(217 days)
Not Found
No
The device description and performance studies focus on basic heating and airflow mechanisms, with no mention of AI/ML terms or data-driven decision-making.
Yes
The device is intended to prevent and treat hypothermia and provide thermal comfort, which are therapeutic actions.
No
The device is a patient warming system intended to prevent and treat hypothermia and provide thermal comfort. It does not diagnose any condition or disease.
No
The device description explicitly details hardware components including a reusable blower unit, reusable hose, disposable blankets, a PTC heater, a fan/blower, and a user-controlled interface.
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. This is a therapeutic and comfort-based application, not a diagnostic one.
- Device Description: The device description details a system that provides forced warm air to a patient via a blanket. This mechanism is for physical warming, not for analyzing samples from the human body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The Medline ComfortTemp Patient Warming System does not fit this description.
N/A
Intended Use / Indications for Use
The Medline ComfortTemp Patient Warming System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient themal comfort when conditions exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients.
Product codes
DWJ
Device Description
The Medline ComfortTemp Patient Warming System is intended to prevent and treat hypothermia. In addition, the patient warming system provides thermal comfort when conditions exist that may cause patients to feel too warm or too cold. The patient warming system is for adult and pediatric patients. The Medline ComfortTemp Patient Warming System is used in acute care, post-acute care, operating room, and procedural rooms. The system consists of a reusable blower unit, a reusable hose, and single-patient use, disposable blankets. Replacement filters and hoses for the blower unit are additionally available as needed. All components of the ComfortTemp Patient Warming System are non-sterile. The blower unit connects to the single-patient use blanket through a reusable hose and provides forced warm air into the blanket using a PTC (positive temperature coefficient) heater, a fan/blower and a user-controlled interface. Depending on the model, the ComfortTemp blanket is placed either around, over, or underneath adult and/or pediatric patients. The blanket is comprised of two polypropylene and polyethylene layers, which allow the forced warm air to be dispersed over the patient's skin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
acute care, post-acute care, operating room, and procedural rooms
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing (Bench)
Non-clinical verification of the Medline ComfortTemp Patient Warming System has been conducted to evaluate the performance and functionality of the subject device.
- To evaluate the Comfort Temp blower/warming unit and hose, the following testing was performed: Air Flow Testing, Relative Noise Level, Hose Connection Strength, Thermocouple/Temperature Verification, Weight Verification, Drop Testing, Functionality post Distribution Simulation, Life Cycle Testing, Simulated Wipe Testing.
- To evaluate the ComfortTemp blankets, the following testing was performed: Tensile Strength and Elongation per ASTM D5034 2021, Tearing Strength per ASTM D5587 2015 (Reapproved 2019), Film Thickness per ASTM D6988-13, Seal Strength per ASTM F88/F88M-21, Basis Weight per ASTM D3776/D3776M-17, Flammability per 16 CFR Part 1610-19, Port Connection Strength, Peel Adhesion per ASTM D3330 - 2004 (Reapproved 2018), Heat Mapping Testing, Flow Rate Testing, Radiopacity Testing, Air Permeability Testing, Visual Inspection post Distribution Simulation.
Usability Testing
Human factors/usability testing was conducted on the Medline ComfortTemp Patient Warming System in accordance with the FDA guidance document. Applying Human Factors and Usability Engineering to Medical Devices. The study was conducted in a simulated-use format in which intended users performed tasks necessary to use the ComfortTemp System as intended.
Cleaning Validation
The cleaning instructions for the reusable blower unit and hose were validated in accordance with ANSI/AAMI ST98-2022, Cleaning Validation of Health Care Products – Requirements for Development and Validation of a Cleaning Process for Medical Devices. The study utilized a simulated test soil to evaluate the effectiveness of the cleaning procedure based on protein residual analysis, hemoglobin residual analysis, and visual inspection.
Biocompatibility Testing
The biological evaluation for the Medline ComfortTemp Patient Warming System was conducted in accordance with FDA guidance document "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and ISO 10993-1 Biological Evaluation of the Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process. The ComfortTemp blankets are categorized as a surface-contacting device, on intact skin for a limited duration (
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 1, 2023
Medline Industries LP Claire Pigman Sr. Manager, Regulatory Affairs 3 Lakes Drive Northfield, Illinois 60093
Re: K231211
Trade/Device Name: Medline ComfortTemp Patient Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: October 31, 2023 Received: November 1, 2023
Dear Claire Pigman:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole M. Gillette -S
Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known)
K231211
Device Name Medline ComfortTemp Patient Warming System
Indications for Use (Describe)
The Medline ComfortTemp Patient Warming System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient themal comfort when conditions exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients.
| 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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Image /page/3/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is in white, bold, sans-serif font. Above and below the word is a white, stylized star shape, with the bottom point extending further down than the top point.
