(369 days)
Geratherm UniqueTemp® is a thermal regulating system for adult patients in order to prevent hypothermia in the operating theater. It is suitable for pre-, intra- and post-operative use. The device is not life-supporting. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Geratherm UniqueTemp® has been developed for the prevention of hypothermia. The Geratherm warming blankets can be used for covering the patient in various ways without restricting the surgical area and provide active warming to the patient. All the blankets can be freely combined. The flexibility of the blankets makes it possible to warm the patient, even if complicated positioning on the operating table is required. After being placed over the patient, Geratherm UniqueTemp® can itself be covered with surgical drapes. Geratherm UniqueTemp® is suitable for use with adult patients of all sizes. The blankets should not be used for children. Geratherm UniqueTemp® is intended to be used during lengthy operations as well as by hypothermic patients. The device is not life-supporting. Geratherm UniqueTemp® should be operated only by qualified medical professionals. The Geratherm UniqueTemp9 consists of the following components: Control unit, Holding claw, Mains cable, Arm/shoulder blanket, Reusable cover for arm/shoulder blanket, Torso blanket, Reusable cover for torso blanket, Leg blankets, Reusable cover for leg blankets, Connecting cable, Body temperature sensor. The Controller is made of anodized aluminum (colorless or black); furthermore, the control unit has a glass screen. All blankets and covers have a PU coated material. The connecting cable is made of silicone.
The provided text describes the Geratherm UniqueTemp® Patient Warming System and its 510(k) summary. However, it does not contain specific acceptance criteria, a detailed study protocol for performance, or quantitative results that would allow for the direct completion of the requested table and study details.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Hot Dog Patient Warming System K052392) through comparisons of intended use, indications for use, safety characteristics, and compliance with various international standards.
Therefore, I cannot extract the specific acceptance criteria and detailed study information as requested.
However, I can summarize what is available in the document regarding performance and regulatory compliance:
Summary of Device Performance Information from the Document:
The document states:
- "The presented data which was conducted using the Geratherm UniqueTemp®, in comparison to the predicate device, shows that the product is safe and effective for its intended use." - This is a general claim rather than specific performance metrics.
- "Both devices are similar regarding the performance characteristics and reach a similar maximum temperature of 42°C and 43°C respectively." - This indicates a performance characteristic (maximum temperature) but does not provide acceptance criteria or a study comparing the devices' ability to maintain a target temperature or prevent hypothermia.
- "The product components which are covered by this 510(k) premarket notification have been successfully tested for biocompatibility, electromagnetic compatibility, functionality and safety according to international standards." - This refers to testing against general standards, not specific clinical performance criteria.
- The device meets the requirements of Council Directive 93/42 EEC on Medical Devices and specific IEC standards (60601-1, 60601-1-2, and 80601-2-35). These standards cover general safety, electromagnetic compatibility, and particular requirements for heating devices, implying compliance with their respective criteria, but the document doesn't detail what these criteria are or the specific test results.
In the absence of the requested data, I will present the information that can be inferred or directly stated from the provided text, and explicitly note where the requested information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred/General) | Reported Device Performance (Summary from Text) |
|---|---|
| Safety: Device is safe for intended use. | "The presented data... shows that the product is safe... for its intended use." |
| Effectiveness: Device is effective for intended use (prevention of hypothermia). | "The presented data... shows that the product is... effective for its intended use." |
| Biocompatibility: Product components are biocompatible. | "Successfully tested for biocompatibility according to international standards." |
| Electromagnetic Compatibility (EMC): Device meets EMC requirements. | "Successfully tested for electromagnetic compatibility... according to international standards." (Specifically cites IEC 60601-1-2) |
| Functionality: Device functions as intended. | "Successfully tested for... functionality... according to international standards." |
| General Safety (Electrical/Mechanical): Device meets general safety requirements for medical electrical equipment. | Complies with IEC 60601-1 (General requirements for safety). |
| Particular Safety for Heating Devices: Device meets specific safety requirements for heating blankets. | Complies with IEC 80601-2-35 (Particular requirements... of heating devices using blankets, pads and mattresses...). |
| Maximum Temperature Output: Comparable to predicate device. | Reaches a "similar maximum temperature of 42°C." (Predicate reaches 43°C). |
| Quality Management System: Ensures requirements are met. | EN ISO 13485 certified quality management system. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "presented data" and "successful testing" but does not provide details on the number of subjects (if clinical) or units (if bench testing) used in performance tests.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the tests were retrospective or prospective. Given the manufacturer is German and the correspondent is also in Germany, it's plausible testing was conducted in Europe, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This type of information (expert consensus for ground truth) is typically relevant for diagnostic devices or those involving interpretation of medical images/data. The Geratherm UniqueTemp® is a patient warming system, where "ground truth" would likely refer to objective physical measurements (e.g., temperature) or established safety standards, rather than expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically used in studies where multiple human readers assess a case and their discrepancies need to be resolved to establish ground truth (e.g., in diagnostic imaging studies). This is not relevant for a patient warming device.
