(83 days)
No
The device description details a chemical reaction for cold therapy and makes no mention of AI or ML.
Yes
The device is described as providing "temporary cold therapy for body surfaces," which aligns with the definition of a therapeutic device designed to treat a condition (e.g., swelling, pain) through physical means (cold therapy).
No
Explanation: The device provides temporary cold therapy for body surfaces and is not used to diagnose a medical condition.
No
The device description clearly states it is a "self contained disposable unit" consisting of physical components (inner and outer pouches, water, ammonium nitrate) that undergo a chemical reaction. This is a hardware-based device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Certi*Cool Function: The Certi*Cool Instant Cold Compress is a physical therapy device that applies cold to the body surface. It does not analyze any biological specimens.
The description clearly states its purpose is "temporary cold therapy for body surfaces" and describes a chemical reaction that produces cold. This aligns with a physical therapy or general medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Certi*Cool Instant Cold Compress is a self contained disposable unit that provides temporary cold therapy for body surfaces.
Product codes
Not Found
Device Description
The Certi*Cool Instant Cold Compress is a self contained disposable unit that provides temporary cold therapy for body surfaces. Each unit is labeled with instructions for use as well as specific warning statements. Our product consists of an inner plastic pouch containing a green-colored water and an outer pouch containing ammonium nitrate. To activate the product, simply rupture the inner pouch by using an external force, such as a fist. Then, as the two ingredients mix, a chemical reaction results by producing temperatures below 40°F for a minimum of 15 minutes. These are single use devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surfaces
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY
THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF THE SAFE MEDICAL DEVICE ACT OF 1990.
510(k) Summary of Safety and Effectiveness Certi*Cool Instant Cold Compress
MAY -6 1996
Submitted by: Certified Safety Manufacturing, Inc. 1400 Chestnut Kansas City, MO. 64127 (816) 483-9090 Fax (816)-483-9091
Howard Gerson, Vice President Contact: Date Prepared: February 8, 1996 Trade Name: Certi*Cool Instant Cold Compress Common Name: Disposable Cold Pack
Classification Name: Disposable Cold Packs are classified as Class I medical devices, and are listed in 21 CFR 890.5710 as cold disposable pack.
The Certi*Cool Instant Cold Compress is substantially equivalent in design, composition and function to other disposable cold packs on the marketplace that employ a chemical reaction to produce cold. It is also substantially equivalent to our Edcool and Edcool J. Instant Cold Packs which were found SE by FDA on March 25, 1987 and assigned #K871006.
The Certi*Cool Instant Cold Compress is a self contained disposable unit that provides temporary cold therapy for body surfaces. Each unit is labeled with instructions for use as well as specific warning statements. Our product consists of an inner plastic pouch containing a green-colored water and an outer pouch containing ammonium nitrate. To activate the product, simply rupture the inner pouch by using an external force, such as a fist. Then, as the two ingredients mix, a chemical reaction results by producing temperatures below 40°F for a minimum of 15 minutes. These are single use devices.