K231211 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, LP 3 Lakes Drive Northfield, IL 60093
Registration Number: 1417592
Contact Person Submission Contact: Claire Pigman, Sr. Manager Regulatory Affairs Email: cpigman@medline.com
Summary Preparation Date December 1, 2023
Type of 510(k) Submission Traditional
Device Name / Classification
Trade Name: Medline ComfortTemp Patient Warming System Common Name: Patient Warming System Classification Name: Thermal Regulating System Product Code: DWJ Classification Panel: Cardiovascular Regulatory Class: II Regulation Number: 21 CFR 870.5900
Predicate Device K210603, 3M Bair Hugger Model 675 Total Temperature Management System
Device Description
The Medline ComfortTemp Patient Warming System is intended to prevent and treat hypothermia. In addition, the patient warming system provides thermal comfort when conditions exist that may cause patients to feel too warm or too cold. The patient warming system is for adult and pediatric patients. The Medline ComfortTemp Patient Warming System is used in acute care, post-acute care, operating room, and procedural rooms. The system consists of a reusable blower unit, a reusable hose, and single-patient
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Image /page/4/Picture/0 description: The image is a logo for Medline. The logo is a blue square with the word "MEDLINE" in white, sans-serif font on the upper left. A white, stylized cross is behind the text, with the top and bottom points of the cross extending beyond the text. There is a gray rectangle on the right side of the image.
use, disposable blankets. Replacement filters and hoses for the blower unit are additionally available as needed. All components of the ComfortTemp Patient Warming System are non-sterile. The blower unit connects to the single-patient use blanket through a reusable hose and provides forced warm air into the blanket using a PTC (positive temperature coefficient) heater, a fan/blower and a user-controlled interface. Depending on the model, the ComfortTemp blanket is placed either around, over, or underneath adult and/or pediatric patients. The blanket is comprised of two polypropylene and polyethylene layers, which allow the forced warm air to be dispersed over the patient's skin.
Indications for Use
The Medline ComfortTemp Patient Warming System in intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patients thermal comfort when conditions exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients.
Summary of Technological Characteristics
Please refer to Table 1 for a side-by-side comparison of the subject device and the predicate device, the 3M Bair Hugger Model 675 Total Temperature Management System (K210603).
| Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Product Name | Medline ComfortTemp Patient Warming
System | 3M Bair Hugger Model 675 Total
Temperature Management System | N/A |
| 510(k) Reference | K231211 | K210603 | N/A |
| Product Owner | Medline Industries, LP | 3M Company | N/A |
| Product Code | DWJ | DWJ | Same |
| Regulation
Number | 21 CFR 870.5900 | 21 CFR 870.5900 | Same |
| Intended Use | Intended to prevent and treat
hypothermia. In addition, the
temperature management system can be
used to provide patient thermal comfort
when conditions exist that may cause
patients to feel too warm or too cold.
The temperature management system
can be used with adult and pediatric
patients. | The Bair Hugger temperature
management system is intended to
prevent and treat hypothermia. In
addition the temperature management
system can be used to provide patient
thermal comfort when continuations
exist may cause patients to feel too
warm or too cold. The temperature
management system can be used with
adult and pediatric patients | Same |
| Regulation
Number | 21 CFR 870.5900 | 21 CFR 870.5900 | Same |
| System
Components | Reusable Blower unit
Reusable Connecting hose
Single Patient Use Blankets | Model 675 portable warming unit (with
optional rolling cart)
Warming blanket or warming gown.
Connecting hose | Same |
| Blanket Design
Configurations | Adult Full Body Blanket
Adult Full Body, Multi-Access Blanket
Adult Upper Body Blanket
Adult Lower Body Blanket
Adult Underbody Blanket
Large Pediatric/Adult Underbody
Blanket
Pediatric Underbody Blanket
Adult Large Underbody Blanket | Adult Full Body Blanket
Adult Full Body, Multi-Access Blanket
Adult Upper Body Blanket
Adult Lower Body Blanket
Adult Underbody Blanket
Large Pediatric/Adult Underbody
Blanket
Pediatric Underbody Blanket
Adult Large Underbody Blanket | Same |
| Materials | Polyethylene
Polypropylene | SMS
Polyethylene
Polypropylene | Similar |
| Prescription vs.
OTC | Rx Only | Rx Only | Same |
| Sterile vs. Non-
Sterile | Non-Sterile | Non-Sterile | Same |
| Single Use vs.
