REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)

• K Number: K093100
• Device Name: REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)
• Manufacturer: SHENZHEN COMFORT TECHNOLOGY CO., LTD.
• Date Cleared: 2009-11-24 ( 54 days)
• Product Code: IMC
• Regulation Number: 890.5110
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: K022626

Intended Use

The Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath is:

• Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation.
• Relaxes muscles, relieves stiffness and muscle spasm
• Stimulates circulation and for other conditions where heat is indicated.

Device Description

The Revlon RVSP3501 (Type SPB3752EA) Spa MoistureStay Paraffin Bath is an 80 Watt paraffin bath unit, with a thermostat that varies the heat from High to Keep Warm. There are two LEDs, a red LED for the heater, and a green LED to indicate the power. The unit is provided with 3lbs of paraffin wax, a plastic mat when dipping the hands or feet, glove liners, and a pair of mitts.

AI/ML Overview

This document is a 510(k) summary for a Paraffin Bath device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device. Instead, it details the substantial equivalence to a predicate device based on safety and performance testing for a physical medical device.

Therefore, I cannot provide the requested information. The document does not describe:

• Acceptance criteria in terms of performance metrics like sensitivity, specificity, or AUC for an AI/ML device.
• A study proving the device meets such acceptance criteria.
• Sample sizes for test sets (beyond an implication of comparing two physical units).
• Data provenance for AI/ML development.
• Number of experts for ground truth establishment.
• Adjudication methods.
• MRMC studies to compare human readers with and without AI.
• Standalone algorithm performance.
• Ground truth type in the context of AI/ML (e.g., pathology, outcomes data).
• Training set sample size or ground truth establishment for a training set.

The document focuses on:

• Safety Testing: Compliance with UL1431 and CAN/CSA C22.2 No. 64-M91 standards for electrical and health care appliances.
• Performance Testing: A comparison of the time required to melt wax between the new device and the predicate device, noting the difference was expected due to power consumption differences.
• Substantial Equivalence: The key argument for approval is that the new device is as safe and effective as a previously cleared predicate device, with similar indications for use, design, and function, and that technological differences do not raise new safety or effectiveness concerns.

Regulation Number and Section

§ 890.5110 Paraffin bath.

(a)
Identification. A paraffin bath is a device intended for medical purposes that consists of a tub to be filled with liquid paraffin (wax) and maintained at an elevated temperature in which the patient's appendages (e.g., hands or fingers) are placed to relieve pain and stiffness.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.