(90 days)
Florida Medical Industries, Recover® Infant Heel Warmer Pre 1976 Device
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No
The device description details a simple chemical reaction for heating and there is no mention of AI or ML terms or concepts.
No.
This device is for warming the heel site of an infant prior to a heel stick procedure to enhance vasodilation and increase blood flow for sampling. It does not treat or prevent any disease or condition, which is the primary characteristic of a therapeutic device.
No
The device is described as a warmer used to enhance vasodilation and increase blood flow for blood sampling, which is a preparation step for a medical procedure, not a diagnostic act itself. It doesn't analyze or process data to determine a medical condition.
No
The device description clearly states it is a physical product made of sodium acetate, water, a stainless steel disc, and a laminate bag, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Recover® Infant Heel Warmer is a device that applies heat externally to the infant's heel. Its purpose is to improve blood flow before a sample is taken, not to analyze the sample itself.
- Intended Use: The intended use clearly states it's for "warming the heel site of an infant prior to a heel stick procedure." This is a preparatory step for a diagnostic procedure (the blood draw and subsequent analysis), but the warmer itself is not performing the diagnostic test.
Therefore, based on the provided information, the Recover® Infant Heel Warmer is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Recover® Infant Heel Warmer is intended to be used for warming the heel site of an infant prior to a heel stick procedure. The warmth enhances vasodilation and increases blood flow in an infant's heel to ensure adequate blood for sampling.
Product codes
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Device Description
Non Toxic, Food Grade Sodium Acetate and water with a stainless steel catalytic disc sealed in a nylon /polyethylene laminate bag. Provides heat to 105°F.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
heel
Indicated Patient Age Range
infant
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Florida Medical Industries, Recover® Infant Heel Warmer Pre 1976 Device
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K964523
510(K) SUMMARY
FEB 1 0 1997
(as required by 807.92(c))
Regulatory & Marketing Services, Inc. (RMS) Submitter of 510(k): 40178 U.S. 19 North Tarpon Springs, FL 34689
Phone: 813-942-3908 Fax: 813-942-3828
Patrick J. Lamb or Edward H. Ransom
Contact Person:
Date of Summary:
Trade Name: Recover® Infant Heel Warmer
Classification Name: Pack, Hot, Disposable
Predicate Device: Florida Medical Industries, Recover® Infant Heel Warmer Pre 1976 Device
October 18 , 1996
Device Description/ Comparison:
Non Toxic, Food Grade Sodium Acetate and water with a stainless steel catalytic disc sealed in a nylon /polyethylene laminate bag. Provides heat to 105°F.
| Proposed Device | Marketed Device | |
|---|---|---|
| Florida Medical | ||
| Industries | Florida Medical | |
| Industries | ||
| Contents | Food-grade sodium | |
| acetate and water. | ||
| Disc: Stainless Steel | ||
| Catalytic disc. | Magnesium Sulphate | |
| (Kieserite); Colloidal Clay; water. | ||
| Temp. | 105° | 105° |
Intended Use:
The Recover® Infant Heel Warmer is intended to be used for warming the heel site of an infant prior to a heel stick procedure. The warmth enhances vasodilation and increases blood flow in an infant's heel to ensure adequate blood for sampling.