(76 days)
Not Found
No
The device description details a chemical reaction for heat generation and does not mention any computational or learning components.
No
The device uses heat therapy to increase blood flow for blood sampling, which is a supportive action for a medical procedure rather than a direct therapeutic treatment for a condition or disease.
No
The device is a heat therapy pack used to increase blood flow for easier blood sampling, not to diagnose a condition.
No
The device description clearly outlines physical components (pouch, chemical mixture, activator disk) and a chemical reaction, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to increase peripheral blood flow and oxygenation prior to blood sampling. It is a physical therapy device used externally on the body.
- Mechanism of Action: The device works by generating heat through a chemical reaction, which is a physical process applied to the skin. It does not analyze biological samples (like blood, urine, etc.) to provide diagnostic information.
- Device Description: The description details the physical components and the exothermic reaction, not any components or processes related to analyzing biological specimens.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform such analysis.
N/A
Intended Use / Indications for 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.
Product codes
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Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
infant's heel
Indicated Patient Age Range
infant
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
All materials used in the composition of this hot pack are evaluated through USP XXII/Sodium Acetate Solution and relevant tests identifed 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5710 Hot or cold disposable pack.
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
0
Surgical Group
Baxter Healthcare Corporation 1500 Waukegan Road. Bldg. K McGaw Park, Illinois 60085
708.473.1500 FAX: 708.785.2460
SUMMARY OF SAFETY AND EFFECTIVENESS Appendix F
JUN - 6 1996
Baxter Healthcare Corporation Manufacturer: Surgical Group Thermal Business Unit 808 Highway 24 West Moberly, Missouri 65270
Marvalice Smith Surgical Group 1500 Waukegan Road McGaw Park, Illinois 60085
Telephone:
Date Summary Prepared:
Requlatory Affairs Contact
Product Trade Name:
Common Name:
Classification:
Predicate Device:
Description:
(847) 785-3322
February, 1996
Baxter Sodium Acetate Infant Heel Warmer™
Infant Heel Warmer
Hot Disposable Pack
Baxter Infant Heel Warmer™ (K950680)
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.
1
Intended Use:
Substantial Equivalence:
Summary of Testing:
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.
The Baxter Sodjum 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
All materials used in the composition of this hot pack are evaluated through USP XXII/Sodium Acetate Solution and relevant tests identifed 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.