(67 days)
Jack Frost Laboratories Instant Hot Pack
None
No
The summary describes a simple instant hot pack and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details related to training/test sets and performance metrics typically associated with AI/ML devices.
No.
The device is used for first aid to reduce pain and discomfort, which aligns with common definitions of a therapeutic device. However, the input explicitly states the Predicate Device is an "Instant Hot Pack." Instant hot packs are typically considered consumer products for immediate comfort rather than regulated therapeutic devices. In the context of medical devices, "therapeutic" usually implies a more direct and medically significant intervention for treating a disease or condition, which an instant hot pack for first aid pain reduction generally doesn't meet in a regulatory sense.
No
Explanation: The device provides "instant hot treatment used for first aid purposes to reduce local pain and discomfort" and does not diagnose any condition.
No
The device description explicitly states "INSTANT HOT PACK," which is a physical, hardware-based product, 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 "instant hot treatment used for first aid purposes to reduce local pain and discomfort." This describes a physical therapy or first aid application, not a diagnostic test performed on samples taken from the body.
- Device Description: "INSTANT HOT PACK" further reinforces that it's a physical device for applying heat externally.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, this device falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
the device provides instant hot treatment used for first aid purposes to reduce local pain and discomfort.
Product codes
890.5710
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Jack Frost Laboratories Instant Hot Pack
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
KIck Ice, Inc.
P.O. Box 5519 EKS
Johnson City, Tn 37603
(423) 975-KICK
NOV 25 1996
510K SUMMARY
September 19, 1996
TRADE NAME: INSTANT HOT PACK COMMON NAME: INSTANT HOT PACK CLASSIFICATION NAME: HOT OR COLD DISPOSABLE PACK 890.5710
Per Section 807.92(a)(3)(5), equivalency is being claimed on Jack Frost Laboratories Instant Hot Pack. The device provides instant hot treatment used for first aid purposes to reduce local pain and discomfort.
This type of hot therapy application has been on the market for approximately 32 years and has proven to be a safe and effective for giving medical attention wherever heat therapy is way indicated.
Our contact is Victoria M. Phillips at (800) 833-7678.
-7-