MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM by LUXAR CORP.

The intended use of the modified LX-20 is identical to that of the LX-20, namely the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the listed surgical specialties of:

· Gynecology
· Laparoscopic Surgery including GYN laparoscopy
· Dermatology
· Dental and oral surgery
· Orthopedic
· General Surgery
· Otorhinolaryngology
· Podiatry

No new indications were sought in the premarket notification and no clinical data were presented.

Device Description

The Luxar modified LX-20 surgical laser system produces laser (infrared) energy at a wavelength of 10.6 microns which is directed to soft tissue through a knuckled beam delivery assembly, hollow fiber waveguides, handpieces, and sterile delivery tips.

AI/ML Overview

This document describes a 510(k) summary for a modified CO2 surgical laser system (Luxar modified LX-20). The submission focuses on demonstrating substantial equivalence to a predicate device (Luxar LX-20 CO2 Surgical Laser System, K953074) and explicitly states that no new indications were sought and no clinical data were presented.

Therefore, there is no information available within this document to address the requested points about acceptance criteria and a study proving device performance as they would typically apply to a new or significantly modified device that requires clinical data. The submission relies solely on comparing technological characteristics to the predicate device to establish safety and effectiveness.

Here's how the provided information relates to your request:

A table of acceptance criteria and the reported device performance: This information is not present. The submission focuses on technological equivalence, not performance against specific acceptance criteria.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no clinical data or test set was used for performance evaluation.
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): Not applicable. No test set requiring expert ground truth was utilized.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was utilized.
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 is a surgical laser device, not an AI or diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical laser device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical data or ground truth was established for this submission.
The sample size for the training set: Not applicable. No training set was used as no AI/machine learning component is described.
How the ground truth for the training set was established: Not applicable. No training set was used.

In summary, this 510(k) submission is for a modification to an existing device where the intended use, laser output characteristics, and core components are identical to the predicate. The changes are minor (addition of an accessory patterning handpiece, cabling, and control software/electronics) and are stated to "not raise any new issues of safety and effectiveness." Therefore, a detailed performance study with acceptance criteria, test sets, and expert evaluations was not deemed necessary and was not included in this summary.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for LUXAR Corporation. The logo is in black and white and features a bold, sans-serif font. The word "LUXAR" is in large letters, with the word "CORPORATION" in smaller letters below.

K960475

APR 26 1996

12.0 510(K) SUMMARY

Page 1 of 2

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Submitter's name, address, telephone, fax, & contact person 1. Luxar Corporation 19204 N Creek Parkway Bothell, Wa. 98011 Phone: 206-483-4142 Fax: 206-483-6844 Phillip Burwell, Product Assurance Manager
Date summary prepared: 2. January 30, 1996
Product trade or propietary name: 3. Luxar modified LX-20 C02 Surgical Laser System
1. Product common name: C02 Laser
న్. Product classification name 21C.F.R. § 878.4810 Lasers in general and plastic surgery and in dermatology 21C.F.R. § 874.4500 Lasers for use in ENT 21C.F.R. § 884.4550 Gynecologic surgical laser
Legally marketed predicate device used for equivalency: 6. Luxar LX-20 C02 Surgical Laser System (K953074)
1. Description:

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Image /page/1/Picture/0 description: The image shows the logo for LUXAR CORPORATION. The word "LUXAR" is in large, bold, sans-serif font, with the "U" having a distinctive curved top. Below "LUXAR", in a smaller font size, is the word "CORPORATION", with each letter spaced apart. The logo has a textured, slightly distressed appearance.

Page 2 of 2

1. Statement of intended use:
  The intended use of the modified LX-20 is identical to that of the LX-20, namely the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the listed surgical specialties of:
· Gynecology
· Laparoscopic Surgery including GYN laparoscopy
· Dermatology
· Dental and oral surgery
· Orthopedic
· General Surgery
· Otorhinolaryngology
· Podiatry

No new indications were sought in the premarket notification and no clinical data were presented.

9. Technological characteristics:

The laser output characteristics of the modified LX-20 system and the cleared LX-20 system are identical in average power, increments of power available, and wavelength. The modified LX-20 and the cleared LX-20 share the same RF excited lasing tube, delivery system construction, main chassis, power supply, safety systems, microprocessor controller, and much of the same electronics. The modified LX-20 laser system maintains the same 3 base consoles established pursuant to the predicate K953074 - namely the LX-20i, the LX-20SP, and the LX-20LP. The technological characteristics of the modified LX-20 that are different from the predicate LX-20 are as follows:

The modified unit adds an accessory patterning handpiece and related tip, cabling, and control software and electronics.

Luxar believes that the minor differences in the delivery capabilities of the modified LX-20 and the LX-20 do not raise any new issues of safety and effectiveness.

Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients or operators due to operator error or in high risk procedures.

Modified LX-20 Laser system 510(k) submission Page 66 1/31/96 510KSCN3.DOC 19204 NORTH CREEK PKWY. · BOTHELL, WA 98011-8009 (206) 483-4142 FAX: (206) 483-6844

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.