(37 days)
Not Found
No
The description focuses on basic temperature control and water circulation, with no mention of AI/ML terms or capabilities.
Yes
The device is intended to prevent hypothermia and maintain patient comfort through conductive heat transfer, which constitutes a therapeutic action.
No
Explanation: The device is a hyperthermia system intended to prevent hypothermia and maintain patient comfort by regulating body temperature through conductive heat transfer, not to diagnose a condition.
No
The device description explicitly states it is a "water re-circulating system" composed of a "heater, circulating pump, and blankets/pads," indicating it is a hardware-based system.
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 for diagnosis, monitoring, or screening.
- Device Function: The Norm-O-Temp Model 111Z is a thermal regulating system that applies heat directly to the patient's body through water-filled blankets. It does not analyze any biological samples.
- Intended Use: The intended use is to prevent hypothermia and reduce cold discomfort during and after surgical procedures by maintaining the patient's body temperature. This is a therapeutic and comfort-related function, not a diagnostic one.
The device description and intended use clearly indicate that it is a system for external temperature management of the patient's body, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The Norm-O-Temp® Model 111Z hyperthermia system is intended to prevent hypothermia during surgical procedures and to reduce cold discomfort before, during, and after a surgical procedure. The thermal regulating system is used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer. The water heated blankets transfer the thermal energy to adult, pediatric, and infant (includes neonates) patients to keep a patient at a comfortable temperature. The Norm-O-Temp system is composed of a heater, circulating pump, and blankets/pads. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Product codes
DWJ
Device Description
The Cincinnati Sub-Zero Norm-O-Temp (Model 111Z) is a water re-circulating system providing either hyperthermia or normothermia treatment as determined by the health care provider. It is a total body hyperthermia system used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer. Water is heated and pumped from the device, through connecting flexible tubing, to disposable or reusable blankets/pads. The blankets/pads rest under, on top of and/or around the patient and are designed so that the water circulates through the blankets/pads and returns back to the device. The device is designed to operate based on the temperature of the circulating water. The system is used in Operating rooms, Post Anesthesia Care Units, Recovery rooms, Intensive Care Units, and Emergency Rooms with adult, pediatric and infant (including neonate) patients. The blankets/pads that are used with the Norm-O-Temp system are offered in a variety of sizes from large to small to meet the needs of the patients.
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, and infant (including neonate) patients
Intended User / Care Setting
appropriately trained healthcare professionals in clinical environments. Operating rooms, Post Anesthesia Care Units, Recovery rooms, Intensive Care Units, and Emergency Rooms
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)
Bench testing was performed in order to validate the design according to the company's specified design requirements, and to demonstrate the new system is substantially equivalent to the predicate devices. The following bench tests were performed: Temperature Performance Testing (per ASTM F-2196), System Safety Limit Testing (per ASTM F-2196), Transportation Testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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|2008|
Cincinnati Sub-Zero Products, Inc. 510(k) Premarket Notification for Norm-O-Temp® Model 111Z Hyperthermia System
510(k) Summary
FEB 1 7 2012
-
- COMPANY INFORMATION
Cincinnati Sub-Zero Products, Inc. 12011 Mosteller Road Cincinnati, Ohio 45241-1528 Telephone: (513) 772-8810 FAX: (513) 772-9119
- COMPANY INFORMATION
- CONTACT INFORMATION
Steven J. Berke President and CEO Telephone: (513) 772-8810 ext 3212 FAX: (513) 772-9119 Email: sjberke@cszinc.com
- DATE PREPARED: February 10, 2012
-
- DEVICE TRADE NAME: Norm-O-Temp® Model 111Z Hyperthermia System including blankets/pads
-
- COMMON NAME: Temperature management system
-
- CLASSIFICATION NAME: System, Thermal Regulating
-
- CLASSIFICATION REGULATION: 21 CFR 870.5900
-
- CLASSIFICATION PRODUCT CODE: DWJ
-
- PANEL: Cardiovascular
-
- DEVICE CLASSIFICATION: Class II
-
- IDENTIFICATION OF PREDICATES:
- Seabrook Medical Systems Mini-Temp Hyperthermia system includa. ing blankets (K881332)
- Cincinnati Sub-Zero Blanketrol III Model 233 Hyper-Hypothermia b. system including blankets/pads (K101589)
- c. SIMS Level 1 Snuggle Warm 4000/Equator 5000 Convective Warming system including blankets (now sold by Smiths Medical ASD) (K011907)
1
Cincinnati Sub-Zero Products, Inc.
