(330 days)
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.
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.
The provided document is a 510(k) summary for the Inditherm Patient Warming System. It details the device's characteristics, intended use, and its substantial equivalence determination by the FDA. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the way typically associated with AI/ML device performance evaluations.
Here's an analysis based on the information provided, highlighting why most of the requested fields cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with BS EN 60601-1:1990 (Medical Electrical Equipment - Part 1: General Requirements for Safety) | Complies with standard |
| Compliance with 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) | Complies with standard |
| Compliance with MDD: 93/42/EEC (Medical Device Directive) | Complies with standard |
| Substantial Equivalence to Predicate Devices (K011859, K031728) in technological characteristics and indications for use. | Found to be equivalent |
Reasons for limited information:
- This is a traditional medical device (patient warming system), not an AI/ML device. Therefore, the concept of "device performance" in terms of clinical metrics like sensitivity, specificity, accuracy, or AUC, as applied to AI algorithms, is not relevant here.
- The performance standards listed (BS EN 60601-1, BS EN 60601-2-35, MDD) are general safety and performance standards for medical electrical equipment and specific heated blankets/mattresses, not performance metrics like accuracy for a diagnostic algorithm.
- The primary "performance" discussed for this type of device in a 510(k) context is its substantial equivalence to predicate devices, focusing on technological characteristics and intended use.
2. Sample size used for the test set and the data provenance:
Not applicable. This device is a hardware/software system for patient warming, not a diagnostic or prognostic algorithm that uses a "test set" of data for performance evaluation in the AI/ML sense. The document states: "The Inditherm Patient Warming System has been in clinical use since Clinical Data: 1999 in Europe. No additional clinical testing was required." This implies a reliance on pre-existing clinical use and compliance with technical standards rather than a formal clinical study with a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. See point 2. The device does not produce an output that requires expert adjudication for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. See point 2 and 3.
5. 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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. It's a patient warming system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The ground truth concept for this device would relate to its ability to maintain a target temperature, safety, and effectiveness in preventing hypothermia (as indicated by its intended use). Compliance with technical standards and prior clinical use serve as the "proof" rather than a specific ground truth for an AI prediction.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable. See point 8.
{0}------------------------------------------------
Section 5: 510(k) Summary
даг 2 7 1905
510(k) Summary
21 CFR § 807.92
| Submitter: | Inditherm MedicalHoundhill ParkBolton RoadRotherham S63 7LGUnited Kingdom |
|---|---|
| Contact: | Nick Bettles, Division Director - Medical |
| Date Prepared: | 1 June, 2005 |
| Trade Name: | Inditherm Patient Warming SystemModel 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 precisiontemperature control unit that controls and monitors the temperature ofa mattress or blanket composed of a carbon polymer material. Apressure relief pad is integrated into the mattress, underneath theflexible warming surface. |
| Intended Use: | Designed for use in the operating room, recovery room, anestheticroom, intensive care, medical and surgical floors, patient transportand emergency department; the Inditherm Patient Warming Systemprovides safe and controlled warming to assist patients to maintainnormal body temperature. In addition to providing warming andcontrol, the mattress also provides pressure relief to help preventpressure sores. |
| TechnologicalCharacteristics: | Comparisons between the new and predicate devices shows thattechnological characteristics (i.e. device design, materials,components, and dimensions) and indications for use for the IndithermPatient Warming System are equivalent to the currently marketedpredicate 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 ofblankets, pads and mattresses, intended forheating 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
§ 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).