ALLEGIANCE PORTA-WARM MATTRESS

K982652 · Allegiance Healthcare Corp. · IMD · Jan 21, 1999 · Physical Medicine

Device Facts

• Record ID: K982652
• Device Name: ALLEGIANCE PORTA-WARM MATTRESS
• Applicant: Allegiance Healthcare Corp.
• Product Code: IMD · Physical Medicine
• Decision Date: Jan 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5710
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Allegiance Porta-Warm™ Mattress is a singleuse, non-sterile heat therapy pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces.

Device Story

Device is single-use, non-sterile hot therapy pack; consists of plastic pouch containing supercooled solution of sodium thiosulfate, dextrose, and water; inner bubble houses chemical mixture. Activation occurs by folding unit to rupture inner bubble; physical exothermic reaction generates heat. Used for medical purposes to provide hot therapy to body surfaces. Device is simple, manual, and disposable.

Clinical Evidence

Bench testing only. Materials evaluated for skin sensitization, intracutaneous reactivity, and cytotoxicity per ISO 10993 Part 1. Physical testing included temperature performance and tensile strength. Active chemical mixture subjected to primary skin irritation testing and verified against Food Chemicals Codex specifications.

Technological Characteristics

Single-use, non-sterile plastic pouch containing sodium thiosulfate, dextrose, and water. Exothermic reaction triggered by mechanical activation (folding). Materials tested per ISO 10993-1. Active ingredient meets Food Chemicals Codex (1981) specifications.

Indications for Use

Indicated for medical purposes as a hot therapy pack for body surfaces.

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

• Porta-Warm™ Mattress (K950860)
• Allegiance Infant Heel™ Warmer (K934631)
• Prism Technologies, Inc. Transwarmer™

Submission Summary (Full Text)

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JAN 2 1 1999

K98657

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FAX: [phone]

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085 847.473.1500

## ATTACHMENT F

## SUMMARY OF SAFETY AND EFFECTIVENESS

Manufacturer:

Allegiance Healthcare Corporation Thermal Business Unit 808 Highway 24 West Moberly, Missouri 65270

Regulatory Affairs Contact Patricia Sharpe-Gregg 1500 Waukegan Road McGaw Park, Illinois 60085

Telephone:

Date Summary Prepared:

Product Trade Name:

Common Name:

Classification:

Predicate Device: Preamendment (K950860) (K934631)

Description:

[phone]

April 28, 1998

Allegiance Porta-Warm™ Mattress

Hot Pack

Cold and Hot Disposable Pack

Allegiance Porta-Warm™ ™ Mattress Allegiance Infant Heel™ Warmer Prism Technologies, Inc. Transwarmer™

The. Porta-Warm™ Mattress consists of a heat source housed in a plastic pouch. The heat source pouch consists of a supercooled solution of sodium thiosulfate, dextrose and water. The sodium thiosulfate, dextrose and water "bubble" is housed in a separate plastic pouch inside the outer pouch. Activation of the heat source occurs by folding the unit to open the inner bubble which releases the liquid, thus creating a physical exothermic reaction.

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## Allegiance Healthcare Corporation

ATTACHMENT F Page 2 of 2

1500 Waukegan Road McGaw Park, IL 60085 847.473.1500 FAX: [phone]

Intended Use:

The Allegiance Porta-Warm™ Mattress is a singleuse, non-sterile heat therapy pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces.

The Allegiance Porta-Warm™ Mattress is substantially equivalent to the preamendment Porta-Warm™ Mattress and the Allegiance Infant Heel™ Warmer in that the:

- chemical composition is the same
- performance attributes of active chemical ingredients are the same.
- method of activation is the same

The Allegiance Porta-Warm™ Mattress is substantially equivalent to the preamendment Porta-Warm™ Mattress and Prism Technologies, Inc. Transwarmerl™ in that the:

- intended use is the same
- performance attributes are the same

All materials used in the composition of this hot pack were identified, evaluated and tested as required in ISO Standard 10993 Part 1. The materials were subiected to skin sensitization. intracutaneous reactivity and cytotoxicity testing. Physical tests completed include: temperature performance and tensile strength tests. The active chemical mixture was subjected to primary skin irritation testing. This mixture was found to be toxicologically acceptable for its intended usage. The active chemical ingredient was tested as identified in the specifications of the Food Chemicals Codex. 3rd Ed. (1981), p. 304, which is incorporated by reference in the Code of Federal Requlations, 21 CFR 184.1807. Sodium Thiosulfate meets all food grade requirements. This product is in compliance with established standards, where applicable, and was deemed acceptable for its intended use.

Substantial Equivalence:

Summary of Testing:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1999

Patricia Sharpe-Gregg, R.N., B.S.N. Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building MP-WM McGaw Park, Illinois 60085

Re: K982652 Allegiance Porta-Warm™ Mattress Trade Name: Regulatory Class: I Product Code: IMD Dated: November 19, 1998 December 2, 1998 Received:

Dear Ms. Sharpe-Gregg:

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 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). 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 Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further announcements action. 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

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Page 2 - Ms. Sharpe-Gregg

through 542 of the Act for devices under the Electronic Chrough 542 OF the notrol provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as Inis recei will as on the motification. The FDA described in your sio\n privalence of your device to a legally I inding of subbeancial ogeresults in a classification for your marketed predication of mits 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 regulacion (ic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at [phone]. the regulation entitled, "Misbranding by reference to ene regaracontification" (21CFR 807.97). " Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance oblained from cho momber [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Manois 60085 USA 847-473-1500 FAX: [phone]

510(k) Notification Porta-Warm™ Mattress Thermal Business Unit Page 1 of 1

| 510(k) Number (if known): | Unknown |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Allegiance Porta-Warm™ Mattress |
| Indications For Use: | Hot disposable pack intended for medical<br>purposes that consists of a sealed plastic bag<br>incorporating chemicals that, upon activation,<br>provides hot therapy for body surfaces. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use . (Per 21 CFR 801.109) or

Over-The Counter Use سَرِ حَ

| (Division Sign-Off). | B. Ballee |
|----------------------|-----------|
|----------------------|-----------|

Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | K982652 |
|---------------|---------|
|---------------|---------|