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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.
This is a 510(k) summary for a portable heating pad (PT-Pac). It does not contain information about acceptance criteria, device performance metrics, or study designs typically associated with AI/ML-driven diagnostics or complex medical devices requiring such detailed evaluations.
The provided text focuses on:
- Device Description: A portable heating pad, battery-powered, using thermoelectric tiles and microprocessor control.
- Predicate Comparison: Similar to existing powered heating pads (890.5740), but portable and safer due to low-voltage DC batteries and safety circuits.
- Intended Use: Providing soothing warmth in the temperature range of predicate devices.
- Safety Features: Low-voltage DC, two safety circuits, finite battery life.
Therefore, I cannot answer your specific questions because the provided input is for a relatively simple, low-risk device where the evaluation criteria are fundamentally different from those for a device requiring extensive clinical studies, AI performance metrics, or expert reviews as implied by your questions.
To elaborate, for a device like the PT-Pac, acceptance criteria would likely revolve around:
- Temperature Range: Does it consistently output heat within a specified safe and effective range (e.g., 38°C to 45°C)?
- Temperature Uniformity: Is the heat distributed evenly across the pad's surface?
- Over-temperature Protection: Do the safety circuits reliably prevent the device from exceeding a maximum safe temperature?
- Battery Life: Does it operate for a reasonable duration on a single charge/set of batteries?
- Biocompatibility: Is the cover material safe for skin contact?
- Electrical Safety: Does it meet relevant standards for low-voltage devices (e.g., current leakage, insulation)?
- Durability: Does it withstand typical use and handling?
However, the provided summary does not include any data or study results demonstrating that the PT-Pac meets these or any other specific acceptance criteria. It merely describes the device and its intended function and safety features relative to predicate devices.
§ 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.