THIS DEVICE IS INDICATED TO MAINTAIN PRESET BODY TEMPERATURE AS DETERMINED By THE PHYSICIAN. IT CAN ALSO BE UTILIZED TO MAINTAIN NORMAL BODY TEMPERATURE DURING SURCICAL PROCEDURES . IT IS INDICATED FOR USE IN HOSPITAL INVASIVE AND CORONARY CARD UNITS, IN OPERATING, RECOVERY AND EMERGENCY IN BURN UNITS, Rock's AND ON MEDICAL | SURGICAL floors

Device Description

This device is an external thermal regulating system consisting of a mat that is placed in contact with the patient and a temperature controller and is to regulate the patient's temperature between 30 and 37.7 ℃ (86 and 100ºF), using carbon technology. The heating element and sensor are both embedded inside the mat. Two mat sizes are available: 1- 95 Watts, Standard 0.950 by 0.495 meters (3.1 by 1.6 ft) and 9mm high (0.35 inches) weighing 5 kg (11 lbs) (Product code 75/95/12M) for adult patients 2- 55 Watts, Pediatric 0.550 by 0.495 meters (1.8 by 1.6 ft) and 9mm high (0.35 inches) weighing 3.5 kg (7.7 lbs) (Product code 55/95/12M) for pediatric patients 75/95/12PRM consists of the Controller Micro 75-150 (product code 120/240/12PM) and mat 75/95/12M 55/95/12PRM consists of the Controller Micro 75-150 (product code 120/240/12PM) and mat 55/95/12M

AI/ML Overview

The provided 510(k) summary for the Klimamed® Thermal Mat & Controller 95 & 55 Watts does not contain detailed information about specific acceptance criteria, a study proving device performance, sample sizes for test or training sets, expert qualifications, or adjudication methods.

Instead, the submission primarily focuses on demonstrating substantial equivalence to a predicate device (Allon 2001 by M.T.R.E Advanced Technology, Ltd, K001546) based on technological characteristics.

Here's a breakdown of the available information and what's missing:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define acceptance criteria as numerical targets or benchmarks that the device had to achieve. Instead, it relies on a comparative table to show that the Klimamed® device's characteristics are "Identical" or "Similar" to the predicate device.

Characteristic	Comparison Result (Klimamed® vs. Predicate)
Indications for use	Identical
Target population	Identical
Design	Similar
Materials	Similar
Performance	Identical
Sterility	Identical
Biocompatibility	Identical
Mechanical safety	Similar
Chemical safety	Similar
Anatomical sites	Identical
Human factors	Similar
Energy used and/or delivered	Similar
Compatibility with environment and other devices	Identical
Where used	Identical
Standards met	Identical
Electrical safety	Similar
Thermal safety	Similar
Radiation safety	Similar

What's missing regarding "reported device performance":
The document states "Performance: Identical" in the comparison table, but it does not provide any specific performance metrics, data, or results from tests conducted on the Klimamed® Thermal Mat & Controller itself. It implicitly claims that because its performance is "Identical" to a legally marketed predicate, it meets an unstated, accepted level of performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The submission does not describe a specific clinical or performance test set with a defined sample size. The equivalence is primarily based on a comparison of technological characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. As no specific performance study on a test set is described, there's no mention of experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

This is not applicable to this device. The Klimamed® Thermal Mat & Controller is a thermal regulating system, not an AI-assisted diagnostic device that would involve human readers interpreting cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable to this device. It is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. No specific test set or ground truth establishment is described. The "ground truth" for demonstrating substantial equivalence appears to be the established safety and effectiveness of the predicate device based on its prior market clearance.

8. The sample size for the training set

This information is not provided. This device is a physical medical device, not a machine learning model, so the concept of a "training set" in this context does not apply.

9. How the ground truth for the training set was established

This is not applicable as there is no training set for this type of device.

In summary:

The 510(k) submission for the Klimamed® Thermal Mat & Controller relies on a comparison of technological characteristics to a predicate device to demonstrate substantial equivalence, rather than providing detailed acceptance criteria and the results of a specific performance study against those criteria. The argument is that since the device's characteristics (including "Performance") are "Identical" or "Similar" to a device already cleared by the FDA, it is considered safe and effective.

