ALLEGIANCE KWIK HEAT WARM PERINEAL PACK

K973770 · Allegiance Healthcare Corp. · IMD · Nov 13, 1997 · Physical Medicine

Device Facts

• Record ID: K973770
• Device Name: ALLEGIANCE KWIK HEAT WARM PERINEAL PACK
• Applicant: Allegiance Healthcare Corp.
• Product Code: IMD · Physical Medicine
• Decision Date: Nov 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5710
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The Allegiance Kwik Heat™ Perineal Warm Pack is an Over-The-Counter, single-use, non-sterile device. It is a heat therapy pack intended to provide heat therapy for body surfaces. Additionally, this pack can be used post delivery to absorb postpartum lochia and provide therapeutic heat to relieve pain associated with an episiotomy incision.

Device Story

Single-use, non-sterile, over-the-counter perineal warm pack; consists of outer polyester-wrapped pouch containing perineal pad and internal plastic bubble; internal bubble houses supercooled solution of sodium thiosulfate, dextrose, and water; activation via folding unit to rupture internal bubble and kneading to initiate exothermic chemical reaction; provides localized heat therapy; used post-delivery to absorb lochia and relieve episiotomy-related pain/inflammation; intended for patient self-use.

Clinical Evidence

Bench testing only. Materials evaluated per ISO 10993-1, including skin sensitization, intracutaneous reactivity, and cytotoxicity. Active chemical mixture underwent primary skin irritation testing and confirmed toxicologically acceptable. Temperature performance testing conducted. Sodium thiosulfate meets Food Chemicals Codex (1981) and 21 CFR 184.1807 food-grade requirements.

Technological Characteristics

Materials: non-woven wrapped cellulose wood pulp fiber pad, polyester wrap, plastic pouch. Energy source: exothermic chemical reaction (sodium thiosulfate, dextrose, water). Form factor: perineal pad with integrated heat pack. Biocompatibility: ISO 10993-1 compliant. Chemical standards: Food Chemicals Codex (1981), 21 CFR 184.1807.

Indications for Use

Indicated for use as a heat therapy pack for body surfaces and post-delivery for absorbing lochia and relieving edema, inflammation, and pain associated with episiotomy incisions.

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

• Allegiance Kwik Kold™ Peri Cold Pack (K970399)
• Jack Frost Perineal Pad (Warm)
• H.M.S. ™ Peri Warm™ Perineal Pack
• Allegiance Preamendment Small Hot Pack

Submission Summary (Full Text)

{0}------------------------------------------------

Allegiance Healthcare Corporation 510(k) Notification Allegiance Kwik Heat™ Perineal Warm Pack Thermal Business Unit

NOV 1 3 1997

K973770

# ATTACHMENT F

## SUMMARY OF SAFETY & EFFECTIVENESS

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol that resembles a plus sign, but it is made up of many small squares. The word "Allegiance" is the main focus of the image.

Allegiance Healthcare Corporation

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

Kg73770

### ATTACHMENT F

### SUMMARY OF SAFETY AND EFFECTIVENESS

Manufacturer:

Regulatory Affairs Contact

Telephone:

Date Summary Prepared:

Product Trade Name:

Common Name:

Classification:

Predicate Device: (K970399) Preamendment

Description:

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

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

[phone]

September 26, 1997

Allegiance Kwik Heat™ Perineal Warm Pack

Perineal Hot Pack

Cold and Hot Disposable Pack

Allegiance Kwik Kold™ Peri Cold Pack Large Adult Hot Pack

The Allegiance Kwik Heat™ Perineal Warm Pack is comprised of an outer pouch which is secured to a perineal pad and then wrapped in a polyester material. 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. The perineal pad is made of a non-woven wrapped cellulose wood pulp fiber. Activation of the heat source occurs by folding the unit to open the inner bubble which releases the liquid, and kneading the unit, thus creating a physical exothermic reaction.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a plus sign made up of small dots. The word is in black and the plus sign is also in black.

#### Allegiance Healthcare Corporation

・。

| 1500 Waukegan Road<br>McGaw Park, IL 60085<br>847.473.1500<br>FAX: [phone] | Page 2 of 2 |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Allegiance Kwik Heat™ Perineal Warm Pack<br>is an Over-The-Counter, single-use, non-sterile<br>device. It is a heat therapy pack intended to<br>provide heat therapy for body surfaces.<br>Additionally, this pack can be used post delivery to<br>absorb postpartum lochia and provide therapeutic<br>heat to relieve pain associated with an episiotomy<br>incision. |
| Substantial Equivalence: | The Allegiance Kwik Heat™ Perineal Warm Pack<br>is substantially equivalent to the Allegiance Kwik<br>Kold™ Peri Cold Pack, the Jack Frost Perineal Pad<br>(Warm), and the H.M.S. ™ Peri Warm™ Perineal<br>Pack in that the:<br>- intended use is the same<br>- performance attributes are the same<br>- method of activation is the same<br>The Allegiance Kwik Heat™ Perineal Warm Pack<br>is substantially equivalent to the Allegiance<br>Preamendment Small Hot Pack in that the:<br>- chemical composition is the same<br>- performance attributes of active<br>chemical ingredients are the same. |
| Summary of Testing: | All materials used in the composition of this hot<br>pack were identified, evaluated and tested as<br>required in ISO Standard 10993 Part 1. The<br>materials were subjected to skin sensitization,<br>intracutaneous reactivity and cytotoxicity testing.<br>Physical tests completed include: temperature<br>performance testing. The active chemical mixture<br>was subjected to primary skin irritation testing.<br>This mixture was found to be toxicologically<br>acceptable for its intended usage. The active<br>chemical ingredient was tested as identified in the<br>specifications of the Food Chemicals Codex, 3rd<br>Ed. (1981), p. 304, which is incorporated by<br>reference in the Code of Federal Regulations, 21<br>CFR 184.1807. Sodium Thiosulfate meets all food<br>grade requirements. This product is in compliance<br>with established standards, where applicable, and<br>was deemed acceptable for its intended use. |

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic element resembling an abstract human form, positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". The text is arranged in a circular fashion around the graphic, emphasizing the department's name and its association with the United States of America.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 1997

Ms. Patricia Sharpe-Gregg Manager, Regulatory Affairs Alleqiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085

Re: K973770 Allegiance Kwik Heat™ Perineal Warm Pack Regulátory Class: I Product Code: IMD Dated: October 1, 1997 Received: October 2, 1997

#### 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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 requlations.

{4}------------------------------------------------

Page 2 - Ms. Patricia Sharpe-Gregg

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 ene rogalacion Chororos) 211655 and .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

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "Allegiance" in a bold, italicized font. To the left of the word is a symbol that resembles a plus sign, but it is made up of many small dots. The word "Allegiance" is the main focus of the image and is prominently displayed.

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

510(k) Notification Kwik Heat™Warm Perineal Pack Thermal Business Unit Page 1 of 1

| 510(k) Number (if known): | Unknown |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

Indications For Use:

Allegiance Kwik Heat™ Warm Perineal Pack

Hot disposable pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces. Also used as a heat therapy pack with an absorbent perineal pad; for use post delivery to absorb lochea while relieving edema and inflammation associated with an episiotomy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
|------------------------------------------|------------------------------------------------------------------------|
| | Over-The Counter Use <span style="text-decoration: overline;">X</span> |

(Division Sign-Off)
sion of General Restorat

| 510(k) Number | K973770 |
|---------------|---------|
|---------------|---------|