Thulium Fiber Laser (FiberLAZE+, FiberLAZE) by Allengers Global Healthcare Private Limited

Thulium Fiber Laser is intended for incision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue in the following indications: Urology, Lithotripsy, Gastroenterological surgery and Gynecological Surgery.

Urologv

· Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
· Laser Resection of the Prostrate (LRP)
· Laser Enucleation of the Prostate (LEP)
· Laser Ablation of the Prostate (LAP)
· Transurethral Incision of the Prostate (TUIP)
· Condylomas
· Urethral strictures
· Lesions of external genitalia
· Bladder neck incisions (BNI)
· Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
· Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
· Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

· Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
· Endoscopic fragmentation of renal calculi
· Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:

· Appendectomy
· Angiodysplasia
· Polyps
· Colorectal cancer
· Biopsy
· Telangiectasias
•Gall Bladder calculi
· Telangiectasias of the Osler-Weber-Renu disease
· Biliary/Bile duct calculi
· Vascular Malformation
· Ulcers
· Gastritis
· Gastric ulcers
· Esophagitis
· Duodenal ulcers
· Esophageal ulcers
Non Bleeding Ulcers
Varices
Pancreatitis
Colitis
Haemorrhoids
Mallory-Weiss tear
Cholecystectomy
Gastric Erosions
Benign and Malignant Neoplasm

Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

Device Description

Thulium Fiber Laser is a laser system that emits a wavelength of 1.94 um with a laser output power up to 60W and 35W respectively. Laser radiation is delivered to the patient via an optical fiber.

The main subsystems of the device are the laser, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user select device settings. Laser emission is triggered by a footswitch.

AI/ML Overview

This document details the FDA's 510(k) clearance for the Thulium Fiber Laser (FiberLAZE+, FiberLAZE) manufactured by Allengers Global Healthcare Private Limited. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.

The provided text describes a medical device, specifically a Thulium Fiber Laser system, and its substantial equivalence to a predicate device. The performance testing outlined focuses on electrical, laser, and software safety and usability standards (e.g., ISO, IEC, FDA guidance for software), which are relevant for hardware and software functionality but do not cover AI/ML performance.

Therefore, I cannot extract the requested information about acceptance criteria for AI/ML performance and a study proving its fulfillment because this information is not present in the provided document. The document pertains to a traditional medical device clearance that does not involve AI or machine learning components.

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.