SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM

K011907 · Sims Level 1, Inc. · DWJ · Dec 18, 2001 · Cardiovascular

Device Facts

• Record ID: K011907
• Device Name: SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
• Applicant: Sims Level 1, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Dec 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Snuggle Warm 4000 Convective Warming System 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. It is intended for use by appropriately trained healthcare professionals in clinical environments.

Device Story

System comprises disposable single-use warming blanket and warming unit with hose-end temperature control; unit generates warm air distributed through blanket to patient. Used in clinical environments by trained healthcare professionals during and after surgery. Provides thermal regulation to prevent hypothermia and reduce cold discomfort. Device modifications improve performance over predicate.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Convective warming system consisting of a warming unit and disposable blanket. Features hose-end temperature control. Manufactured and certified in compliance with applicable US and international standards.

Indications for Use

Indicated for patients undergoing or recovering from surgical procedures to prevent hypothermia and reduce cold discomfort. 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

• Temp Marq™/ Snuggle Warm Convective Warming System (K904690)

Submission Summary (Full Text)

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DEC 1 82001

KD11907

## Summary of Safety and Effectiveness

### 510(k) Premarket Notification for the Snuggle Warm® 4000 Convective Warming System

### US FDA, Division of General, Restorative and Neurological Devices (DGRND) Branch: General Surgery Devices

The following information is provided in accordance with 21 CFR 807.92(a):

- Sponsor name and address: 1.
SIMS® LEVEL 1®, Inc. 160 Weymouth Street, Rockland, MA. 02370

- Sponsor telephone number: 781-878-8011, Ext. 730 2.
- Contact Person: Gabriel J. Muraca, Jr. Manager Regulatory Affairs 3.
- Date summary was prepared: June 6, 2001 4.
- Device Name: Snuggle Warm® 4000 Convective Warming System న్.
- Common Name: an external convective warming system used to warm the patient (). during and after surgical procedures.
- The legally marketed predicate device currently in commercial distribution is the 7. Temp Marq™/ Snuggle Warm Convective Warming System, described in premarket notification K904690 and cleared for market on February 1, 1991.

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#### Description of device: 8.

The Snuggle Warm consists of a disposable single use warming blanket that is placed in contact with the patient and a warming unit with a hose end temperature control connected to the blanket. 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 use by appropriately trained healthcare professionals in clinical environments.

#### Indications for use: 9.

The Snuggle Warm Convective Warming System 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. It is intended for use by appropriately trained healthcare professionals in clinical environments.

Technological characteristics: 10.

There are no significant changes in technological characteristics or intended use that impact the safety or effectiveness of these warming devices. As described in this submission, Level 1 has initiated modifications to improve the performance of the Snuggle Warm 4000 without affecting the safety or effectiveness of the Convective Warming System. The Snuggle Warm Convective Warming Systems are manufactured and certified in compliance with applicable International and US standards.

Gabriel J. Moreno, Jr.

Gabriel J. Muraca, Jr. Manager Regulatory Affairs SIMS® LEVEL 1®, Inc.

June 6, 2001

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DEPARTMENT OF HEALTH & HUMAN SERVICES • USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2001

Mr. Gabriel J. Muraca, Jr. Manager, Regulatory Affairs SIMS Level 1, Inc. 160 Weymouth Street Rockland, MA 02370

Re: K011907

K011907
Trade Name: Snuggle Warm� 4000 Convective Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulation System Regulatory Class: Class II (two) Product Code: DWJ Dated: September 28, 2001 Received: October 2, 2001

Dear Mr. Muraca:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your becaon 3 rQxy premised the device is substantially equivalent of in interests of 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 commerce prior to May 20, 1976, the ensordance with the provisions of the Federal Food, Drug, devices that have been receasinou in doce approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval incr You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicierore, market also actives, colorements for annual registration, listing of general controls provisions of assice, 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 If your device is classified (\$60 docro) ins. Existing major regulations affecting your device can thay be subject to such addresses connections, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Gabriel J. Muraca, Jr.

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 or my r vature 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Signature

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

Enclosure

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### INDICATIONS FOR USE

KO11907 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Snuggle Warm® 4000 Convective Warming System Device Name:

### Indications for Use:

The Snuggle Warm 4000 Convective Warming System 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. It is intended for use by appropriately trained healthcare professionals in clinical environments.

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Concurrence of CDRH. Office of Device Evaluation (ODE)

**Division of Cardiovascular & Respiratory Devices**
510(k) Number K011907

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Prescription Use (Per 21 (FR 801 109)

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Over-the-Counter Use