Who is the manufacturer of Medline ComfortTemp Patient Warming System?

Medline Industries, LP filed the 510(k) submission for Medline ComfortTemp Patient Warming System (K231211).

What is the FDA product code for Medline ComfortTemp Patient Warming System?

DWJ. It is classified under 21 CFR 870.5900 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Medline ComfortTemp Patient Warming System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Medline ComfortTemp Patient Warming System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Medline ComfortTemp Patient Warming System

K231211 · Medline Industries, LP · DWJ · Dec 1, 2023 · Cardiovascular

Device Facts

Record ID	K231211
Device Name	Medline ComfortTemp Patient Warming System
Applicant	Medline Industries, LP
Product Code	DWJ · Cardiovascular
Decision Date	Dec 1, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5900
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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.

Device Story

System provides forced warm air to patients to prevent/treat hypothermia or provide thermal comfort. Components: reusable blower unit, reusable hose, single-patient-use disposable blankets. Blower uses PTC heater and fan to push air through hose into blanket; blanket disperses air over patient skin. Used in acute care, post-acute care, OR, and procedural rooms by clinicians. Blower features user-controlled interface with temperature settings (High 43°C, Medium 38°C, Low 32°C, Ambient) and safety alarms (High/Low/Over Temperature). Benefits patient by maintaining normothermia or providing comfort during procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via airflow, noise, hose strength, temperature accuracy, drop testing, life cycle, and distribution simulation. Blanket material testing per ASTM standards (tensile, tear, seal strength, flammability, etc.). Biocompatibility testing (cytotoxicity, skin irritation, sensitization) per ISO 10993. Cleaning validation per ANSI/AAMI ST98-2022.

Technological Characteristics

System consists of reusable blower (110-120 VAC, 800W PTC heater, 0.3 micron filter), reusable hose, and disposable polypropylene/polyethylene blankets. Non-sterile. Blower provides non-adjustable airflow (39.5 +/- 2 CFM). Temperature accuracy +/- 1.5°C. Alarms: High, Low, Over Temperature. Materials tested per ASTM D5034, D5587, D6988, F88, D3776, D3330. Biocompatibility per ISO 10993.

Indications for Use

Indicated for adult and pediatric patients to prevent and treat hypothermia and provide thermal comfort in clinical settings.

Regulatory Classification

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.

Predicate Devices

3M Bair Hugger Model 675 Total Temperature Management System (K210603)

Related Devices

K171373 — 3M Bair Hugger Model 675 Total Temperature Management System · 3M Company · Oct 10, 2017
K073712 — SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 · Adroit Medical Systems, Inc. · Jun 6, 2008
K102856 — SIROCCO THERMAL REGULATING SYSTEM · Galmaz Biotech S.L. · Jun 30, 2011
K231596 — IOB Temperature Management System · Iob Medical, Inc. · Jun 30, 2023
K053645 — MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS · Arizant Healthcare, Inc. · Mar 9, 2006

Submission Summary (Full Text)

{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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." 012 {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 ● {7}------------------------------------------------ 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 (< 24 hours). The blower unit and hose components are not intended to come in contact with the patient. The following biocompatibility tests were performed on a final, finished ComfortTemp blanket: - Cytotoxicity in accordance with ISO 10993-5:2009 Biological evaluation of medical devices . Part: 5 Tests for cytotoxicity - Skin Sensation in accordance with ISO 10993-10:2010 Biological evaluation of medical devices ● - Part: 10 Tests for irritation and skin sensitization - . Skin Irritation in accordance with ISO 10993-10:2010 Biological evaluation of medical devices – Part: 10 Tests for irritation and skin sensitization #### Performance Testing (Animal) This section does not apply. No animal testing was performed. #### Performance Testing (Clinical) This section does not apply. No clinical testing was performed. #### Conclusion In accordance with 21 CFR Part 807 and based on the information provided in this premarket notification, Medline Industries, LP concludes that the Medline Comfort Temp Patient Warming System {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, sans-serif font, stacked on top of a white, stylized starburst symbol. The background is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional. is substantially equivalence to the predicate device, 3M Bair Hugger Temperature Management System (K210603).