(156 days)
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.
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.
The provided text describes the CosyTherm Neonatal Warming System (K061902) and its 510(k) submission. However, it does not contain specific acceptance criteria, a detailed study proving the device meets those criteria, or the other specific details requested in your prompt (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information).
The document states:
- 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 equivalent to the Inditherm Patient Warming System."
This indicates that acceptance was based on non-clinical performance and safety testing against predetermined specifications, and a demonstration of substantial equivalence to a predicate device. The detailed "predetermined specifications" that would serve as acceptance criteria are not explicitly listed, nor are the specific results of those tests.
Therefore, I cannot populate the table or answer most of your questions with the information provided.
Here is what can be inferred or stated from the provided text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: "predetermined specifications" for electrical safety, electromagnetic emissions and immunity, temperature accuracy, stability, and proper functioning of thermal safety features. (Specific values or ranges are not provided).
- Reported Device Performance: "All test results verify the device meets or exceeds predetermined specifications." (Specific results or metrics are not provided).
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Sample sized used for the test set and the data provenance: Not provided for non-clinical testing. No clinical test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical testing or expert ground truth was established for the 510(k) given.
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Adjudication method for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a thermal regulating system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used: For the non-clinical performance testing, the ground truth would be established by calibrated measurement instruments against engineering specifications.
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The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable.
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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
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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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§ 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).