The device is intended to warming pre-set body temperature as determined by the physician. It can also be utilized to warming 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. The device has heating capability, not cooling.

Device Description

This device is an external thermal regulating system consisting of blankets that are placed in contact with the patient, and a temperature controller and is to warming the patient's temperature using carbon technology between 30 and 40 ℃ (86 and 104ºF). The function of the device is heating, not cooling. The heating element and sensor are both embedded inside the blankets. Four blanket sizes are available: 11- 100 Watts, Pediatric: 1.0 by 0.65 meters (3.3 by 2.17) and 3mm high (0.12 inches) weighing 0.9 kgs (Product code WD-01-100); 2 140 Watts, Adult: 2.0 by 1.35 meters (6.6 by 4.5 ft) and 3mm high (0.12 inches) weighing 2.0 kgs (Product code WD-01-200); 3- 40 Watts, Arm Shoulder: 1.5 meters (5.0 ft) and 3mm high (0.12 inches) weighing 1.0 kg (Product code 150-AW); 4- 50 Watts, Leg Warmer: 0.95 meters (3.17 ft) and 3mm high (0.12 inches) weighing 1.2 kgs (Product code 100-DB).

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results for the new device.

However, based on the available information, I can extract and infer some points regarding the study and acceptance criteria as presented in a 510(k) context:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Claimed)
Indications for Use: Identical to predicate device	Identical
Target Population: Identical to predicate device	Identical
Design: Similar to predicate device	Similar
Materials: Similar to predicate device	Similar
Performance: Identical to predicate device	Identical
Biocompatibility: Similar to predicate device	Similar
Mechanical safety: Identical to predicate device	Identical
Chemical safety: Identical to predicate device	Identical
Anatomical sites: Identical to predicate device	Identical
Human factors: Identical to predicate device	Identical
Energy used and/or delivered: Identical to predicate device	Identical
Compatibility with environment and other devices: Identical	Identical
Where used: Identical to predicate device	Identical
Standards met: Identical to predicate device	Identical
Electrical safety: Identical to predicate device	Identical
Thermal safety: Identical to predicate device	Identical
Radiation safety: Identical to predicate device	Identical
Function: Heating the patient's temperature using carbon technology between 30 and 40 ℃ (86 and 104ºF).	The device's description states it performs this function.

Explanation for "Inferred" Acceptance Criteria:
In a 510(k) submission, "acceptance criteria" are generally tied to demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This means the new device must perform as safely and effectively as the predicate, often by having the same technological characteristics or having different characteristics that do not raise new questions of safety or effectiveness and are demonstrated to be as safe and effective. The table above reflects the claims made in the "Summary comparing technological characteristics with other predicate device" section.

2. Sample Size for Test Set and Data Provenance:

The document describes a comparison to a predicate device (Klimamed® Thermal Mats, 510k # K011859) rather than a clinical performance study with a distinct "test set" and a specified sample size.
Data Provenance: Not explicitly stated. The comparison is based on the characteristics of the devices themselves, suggesting a technical and regulatory review rather than a new clinical study.
Retrospective/Prospective: Not applicable in the context of the provided information, as it's a comparative analysis against an existing device's characteristics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

This information is not provided in the document. The substantial equivalence claim is based on a comparison of technical and performance specifications, not on expert consensus or ground truth derived from clinical cases for a test set.

4. Adjudication Method for the Test Set:

This information is not provided as there is no mention of a test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study is not mentioned in the provided text. This type of study is more relevant for diagnostic imaging devices where human reader performance with and without AI assistance is being evaluated. The Klimamed® Thermal Blankets are therapeutic devices (warming blankets).

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study is not mentioned. The device is a physical product (thermal blankets and a controller) for warming patients, not an algorithm, so this concept does not apply in the usual sense. The "performance" mentioned in the comparison refers to its functional performance as a warming device.

7. Type of Ground Truth Used:

The concept of "ground truth" as typically used in AI/diagnostic device studies (e.g., pathology, outcomes data) is not directly applicable here. The "truth" in this context is the demonstrated safety and effectiveness of the predicate device, and the new device's characteristics are compared against that established benchmark.

