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.

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.

AI/ML Overview

The provided text describes a Special 510(k) submission for a device modification, not a study evaluating a device's performance against acceptance criteria in the way a diagnostic or AI-driven device would be.

The document pertains to the WarmAir® Model 135 Hyperthermia System, specifically a modification to add a new non-sterile blanket with modified geometry. This is a Class II medical device (Thermal Regulating System), and the submission focuses on demonstrating substantial equivalence to existing predicate devices (cleared WarmAir® Model 135 Hyperthermia System including blankets K101148 and K121669).

Therefore, many of the requested categories for a study proving a device meets acceptance criteria (like sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission because it's not a clinical performance study in the traditional sense for a diagnostic device.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

For this device modification, the "acceptance criteria" are related to safety and performance specifications for a warming blanket, as established by a recognized standard. The "reported device performance" is a statement that the modified blanket meets these specifications.

Acceptance Criteria	Reported Device Performance
Criteria for Blanket Safety (Maximum Contact Surface Temperature): Meeting requirements identified in ASTM F-2196. This standard likely specifies limits on how hot the blanket surface can get to prevent burns or discomfort to the patient.	Modified blanket meets the specification for maximum contact surface temperature to be within the requirements identified in ASTM F-2196. (Stated as a positive outcome of testing)
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.	Testing shows the modified blanket to perform similarly to the predicate blankets. (Supports the claim of substantial equivalence for regulatory approval.)

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document states "Testing of the blanket under a simulated patient," implying controlled laboratory testing of the blanket unit itself, rather than a clinical trial with a patient population. It would likely involve a small number of physical blanket prototypes.
Data Provenance: The testing was conducted internally by Cincinnati Sub-Zero Products, Inc. in Cincinnati, Ohio, as part of their design control activities. It is not clinical data from patients or a specific country of origin. It's retrospective in the sense that it's performed on a prototype before market release, but not involving pre-existing patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in the context of diagnostic performance (e.g., expert consensus on an image) is not relevant here. The ground truth for this engineering-based acceptance criteria would be the objective measurements obtained during simulated testing against the ASTM standard.

4. Adjudication method for the test set

Not applicable. There is no subjective assessment requiring adjudication in this type of engineering test. The "adjudication" is essentially the direct measurement against the ASTM F-2196 standard.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a special 510(k) for a physical medical device (a warming blanket modification), not an AI or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance evaluation is the objective measurement of the blanket's maximum contact surface temperature against the predefined limits specified in the ASTM F-2196 standard.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. (See #8)

Summary

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K123946

WarmAir 135 Device Modification Special 510(k)

Special 510(k) Summary

JAN 1 7 2013

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

Steve Berke President and CEO Telephone; (513) 772-8810 ext 3212 FAX: (513) 772-9216 Email: siberke@cszinc.com

1. DATE PREPARED: December 19, 2012
1. DEVICE TRADE NAME: WarmAir® Model 135 Hyperthermia System including FilteredFlo® blankets
1. COMMON NAME: Temperature Management System
1. CLASSIFICATION NAME: System, Thermal Regulating
1. CLASSIFICATION REGULATION: 21 CFR 870.5900
1. CLASSIFICATION PRODUCT CODE: DWJ (Thermal Regulating System)
1. PANEL: Cardiovascular
1. 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 (Ki01148 and K121669)

DEVICE DESCRIPTION

Cincinnati Sub Zero

12011 Mosteller Road

Cincinnati, OH

WA 135 Special 510(k) Page 15 of 59

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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. A subsequent submission K121669 added a sterile cardiac blanket to the blanket family. This submission is to add a non-sterile blanket with modified geometry to the family of WarmAir 135 FilteredFlo® blankets. The modified blanket is manufactured from the same materials using the same manufacturing methods as the already cleared blankets. The major differences are that the modified blanket differs in size from other blankets and is placed under the body of the patient in the same manner as the neonate/pediatric FilteredFlo® blanket previously cleared in K 101148. There is no change to the intended use statement.

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 criteria in ASTM F-2196 as did the other FilteredFlo® blankets. Testing of the blanket under a simulated patient showed the modified blanket meets the specification for maximum contact surface temperature to be within the requirements identified in ASTM F-2196.

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 thus meeting the definition of substantial equivalence. Testing shows the modified blanket to perform similarly to the predicate blankets.

Cincinnati Sub Zero

12011 Mosteller Road

Cincinnati, OH

WA 135 Special 510(k) Page 16 of 59 .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JAN 1 7 2013

Cincinnati Sub-Zero Products, Inc. Mr. Steve Berke, President and CEO 12011 Mosteller Road · Cincinnati, Ohio 45241-1528

Re: K123946

Trade/Device Name: WarmAir 9, Model 135 Hyperthermia System (Controller and Blankets) Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: DWJ Dated: December 14, 2012 Received: December 21, 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 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

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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/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 vours.

Matthew G. Hillebrenner

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): K123940

Device Name: Warm Air® Model 135 and Blankets

Indications for Use:

X Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K123946
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(Posted November 13, 2003)
Page 1 of 1WA 135 Special 510(k) Page 14 of 59

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).