(154 days)
NaturaLase CO2 laser operating in tractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
NaturaLase CO2 laser operating in fractional mode is indicated for ablative skin resurfacing.
The NaturaLase CO2 is an RF excited CO2 laser. The main console of the NaturaLase CO2 laser system contains the following components:
- CO2 laser tube
- Power Supply
- Optical bench assembly
- Articulated Arm
- Hand-pieces: scanning and surgical
- Touch screen controller/user interface
The laser source is a sealed CO2 laser tube that is mounted vertically within the main cabinet and the laser beam is passed from the laser tube into the articulated arm. The NaturaLase CO2 laser unit is equipped with a switching-mode power supply, which converts the input line voltage to the high voltage required for laser operation. The optical bench assembly consists of the articulated arm mount, the aiming beam diode laser (3mW @ 650nm) and optics to align the laser beam and the aiming beam to the articulated arm. The laser energy is delivered through an articulated arm to a hand-piece (scanner or surgical) that distributes the laser energy on the target in a controlled and uniformed way. The user-interface microprocessor-based touch screen allows operator to control all operating functions.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "NaturaLase CO2 Laser System." This document aims to demonstrate the substantial equivalence of the new device to previously cleared predicate devices, rather than proving its performance against specific acceptance criteria for a new clinical indication or a new type of device requiring complex performance studies (like AI/ML-driven diagnostic devices).
Therefore, many of the typical acceptance criteria and study elements listed in your request (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, ground truth types for training data) are not applicable to this type of regulatory submission. This document focuses on showing that the NaturaLase CO2 Laser System operates similarly to predicate devices and does not introduce new questions of safety or effectiveness.
Here's how to address your request based on the provided document:
Acceptance Criteria and Device Performance
For a device like the NaturaLase CO2 Laser System seeking 510(k) clearance, the primary "acceptance criterion" is demonstrating substantial equivalence to existing predicate devices. This is achieved by showing that the new device has the same intended use and technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
The document demonstrates this through:
- Comparison of Technical Specifications: The core method of proving substantial equivalence is through direct comparison of the new device's technical specifications and operating principles with those of the predicate devices.
- Performance Testing (Bench Testing): The document refers to engineering verification and validation tests to ensure the device performs according to its own specifications and functions as intended, and conforms to relevant safety standards. This is not clinical performance testing against a disease state, but rather engineering and safety performance.
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are implicitly the parameters of the predicate devices a new device must match or fall within to demonstrate substantial equivalence, alongside compliance with relevant safety standards. The "reported device performance" are the specifications of the NaturaLase CO2 Laser System.
| Criterion (Predicate Device Parameter Range / Safety Standard) | NaturaLase CO2 Laser System Performance (Acceptance) |
|---|---|
| Intended Use | Same as Predicate Devices |
| Laser Type (CO2 Laser) | CO2 Laser (Matches Predicate) |
| Wavelength (10.6 μm) | 10.6 μm (Matches Predicate) |
| Power (Up to 30 W) | Up to 30 W (Matches Predicate) |
| Pulse Width (Fraction) (0.2-20 ms; 0.2-10 ms) | 0.2-10 ms (Falls within Predicate Range) |
| Pulse Width (Surgical) (0.5-80 ms; .2 to 10ms) | .2 to 10ms (Falls within Predicate Range) |
| Spot Size (Fraction) (120 and 300 μm; 300 μm) | 120 and 300 μm (Matches Predicate) |
| Spot Size (Surgical) (200, 400, 1000 μm; 300 μm) | 300 μm (Matches Predicate) |
| Energy Emission (Pulse/single pulse/cw) | Pulse/single pulse/cw (Matches Predicate) |
| Energy to tissue (10-45 mJ per micro spot) | 10-45 mJ per micro spot (Matches Predicate) |
| Peak Power (60 W) | 60 W (Matches Predicate) |
| Aiming beam ( |
§ 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.