BAXTER SODIUM ACETATE INFANT HEEL WARMER

K961154 · Baxter Healthcare Corp · MPO · Jun 6, 1996 · Physical Medicine

Device Facts

• Record ID: K961154
• Device Name: BAXTER SODIUM ACETATE INFANT HEEL WARMER
• Applicant: Baxter Healthcare Corp
• Product Code: MPO · Physical Medicine
• Decision Date: Jun 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5710
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The Baxter Sodium Acetate Infant Heel Warmer™ is a single-use, non-sterile device. It is a heat therapy pack intended to be used on an infant's heel in order to increase peripheral blood flow and oxygenation prior to blood sampling.

Device Story

Single-use, non-sterile heat therapy pack; polyethylene/BON pouch containing sodium acetate, water, and activator disk. User pinches/flexes internal trigger to release aluminum oxide grit; initiates exothermic chemical reaction. Reaches max temperature 104 °F +/- 2.9 °F; heat gradually diminishes. Used in clinical settings by healthcare providers to warm infant heels; facilitates blood sampling by increasing peripheral blood flow and oxygenation.

Clinical Evidence

Bench testing only. Materials evaluated per USP XXII and ISO 10993. Testing included skin sensitization (guinea pig maximization), primary skin irritation, and cytotoxicity. Physical testing included tensile strength (material and seals), peak temperature, time at peak temperature, and temperature at five minutes. Chemical mixture confirmed non-toxic and food grade.

Technological Characteristics

Polyethylene/BON pouch; sodium acetate/water chemical mixture; aluminum oxide grit activator. Exothermic chemical reaction principle. Single-use, non-sterile. Compliant with ISO 10993 and USP XXII standards.

Indications for Use

Indicated for infants requiring increased peripheral blood flow and oxygenation prior to blood sampling.

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

• Baxter Infant Heel Warmer™ (K950680)

Reference Devices

• PRISM Infant Heel Warmer
• RECOVER® Infant Heel Warmer

Submission Summary (Full Text)

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Baxter Surgical Group

Baxter Healthcare Corporation
1500 Waukegan Road, Bldg. K
McGaw Park, Illinois 60085
USA
708.473.1500
FAX: [phone]
14961154

# SUMMARY OF SAFETY AND EFFECTIVENESS
## Appendix F
JUN - 6 1996

**Manufacturer:**
Baxter Healthcare Corporation
Surgical Group
Thermal Business Unit
808 Highway 24 West
Moberly, Missouri 65270

**Regulatory Affairs Contact**
Maryalice Smith
Surgical Group
1500 Waukegan Road
McGaw Park, Illinois 60085

**Telephone:**
[phone]

**Date Summary Prepared:**
February, 1996

**Product Trade Name:**
Baxter Sodium Acetate Infant Heel Warmer™

**Common Name:**
Infant Heel Warmer

**Classification:**
Hot Disposable Pack

**Predicate Device:**
Baxter Infant Heel Warmer™ (K950680)

**Description:**
The Baxter Sodium Acetate Infant Heel Warmer™ is comprised of a polyethylene/BON pouch enclosing the phase change chemical and the activator disk-like trigger. Upon pinching and flexing trigger also located within the pouch, aluminum oxide grit is released into the sodium acetate and water mixture thus initiating a chemical exothermic reaction. The hot pack immediately reaches a maximum temperature of 104 °F +/- 2.9 °F and gradually diminishes over time.

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Intended Use:

The Baxter Sodium Acetate Infant Heel Warmer™ is a single-use, non-sterile device. It is a heat therapy pack intended to be used on an infant's heel in order to increase peripheral blood flow and oxygenation prior to blood sampling.

Substantial Equivalence:

The Baxter Sodium Acetate Infant Heel Warmer™ is substantially equivalent to the Baxter Infant Heel Warmer™, PRISM Infant Heel Warmer and the RECOVER® Infant Heel Warmer in that:

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

Summary of Testing:

All materials used in the composition of this hot pack are evaluated through USP XXII/Sodium Acetate Solution and relevant tests identified in ISO Standard 10993. The outer pouch material was subjected to Skin Sensitization (Guinea pig Maximization), Primary Skin Irritation, and cytotoxicity testing. The materials were subjected to the following physical tests: material tensile strength width/length, side and top seal tensile strength, peak temperature, time at peak temperature, temperature at five minutes. The active chemical mixture was subjected to Primary Skin Irritation testing. This mixture was found to be non-toxic, food grade and toxicologically acceptable for its intended usage. This product is in compliance with established standards, where applicable, and was deemed acceptable for its intended use.