WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET

K131361 · Covidien · DWJ · Jul 29, 2013 · Cardiovascular

Device Facts

• Record ID: K131361
• Device Name: WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
• Applicant: Covidien
• Product Code: DWJ · Cardiovascular
• Decision Date: Jul 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

WarmTouch Surgical Access & Torso Blankets are convective warming accessories used with WarmTouch warming units. Surgical Access Blanket: sterile, full-body, rectangular opening for abdominal/spinal access, medial tape fixation. Torso Blanket: non-sterile, covers shoulders to hips, side flaps for tucking, distal tape fixation. Used in hospital/clinical environments by trained caregivers to prevent/treat hypothermia and maintain normothermia. Blankets distribute warm air from the unit to the patient. Benefits include thermal regulation during surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing: contact surface temperature, useful life, usability, anthropomorphic design, and biocompatibility.

Technological Characteristics

Convective warming blankets. Materials: medical-grade materials with integrated medical tape. Features: orientation labels, face shields, access windows, specific tabs. Connectivity: requires WarmTouch convective warming units (models 5015300A, 5015900, 5016000).

Indications for Use

Indicated for prevention and treatment of hypothermia and management of normothermia in hospital or clinical settings. Surgical Access Blanket for abdominal, laparotomy, and spinal procedures. Torso Blanket for lower body or lower extremity procedures. For use by trained, licensed caregivers only.

Regulatory Classification

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.

Predicate Devices

• WarmTouch CareDrape Cardiac Blanket (K014121)

Submission Summary (Full Text)

{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: | Covidien<br>6135 Gunbarrel Avenue<br>Boulder, CO 80301 |
|-----------------------------------|----------------------------------------------------------------------|
| Date: | July 26, 2013 |
| Contact Person: | Kelsey Lee<br>Senior Regulatory Affairs Specialist<br>[phone] |
| 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<br>(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.

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.

{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 from<br>Predicate | Verification/Validation Test | Results |
|------------------------------------|------------------------------------------------------|--------------------------------|-----------|
| Surgical Access<br>Blanket | New blanket design | Contact Surface<br>Temperature | Pass |
| | New blanket design and<br>construction | 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 Surface<br>Temperature | Pass |
| | New blanket design and<br>construction | Useful Life | Pass |
| | New blanket design | Usability | Pass |
| | New blanket design | Anthropomorphic Design | Pass |
| Surgical Access &<br>Torso Blanket | New blanket design,<br>construction and<br>materials | 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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

> 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:

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.

> 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)