(186 days)
890.5740
Not Found
No
The description mentions a microprocessor for temperature regulation and safety circuits, but there is no indication of AI or ML being used for decision-making, pattern recognition, or learning from data.
No
A therapeutic device intends to treat or cure a disease or condition. The PT-Pac is described as a portable heating pad that provides "soothing warmth," which is typically for comfort or temporary relief rather than treatment of a medical condition. It is compared to powered heating pads, which are generally considered consumer devices for comfort.
No
Explanation: The device description states that the PT-Pac is a portable heating pad used for providing warmth to a body region, which is a therapeutic function, not a diagnostic one. It is similar to other powered heating pads.
No
The device description explicitly states it is a "portable heating pad" and describes physical components like "thermoelectric tiles" and a "biocompatible (100% cotton) cover," indicating it is a hardware device with embedded software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description states the device provides "soothing warmth to a defined body region." This is a therapeutic or comfort-based use, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and function of a heating pad, which is a physical therapy or comfort device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for the diagnosis of a disease or condition.
- Predicate Device: The predicate devices are "powered heating pads," which are also not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The PT-Pac does not fit this description.
N/A
Intended Use / Indications for Use
Not Found
Product codes
890.5740
Device Description
The PT-Pac is a portable heating pad. It is a non-significant risk device similar to predicate devices (powered heating pads 890.5740) in providing sustained electrical powered heat to a defined body region. As with approved heating pads, the skin contacts only a biocompatible (100% cotton) cover. The PT-Pac claims the ability to provide soothing warmth in the temperature range of predicate devices. PT-Pac differs from alternating current powered devices in that it is powered by low-voltage, direct-current batteries, making it portable as well as safer than conventional heating pads. The PT-Pac uses highly reliable thermoelectric tiles to transfer heat. These are microprocessor-controlled, providing strict temperature regulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
a defined body region
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
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5740 Powered heating pad.
(a)
Identification. A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.
0
October 11, 1996 510(k) number: 19638 PT-Pac Portable Heatin
510(k) SUMMARY:
The PT-Pac is a portable heating pad. It is a non-significant risk device similar to predicate devices (powered heating pads 890.5740) in providing sustained electrical powered heat to a defined body region. As with approved heating pads, the skin contacts only a biocompatible (100% cotton) cover. The PT-Pac claims the ability to provide soothing warmth in the temperature range of predicate devices. PT-Pac differs from alternating current powered devices in that it is powered by low-voltage, direct-current batteries, making it portable as well as safer than conventional heating pads. The PT-Pac uses highly reliable thermoelectric tiles to transfer heat. These are microprocessor-controlled, providing strict temperature regulation. The redundancy of two safety circuits, together with the finite time that the batteries can power the unit, make the safety of this device more robust than that of predicate devices.