Reusable | Single Patient Use Blankets
Reusable Blower Unit and Hose | Single Patient Use Blankets
Reusable Blower Unit and Hose | Same |
| Blower Input
Rating | 110-120 VAC, 50/60Hz | 110-120 VAC, 50/60Hz | Same |
| Blower Motor
Airflow | $39.5 +/-2$ CFM
Non-adjustable, one speed | Up to 44 CFM
Non-adjustable, one speed | Similar |
| Blower Heating
Element | 800W PTC | 1190 W Resistive | Different |
| Blower Unit
Filter | 0.3 micron | MERV 14 | Similar |
| Temperature
Sensor Range | -55°C to +125°C | Not known | N/A |
| Temperature
Accuracy | +/- 1.5°C | +/- 3°C | Similar –
temperature
accuracy rating on
subject device
blower is tighter |
| Blower Unit
Temperature
Settings | High: 43° C
Medium: 38° C
Low: 32° C
Ambient Room Temperature | High: 43° C
Medium: 38° C
Low: 32° C
Ambient Room Temperature | Same |
| Blower Unit
Alarms | High Temperature
Low Temperature
Over Temperature | Over-Temperature
Under-Temperature | Same – subject
device includes an
additional alarm |
| Blower Weight | 12 lbs | 10lbs | Similar |
Table 1. Comparison of Subject and Predicate Devices
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Image /page/5/Picture/0 description: The image is a logo for Medline. The logo features the word "MEDLINE" in white, bold letters, positioned to the left of a white star-like symbol. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a symbolic representation.
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Image /page/6/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue square background. The word "MEDLINE" is written in a bold, sans-serif font, positioned to the left of a white, stylized star-like symbol. The symbol has four points, with the top and bottom points being longer than the side points.
Shelf Life and Sterilization
The Medline ComfortTemp Patient Warming System is non-sterile and is not labeled with an expiration date.
Summary of Testing and Supporting Information
Testing was conducted on the Medline ComfortTemp Patient Warming System to demonstrate its equivalence to the 3M Bair Hugger Model 675 Total Temperature Management System. A summary of testing is presented below.
Performance Testing (Bench)
Non-clinical verification of the Medline ComfortTemp Patient Warming System has been conducted to evaluate the performance and functionality of the subject device. To evaluate the Comfort Temp blower/warming unit and hose, the following testing was performed -
- Air Flow Testing
- Relative Noise Level
- Hose Connection Strength ●
- Thermocouple/Temperature Verification
- Weight Verification ●
- Drop Testing
- Functionality post Distribution Simulation
- Life Cycle Testing
- . Simulated Wipe Testing
To evaluate the ComfortTemp blankets, the following testing was performed -
- Tensile Strength and Elongation per ASTM D5034 2021 ●
- Tearing Strength per ASTM D5587 2015 (Reapproved 2019) ●
- Film Thickness per ASTM D6988-13
- Seal Strength per ASTM F88/F88M-21
- Basis Weight per ASTM D3776/D3776M-17
- Flammability per 16 CFR Part 1610-19
- . Port Connection Strength
- Peel Adhesion per ASTM D3330 - 2004 (Reapproved 2018)
- Heat Mapping Testing
- Flow Rate Testing ●
- Radiopacity Testing ●
- Air Permeability Testing ●
- Visual Inspection post Distribution Simulation ●
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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, uppercase letters, positioned to the left of a white, stylized starburst symbol. The background is a solid dark blue. A small portion of a gray rectangle is visible in the upper right corner of the image.
Usability Testing
Human factors/usability testing was conducted on the Medline ComfortTemp Patient Warming System in accordance with the FDA guidance document. Applying Human Factors and Usability Engineering to Medical Devices. The study was conducted in a simulated-use format in which intended users performed tasks necessary to use the ComfortTemp System as intended.
Cleaning Validation
The cleaning instructions for the reusable blower unit and hose were validated in accordance with ANSI/AAMI ST98-2022, Cleaning Validation of Health Care Products – Requirements for Development and Validation of a Cleaning Process for Medical Devices. The study utilized a simulated test soil to evaluate the effectiveness of the cleaning procedure based on protein residual analysis, hemoglobin residual analysis, and visual inspection.
Biocompatibility Testing
The biological evaluation for the Medline ComfortTemp Patient Warming System was conducted in accordance with FDA guidance document "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and ISO 10993-1 Biological Evaluation of the Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process. The ComfortTemp blankets are categorized as a surface-contacting device, on intact skin for a limited duration (