IntraTemp Solution Warmer

K150190 · Ecolab, Inc. · LHC · Feb 26, 2015 · Physical Medicine

Device Facts

• Record ID: K150190
• Device Name: IntraTemp Solution Warmer
• Applicant: Ecolab, Inc.
• Product Code: LHC · Physical Medicine
• Decision Date: Feb 26, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5950
• Device Class: Class 1

Intended Use

The IntraTemp Solution Warmer (ITW6L) is designed to warm and maintain the temperature of surgical solutions prior to their use.

Device Story

IntraTemp Solution Warmer (Model ITW6L) is a device designed to warm and maintain surgical solutions at a specific temperature before clinical application. It is intended for use in healthcare environments to ensure solutions are at an appropriate temperature for patient procedures. The device functions by heating and regulating the temperature of the solutions, which are then used by clinicians during surgical or medical interventions. By maintaining optimal solution temperatures, the device supports clinical workflows and helps ensure that solutions are ready for use as required by the healthcare provider.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a solution warmer (Model ITW6L) designed for heating and maintaining surgical solutions. It operates as a standalone unit. Specific materials, dimensions, and software details are not provided in the document.

Indications for Use

Indicated for warming and maintaining the temperature of surgical solutions prior to use in a clinical setting. Prescription use only.

Regulatory Classification

Identification

A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 26, 2015

Ecolab. Incorporated Michelle Nivala Manager, Regulatory - Healthcare 370 Wabasha Street North St. Paul, Minnesota 55102-1390

Re: K150190

Trade/Device Name: IntraTemp™ Solution Warmer, Model ITW6L Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: LHC Dated: January 23, 2015 Received: January 27, 2015

Dear Ms. Nivala:

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 (reporting of medical

{1}------------------------------------------------

device-related 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Erin - Keith -S

Erin Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K150190

Device Name

IntraTemp™ Solution Warmer, Model ITW6L

Indications for Use (Describe)

The IntraTemp Solution Warmer (ITW6L) is designed to warm and maintain the temperature of surgical solutions prior to their use.

Type of Use (Select one or both, as applicable)

X 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 [e-mail]

"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."