(321 days)
Not Found
No
The description focuses on a thermal regulating system with a mat, temperature controller, and carbon technology. There is no mention of AI, ML, or any learning or adaptive capabilities in the device description or the provided sections.
Yes
The device is indicated to maintain preset body temperature and normal body temperature, which are therapeutic functions. It is used to regulate the patient's temperature within a specific range, indicating a therapeutic intervention rather than just diagnostic or monitoring.
No
The device is described as an external thermal regulating system used to maintain preset body temperature, not to diagnose a condition.
No
The device description clearly outlines hardware components including a mat with embedded heating elements and sensors, and a temperature controller.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states this device is an "external thermal regulating system consisting of a mat that is placed in contact with the patient." Its purpose is to directly regulate the patient's body temperature.
- Intended Use: The intended use is to "maintain preset body temperature" and "maintain normal body temperature during surgical procedures." This is a therapeutic or supportive function, not a diagnostic one based on analyzing biological samples.
The device's function and intended use are entirely focused on directly interacting with the patient's body to manage their temperature, which is not the role of an IVD.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
75/95/12M, 55/95/12M, 120/240/12PM, DWJ
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anatomical sites: Identical
Indicated Patient Age Range
Adult, Pediatric
Intended User / Care Setting
Physicians in clinics and hospitals, hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
MAY 0-1 2002
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
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
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)
OR
Over-The-Counter Use
(Optional Formal 1.2.96)