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
- No. This type of study is entirely irrelevant for a patient warming device. An MRMC study is designed for diagnostic systems that involve human interpretation, often assisted by AI. The Geratherm UniqueTemp® is a therapeutic device that performs a function directly.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The "Non-Clinical Performance Data" section and the statement "The product components... have been successfully tested for biocompatibility, electromagnetic compatibility, functionality and safety according to international standards" indicate that testing of the device's technical performance and safety characteristics was done in a standalone manner, without explicit human interaction being part of the primary performance measurement (other than operation). The device's function (heating) is inherently "standalone" in its operation once set.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Known Standards and Objective Measurements. For a device like a warming system, "ground truth" would be established by:
- Compliance with International Standards: The document explicitly states compliance with IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), and IEC 80601-2-35 (specific heating device requirements). These standards define objective performance and safety criteria.
- Objective Physical Measurements: Testing would involve measuring temperature output, power consumption, safety cut-offs, material properties, etc., against predefined specifications derived from product design and regulatory requirements.
- Comparison to Predicate Device: The concept of "substantial equivalence" means the new device's performance is compared to a legally marketed predicate device, implying the predicate device's performance serves as a benchmark for effectiveness and safety.
8. The sample size for the training set
- Not Applicable/Not Provided. The concept of a "training set" typically applies to AI/machine learning algorithms. The Geratherm UniqueTemp® is not described as an AI-powered device. Therefore, there is no training set in that context. If "training set" refers to developmental or internal testing, that information is not provided.
9. How the ground truth for the training set was established
- Not Applicable. (See point 8).
{0}------------------------------------------------
Geratherm
Medical Diagnostic Systems
510(k) Summary as required by section 807.92(c)
10/19/2010
OCT 1 9 2010
.
Submission Applicant: Geratherm Medical AG Thomas Robst Fahrenheitstraße 1 98716 Geschwenda / Germany Establishment Registration Number: 3003591690
Phone: +49 36205 98-0 Fax: +49 36205 98-116 E-mail: t.robst@geratherm.com
Application Correspondent/Contact: think! Andrea Pecsi Schwarzwaldstraße 5 78532 Tuttlingen Germany
Phone: +49-7462-924 051 Fax: +49-7462-924 128 E-mail: andrea@thinkworks.biz
Trade Name: Geratherm UniqueTemp®
Common Name: Warming systems / blankets
Classification Name: Thermal regulating systems (21 CFR 870.5900, Product code DWJ)
Substantial Equivalence Warming System: 510(k)-Number: K052392 - Hot Dog Patient Warming System Firm: AUGUSTINE BIOMEDICAL & DESIGN, LLC.
Description of the Device:
Geratherm UniqueTemp® has been developed for the prevention of hypothermia. The Geratherm warming blankets can be used for covering the patient in various ways without restricting the
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for "Geratherm Medical Diagnostic Systems". The word "Geratherm" is in a bold, sans-serif font, with a registered trademark symbol to the right of the word. Below "Geratherm" is the text "Medical Diagnostic Systems" in a smaller, sans-serif font.
surgical area and provide active warming to the patient. All the blankets can be freely combined. The flexibility of the blankets makes it possible to warm the patient, even if complicated positioning on the operating table is required. After being placed over the patient, Geratherm UniqueTemp® can itself be covered with surgical drapes.
Geratherm UniqueTemp® is suitable for use with adult patients of all sizes. The blankets should not be used for children.
Geratherm UniqueTemp® is intended to be used during lengthy operations as well as by hypothermic patients. The device is not life-supporting. Geratherm UniqueTemp® should be operated only by qualified medical professionals.