Summary

{0}------------------------------------------------

MAY 0-1 2002

K011859

510(k) Summary As Required by 21 section 807.92 ( c )

1-Submitter Name: Klimamed® Technologie Medizingeräte GmbH

2-Address: Oderstr 3 D-71083
Herrenberg GERMANY
(011) 49-7032-83190 3-Phone:
4-Fax: (011) 49-7032-83290

Thomas Schneider, quality inspector 5-Contact Person:

6-Date summarv prepared: May 30tt, 2001

7- Official Correspondent: Mansour Consulting

8- Address: 1308 Morningside Park Dr
Alpharetta, GA 30022 USA
9- Phone: (678) 429-8180
10- Fax (425) 795- 9341

11- Contact person: Jay Mansour, president

12-Device Trade or Proprietary Name: Klimamed® Thermal Mat & Controller 95 & 55 Watts

13-Device Common or usual name: Thermal mat and controller

14-Device Classification Name: System, Thermal regulating

15-Substantial Equivalency is claimed against the following device:

Allon 2001 by M.T.R.E Advanced Technology, Ltd (refer to appendix 2) .
16-Description of the Device:

DESCRIPTION/INDICATION FOR USE by physicians in clinics and hospitals

The heating element and sensor are both embedded inside the mat. Two mat sizes are available:

1- 95 Watts, Standard 0.950 by 0.495 meters (3.1 by 1.6 ft) and 9mm high (0.35 inches) weighing 5 kg (11 lbs) (Product code 75/95/12M) for adult patients
2- 55 Watts, Pediatric 0.550 by 0.495 meters (1.8 by 1.6 ft) and 9mm high (0.35 inches) weighing 3.5 kg (7.7 lbs) (Product code 55/95/12M) for pediatric patients

75/95/12PRM consists of the Controller Micro 75-150 (product code 120/240/12PM) and mat 75/95/12M 55/95/12PRM consists of the Controller Micro 75-150 (product code 120/240/12PM) and mat 55/95/12M

The device is intended to maintain pre-set body temperature as determined by the physician. It can also be utlized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors

17-Intended use of the device:

The device is intended to maintain pre-set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors

18-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above.

This is better expressed in the tabulated comparison (Paragraph 19 below)

{1}------------------------------------------------

19-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that Klimamed® mat & controller is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency detailed chart path is attached.

FDA file reference number	510k K001546
Attachments inside notification submission file	510k summary print out
TECHNOLOGICAL CHARACTERISTICS	Comparison result
Indications for use	Identical
Target population	Identical
Design	Similar
Materials	Similar
Performance	Identical
Sterility	Identical
Biocompatibility	Identical
Mechanical safety	Similar
Chemical safety	Similar
Anatomical sites	Identical
Human factors	Similar
Energy used and/or delivered	Similar
Compatibility with environment and other devices	Identical
Where used	Identical
Standards met	Identical
Electrical safety	Similar
Thermal safety	Similar
Radiation safety	Similar

REFER TO PAGES 9 AND 10 FOR DETAILED INFORMATION

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines emanating from its head, representing health, services, and people.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Klimamed® Technologie Medizingeräte GmbH c/o Mr. Jav Mansour President Mansour Consulting 1308 Morningside Park Drive Alpharetta, GA 30022

Re: K011859

Trade Name: Klimamed® Thermal Mat & Controller 95 & 55 Watts Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (two) Product Code: DWJ Dated: January 21, 2002 Received: January 31, 2002

Dear Mr. Mansour:

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.

{3}------------------------------------------------

Page 2 - Mr. Jay Mansour

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); 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Donna-Bea Tillman, Ph.D.

nna-Bea Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page of

510(k) Number (if known): K011859

Device Name: THER HAL HAT & Contreautes ( REF. 75/95/12 PRM & S Indications For Usc:

THIS DEVICE IS INDICATED TO MAINTAIN PRESET BODY TEMPERATURE AS DETERMINED By THE PHYSICIAN.

IT CAN ALSO BE UTILIZED TO MAINTAIN NORMAL BODY TEMPERATURE DURING SURCICAL PROCEDURES .

IT IS INDICATED FOR USE IN HOSPITAL INVASIVE AND CORONARY CARD UNITS, IN OPERATING, RECOVERY AND EMERGENCY IN BURN UNITS, Rock's AND ON MEDICAL | SURGICAL floors

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K011859

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Formal 1.2.96)

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).