8. Sample Size for the Training Set:

Not applicable/Not provided. The device is a physical medical device, not an AI/machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

Summary

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

007 1 % 2004

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

1-Submitter Name:	Klimamed® Technologie Medizingeräte GmbH
2-Address:	Oderstr 3 D-71083Herrenberg GERMANY
3-Phone:	(011) 49-7032-83190
4-Fax:	(011) 49-7032-83290
5-Contact Person:	Thomas Schneider, quality inspector
6-Date summary prepared:	July 21st, 2004
7- Official Correspondent:	Mansour Consulting LLC
8- Address:	1308 Morningside Park DrAlpharetta, GA 30022 USA
9- Phone:	(770) 777-4146
10- Fax	(425) 795-9341
11- Contact person:	Jay Mansour, president
12-Device Trade or Proprietary Name:	Klimamed® Thermal Blankets, including Arm

Shoulder West Thermal Blanket and Leg Warmer Thermal Blanket

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

System, Thermal regulating 14-Device Classification Name:

15-Substantial Equivalency is claimed against the following device:

Klimamed® Thermal Mats, 510k # K011859 (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 blankets. Four blanket sizes are available:
- 11- 100 Watts, Pediatric: 1.0 by 0.65 meters (3.3 by 2.17) and 3mm high (0.12 inches) weighing 0.9 kgs (Product code WD-01-100)
- 2 140 Watts, Adult: 2.0 by 1.35 meters (6.6 by 4.5 ft) and 3mm high (0.12 inches) weighing 2.0 kgs (Product code WD-01-200)
- 3- 40 Watts, Arm Shoulder: 1.5 meters (5.0 ft) and 3mm high (0.12 inches) weighing 1.0 kg (Product code 150-AW)
- 4- 50 Watts, Leg Warmer: 0.95 meters (3.17 ft) and 3mm high (0.12 inches) weighing 1.2 kgs (Product code 100-DB)

17-Intended use of the device:

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}------------------------------------------------

K031728

p212

19-Summary comparing technological characteristics with other predicate device:

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

FDA file reference number	510k K011859
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 (not applicable)
Biocompatibility	Similar
Mechanical safety	Identical
Chemical safety	Identical
Anatomical sites	Identical
Human factors	Identical
Energy used and/or delivered	Identical
Compatibility with environment and other devices	Identical
Where used	Identical
Standards met	Identical
Electrical safety	Identical
Thermal safety	Identical
Radiation safety	Identical

REFER TO MAIN SUBMISSION FOR DETAILED INFORMATION

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The overall design is simple and conveys a sense of national identity and governmental authority.

OCT 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Klimamed® Technologie Medizingerate GmbH c/o Mr. Jay Mansour Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, GA 30022

Re: K031728

K031728
Klimamed® Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg Warmer Thermal Blanket Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulation System Regulatory Class: Class II (two) Product Code: DWJ Dated: July 21, 2004 Received: August 13, 2004

Dear Mr. Mansour:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(t) premaire is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have decemblied the devices marketed predicate devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chaculture auth the provisions of the Federal Food, Drug, devices that have been reculted in accordance was are approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject to annual registration, listing of
general controls provisions of the Act include requirements for annual management general controls provisions of the fret merade comments of the summer misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mist exist ease increase and more can and may be subject to such additional controller Entroling and to 898. In addition, FDA may be found in the Code of Federal Tregations, 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 Please be advised that FDA s issualled of a bacamate requirements of the Act that FDA has made a determination administered by other Federal agencies. You must of any Federal statutes and regulations daminders but not limited to: registration and listing (21 comply with an the Act 3 requirements, not 801); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 807), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declines on a sectibed in your Section 510(k) I his letter will anow you to ocgin manetally your and equivalence of your device to a legally premarket notification. The PDA maing of basification 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 If you desire speedine at 1301) 594-4646. Additionally, for questions on the comact the Office of Compitance an evice, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (2017) 574-4057. Allso, production and obtain. Other general information on your premarks. Inomicallon - (2) Of ICP are also obtained from the Division of Small Manufacturers, Itsponsibilities ander the Are Hey so out 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,

Blummenhof

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

510(k) Number (if known): K031728

Device Name: THERMAL BLANKETS AND CONTROLLER

Indications For Use:

THERMAL BLANKETS AND CONTROLLER

1- 40 Watts Arm Shoulder blanket and controller
2- 50 Watts Leg Warmer blanket and controller
3- 100 Watts Thermal pediatric blanket and controller

3- 140 Watts Adult Thermal blanket and controller

The device is intended to warming pre-set body temperature as determined by the physician. The device is intended to warming pro oct body temperature during surgical procedures. It is It can also be unitized to warming normal care units, in operating, recovery and thurcated for use in nosplan madical / surgical floors. The device has heating capability, not cooling.

V Prescription Use (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)

Bhimmlama

(Division Sian-Off) Cordiovascular Devices 510(k) N

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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).