(330 days)
Not Found
No
The summary describes a temperature control system based on a carbon polymer material and pressure relief. There is no mention of AI, ML, image processing, or data-driven performance metrics that would indicate the use of AI/ML. The performance studies reference compliance with standards and prior clinical use, not AI/ML model validation.
Yes
The device is designed to provide "safe and controlled warming to assist patients to maintain normal body temperature" and also offers "pressure relief to help prevent pressure sores," indicating a direct therapeutic benefit to the patient.
No
The device is a patient warming system intended to maintain normal body temperature and provide pressure relief, not to diagnose medical conditions.
No
The device description explicitly states it consists of a "precision temperature control unit" and a "mattress or blanket composed of a carbon polymer material," 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 patient warming to maintain normal body temperature and pressure relief. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The device description details a system for controlling the temperature of a mattress or blanket. This aligns with a warming device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Designed for use in the operating room, recovery room, anesthetic room, intensive care, medical and surgical floors, patient transport and emergency department; the Inditherm Patient Warming System provides safe and controlled warming to assist patients to maintain normal body temperature. In addition to providing warming and control, the mattress also provides pressure relief to help prevent pressure sores.
Product codes (comma separated list FDA assigned to the subject device)
DWJ
Device Description
The Inditherm Patient Warming 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
Not Found
Intended User / Care Setting
Operating room, recovery room, anesthetic room, intensive care, medical and surgical floors, patient transport and emergency department.
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)
The Inditherm Patient Warming System has been in clinical use since Clinical Data: 1999 in Europe. No additional clinical testing was required.
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
Section 5: 510(k) Summary
даг 2 7 1905
510(k) Summary
21 CFR § 807.92
| Submitter: | Inditherm Medical
Houndhill Park
Bolton Road
Rotherham S63 7LG
United Kingdom |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nick Bettles, Division Director - Medical |
| Date Prepared: | 1 June, 2005 |
| Trade Name: | Inditherm Patient Warming System
Model numbers: MECU1, OTM1, OTM2, GTM1, PTM1, OTB, RB1 |
| Common Name: | Thermal Regulating System |
| Equivalence to: | Klimamed Thermal Mat and Controller (K011859)
Klimamed Thermal Blanket and Controller (K031728) |
| Description: | The Inditherm Patient Warming 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 operating room, recovery room, anesthetic
room, intensive care, medical and surgical floors, patient transport
and emergency department; the Inditherm Patient Warming System
provides safe and controlled warming to assist patients to maintain
normal body temperature. In addition to providing warming and
control, the mattress also provides pressure relief to help prevent
pressure sores. |
| Technological
Characteristics: | Comparisons between the new and predicate devices shows that
technological characteristics (i.e. device design, materials,
components, and dimensions) and indications for use for the Inditherm
Patient Warming System are equivalent to the currently marketed
predicate devices. |
1
Non-Clinical Data:
The Inditherm Patient Warming System complies with the following performance standards:
| Standard | Description |
|---|---|
| BS EN 60601-1:1990 | Medical Electrical Equipment - Part 1: |
| General Requirements for Safety | |
| BS EN 60601-2-35:1997 | Medical Electrical Equipment – Part 2: |
| Particular Requirements for the safety of | |
| blankets, pads and mattresses, intended for | |
| heating in medical use. | |
| MDD: 93/42/EEC | Medical Device Directive (MDD) |
The Inditherm Patient Warming System has been in clinical use since Clinical Data: 1999 in Europe. No additional clinical testing was required.
The Inditherm Patient Warming System was found to be equivalent to Conclusion: technological characteristics and indications for use for the predicate device(s).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
P
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2005
Inditherm Medical c/o M.W. (Andy) Anderson, Ph.D. Senior Regulatory Project Director Regulatory and Clinical Research Institute, Inc. 5353 Wayzata Boulevard, Suite 505 Minneapolis, MN 55416
Re: K051419
Patient Warming Systems Model Numbers: MECU1, OTM1, OTM2, GTM1, PTM1, OTB. RB1 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (Two) Product Code: DWJ Dated: April 20, 2006 Received: April 21, 2006
Dear Dr. 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
3
Page 2 - M.W. (Andy) Anderson, Ph.D.
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 aft 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the eest onc 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 3 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) 276-0120. Also, please note the regulation over), pro "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ohtain 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) 633-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Vochmer
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number: K0501419
Inditherm Patient Warming System Device Name:
Indications for Use:
Designed for use in the operating room, recovery room, anesthetic room, intensive care, medical and surgical floors, patient transport and emergency department, the Inditherm Patient Warming System provides safe and controlled warming to assist patients to maintain normal body temperature. The mattress includes a pressure-relieving pad.
Prescription Use X ( 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - (CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Lachner
Jivision Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devic
510(k) Number K05014