LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET

K061513 · Smiths Medical Asd, Inc. · DWJ · Aug 1, 2006 · Cardiovascular

Device Facts

• Record ID: K061513
• Device Name: LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET
• Applicant: Smiths Medical Asd, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Aug 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

For thermal regulation of a patient's temperature to prevent hypothermia and/or reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.

Device Story

Level 1 Snuggle Warm Pediatric Underbody Blanket is a single-use convective warming blanket component of the Snuggle Warm 4000 Convective Warming System. System consists of a warming unit (temperature controller), hose, and blanket. Warming unit generates warm air, delivered through hose to blanket placed under patient. Used in clinical environments by trained healthcare professionals during and after surgical procedures. Device provides thermal regulation to maintain patient normothermia and reduce cold discomfort. Benefits include prevention of hypothermia.

Clinical Evidence

No clinical data. Bench testing only to demonstrate substantial equivalence to existing convective warming blankets, including compliance with ASTM F2196:2002 and ISO 10993-1:2003.

Technological Characteristics

Single-use convective warming blanket; underbody configuration. Materials and manufacturing processes consistent with predicate. Complies with ASTM F2196:2002 (forced air patient temperature management) and ISO 10993-1:2003 (biocompatibility). Energy source: forced warm air from external warming unit.

Indications for Use

Indicated for thermal regulation of patients to prevent hypothermia and/or reduce cold discomfort during and after surgical procedures. Intended for use by trained healthcare professionals in clinical settings.

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

• Snuggle Warm® 4000 Convective Warming System (K011907)

Submission Summary (Full Text)

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## SECTION 5, 510(k) Summary

### 510(K) SUMMARY:

### Company Information:

Smiths Medical ASD, Inc. 160 Weymouth Street Rockland, MA 02370 [phone], prompt 4, ext 2457 Contact: Timothy J. Talcott Director, Regulatory Affairs and Compliance

Summary Prepared: May 26, 2006

### Product Name:

Trade Name: Level 18 Snuggle Warm® Pediatric Underbody Blanket Common Name: Convective Warming System

Classification Name: Thermal Regulating System (21 CFR 870.5900, Product Code DWJ)

### Predicate Device(s):

K011907 Smiths Medical ASD, Inc. (formerly Level 1 Inc.), Snuggle Warm® 4000 Convective Warming System. The Snuggle Warm 4000 Convective Warming System consists of a Convective Warming Unit, a hose (that connects to the Convective Warming Unit on one end) and a blanket; which connects onto the other end of the hose. The forced warm air travels from the Warming Unit through the hose to the blanket that is placed on the patient. There are currently 7 variations of Convective Warming Blankets in the non-sterile blanket family.

### Disposables Single-Use Blankets

- SW2001 Full Body Blanket .
- SW2002 Pediatric Blanket
- SW2003 Upper Body Blanket
- SW2004 Lower Body Blanket ●
- SW2005 Neonate to Small Child Intraoperative Blanket
- SW2006 Preemic to Neonate Intraoperative Blanket
- SW2007 Tube Blanket

### Device Description:

### Smiths Medical ASD, Inc.

#### Anesthesia and Safety Devices Division

10 Bowman Drive Keene NH 03431-0724 USA Tel: [phone] Fax: [phone] Fax: [phone]
www.smiths-medical.com AUG (0) 1 2006

K061513
Page 1 of 3

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Snuggle Warm 4000 Convective Warming System that will include the Pediatric and Large Pediatric Underbody blankets (Model SW2009 & SW2011)

- The Snuggle Warm® 4000 Convective Warming System, identified as a Thermal . Regulation System by the FDA, consists of a Convective Warming Unit (temperature controller), a hose, and a single-use Convective Warming Blanket (including the underbody blankets).
- The Snuggle Warm® 4000 Convective Warming System's single-use disposable . Convective Warming Blankets (including the underbody blankets) are placed in contact with the patient and attached to a warming unit via a hose with end temperature controls. The warming unit generates warm air that is distributed throughout the warming blanket to warm the patient during and after surgical procedures.
- It is intended for thermal regulating a patient's temperature to prevent hypothermia by . a warm air heated blanket system to reduce cold discomfort during and after surgical procedures.

The Pediatric and Large Pediatric Underbody Blankets are single-use Convective Warming Blankets that will be added to the existing Convective Warming Blanket family. The Pediatric and Large Pediatric Underbody Blankets are components of the Snuggle Warm 4000 Convective Warming System of which the indications for use remains the same.

## Indications for Use:

For thermal regulation of a patient's temperature to prevent hypothermia and/or reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.

## Technological Characteristics:

The proposed and predicate devices are made of similar materials and employ similar manufacturing processes. These blankets are intended to be used under the body, rather than over the body.

## Non-Clinical Data:

Bench testing is performed to demonstrate that the proposed convective warming blankets are substantially equivalent to the existing convective warming blankets currently marketed by Smiths Medical. The blankets are designed to meet the requirements of the following standards:

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- ASTM F2196:2002, Standard Specification for Circulating Liquid and Forced Air � Patient Temperature Management
- ISO 10993-1 2003, Biological Evaluation of Medical Devices Evaluation and . Testing

## Clinical Data:

Not required

## Conclusion:

The proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

SMITHS,MEDICAL ASD, INC

Timothy A. Baker

Timothy J. Talcott Director, Regulatory Affairs and Compliance

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG () 1 2006

Smiths Medical ASD, Inc. c/o Mr. Timothy J. Talcott Director, Regulatory Affairs and Compliance 10 Bowman Drive Keene, NH 03431-0724

Re: K061513

Level 1® Snuggle Warm® Pediatric Underbody Blanket Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulation System Regulatory Class: Class II (two) Product Code: DWJ Dated: May 26, 2006 Received: June 1. 2006

Dear Mr. Talcott:

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 cnactment 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. WDA max publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Timothy J. Talcott

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

sina R. Vicher

A 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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## SECTION 4, Indications for Use Statement

# Indications for Use

510(k) Number (if known): K0615-13

Device Name: Level 1® Snuggle Warm® Pediatric Underbody Blanket

Indications for Use:

For thermal regulation of a patient's temperature to prevent hypothermia and/or reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

D.m.m. R. L. h.m.i

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(Division Sign-Off) Division of Cardiovascular Devices

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