(30 days)
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No
The summary describes a solution warmer and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device warms and maintains the temperature of surgical solutions, which are then used on patients. The device itself does not directly treat a disease or condition in a patient, which is the definition of a therapeutic device.
No
Explanation: The device is described as warming and maintaining the temperature of surgical solutions, which is a therapeutic or supportive function, not a diagnostic one. It does not identify or detect diseases or conditions.
No
The intended use clearly describes a device designed to warm and maintain the temperature of surgical solutions, which implies a physical heating component and is not consistent with a software-only device.
Based on the provided information, the IntraTemp Solution Warmer (ITW6L) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "warm and maintain the temperature of surgical solutions prior to their use." This describes a device used in a surgical setting to prepare materials for use on or in a patient, not a device used to examine specimens taken from the body (which is the definition of an IVD).
- Lack of IVD Indicators: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device's function is purely to warm solutions, which is a supportive function in a medical procedure, not a diagnostic one.
N/A
Intended Use / Indications for Use
The IntraTemp Solution Warmer (ITW6L) is designed to warm and maintain the temperature of surgical solutions prior to their use.
Product codes
LHC
Device Description
IntraTemp™ Solution Warmer, Model ITW6L
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.5950 Powered heating unit.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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