(156 days)
Not Found
No
The summary describes a temperature control system for warming infants and does not mention any AI or ML components or capabilities.
Yes
The device is designed to provide "safe and controlled warming to assist newborn infants to maintain normal body temperature," which is a therapeutic intervention for newborns, particularly in critical care settings.
No
The device is described as a warming system designed to assist newborn infants in maintaining normal body temperature, and it includes a pressure relief pad. Its function is therapeutic (warming) and supportive (pressure relief), not to diagnose a condition.
No
The device description explicitly states it consists of a temperature control unit, a mattress/blanket made of carbon polymer, and a pressure relief pad, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide warming to newborn infants to help them maintain normal body temperature. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The device is a warming system consisting of a control unit and a heated mattress/blanket. It does not involve the analysis of biological samples (blood, urine, tissue, etc.), which is the core function of an IVD.
- No Mention of Diagnostic Testing: There is no mention of the device being used to diagnose any condition or disease.
- No Mention of Biological Samples: The description does not involve the collection or analysis of any biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Designed for use in the neonatal intensive care unit (NICU), Special Care Baby Unit (SCBU), delivery suite and post-natal wards, the CosyTherm system provides safe and controlled warming to assist newborn infants to maintain normal body temperature. In addition to providing warming, the mattress also includes a pressure relief pad.
Product codes (comma separated list FDA assigned to the subject device)
DWJ
Device Description
The Inditherm CosyTherm system consists of a precision temperature control unit that controls and monitors the temperature of a mattress or blanket composed of a carbon polymer material. A pressure relief pad is integrated into the mattress, underneath the flexible warming surface.
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
newborn infants
Intended User / Care Setting
neonatal intensive care unit (NICU), Special Care Baby Unit (SCBU), delivery suite and post-natal wards
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)
Non-Clinical Testing: Inditherm conducted testing against recognized standards for electrical safety and electromagnetic emissions and immunity. Performance testing was also conducted to assure adequate temperature accuracy and stability as well as the proper functioning of thermal safety features. All test results verify the device meets or exceeds predetermined specifications. Clinical Testing: None submitted
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
KOC1902
CosyTherm 510(k) Notification
510(k) Summary (21CFR § 807.92)
DEC - 8 2006
Submitted by: Inditherm Medical Houndhill Park Bolton Road Rotherham S63 7LG United Kingdom Contact: Nick Bettles, Division Director - Medical Establishment Registration Number: 3005246910 Date Prepared: June 30, 2006
Trade Name: Inditherm CosyTherm Neonatal Warming System Model numbers: NCM1, NCM2, NCB1, CCU1, CRU1
Common Name: Thermal Regulating System
Device Classification: Thermal Regulating System 21 CFR 870.5900
Class: II
Product Code: DWJ
Classification Panel: Cardiovascular Therapeutic Devices
Equivalent Marketed Inditherm Patient Warming System (K051419) Device:
Device Description: The Inditherm CosyTherm system consists of a precision temperature control unit that controls and monitors the temperature of a mattress or blanket composed of a carbon polymer material. A pressure relief pad is integrated into the mattress, underneath the flexible warming surface.
Intended Use: Designed for use in the neonatal intensive care unit
Confidential
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CosyTherm 510(k) Notification (NICU), Special Care Baby Unit (SCBU), delivery suite and post-natal wards, the CosyTherm system provides safe and controlled warming to assist newborn infants to maintain normal body temperature. In addition to providing warming, the mattress also includes a pressure relief pad. Contrast to Predicate: The predicate device is sized for and intended for use in adult and pediatric populations in the operating room, anaesthetic room, intensive care, emergency department, on medical and surgical wards and for patient transport. Technological The CosyTherm system uses the same technology as the Characteristics: predicate device; resistive carbon polymer technology. The CosyTherm predicate device has similar intended uses and has similar features which include: principle of operation, indications for use, safety standards compliance, thermal safety features, EMI compatibility and configurations Non-Clinical Testing: Inditherm conducted testing against recognized standards for electrical safety and electromagnetic emissions and immunity. Performance testing was also conducted to assure adequate temperature accuracy and stability as well as the proper functioning of thermal safety features. All test results verify the device meets or exceeds predetermined specifications. Clinical Testing: None submitted Summary: Based on Performance Testing results and specifications, the CosyTherm system is substantially cquivalent to the Inditherm Patient Warming System.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around the perimeter. At the center of the seal is a stylized caduceus symbol, which is often associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC = 8 2006
Inditherm Medical c/o Andy Anderson 5353 Wayzata Blvd. Suite 505 Minneapolis, MN 55416
Re: K061902
Trade/Device Name: Cosytherm Neonatal Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: II Product Code: DWJ Dated: November 16, 2006 Received: November 17, 2006
Dear Mr. Anderson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Mr. Anderson
CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-4080. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
07 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CosyTherm 510(k) Notification
- Kob1902 Indication For Use Statement 4.
Designed for use in the neonatal intensive care unit (NICU), Special Care Baby Unit (SCBU), delivery suite, post-natal wards and during transport, the CosyTherm warming system provides safe and controlled warming to assist newborn infants to maintain normal body temperature. In addition to providing warming, the mattress also includes a pressure relief pad.
Prescription Use _ X (21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - (CONTINUE ON ANOTHER PAGE IF NEEDED)
ffige of Device Evaluation (ODE) Concurrence of
(Division Sign-Off)
Division of Cardiovascular Devices
OR
510(k) Number K061902
Confidential
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