The WarmTouch™ Surgical Access Blanket is intended for prevention and treatment of hypothermia, and for the management of appropriate normothermia. The warming system is for use only in a hospital or clinical environment, and only by trained and licensed caregivers.

The WarmTouch™ Torso Blanket is intended for prevention and treatment of hypothermia, and for the management of appropriate normothermia. The warming system is for use only in a hospital or clinical environment, and only by trained and licensed caregivers.

Device Description

The WarmTouch Surgical Access Blanket is a sterile full body blanket with a rectangular opening that allows access to the abdominal or lower back. This blanket stays in place via medial tape.

The WarmTouch Torso Blanket is a non-sterile blanket that is intended to cover the patient from the shoulders to the waist/hips. This blanket has flaps on either side that are tucked underneath the patient and medical tape at the distal end.

These blankets are intended to be used with the WarmTouch convective warming units.

AI/ML Overview

The document describes a 510(k) premarket notification for the "WarmTouch Surgical Access & Torso Blankets," demonstrating substantial equivalence to a predicate device. This submission focuses on non-clinical performance and does not involve AI or algorithms, and therefore does not include information typically found in studies for AI/ML devices.

Here's the information based on the provided text, with clarifications where the requested information is not applicable to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Device Performance (Result)
Surgical Access Blanket:
Contact Surface Temperature	Pass
Useful Life	Pass
Usability	Pass
Anthropomorphic Design	Pass
Cleanliness & Sterilization	No Impact

Torso Blanket:
Contact Surface Temperature	Pass
Useful Life	Pass
Usability	Pass
Anthropomorphic Design	Pass

Surgical Access & Torso Blanket:
System Usability	Pass
Biocompatibility	No Impact
Design Validation	Pass

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

The document does not explicitly state the sample sizes for each specific test (e.g., number of blankets tested for Contact Surface Temperature or Useful Life). It refers to "verification and validation testing."

Data Provenance: Not specified, but generally, such non-clinical testing would be conducted in a laboratory or simulated environment by the manufacturer (Covidien, USA). The data is retrospective in the sense that the testing was completed before the submission to demonstrate compliance.

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

This information is not applicable to this submission. "Ground truth" in the context of expert review is typically relevant for diagnostic AI devices where human experts label data. For this device, the "ground truth" is established by engineering specifications, regulatory standards, and objective physical measurements to determine if a "Pass" or "Fail" outcome is met.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies with human assessors, particularly for subjective assessments or when there's disagreement among experts. Here, the tests are primarily objective measurements against predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a medical device (surgical blankets) and not an AI/ML diagnostic or treatment assistance device. Therefore, no MRMC study or AI-related performance improvement metrics are relevant.

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. The device's performance is standalone in the sense that it functions physically as intended without algorithmic intervention.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, established industry standards, and regulatory requirements for the safety and effectiveness of thermal regulating systems. For example, "Contact Surface Temperature" would have a defined acceptable range, and if the blanket's temperature falls within that range, it "Passes."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set." The engineering and design processes involve iterative development and prototyping, but not in the context of machine learning model training.

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

Not applicable, as there is no training set for an AI/ML model. The design and performance criteria for the blankets are established through engineering design principles, risk analysis, and compliance with medical device standards.

Summary

{0}------------------------------------------------

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Substantial Equivalence for the WarmTouch Surgical Access & Torso Blankets.

Submitted By:	Covidien6135 Gunbarrel AvenueBoulder, CO 80301
Date:	July 26, 2013
Contact Person:	Kelsey LeeSenior Regulatory Affairs Specialist(303) 305-2760
Proprietary Name:	WarmTouch Surgical Access & Torso Blankets
Common Name:	Thermal Regulation System
Device Classification Regulation:	21 CFR 870.5900 - Class II
Device Product Code & Panel:	DWJ
Predicate Device:	WarmTouch CareDrape Cardiac Blanket(K014121)

JUL 2 9 2013#### Device Description

The WarmTouch Surgical Access Blanket is a sterile full body blanket with a rectangular opening that allows access to the abdominal or lower back. This blanket stays in place via medial tape.

