INTRATEMP SOLUTION WARMER

K083417 · C Change Surgical, LLC · LHC · Jan 13, 2009 · Physical Medicine

Device Facts

• Record ID: K083417
• Device Name: INTRATEMP SOLUTION WARMER
• Applicant: C Change Surgical, LLC
• Product Code: LHC · Physical Medicine
• Decision Date: Jan 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5950
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The IntraTemp™ Solution Warmer (TCT-6LW) is designed to warm and maintain the temperature of surgical solutions prior to their use.

Device Story

IntraTemp™ Solution Warmer (TCT-6LW) is a powered heating unit used in clinical settings to warm and maintain surgical solutions. Device operates by heating solutions to a specified temperature range before use in surgical procedures. Clinicians use the device to ensure solutions are at appropriate temperatures, potentially improving patient outcomes by preventing hypothermia during irrigation or other surgical applications. Device is a standalone heating unit.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered heating unit; Class I device; Product Code LHC; 21 CFR 890.5950.

Indications for Use

Indicated for warming and maintaining temperature of surgical solutions prior to clinical use.

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.

Reference Devices

• C Change Surgical IntraTemp™

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

C Change Surgical LLC C/O Mr. Patrick Kammer 101 N. Chestnut Street, Suite 301 Winston-Salem, North Carolina 27101

JAN 1 0 2017

Re: K083417

Trade/Device Name: IntraTemp™ Solution Warmer Regulation Number: 21 CFR 890.5950 Regulation Name: Powered Heating Unit Regulatory Class: Class I Product Code: LHC Dated: January 6, 2009 Received: January 8, 2009

Dear Mr. Kammer:

This letter corrects our substantially equivalent letter of January 13, 2009.

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 Parts 801 and 809 ); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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Page 2 - Mr. Patrick Kammer

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 Parts 801 and 809), 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/ResourcesforYou/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/ReportalProblem/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 | 歌eith -S

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

Enclosure

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C+Change

· Reference Device: . C Change Surgical IntraTemp™

## Indications for Use

510(k) Number (if known):

K083417

Device Name:

IntraTemp™ Solution Warmer

Indications for Use:

The IntraTemp™ Solution Warmer (TCT-6LW) is designed to warm and maintain the temperature of surgical solutions prior to their use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K083417

Daniel Krone for WIXAI

(Division Sign. Off) Division of General, Restorative, and Neurological Devices

Page 1 of 1

(Posted November 13, 2003)

510(k) Number

Premarket Submission 510(k) 17/09

TCT-6LW Rev. C