The Medi-Therm is intended for use in supplying warm or cold water at controlled temperatures via water circulating blankets or body wraps for the application of regulating patient temperature in situations where a physician determines that temperature therapy is necessary and desirable.

Indications for use for the Medi-Therm thermal regulating system include:
a. To maintain pre-set body temperature as determined by the physician
b. To maintain normal body temperature during surgical procedures
c. For use in all hospital areas including invasive and coronary care units, in operating, recovery and emergency rooms, in burn units and on medical/surgical floors
d. This system can be used with adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients

Device Description

The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket/s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device's control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system.

The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.

AI/ML Overview

The provided document is a 510(k) summary for the Gaymar Medi-Therm Hyper/Hypothermia System. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the technological characteristics, intended use, and general safety and effectiveness.

Based on the provided text, there is no information available regarding a study that assesses device performance against specific acceptance criteria in the format you requested (e.g., diagnostic accuracy metrics like sensitivity, specificity, or reader improvement with AI).

The document mentions "Bench testing was conducted to confirm the MTA6900 and MTA7900 and their disposable accessories operate as described in this submission and therefore are as safe and effective as the predicate devices to which it claims substantial equivalence." The types of bench testing listed are:

Temperature Control Performance
Temperature Stability and Flow
Biocompatibility (ISO 10993-5; ISO10993-10; 16 CFR 1500)
Ship Testing (ISTA 1A)

However, the document does not provide:

Specific acceptance criteria for these tests (e.g., "temperature control performance must maintain patient temperature within +/- 0.5°C").
Reported device performance against such criteria in a quantitative table.
Details about sample sizes, data provenance, ground truth establishment, expert involvement, or MRMC studies. The context of this device (a thermal regulating system) does not typically involve the kinds of diagnostic accuracy studies (MRMC, standalone, human-in-the-loop) that would require such detailed information on ground truth, expert consensus, and reader performance.

Therefore, I cannot populate the table or answer most of your specific questions as the necessary information is not present in the provided 510(k) summary. The document focuses on demonstrating that the device meets safety and performance standards generally expected for its product classification and is substantially equivalent to existing devices through engineering and functional comparisons, not clinical performance metrics in the way a diagnostic AI device would be evaluated.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document. The document states "Bench testing was conducted to confirm the MTA6900 and MTA7900 and their disposable accessories operate as described."	Not specified in the document. The document concludes "Results of the bench testing concludes that the design, operational and technical characteristics of the Medi-Therm Hyper/Hypothermia System is substantially equivalent to and as safe and effective as that of the predicate devices."

Detailed Study Information (Based on the document):

Sample size used for the test set and the data provenance: Not applicable/not provided. The document refers to "Bench testing," which implies laboratory-based tests rather than patient data test sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth establishment with experts is typically for diagnostic devices assessing images or other complex data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not mentioned and is not typically relevant for a thermal regulating system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This refers to diagnostic algorithm performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not provided. For bench testing, the "ground truth" would be the expected physical or electrical output/behavior based on design specifications or industry standards.
The sample size for the training set: Not applicable/not provided. This device is not described as involving machine learning or algorithms that require a "training set" in the context of data analysis. Its "microprocessor control" refers to conventional programming.
How the ground truth for the training set was established: Not applicable/not provided.

Summary

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510(k) Summarv

Gaymar Industries Inc.

JAN 2 0 2011

Medi-Therm Hyper/Hypothermia System

K100585

SUBMITTER/510(K) HOLDER

Name:
Address:

Telephone:

Gaymar Industries Inc. 10 Centre Dr. Orchard Park NY 14127 Contact Person: Brian L. Orwat 716 662 8647

Date Prepared: May 7, 2010

DEVICE NAME

Proprietary Name: Catalog Numbers: Common/Usual Name: Classification Name: Product Code:

Medi-Therm Hyper/Hypothermia System MTA6900, MTA7900 Hyper/Hypothermia System Thermal Regulating System (21 CFR § 870.5900) DWJ

PREDICATE DEVICES

Gaymar Industries Inc. ("Gaymar") claims substantial equivalence to:

Gaymar Industries Inc. Medi-Therm System MTA5900 (K912051) 1.
1. MedCool Inc. RapidCool™ Patient Temperature Management System. (K070112)
1. Medivance ArcticSun Temperature Management System (K071341)
1. M.T.R.E. Advanced Technology Ltd. CritiCool System (K083662)
1. M.T.R.E. Advanced Technology Ltd. Allon 2001 System (K003349)

DEVICE DESCRIPTION

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using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system.

The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.

INTENDED USE

Indications for use for the Medi-Therm thermal regulating system include:

To maintain pre-set body temperature as determined by the physician a.
b. To maintain normal body temperature during surgical procedures
c. For use in all hospital areas including invasive and coronary care units, in operating. recovery and emergency rooms, in burn units and on medical/surgical floors
d. This system can be used with adult and pediatric patients
Monitoring and controlling patient temperature e.
Temperature reduction in patients where clinically indicated, e.g. in hyperthermic f. patients

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Substantial equivalence is based on five predicate devices. All above referenced predicates are thermal regulating systems as defined in 21 CFR § 870.5900.