The Geratherm UniqueTemp9 consists of the following components:
- . Control unit
- · Holding claw
- Mains cable
- · Arm/shoulder blanket
- · Reusable cover for arm/shoulder blanket
- · Torso blanket
- · Reusable cover for torso blanket
- · Leg blankets
- · Reusable cover for leg blankets
- · Connecting cable
- · Body temperature sensor
The Controller is made of anodized aluminum (colorless or black); furthermore, the control unit has a glass screen. All blankets and covers have a PU coated material. The connecting cable is made of silicone.
Indications for Use:
Geratherm UniqueTemp® is a thermal regulating system for adult patients in order to prevent hypothermia in the operating theater. It is suitable for pre-, intra-, and post-operative use. The device is not life-supporting. It is intended for use by appropriately trained healthcare professionals in clinical environments.
{2}------------------------------------------------
Comparison with Predicate Device:
The Geratherm UniqueTemp® is identical to the predicate device in intended use, indications for use, where it is used, method of operation, safety characteristics, standards which are met (whereas the Geratherm UniqueTemp9 complies with a wider range of standards than the predicate device), used material and sterilization instructions. However, unlike the predicate device, the UniqueTemps has reusable covers which are steam permeable and washable up to 95°C. Therefore, the new device can be cleaned much easier.
The main technical characteristics are similar between the new and predicate device, but the UniqueTemp® has some new components. For instance, the new device has a color (TFT 3.5") temperature display with a touch screen and individual blanket control. Furthermore, the UniqueTemp® is equipped with a temperature pre-selection from 37°C up to 42°C in increments of 0.1°C (the predicate device has 3 possible preset temperatures of 38°C, 40°C and 43°C).
The UniqueTemp® is different from the predicate device in terms of the target population. The new device should be used for adult patients of all sizes, but not for children, whereas the Hot Dog Patient Warming System is intended for all patients.
Both devices are similar regarding the performance characteristics and reach a similar maximum temperature of 42°C and 43°C respectively. The only difference is the output power of the control unit, which does not raise questions regarding safety and effectiveness. Thus, the UniqueTemp® Patient Warming System is substantially equivalent to the predicate device.
Non-Clinical Performance Data:
Geratherm UniqueTemp9 meets the requirements of Council Directive 93/42 EEC of 14.06.93 on Medical Devices and of the standard IEC 60601-1 (Medical electrical equipment, Part 1: General requirements for safety), IEC 60601-1-2 (Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and Tests), and IEC 80601-2-35 (EMC, Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use). An EN ISO 13485 certified quality management system ensures that these requirements are met and entitles the manufacturer to use the CE 0118 label. Geratherm certifies compliance with relevant ISO/IEC/EN and other device-related standards.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for "Geratherm Medical Diagnostic Systems". The word "Geratherm" is in a bold, sans-serif font, with a registered trademark symbol to the right of the word. Below the word "Geratherm" are the words "Medical Diagnostic Systems" in a smaller, sans-serif font. The logo is black and white.
Summary:
The substantial equivalence of the Geratherm UniqueTemp® and the referenced and approved earlier warming system, Hot Dog Patient Warming System (K052392), is based upon substantially similar methods for warming patients in the operating theater.
The presented data which was conducted using the Geratherm UniqueTemp®, in comparison to the predicate device, shows that the product is safe and effective for its intended use. The product components which are covered by this 510(k) premarket notification have been successfully tested for biocompatibility, electromagnetic compatibility, functionality and safety according to international standards.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes, positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Geratherm Medical AG c/o Ms. Andrea Pecsi Think! Schwarzwaldstrasse 5 78532 Tuttlingen Germany
OCT 1 9 2010
Re: K093244
Trade Name: Geratherm UniqueTemp® warming blankets Dated: September 15, 2010 Received: October 7, 2010
Dear Ms. Pecsi:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{5}------------------------------------------------
Page 2 - Ms. Andrea Pecsi
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Bram D. Zuckerman, M.D.
am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indication for Use
510(k) Number (if known): K093244
Device Name: Geratherm UniqueTemp® Patient Warming System
OCT 1 9 2010
Indications for Use:
Geratherm UniqueTemp® is a thermal regulating system for adult patients in order to prevent hypothermia in the operating theater. It is suitable for pre-, intra- and post-operative use. The device is not life-supporting. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Prescription Use _X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K93244
§ 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).