DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS

K980509 · Deroyal Industries, Inc. · IMD · Feb 26, 1998 · Physical Medicine

Device Facts

• Record ID: K980509
• Device Name: DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS
• Applicant: Deroyal Industries, Inc.
• Product Code: IMD · Physical Medicine
• Decision Date: Feb 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5710
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The DeRoyal Industries, Inc. Infant Transport Mattress is indicated for use to assist in maintaining infant body temperature.

Device Story

Device is a chemical hot pack for infant transport; provides warm therapy to maintain body temperature. Consists of low-density polyethylene (LDPE) pouch containing food-grade sodium acetate. Activation occurs via internal trigger; exothermic reaction achieves approximately 105° F. Used in clinical transport settings to support thermoregulation. Non-sterile device.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Low-density polyethylene (LDPE) film. Active ingredient: Food-grade sodium acetate. Energy source: Exothermic chemical reaction. Dimensions: 16" x 9.5". Sterility: Non-sterile.

Indications for Use

Indicated for infants requiring assistance in maintaining body temperature.

Regulatory Classification

Identification

A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

Predicate Devices

• Prism Technologies

Submission Summary (Full Text)

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K980804

# DeRoyal Industries, Inc. Infant Transport Mattress

FEB 2 6 1998

#### 510(k) Summary

# SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED

#### SUBMITTER INFORMATION

| NAME: | DeRoyal Industries, Inc. | TELEPHONE: | [phone] |
|----------|-------------------------------------|----------------------|------------------|
| ADDRESS: | 200 DeBusk Lane<br>Powell, TN 37849 | CONTACT: | Camille Matlock |
| | | DATE OF PREPARATION: | February 9, 1998 |

## DEVICE NAMES

NAME: COMMON/USUAL NAME: CLASSIFICATION NAME (if known): DeRoyal Industries, Inc. Infant Transport Mattress . Infant Transport Mattress Pack, Hot, Chemical

## PREDICATE OR LEGALLY MARKETED DEVICES

Prism Technologies

## DEVICE DESCRIPTION

The DeRoyal Industries, Inc. Infant Transport Mattress is a device intended for medical purposes to provide warm therapy that helps maintain infant body temperature.

Device Design/Materials UsedPhysical Properties: The DeRoyal Infant Transport Mattress is designed similar to those marketed by other manufacturers. The pouch is comprised of a low-density polyethylene (LDPE) film bag which contains the activation ingredient, sodium acetate (food grade).

## DEVICE INTENDED USE

The DeRoyal Industries, Inc. Infant Transport Mattress is indicated for use to assist in maintaining infant body temperature.

## TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)

| Characteristic | DeRoyal Device | Other Devices |
|---------------------------------------------------|-----------------------------|-----------------------------------|
| Pouch Dimension | Approximately 16" X 9.5" | Approximately 13" X 9" |
| Pouch Material | LDPE | LDPE or<br>Other Similar Material |
| Active Ingredient | Sodium Acetate (Food Grade) | Sodium Acetate (Food Grade) |
| Trigger | Internally Located | Internally Located |
| Sterility | Non-Sterile | Non-Sterile |
| Approximate Temperature<br>Achieved at Activation | 105° F | 104° F |

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all connected by a single line that runs from the top of the head to the bottom of the chin. The image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 1998

Ms. Camille Matlock Regulatory Affairs DeRoyal Industries, Inc. 200 DeBusk Lane Powell, Tennessee 37849

K980509 Re: Trade Name: DeRoyal Industries, Inc. Infant Transport Mattress Requlatory Class: I Product Code: IMD February 9, 1998 Dated: Received: February 10, 1998

Dear Ms. Matlock:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Camille Matlock

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure --------------------------------------------------------------------------------------------------------------------------------------------------------------------

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| 510(k) Number (if known): | |
|---------------------------|---------------------------------------------------|
| Device Name: | DeRoyal Industries Inc. Infant Transport Mattress |

Indications for Use:

:

:

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The DeRoyal Industries Inc. Infant Transport Mattress is to be used to assist in maintaining infant body temperature.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="signature" src="signature.png"/> |
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| Sign-Off of General Restorative Devices Number | K980509 |

| Prescription Use (Per 21 CFR § 801.109) <img alt="checkbox" src="checkbox.png"/> | OR | Over-The-Counter Use ______ |
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