is used with the Snuggle Warm® Convective Warming Blankets.
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)
Non-clinical testing of the Level 1® Convective Warmer was assessed and tested as a system, including the subject device, connection hose and Snuggle Warm® Convective Warming Blanket, appropriately to design controls; i.e. design verification, design validations. The test results conclude the Level 1® Convective Warmer to be substantially equivalent to the predicate device, Equator® Convective Warmer (EQ-5000HF).
Testing is listed below:
- Electrical Safety and Electromagnetic Compatibility testing was conducted per IEC 60601-1 and IEC 60601-1-2 respectively to ensure that the device performs safely under normal use conditions. All requirements were met.
- Particular Safety Testing was completed per IEC 80601-2-35 to ensure the device meets basic safety and essential performance of heating devices using blankets, pads or mattresses in medical use. All requirements were met.
- Safety testing was conducted per IEC 60529 to ensure the level of protection by enclosures meet the specified IP12 rating. The requirement was met.
- Design Validation / Human Factors per IEC 62366 was conducted to ensure the subject device performance is acceptable for its intended use. All requirements were met.
- System validation testing for compatibility with warming blankets was performed to ensure function. All requirements were met.
- Bench testing was conducted to ensure the device meets the System Requirements Specification in DP-0003-938. All requirements were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 26, 2018
Smiths Medical ASD, Inc. % Mark Job Regulatory Technology Services, LLC 1394 25th Street. Nw Buffalo, Minnesota 55313
Re: K181699
Trade/Device Name: Level 1 Convective Warmer Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: DWJ Dated: June 25, 2018 Received: June 27, 2018
Dear Mark Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Fernando
Aguel-S
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)
Device Name Level 1® Convective Warmer
Indications for Use (Describe)
The Level 1® 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 Level 1® Convective Warmer 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K181699 page 1 of 6
smiths medical
bringing technology to life
Smiths Medical 6000 Nathan Lane North Minneapolis, MN 55442 T: +1 763 383 3000 F: +1 763 383 3679 www.smiths-medical.com
| Date of Preparation: | July 20, 2018 (Revised) |
|---|---|
| Submitter: | Smiths Medical |
| 6000 Nathan Lane North | |
| Minneapolis, MN 55442 | |
| USA | |
| Establishment Registration | |
| Number: | 3012307300 |
| Company Contact (Primary): | Donna M. Semlak (Primary Contact) |
| Smiths Medical | |
| Vital Care Business Unit, Interim Manager | |
| Principal Regulatory Affairs Specialist | |
| Regulatory and Clinical Affairs | |
| Tel: +1 763-383-3076 | |
| Email: donna.semlak@smiths-medical.com | |
| Trade Name(s): | Thermal Regulating System |
| Device Name(s) | Level 1® Convective Warmer |
| Device Classification | Class II |
Regulation Number and Product Codes 21 CFR § 870.5900/ DWJ System, Thermal Regulating
4
Purpose
The purpose of this premarket notification Traditional 510(k) is to establish substantial equivalence and obtain FDA Clearance for the Level 1® Convective Warmer which is intended to prevent and treat hypothermia when temperature therapy is clinically indicated.
This submission addresses the introduction of a microprocessor to the subject device to control the monitoring and adjustments of air flow, heating, temperature, and alarms where the predicate device, Equator® Convective Warmer, uses discrete digital and analog circuitry.
Primary Predicate Device
The primary predicate device for this submission is the currently marketed Smiths Medical Equator® Convective Warmer.
| Primary Predicate Device Name | Product Code | FDA 510k Number
Clearance Date |
|-------------------------------|--------------|----------------------------------------|
| Equator Convective Warmer | DWJ | K141686
Cleared on October 28, 2014 |
General Device Description:
The Level 1® Convective Warmer, is a forced air thermal regulating systems which includes a connection hose to attach to the Snuggle Warm® Convective Warming Blankets for patients requiring body temperature requlation in clinical environments which are provided non-sterile and intended to be reused. In order to accommodate various clinical environments, the Level 1® Convective Warmer is able to be placed on the floor, placed on a floor cart, or mounted on an I.V. pole to allow flexible portability. The Level 1® Convective Warmer is used with the Snuggle Warm® Convective Warming Blankets.
