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.

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.

AI/ML Overview

The Cincinnati Sub-Zero Norm-O-Temp® Model 111Z Hyperthermia System is a temperature management system designed to prevent hypothermia and reduce cold discomfort in patients during and after surgical procedures. The device operates by recirculating heated water through blankets/pads to transfer thermal energy to the patient via conductive heat transfer.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Temperature Performance per ASTM F-2196 (Standard Test Method for Measuring Performance of Thermal Regulating Systems for Patient Warming and Cooling)	The device successfully passed Temperature Performance Testing as per ASTM F-2196. This indicates the Norm-O-Temp system can accurately achieve and maintain the desired water temperature within its blankets/pads for effective patient warming.
System Safety Limits per ASTM F-2196	The device successfully passed System Safety Limit Testing as per ASTM F-2196. This suggests the device operates within defined safety parameters, preventing overheating or other dangerous conditions for the patient and user.
Transportation Testing	The device successfully passed Transportation Testing. This indicates the device can withstand the rigors of shipping and handling without compromising its functionality or safety.
IEC 60601-1 (Second Edition) General Requirements for Safety (including Amendments 1 and 2)	The new system meets the applicable requirements of IEC 60601-1 (Second Edition), indicating it adheres to international standards for electrical medical equipment safety.
IEC 60601-1-2:2007 (Third Edition) Electromagnetic Compatibility	The new system meets the applicable requirements of IEC 60601-1-2:2007 (Third Edition), indicating it is electromagnetically compatible with other devices and does not cause or succumb to excessive electromagnetic interference.

2. Sample Size Used for the Test Set and Data Provenance:

The provided document describes bench testing. For bench testing, the "sample size" refers to the number of devices or components tested. The document does not explicitly state the number of Norm-O-Temp Model 111Z Hyperthermia Systems that underwent the listed tests.

The data provenance is from bench laboratory testing, likely conducted by the manufacturer, Cincinnati Sub-Zero Products, Inc. The testing is for design validation and to demonstrate substantial equivalence, indicating it is prospective testing for a new device. There is no information regarding the country of origin of the data beyond the manufacturer's location in Cincinnati, Ohio, USA.

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

This information is not applicable to the type of study conducted. Bench testing for a medical device like a hyperthermia system does not typically involve human experts establishing "ground truth" in the way clinical studies or diagnostic AI algorithms do. Instead, the "ground truth" or acceptance criteria are derived from established industry standards (e.g., ASTM, IEC) and the device's design specifications. The performance is measured against these objective standards.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the testing involves objective measurements against established technical standards, there is no need for human adjudication of results in the traditional sense of a clinical or image-based study. Device performance either meets the objective criteria or it does not.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of medical data (e.g., radiologists reading images) and the impact of AI assistance on that interpretation. The Norm-O-Temp system is a therapeutic device, and its effectiveness is assessed through its physical performance and safety features, not through human reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

This concept is not applicable to the Norm-O-Temp Model 111Z Hyperthermia System in the way it is used for AI-powered diagnostic algorithms. The device itself is a standalone medical device that performs its function (heating water and circulating it) without an "algorithm" in the AI sense that would require human-in-the-loop interaction for interpretation or decision-making. Its performance is measured directly through its physical outputs (temperature, safety limits).

7. Type of Ground Truth Used:

The "ground truth" for this study is based on objective technical specifications and established industry standards. Specifically:

ASTM F-2196: Standard Test Method for Measuring Performance of Thermal Regulating Systems for Patient Warming and Cooling. This standard defines how to measure temperature performance and safety limits.
IEC 60601-1 and IEC 60601-1-2: International standards for the safety and electromagnetic compatibility of medical electrical equipment.
Company's specified design requirements: The manufacturer's internal criteria for the device's functionality and safety.

8. Sample Size for the Training Set:

This information is not applicable. The Norm-O-Temp Model 111Z is a physical medical device, not an AI model that requires a "training set" of data for machine learning. Its operation is based on hardware and software logic, not statistical learning from data.

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

This information is not applicable, as there is no "training set" in the context of this device. The device's functionality is designed and engineered according to specifications and validated through testing against those specifications and relevant standards.

Summary

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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

1. COMPANY INFORMATION
  Cincinnati Sub-Zero Products, Inc. 12011 Mosteller Road Cincinnati, Ohio 45241-1528 Telephone: (513) 772-8810 FAX: (513) 772-9119

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

1. DEVICE TRADE NAME: Norm-O-Temp® Model 111Z Hyperthermia System including blankets/pads
1. COMMON NAME: Temperature management system
1. CLASSIFICATION NAME: System, Thermal Regulating
1. CLASSIFICATION REGULATION: 21 CFR 870.5900
1. CLASSIFICATION PRODUCT CODE: DWJ
1. PANEL: Cardiovascular
1. DEVICE CLASSIFICATION: Class II
1. 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)

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Cincinnati Sub-Zero Products, Inc.

510(k) Premarket Notification for Norm-O-Temp® Model 111Z Hyperthermia System

DEVICE DESCRIPTION

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

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:

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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.

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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

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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

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Indications for Use

510(k) Number (if known): K12008

Device Name: Norm-O-Temp® Model 111Z Hyperthermia System

Indications for Use:

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

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).