510(k) Premarket Notification for Norm-O-Temp® Model 111Z Hyperthermia System
DEVICE DESCRIPTION
The Cincinnati Sub-Zero Norm-O-Temp (Model 111Z) is a water re-circulating system providing either hyperthermia or normothermia treatment as determined by the health care provider. It is a total body hyperthermia system used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer.
Water is heated and pumped from the device, through connecting flexible tubing, to disposable or reusable blankets/pads. The blankets/pads rest under, on top of and/or around the patient and are designed so that the water circulates through the blankets/pads and returns back to the device. The device is designed to operate based on the temperature of the circulating water.
The system is used in Operating rooms, Post Anesthesia Care Units, Recovery rooms, Intensive Care Units, and Emergency Rooms with adult, pediatric and infant (including neonate) patients.
The blankets/pads that are used with the Norm-O-Temp system are offered in a variety of sizes from large to small to meet the needs of the patients.
INTENDED USE
The Norm-O-Temp® Model 111Z hyperthermia system is intended to prevent hypothermia during surgical procedures and to reduce cold discomfort before, during, and after a surgical procedure. The thermal regulating system is used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer. The water heated blankets transfer the thermal energy to adult, pediatric, and infant (includes neonates) patients to keep a patient at a comfortable temperature. The Norm-O-Temp system is composed of a heater, circulating pump, and blankets/pads. It is intended for use by appropriately trained healthcare professionals in clinical environments.
BENCH TESTS PERFORMED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Bench testing was performed in order to validate the design according to the company's specified design requirements, and to demonstrate the new system is substantially equivalent to the predicate devices.
The following bench tests were performed:
- Temperature Performance Testing (per ASTM F-2196) .
- System Safety Limit Testing (per ASTM F-2196) . ●
- Transportation Testing ●
.
In addition, the new system meets the applicable requirements of the following standards:
2
- IEC 60601-1 (Second Edition), Medical Electrical Equipment Part 1; Gen-◆ eral Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- IEC 60601-1-2:2007 (Third Edition), Medical Electrical Equipment Part 1-2: . General Requirements for Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
Testing demonstrates substantial equivalence between the Norm-O-Temp system and predicate devices.
SUBSTANTIAL EQUIVALENCE
The new device is substantially equivalent to the predicate devices because it has the same intended use and has the same or similar technological characteristics that do not raise new types of questions of safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name arranged in a circular fashion around a central emblem. The emblem consists of a stylized caduceus-like symbol, with three parallel lines curving and intertwining at the bottom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
际EB 1 7 2012
Cincinnati Sub-Zero Products, Inc. c/o Mr. Steven J. Berke President and CEO 12011 Mosteller Road Cincinnati, OH 45241
Re: K120081
Norm-O-Temp® Model 111Z Hyperthermia Systems Regulation Number: 21 CFR 870.5900 Regulation Name: System, Thermal Regulating Regulatory Class: Class II Product Code: DWJ Dated: February 10, 2012 Received: February 13, 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
4
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 (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,
M.A.Kelleher
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K12008
Device Name: Norm-O-Temp® Model 111Z Hyperthermia System
Indications for Use:
The Norm-O-Temp® Model 111Z hyperthermia system is intended to prevent hypothermia during surgical procedures and to reduce cold discomfort before, during, and after a surgical procedure. The thermal regulating system is used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer. The water heated blankets transfer the thermal energy to adult, pediatric, and infant (includes neonates) patients to keep a patient at a comfortable temperature. The Norm-O-Temp system is composed of a heater, circulating pump, and blankets/pads. 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)
Page 1 of 1
(Posted November 13, 2003)
M. A. Kiebler
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K120081