Indications for Use:
The Level 1® 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 Level 1® Convective Warmer can be used with adult or pediatric patients and is intended for use by appropriately trained healthcare professionals in clinical environments.
Summary of Technological Characteristics:
The subject device, Level 1® Convective Warmer, shares the same technological characteristics as the cleared FDA 510(k) predicate device, Equator® Convective Warmer. These characteristics include the same intended use, same clinical application, same overall design, and the same convective warming principle of operation by drawing ambient air through a filtered opening then
5
heating to the desired temperature for convective warming therapy. Both warmers are forced air heating devices that help to regulate a patient's body temperature and are used with the Snuggle Warm® Convective Warming Blankets.
The difference, however, is that the subject device uses a microprocessor (software) to control. monitor and adjust air flow, heating, temperature, and alarms where the predicate device controls the same outputs through discrete digital and analog circuitry, containing no software.
Also, this submission incorporates three (3) non-significant changes: operating noise level, air temperature settings, and heater power wattage.
Summary of Performance Testing:
The Level 1® Convective Warmer incorporates the same indications for use and the same technological characteristics as the legally marketed predicate device, Equator® Convective Warmer, FDA cleared under K141686, issued October 28, 2014.
Non-clinical testing of the Level 1® Convective Warmer was assessed and tested as a system, including the subject device, connection hose and Snuggle Warm® Convective Warming Blanket, appropriately to design controls; i.e. design verification, design validations. The test results conclude the Level 1® Convective Warmer to be substantially equivalent to the predicate device, Equator® Convective Warmer (EQ-5000HF).
Testing is listed below:
- Electrical Safety and Electromagnetic Compatibility testing was conducted per IEC 60601-1 and IEC 60601-1-2 respectively to ensure that the device performs safely under normal use conditions. All requirements were met.
- . Particular Safety Testing was completed per IEC 80601-2-35 to ensure the device meets basic safety and essential performance of heating devices using blankets, pads or mattresses in medical use. All requirements were met.
- Safety testing was conducted per IEC 60529 to ensure the level of protection by . enclosures meet the specified IP12 rating. The requirement was met.
- . Design Validation / Human Factors per IEC 62366 was conducted to ensure the subject device performance is acceptable for its intended use. All requirements were met.
- . System validation testing for compatibility with warming blankets was performed to ensure function. All requirements were met.
- . Bench testing was conducted to ensure the device meets the System Requirements Specification in DP-0003-938. All requirements were met.
Substantial Equivalence
6
Smiths Medical considers the subject device, Level 1® Convective Warmer, performance to be substantially equivalent to the predicate device, Equator® Convective Warmer (EQ-5000HF), based on the performance test results.
There are no significant differences in intended use, mechanical and functional performance and functional scientific technology, except the difference of the addition a microprocessor software control mechanism for the Level 1® Convective Warmer. Smiths Medical demonstrates through performance testing that no new issues of safety and effectiveness are raised due to the change of the subject device's control mechanism. Both the subject and predicate devices are used to treat the same clinical condition and represent a same principle of operation.