Like the Medi-Therm, all predicate devices utilize a controller incorporating a water circulation pump, hose sets, a disposable non-sterile body surface contact appliance and a means to monitor the patient temperature. The devices all require a physician's prescription for use. The external anatomical sites for the patient contact appliance are similar for all devices - trunk and extremities. The RapidCool additionally uses neck and head patient contact appliances. All device patient contact appliances are applied on, around and/or under the patient where the thermal transfer is dependent upon patient contact.

The Medi-Therm is equivalent in operational characteristics to the predicate devices in that the control units all use microprocessors to circulate temperature-controlled water at similar nonadiustable flow rates through hose sets to a patient contact pad/blanket/garment. Flow rates however, will be determined by pad/blanket/garment size and quantity connected to the devices. The physician determines the size and quantity of pad/blanket/garment to be used.

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In each device's Automatic Mode, patient temperature is monitored and controlled through the use of commercially available YSI 400 series probes connected between the controller and patient. The physician selects a therapeutic temperature and the device user sets the desired patient temperature for hypothermia condition via the controller interface. Each device will channel the temperature controlled water to the patient contact pad/blanket/garment to achieve and maintain the controller setting for patient temperature. The Medi-Therm Automatic mode temperature is in the range of 30 - 41°C. the same range as supported by the predicate devices. Additionally, the Medi-Therm and Arctic Sun have Manual Modes where a user can set. water temperature (not patient temperature) in the range of 4 - 42°C to be circulated to the patient contact pad/blanket/garment.

The Medi-Therm includes additional temperature control options within the Automatic Mode. The user can select either Gradual. Moderate or Rapid cooling modes for the MTA6900. The user can select either Gradual, Moderate or Rapid cooling and warming modes for the MTA7900. These pre-set temperature control modes are within the previously cleared temperature range for the device.

All of the predicate devices' cooling sources are either water/air heat exchanger, thermoelectric or typical refrigeration compressor. The heating sources are electrical heater elements ranging from 500 - 800W. The Medi-Therm, CritiCool and Arctic Sun include a power on self test (POST) and safety alarms for water level, interrupted water flow, patient probe anomalies including patient temperature and open/short circuit, and high water temperature. The redundancy of high water temperature protective circuits is to the tertiary level for the Medi-Therm and Allon 2001 and at least duplicative for the Arctic Sun device. The primary high water temperature for the Medi-Therm is software controlled with bimetallic thermostats for the secondary and tertiary levels.

The patient contact pad/blanket/garment operating water pressure is atmospheric for the Medi-Therm, RapidCool, CritiCool and Allon 2001and Medi-Therm predicates. Whereas, the Arctic Sun's operating pressure is sub-atmospheric.

Bench testing was conducted to confirm the MTA6900 and MTA7900 and their disposable accessories operate as described in this submission and therefore are as safe and effective as the predicate devices to which it claims substantial equivalence. Bench testing included:

Temperature Control Performance .
Temperature Stability and Flow .
Biocompatibility (ISO 10993-5; ISO10993-10; 16 CFR 1500) .
Ship Testing (ISTA 1A) .

The MTA6900 and MTA7900 controller comply with the following standards:

· IEC/EN60601-1-2 Medical Electrical Equipment, Pat 1: General Requirements for Safety, Collateral Standard: Electromagnetic Compatibility Requirements and Tests

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· CISPR 11 / EN 55011, Limits and Methods of Measurements of Radio Disturbance Characteristics of Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment
· UL 416 -- Refrigerated Medical Equipment

Results of the bench testing concludes that the design, operational and technical characteristics of the Medi-Therm Hyper/Hypothermia System is substantially equivalent to and as safe and effective as that of the predicate devices.

The Medi-Therm Hyper/Hypothermia Systems' intended uses are substantially supported by the previously cleared predicate devices. The Medi-Therm Hyper/Hypothermia Systems' indication for use statement includes all the same indications as the previously cleared predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three wavy lines below the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Gaymar Industries, Inc. c/o Mr. Brian L. Orwat 10 Centre Dr. Orchard Park, NY 14127

JAN 2 0 23:1

Re: K100585

Trade/Device Name: Medi-Therm Hyper/Hypothermia System, MTA6900 and MTA7900 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: DWJ Dated: January 14, 2011 Received: January 18, 2011

Dear Mr. Orwat:

【

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

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Page 2 – Mr. Brian L. Orwat

device-related adverse events) (21 CFR 803); 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.

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/CDRHOffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

R. hihner

Image /page/5/Picture/7 description: The image shows a handwritten letter 'A' on the left side and the letters 'B' and 'D' stacked on top of each other on the right side. The letter 'A' is written in a cursive style with a loop at the top. The letters 'B' and 'D' are written in a simple, block-letter style. The image is simple and contains only these letters.

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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Indications for Use

510(k) Number:

K100583

Device Name:

Medi-Therm Hyper/Hypothermia System

Indications for Use:

Indications for use for the Medi-Therm thermal regulating system include:

To maintain pre-set body temperature as determined by the physician a.
b. To maintain normal body temperature during surgical procedures
C. For use in all hospital areas including invasive and coronary care units, in operating, recovery and emergency rooms, in burn units and on medical/surgical floors
d. This system can be used with adult and pediatric patients
e. Monitoring and controlling patient temperature
Temperature reduction in patients where clinically indicated, e.g. in hyperthermic f. patients

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/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)

Duma R. V. Lamer

Page lof 1

Division Sign-Off) Division of Čardiovascular Devices

510(k) Number_K100585

Regulation Number and Section

§ 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).