KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)

K970399 · Allegiance Healthcare Corp. · IMD · Apr 3, 1997 · Physical Medicine

Device Facts

• Record ID: K970399
• Device Name: KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)
• Applicant: Allegiance Healthcare Corp.
• Product Code: IMD · Physical Medicine
• Decision Date: Apr 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5710
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Allegiance Kwik Kold™ Peri Cold Pack is an over-the-counter, single-use, non-sterile device. It is a cold therapy pack intended to be used post delivery to absorb postpartum lochea while providing cold therapy relieving edema and inflammation associated with an episiotomy incision.

Device Story

Device: single-use, non-sterile perineal cold pack; multi-layer pouch secured to perineal pad; wrapped in polyester. Cold source: ammonium nitrate and water in separate internal compartments. Activation: folding and shaking unit to rupture water bubble; endothermic reaction produces cold (approx. 33° F) for 30-35 minutes. Usage: post-delivery; patient self-use or clinician-assisted. Function: absorbs lochea; provides localized cold therapy to reduce edema/inflammation. Benefit: symptomatic relief for postpartum episiotomy recovery.

Clinical Evidence

Bench testing only. Materials evaluated per ISO 10993-1 (skin sensitization, primary skin irritation, cytotoxicity). Physical performance testing included coldest temperature achieved, duration of cold, and temperature at five minutes. Active chemical mixture confirmed toxicologically acceptable.

Technological Characteristics

Materials: non-woven wrapped cellulose wood pulp fiber, polyester wrap, plastic pouch. Cold source: ammonium nitrate and water. Principle: endothermic chemical reaction. Form factor: perineal pad with integrated cold pack. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for postpartum patients requiring cold therapy to relieve edema and inflammation from episiotomy incisions and to absorb postpartum lochea.

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 Peri K™ Perineal Cold Pack (K970399)
• Jack Frost Perineal Cold Pack
• Florida Medical Perineal Cool Comfort Pack
• Hospital Medical Services Peri + Plus Peri Cold Pack

Submission Summary (Full Text)

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Allegiance

Allegiance Healthcare Corporation

1500 Waukegan Road

McGaw Park, IL 60085

847.473.1500

APR - 3 1997

# K970399

# SUMMARY OF SAFETY AND EFFECTIVENESS

# Appendix F

| Manufacturer: | Allegiance Healthcare Corporation Surgical Group Thermal Business Unit 808 Highway 24 West Moberly, Missouri 65270 |
| --- | --- |
| Regulatory Affairs Contact | Maryalice Smith 1500 Waukegan Road McGaw Park, Illinois 60085 |
| Telephone: | [phone] |
| Date Summary Prepared: | November, 1996 |
| Product Trade Name: | Allegiance Kwik Kold™ Peri Cold Pack |
| Common Name: | Perineal Cold Pack |
| Classification: | Cold and Hot Disposable Pack |
| Predicate Device: | Allegiance Peri K™ Perineal Cold Pack |
| Description: | The Allegiance Kwik Kold™ Peri Cold Pack is comprised of a multi layer pouch which is secured to a perineal pad and then wrapped in a one ply polyester material. The cold source pouch consist of ammonium nitrate and water. The water "bubble" is housed in a separate plastic pouch surrounded by ammonium nitrate. The perineal pad is made of a non-woven wrapped cellulose wood pulp fiber. Activation of the cold source occurs by folding and shaking the unit, thus resulting in a cooled solution from an endothermic reaction lasting approximately 30 to 35 minutes with a coldest temperature of approximately 33° F. |
| Intended Use: | The Allegiance Kwik Kold™ Peri Cold Pack is an over-the-counter, single-use, non-sterile device. It is a cold therapy pack intended to be used post delivery to absorb postpartum lochea while providing cold therapy relieving edema and inflammation associated with an episiotomy incision. |

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Substantial Equivalence:

The Allegiance Kwik Kold™ Peri Cold Pack is substantially equivalent to the Allegiance Peri K™ Perineal Cold Pack, Jack Frost Perineal Cold Pack, Florida Medical Perineal Cool Comfort Pack, and Hospital Medical Services Peri + Plus Peri Cold Pack in that the:

- intended use is the same
- performance attributes are equal
- chemical composition is the same
- method of activation is the same
- coldest temperatures achieved are comparable

Summary of Testing:

All materials used in the composition of this cold pack are evaluated and tested as identified in ISO Standard 10993 Part 1. The materials were subjected to skin sensitization (guinea pig maximization), primary skin irritation and cytotoxicity testing. Physical tests performed include: coldest temperature, time at coldest temperature, and temperature at five minutes. The active chemical mixture was subjected to Primary Skin Irritation testing. This mixture was found to be toxicologically acceptable for its intended usage. This product is in compliance with established standards, where applicable, and was deemed acceptable for its intended use.