| Substantial Equivalence Comparison Table | |||
|---|---|---|---|
| Parameter | Subject Device | ||
| Level 1 Convective | |||
| Warmer | |||
| (L1-CW-120V) | Predicate device | ||
| Equator Convective | |||
| Warmer | |||
| (EQ-5000HF) | Comparison | ||
| REGULATORY INFORMATION | |||
| FDA Product Code | DWJ | ||
| System, Thermal | |||
| Regulating | DWJ | ||
| System, Thermal | |||
| Regulating | SAME | ||
| FDA Regulation | 21 CFR 870.5900 | 21 CFR 870.5900 | SAME |
| Classification | Class II | Class II | SAME |
| Indication for Use | The Level 1® | ||
| 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 Level 1® | |||
| Convective Warmer | |||
| 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 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. | SAME | ||
| Substantial Equivalence Comparison Table | |||
| Parameter | Subject Device | ||
| Level 1 Convective | |||
| Warmer | |||
| (L1-CW-120V) | Predicate device | ||
| Equator Convective | |||
| Warmer | |||
| (EQ-5000HF) | Comparison | ||
| 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. | SAME | ||
| TECHNICAL SPECIFICATIONS | |||
| Air Flow Rate via hose | |||
| sans blanket | 44CFM @0.4 inches | ||
| H2O back pressure | 43CFM @0.4 inches | ||
| H2O back pressure | SIMILAR | ||
| Air Temperature | |||
| Settings | 43 ± 1.0 °C | ||
| 40 ± 1.0 °C | |||
| 37 ± 1.0 °C | |||
| Ambient | 44 ± 1.0 °C | ||
| 40 ± 1.0 °C | |||
| 36 ± 1.0 °C | |||
| Ambient | DIFFERENT | ||
| System Power | |||
| Requirement | 115VAC, 50/60 Hz | 115VAC, 50/60 Hz | SAME |
| Heater Power | |||
| Requirement | 950 Watts | 800 Watts | DIFFERENT |
| Dimensions | 15.3"x11.0"x12.6" | 11.75" X 9.5" X 7.5" | SIMILAR |
| Weight | 13.7 lbs. | 15 lbs. | SIMILAR |
| Materials of | |||
| construction | Plastic/Metal | Plastic/Metal | SAME |
| Power On Self-Test | Yes | Yes | SAME |
| SAFETY | |||
| Basic Electrical Safety | IEC 60601-1 | IEC 60601-1 | SAME |
| EMI/EMC Compliant | IEC 60601-1-2 | IEC 60601-1-2 | SAME |
| Basic Safety and | |||
| Essential Performance | |||
| for Heating Devices | IEC 80601-2-35 | IEC 80601-2-35 | SAME |
| Forced Air Over | |||
| Temperature Protection | Electrical Heater Safety | ||
| Relay opens at 47.0 ± | |||
| 1°C | Electrical Heater Safety | ||
| Relay opens at 47.0 ± | |||
| 1°C | SAME | ||
| Control Mechanism | Microprocessor with | ||
| software | Discrete digital and | ||
| analog circuitry | DIFFERENT | ||
| FEATURES | |||
| Air Filter | Replaceable 0.2 micron | Replaceable 0.2 micron | SAME |
| Operating noise level | 42dBA | 53dBA | DIFFERENT |
| Substantial Equivalence Comparison Table | |||
| Parameter | Subject Device | ||
| Level 1 Convective | |||
| Warmer | |||
| (L1-CW-120V) | Predicate device | ||
| Equator Convective | |||
| Warmer | |||
| (EQ-5000HF) | Comparison | ||
| Device Photo | Image: Level 1 Convective Warmer (L1-CW-120V) | Image: Equator Convective Warmer (EQ-5000HF) | N/A |
| Used with the Snuggle | |||
| Warm® Convective | |||
| Warming Blankets | Yes | Yes | SAME |
Level 1® Convective Warmer compared to Equator® Convective Warmer
7
8
Conclusion
Smiths Medical concludes that the Level 1® Convective Warmer is for use with Snuggle Warm® Convective Warming Blankets for patients requiring body temperature regulation being that it is substantially equivalent to the predicate device, thermal regulating system indications (DWJ), and does not raise new questions of safety risks imposed on the patient or the device user.
Smiths Medical's evaluation concludes the subject device, will perform substantially equivalent to the predicate devices.
| Subject Device | Predicate | Predicate 510(k) |
|---|---|---|
| Level 1® Convective Warmer | Equator® Convective Warmer | |
| and Snuggle Warm® | ||
| Convective Warming Blankets | K141686 |