(27 days)
Not Found
No
The summary describes a forced-air patient warming system with no mention of AI or ML capabilities. The device functions based on convective heat transfer and temperature control, not data-driven algorithms.
Yes
The device is intended to prevent hypothermia, raise, and maintain a patient's temperature, which are therapeutic actions.
No
The device is a patient warming system intended to prevent hypothermia and provide thermal regulation; it does not diagnose medical conditions.
No
The device description clearly outlines hardware components including a controller, flexible hose, and disposable blankets, indicating it is a physical system, not software-only.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Function: The WarmAir® 135 patient warming system is a therapeutic device. Its purpose is to directly warm a patient's body through convective heat transfer. It does not analyze any biological samples.
- Intended Use: The intended use clearly states its purpose is to prevent hypothermia and/or reduce cold discomfort by warming the patient.
- Device Description: The description details how the device warms air and delivers it to a blanket placed on the patient. There is no mention of analyzing samples.
Therefore, the WarmAir® 135 patient warming system falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The WarmAir® 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-airheated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Product codes (comma separated list FDA assigned to the subject device)
DWJ
Device Description
The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to a blanket that is placed over or under adult, pediatric or neonatal patients in order to warm them. The heated air is blown through connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), recovery room, medical and surgical floors, emergency department, or any other department or hospital facility requiring patient temperature management.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric or neonate patients
Intended User / Care Setting
appropriately trained healthcare professionals in clinical environments. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), recovery room, medical and surgical floors, emergency department, or any other department or hospital facility requiring patient temperature management.
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)
The changes to the blanket were evaluated under design controls and met the same criteria as non-sterile blankets. Testing showed the sterile blanket meets the specification for maximum temperature delivered to the patient (per ASTM F-2196) post sterilization.
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
K|2|669
II
WarmAir 135 Device Modification Special 510(k)
3 2012 JUL
Special 510(k) Summary
1. COMPANY INFORMATION
Cincinnati Sub-Zero Products, Inc. 12011 Mosteller Road Cincinnati, Ohio 45241-1528 Telephone; (513) 772-8810 FAX: (513) 772-9119
2. CONTACT INFORMATION
Steve Berke President and CEO Telephone; (513) 772-8810 ext 3212 FAX: (513) 772-9216 Email: sjberke@cszinc.com
-
- DATE PREPARED: June 3, 2012
-
- DEVICE TRADE NAME: WarmAir® Model 135 Hyperthermia System including blankets
-
- COMMON NAME: Temperature Management System
-
- CLASSIFICATION NAME: System, Thermal Regulating
-
- CLASSIFICATION REGULATION: 21 CFR 870.5900
-
- CLASSIFICATION PRODUCT CODE: DWJ (Thermal Regulating System)
-
- PANEL: Cardiovascular
-
- DEVICE CLASSIFICATION: Class II No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act
11. IDENTIFICATION OF PREDICATE:
- a. WarmAir® Model 135 Hyperthermia System including blankets (K101148)
DEVICE DESCRIPTION
The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to a blanket that is placed over or under adult, pediatric or neonatal patients in order to warm them. The heated air is blown
Cincinnati Sub Zero
12011 Mosteller Road
Cincinnati, OH
1
through connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air.
The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), recovery room, medical and surgical floors, emergency department, or any other department or hospital facility requiring patient temperature management.
DESCRIPTION OF THE CHANGES TO THE DEVICE
The predicate WarmAir Model 135 System included a variety of blankets in various sizes and shapes and was cleared in K101148. This submission is to add a modified blanket to the family of WarmAir 135 blankets. The modified blanket is manufactured from the same materials using the same manufacturing methods as the already cleared blankets. The differences are that the modified blanket is provided sterile, differs in size from other blankets, and includes a flap to allow access to the groin area of the patient.
INTENDED USE
The WarmAir 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-airheated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric, or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.
COMPLETION OF DESIGN CONTROL ACTIVITIES
The changes to the blanket were evaluated under design controls and met the same criteria as non-sterile blankets. Testing showed the sterile blanket meets the specification for maximum temperature delivered to the patient (per ASTM F-2196) post sterilization.
SUBSTANTIAL EQUIVALENCE
The modified device has the same intended use as the predicates and similar technological characteristics that do not raise different types of questions of safety and effectiveness and the modified device is therefore substantially equivalent to the predicate devices.
Cincinnati Sub Zero
12011 Mosteller Road
Cincinnati, OH
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 3 2012
Cincinnati Sub-Zero Products, Inc. c/o Mr. Steven J. Berke President and Chief Executive Officer 12011 Mosteller Road Cincinnati, OH 45241-1528
· Re: K121669
WarmAir®, Model 135 Hyperthermia System (Controller and Blankets) Regulation Number: 21 CFR 870.5900 Regulation Name: System, Thermal Regulating Regulatory Class: Class II Product Code: DWJ Dated: June 4, 2012 Received: June 6, 2012
Dear Mr. Berke:
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
3
Page 2 - Mr. Steven J. Berke
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 forth in the quality systems (OS) 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/ReportalProblem/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,
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): ال 2 1669
Device Name: Warm Air® Model 135 and Blankets
Indications for Use:
The WarmAir® 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-airheated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Prescription Use _ x (Part 21 CFR 801 Subpart D)
AND/OR
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)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K121669 |
|---|---|
| --------------- | --------- |
Page 1 of 1(Posted November 13, 2003)