These blankets are intended to be used with the WarmTouch convective warming units.

{1}------------------------------------------------

Indications for Use/Intended Use

The WarmTouch Surgical Access Blanket is indicated for use during abdominal, laparotomy, and spinal procedures. The Surgical Access Blanket is to be used only with Warm Touch convective warming units with model numbers 5015300A, 5015900 and 5016000. The warming system is for use only in a hospital or clinical environment, and only by trained and licensed caregivers.

The WarmTouch Torso Blanket is indicated for use during procedures performed on the lower part of the body or lower extremities. The Torso Blanket is to be used only with WarmTouch convective warming units with model numbers 5015300A, 5015900 and 5016000. The warming system is for use only in a hospital or clinical environment, and only by trained and licensed caregivers.

Technological Characteristics Comparison

The subject WarmTouch blankets have similar materials, manufacturing processes, incorporation of a medical grade tape, and the Surgical Access Blanket has an equivalent sterilization method and shelf life as the predicate CareDrape Cardiac Blanket.

The subject WarmTouch blankets have the following new features when compared to the predicate CareDrape Cardiac Blanket:

Surgical Access: label identifying orientation, a face shield, a rectangular access window. different tabs and physical dimensions

Torso: label identifying orientation, a face shield, different tabs and physical dimensions These new technological and labelling features are not expected to raise new questions of safety or efficacy or be not substantially equivalent since the labeling change adds clarity to insure more effective use. The different physical dimensions face shield, tabs and access window have been shown to be substantially equivalent through performance and usability testing and a risk analysis has been performed for these products.

{2}------------------------------------------------

Substantial Equivalence - Non-Clinical Evidence

キ

ﻤﻨﺘﻬﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

Substantial equivalence was shown through the following verification and validation testing:

	Modification fromPredicate	Verification/Validation Test	Results
Surgical AccessBlanket	New blanket design	Contact SurfaceTemperature	Pass
	New blanket design andconstruction	Useful Life	Pass
	New blanket design	Usability	Pass
	New blanket design	Anthropomorphic Design	Pass
	New material and design	Cleanliness & Sterilization	No Impact
Torso Blanket	New blanket design	Contact SurfaceTemperature	Pass
	New blanket design andconstruction	Useful Life	Pass
	New blanket design	Usability	Pass
	New blanket design	Anthropomorphic Design	Pass
Surgical Access &Torso Blanket	New blanket design,construction andmaterials	System Usability	Pass
	New materials	Biocompatibility	No Impact
	New blanket design	Design Validation	Pass

The results of the tests show that the subject WarmTouch Surgical Access & Torso Blankets can be considered substantially equivalent to the legally marketed predicate.

Substantial Equivalence - Clinical Evidence

N/A - Clinical evidence was not necessary to show substantial equivalence

Substantial Equivalence - Conclusions

Substantial equivalence to the predicate is shown through usability, useful life testing, anthropomorphic verification, and contact surface temperature verification. From the evidence presented in the Premarket Notification, the subject devices can be considered substantially equivalent.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a bird or a stylized human figure.

Public Health Service

Food and Drug Administration 0903 New Hamoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 29, 2013

Covidien Ms. Kelsey Lee Sr. Regulatory Affairs Specialist 6135 Gunbarrel Ave. Boulder, CO 80301

Re: K131361

Trade/Device Name: WarmTouch Surgical Access & Torso Blankets Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: June 3, 2013 Received: June 4, 2013

Dear Ms. Lee:

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 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

{4}------------------------------------------------

Page 2 - Ms. Lee

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.Z. Hillman

for

for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number: K131361

Device Name: WarmTouch™ Surgical Access Blanket

Indications for Use:

X Prescription Use _ (Part 21 CFR 801 Subpart D) (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)

M. Z. Hillerman

{6}------------------------------------------------

Indications for Use

510(k) Number: K131361

Device Name: WarmTouch™ Torso Blanket

Indications for Use:

Prescription Use X _______________ AND/OR Over-The-Counter Use_ (Part 21 CFR 801 Subpart D) (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)

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).