FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

JOULE 1927nm Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

Device Description

The JOULE 1927nm Laser System consists of a console and laser deliver accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.

AI/ML Overview

The Sciton, Inc. JOULE 1927nm Laser System is a laser surgical instrument intended for dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions. The device received 510(k) clearance (K182173) on March 6, 2019, based on demonstrating substantial equivalence to predicate devices, namely the Solta FraxelDUAL (K130193) and the Lutronic LASEMD Laser System (K171009).

This device did not undergo a study to prove it met specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, or reader improvement. Instead, its acceptance was based on non-clinical performance data and a comparison of its technological characteristics and indications for use to legally marketed predicate devices.

Here's the breakdown of the information provided in the context of your request:

Table of Acceptance Criteria and Reported Device Performance: This information is not presented as a table of acceptance criteria for clinical performance in the provided document. The device's acceptance was based on demonstrating substantial equivalence to predicate devices in terms of its technological characteristics, intended use, and safety. The provided table (on page 4) lists the specifications of the JOULE 1927nm Laser System and its predicate devices, indicating where they are substantially equivalent.

Specification	Predicate Device (FraxelDUAL)	Predicate Device (LASEMD Laser System)	This Application (JOULE 1927nm)	Substantially Equivalent
Indications for Use	Same as JOULE	Same as JOULE	Dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions.	Yes
CDRH Laser Class	Class 4	Class 4	Class 4	Yes
Laser Type	Thulium Laser	Thulium Laser	Thulium Laser	Yes
Energy Source	1927 nm	1927 nm	1927 nm	Yes
Spot Size	256 – 620 µm	100 - 200 µm	100 – 620 µm	Yes
Maximum Tip Width	7 and 15 mm	10 mm	15 mm	Yes
Wavelength	1927 nm	1927 nm	1927 nm	Yes
Pulse Repetition Rate	0 – 3 kHz	43.5 - 307.7 Hz	0 – 3 kHz	Yes
Pulse Duration	Up to 10 ms	Up to 20 ms	Up to 20 ms	Yes
Energy	Up to 20 mJ	Up to 20 mJ	Up to 20 mJ	Yes
Utilities	120-240 VAC, 50/60 Hz	100-240 VAC, 50/60 Hz	200-240 VAC/25A, 50/60 Hz	Yes
Power	12 W (1927 nm)	5 W (1927 nm)	12 W (1927 nm)	Yes
Aiming Beam	Red	Red	Red	Yes
Delivery System	Fiber optic	Fiber and Handpiece	Articulated Arm or Fiber optic	Yes
Emission Control	Footswitch	Footswitch	Footswitch	Yes
Display Screen	Yes	Yes	Yes	Yes
Cooling System	Air to Air	Air to Air	Water to Air	Yes

Sample size used for the test set and the data provenance: Not applicable. The FDA clearance was based on non-clinical performance data and substantial equivalence arguments, not on a clinical test set with patient data for assessing diagnostic or treatment efficacy in the same way an AI device might be. The non-clinical tests relate to device safety and functionality.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no clinical test set for which ground truth needed to be established by experts for performance evaluation.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a laser system for treatment, not an AI-assisted diagnostic device for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device, a laser system, not an algorithm.
The type of ground truth used: For the non-clinical performance data, the "ground truth" would be established by validated test methods and engineering specifications. For example, for electrical safety, the ground truth is adherence to standards like IEC 60601-1. For biocompatibility, the ground truth is determined by testing against ISO 10993-1. These are objective measures against established standards.
The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary of the "Study" and Acceptance Criteria:

The "study" in this context refers to the non-clinical performance testing and the comparative analysis against predicate devices to demonstrate substantial equivalence.

Acceptance Criteria: The primary acceptance criterion was demonstrating substantial equivalence to the legally marketed predicate devices (Solta FraxelDUAL K130193 and Lutronic LASEMD Laser System K171009) in terms of:
- Intended Use: The JOULE 1927nm Laser System shares the same Indications for Use as the predicates (dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions).
- Technological Characteristics: The device shares similar design features (wavelength, laser medium and delivery systems, power supply, cooling and control system) and functional features (power output, repetition rate, energy, spot size, and fluence). Minor differences in cooling system (Water to Air vs. Air to Air) and physical dimensions were deemed not to raise new questions of safety or effectiveness.
- Safety Standards: Adherence to recognized electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1).
- Software Verification and Validation: Successful performance of software V&V.
- Biocompatibility: Patient-contacting components were tested for biocompatibility per ISO 10993-1.
Device Performance:
- Non-Clinical Performance Data: Electrical safety, electromagnetic compatibility, software verification and validation, and biocompatibility testing were all "successfully performed" according to the relevant standards.
- Comparative Performance: The JOULE 1927nm Laser System's specifications (e.g., energy, pulse repetition rate, spot size, wavelength) fall within the range or are comparable to those of the predicate devices, supporting the claim of substantial equivalence for its intended use.

In conclusion, the FDA clearance for the JOULE 1927nm Laser System was based on non-clinical engineering and safety tests, and a direct comparison of its technical specifications and indications for use against already-cleared predicate devices, rather than a clinical study evaluating its direct performance against a ground truth from a patient-based test set or an AI algorithm's performance.

Summary

Regulation Number and Section

§ 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.