(47 days)
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No
The device description details a chemical reaction for cooling and does not mention any computational or data-driven processes.
No.
The device is used for first aid to reduce minor localized pain, swelling, and discomfort, which are not considered therapeutic purposes.
No
The device provides instant cold treatment for pain, swelling, and discomfort, which is a therapeutic function rather than a diagnostic one. It does not identify or detect any conditions.
No
The device description clearly outlines a physical product (a bag containing chemicals) that undergoes a chemical reaction to produce cold, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing instant cold treatment for first aid purposes to reduce pain, swelling, and discomfort. This is a therapeutic/physical treatment applied externally to the body.
- Device Description: The device works through a chemical reaction to produce cold, which is then applied externally. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to be used in vitro (outside the body) to test samples from the body. This device is used in vivo (on the body) for a physical effect.
N/A
Intended Use / Indications for Use
The device provides instant cold treatment used for first aid purposes to reduce minor local pain, swelling and discomfort.
Product codes
890.5710
Device Description
The Kick Ice pack consists of a bag containing Ammonium Nitrate and a liquid bubble bag containing water. The Ammonium Nitrate in the water produces a chemical reaction- When pressure is applied to the inner bubble through the outer bag the inner bubble of water opens up mixing it with the Ammonium Nitrate thereby producing cold.
The material for the bag will consist of either polyester, or laminated polyethylene.
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
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Indicated Patient Age Range
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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)
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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
ok ice. Inc.
P.O. Box 5519 EKS
Johnson City, Tn 37603
(423) 975-KICK
OCT 30 1986 K 96 3666
510K SUMMARY
October 16, 1996
TRADE NAME: INSTANT COLD PACK COMMON NAME: INSTANT COLD PACK CLASSIFICATION NAME: HOT OR COLD DISPOSABLE PACK 890.5710
Per Section 807.92(a)(3)(5), equivalency is being claimed on ACE Brand Instant Cold Pack, 3M and Jack Frost. The device provides instant cold treatment used for first aid purposes to reduce minor local pain, swelling and discomfort.
Our contact is Victoria M. Phillips at (800) 833-7678.
The Kick Ice pack consists of a bag containing Ammonium Nitrate and a liquid bubble bag containing water. The Ammonium Nitrate in the water produces a chemical reaction- When pressure is applied to the inner bubble through the outer bag the inner bubble of water opens up mixing it with the Ammonium Nitrate thereby producing cold.
The material for the bag will consist of either polyester, or laminated polyethylene.