(417 days)
The Fotona Dynamis Laser System Family, and its accessories, are intended for use in the following procedures:
Dynamis Er: YAG laser (2940 nm wavelength)
- Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and skin resurfacing;
- ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;
- Oral/Maxillofacial Indications: Oral and glossal lesions;
- Ophtalmology Indications: Soft tissue surrounding the eye;
- Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma;
- General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation is necessary;
- Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;
Dynamis Nd: YAG laser (1064 nm wavelength):
- Surgical incison, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy;
- Laser assisted lipolysis;
- Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin;
- Treatment of wrinkles;
- Treatment of mild to moderate inflammatory acne vulgaris;
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins:
- Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.
The Fotona Dynamis Laser System Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er: YAG and Nd: YAG crystals. A red diode aiming beam (650 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beans are guided through an articulated arm to an optical manual or scanner hand piece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical manual or scanner hand piece (in the case of the Nd: YAG laser). Optionally, the Nd: YAG therapeutic and aiming laser beams can be guided through a fiber having a connector on the proximal end and a bare fiber on the distal end. Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows control of the laser energy and the laser pulse duration. The user activates laser emission by means of a footswitch.
The Fotona Dynamis Laser System Family is designed to operate in five configurations (models):
- XS Dynamis: Single Er:YAG laser system
- XP Dynamis: Single Nd:YAG laser system
- SP Dynamis: Combined Er: YAG/Nd: YAG laser system
- XP Spectro: Single Nd:YAG laser system, with lower average output power of Nd:YAG laser and smaller housing
- SP Spectro: Combined Er:YAG/Nd:YAG laser system, with lower average output power of -Nd:YAG laser and unchanged specifications of Er:YAG laser, and smaller housing.
This document is a 510(k) summary for the Fotona Dynamis Er:YAG/Nd:YAG Laser System Family, aimed at demonstrating substantial equivalence to previously cleared devices. It does not contain information about a study proving the device meets a set of acceptance criteria in the way a clinical trial or performance study for a diagnostic AI device would.
Instead, the submission relies on demonstrating technological equivalence to existing devices. This means that the device's characteristics and intended uses are so similar to already approved predicate devices that it is considered equally safe and effective.
Therefore, many of the requested categories for a study proving acceptance criteria are not applicable to this type of submission. However, I can extract the relevant information regarding the comparative aspects presented.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are not explicit performance metrics for a novel technology but rather the demonstration that the new device's technical specifications and intended uses fall within the established parameters of predicate devices. The "reported device performance" is essentially a comparison of these specifications.
| Characteristic | Acceptance Criteria (Predicate Devices - Range/Value) | Reported Device Performance (Fotona Dynamis Family) |
|---|---|---|
| Nd:YAG Laser (1064 nm) | ||
| Wavelength | 1064 nm | 1064 nm |
| Laser media | Flashlamp pumped solid state rod | Flashlamp pumped solid state rod |
| Aiming beam | 650 nm | 650 nm |
| Output mode | Pulsed | Pulsed |
| Pulse energy | up to 120 J (K050293), up to 10 J (K090126) | up to 50 J |
| Pulsewidth | 1 – 200 ms (K050293), 0.1-50 ms (K090126) | 0.1 - 50 msec |
| Repetition rate | up to 12 Hz (K050293), up to 64 Hz (K090126) | up to 50 Hz |
| Power | up to 120 W (K050293), up to 30 W (K090126) | up to 80 W |
| Beam delivery | Fiber | Fiber |
| User interface | Push button control | Push button control |
| Er:YAG Laser (2940 nm) | ||
| Wavelength | 2940 nm | 2940 nm |
| Laser media | Flashlamp pumped solid state rod | Flashlamp pumped solid state rod |
| Aiming beam | 650 nm | 650 nm |
| Output mode | Pulsed | Pulsed |
| Pulse energy | 25 - 1500 mJ (K093162), 40 - 1000 mJ (K021548) | 30 - 1500 mJ |
| Pulsewidth | 50 – 1000 μs (K093162), 75 - 950 μs (K021548) | 100 – 1500 μs |
| Repetition rate | up to 50 Hz (K093162), up to 30 Hz (K021548) | up to 50 Hz |
| Power | up to 20 W (K093162), up to 15 W (K021548) | up to 20 W |
| Beam Delivery | Articulated arm | Articulated arm |
| User interface | Touch screen and push button control (K093162), Push button control (K021548) | Push button control |
Summary of Equivalence: The document states, "The Fotona Dynamis Er:YAG/Nd:YAG Laser System Family is substantially equivalent to Fotona Dualis SP Nd:YAG/Er:YAG Laser System (K021548), Fotona Fidelis III Er:YAG/Nd: YAG Laser System (K093162), Fotona XP Nd:YAG Laser System (K090126) and Fotona XP Plus Nd:YAG Family of Laser Systems (K050293). The Fotona Dynamis Er: YAG/Nd:YAG Laser System Family is substantially equivalent in terms of indications for use and technology based on technical characteristics."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not applicable as there was no "test set" in the context of a performance study for a novel diagnostic or AI device. The submission relies on a comparison of technical specifications to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable as there was no "test set" and no ground truth establishment by experts for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable as there was no "test set" requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable. This is a laser surgical instrument, not an AI diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This is a physical laser device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This information is not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior clearances and clinical use. No new ground truth data of this type was generated for this submission.
8. The sample size for the training set
- This information is not applicable. This is a medical device clearance based on substantial equivalence, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- This information is not applicable. As above, there was no training set for an AI model.
§ 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.