(88 days)
The Erchonia® FX-405 laser is generally indicated:
a. while using the red and violet diodes, for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.
b. and while using the red diodes, as an adjunctive treatment of postoperative pain.
Erchonia® FX-405 is low level laser system that uses three semi-conductor diodes (visible light) 630nm to 650nm with a mean power output of 17.25mW per diode and one semi-conductor diode 400nm to 410nm with a mean power output of 23.00mW. The Erchonia®FX-405 is a variable hertz device. The variable hertz feature of the Erchonia® FX-405 is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX-405 has been classified by the FDA/EC as a Class II device and a Class 2 Laser. The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end user to alter the laser diode output. The device has an adjustable main arm that is attached to the mobile baser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered utilizes internal mechanics that collects the light emitted from each of the four (4) laser diodes and processes each through a proprietary patented lens which redirects the beam with a line refracted light is then bent into a spiraling circle pattern that is totally random and independent of the other diodes. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the four (4) laser output heads to be rotated, titled, and raised / lowered independently. The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended. The exterior materials consist of 6061 T6 AL, Kydex 430 and Copolymer Acetal with powder coating and carbon fiber finish.
The provided text does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria. Instead, it describes a 510(k) premarket notification for the Erchonia FX-405, where substantial equivalence to predicate devices is established.
The document highlights the device's characteristics and compares them to existing cleared devices (Erchonia FX-405, K212595 as primary predicate, and Erchonia XLR8, K211186 as secondary predicate) to demonstrate that the new device is as safe and effective.
Here's an analysis of the information that is not present in the provided text, based on your request:
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Table of acceptance criteria and reported device performance: This is not present. The document focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting specific performance metrics against pre-defined acceptance criteria.
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Sample size used for the test set and data provenance: No clinical test set data is presented in this 510(k) summary, as stated in the "Performance Testing-Clinical" section: "No clinical data was used to establish Substantial Equivalence."
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Number of experts used to establish ground truth and qualifications: Not applicable, as no clinical test set with ground truth was used for this submission.
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Adjudication method for the test set: Not applicable, as no clinical test set with ground truth was used.
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Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned and not performed, as no clinical data was used for substantial equivalence.
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Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable. The Erchonia FX-405 is a physical laser device, not an AI algorithm.
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Type of ground truth used: Not applicable, as no clinical test set requiring ground truth was used.
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Sample size for the training set: Not applicable, as this is a physical device and not an AI/machine learning algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable, as this is a physical device and not an AI/machine learning algorithm.
Summary of available information related to performance and equivalence:
The document states that "No clinical data was used to establish Substantial Equivalence." Instead, the submission relies on a comparison of technological characteristics with predicate devices and compliance with voluntary and performance standards.
The device is substantially equivalent to the primary predicate device (Erchonia FX-405, K212595) because it is described as the "exact same model." For the secondary predicate (Erchonia XLR8, K211186), equivalence is established by comparing technical specifications:
- Wavelength, Energy Source, Mechanism of Action: Identical to the secondary predicate (Erchonia XLR8).
- Number of Diodes, Power, Total Joules Per Minute: Differences are deemed "negligible" and not affecting safety or effectiveness when applied over the treatment area.
- Recommended Treatment Duration: Same for the Indications for Use (IFU) regarding postoperative pain.
- Energy Delivery & Target Size: Differences in floor model vs. handheld, and electronically scanned vs. manually scanned, are stated not to change the physiological mechanism or affect safety/effectiveness.
- Indications for Use: The subject device's indication for adjunctive treatment of postoperative pain (using red diodes) is identical to one of the XLR8's indications. The added indication for nociceptive musculoskeletal pain (red and violet diodes) is covered by the primary predicate.
Performance Data (General Compliance, not specific acceptance criteria):
- Compliance with Voluntary Standards: IEC 60601-1-2:2014 Edition 4.0, IEC 60601-1:2005 Edition 3.1, IEC 60825-1:2014 Edition 3.0.
- Performance Standards: Complies with FDA's performance standards for light-emitting products (21CFR 1040.11 by Laser Notice #50).
- Software: Software verification and validation testing conducted, classified as "minor" level of concern. No patient data storage, no cybersecurity risk of safety or effectiveness, no wireless interfaces.
- Biocompatibility: Not applicable, as the device does not contact patient skin or tissue.
- Sterilization and Shelf-Life: Not provided sterile; device is electro-mechanical, components will not degrade during storage.
Therefore, the "study" referred to in the prompt is essentially the technical comparison and compliance with standards presented in the 510(k) summary, rather than a clinical trial or performance study against specific acceptance criteria.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.