(189 days)
FOX 810:
Indicated for surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, and pulmonology.
FOX 980:
Indicated for surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, pulmonology, and thoracic surgery.
The FOX Lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode, the laser system can radiate one factory set wavelength with either 810nm or 980mm. The FOX is a compact diode laser with a high-resolution color touchscreen for user control.
This document is a 510(k) Premarket Notification from the FDA for the FOX 810 and FOX 980 Diode Laser Systems. It establishes substantial equivalence to predicate devices for surgical applications involving soft tissue. There is no information regarding AI/ML in this document. Therefore, I will answer the questions based on the provided text, primarily focusing on general device performance criteria where applicable.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device (e.g., incision depth, coagulation time) that were then "reported" as meeting those criteria. Instead, it details that the device has been tested against various IEC and EN standards to ensure safety and essential performance, and it performs comparably to its predicate devices in terms of power output and tissue interaction mechanisms.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Device Safety | Compliance with recognized international standards for medical electrical equipment, laser safety, electromagnetic compatibility, usability, and software lifecycle processes to ensure basic safety and essential performance. (IEC 60601-1, IEC 60825-1, EN 60601-1-2, IEC 60601-2-22, IEC 60601-1-6, IEC 62304) | The FOX systems have been tested against IEC 60601-1:2005+ COR1:2006, COR2:2007, AMD1:2012; IEC 60825-1:2014; EN 60601-1-2:2014; IEC 60601-2-22:2007+A1:2012; IEC 60601-1-6:2010/AMD1:2013; and IEC 62304:2006 + A1:2015. The submission concludes that the new devices are "as safe and effective as the predicate devices." |
| Tissue Interaction | Similar wavelengths (810nm and 980nm) and power outputs to the predicate devices, ensuring comparable tissue interactions (ablation, vaporization, hemostasis, coagulation) based on absorption in corresponding chromophores. The predicate devices' performance in terms of incision depth and thermal tissue damage sets the implicit benchmark for acceptable tissue interaction. | The device under evaluation uses 810nm and 980nm wavelengths, sharing the same wavelengths as the primary predicates. The power outputs are: FOX 810: Up to 8 W, FOX 980: Up to 12 W. This is compared to primary predicate Fox Q-810 (Up to 7W) and Fox Q-980 (Up to 9W), and secondary predicate XPulse Pro (810nm: Up to 8W, 980nm: Up to 12W). The document states that the power difference "does not absolutely affect the extent of incision depth and thermal tissue damage" and that "Power alone or pulse length alone do not alter the tissue effect because for every pulse the power is set with a pulse length. These parameters, power and pulse length, equal the pulse energy when multiplied." The submission concludes that the subject devices are substantially equivalent to the predicate devices in terms of safety and efficacy. |
| Operational Modes | Capability for continuous wave, pulsed, and single pulse operation, along with comparable pulse length/duration and frequency ranges to predicate devices. | The subject device operates in Continuous wave, pulsed, single pulse mode. Pulse length/duration: 100μs – 45s. Pulse frequency: 0.01 – 5000 Hz. These are comparable to the predicate devices which have similar modes, and ranges of 2ms - 30s for pulse length/duration and 0.016 – 250 Hz for pulse frequency (primary predicate) or 100 μs to 60 s for pulse length/duration and 0.008 Hz to 5000 Hz for pulse frequency (secondary predicate). |
| Physical and Functional Characteristics | Similar design, user interface (touchscreen/buttons), aiming beam specifications, cooling method (air), delivery devices (optical fibers), main power supply, dimensions, and weight to predicate devices, ensuring equivalent functionality and usability. | The subject device features a touchscreen and buttons for user interface, air cooling, 532nm or 650nm @ |
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.