TRIMEDYNE HOLMIUM LASER SYSTEMS

• K Number: K041660
• Device Name: TRIMEDYNE HOLMIUM LASER SYSTEMS
• Manufacturer: TRIMEDYNE, INC.
• Date Cleared: 2004-09-08 ( 82 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

Superficial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:

1. Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasia [facial, leg], and rosacea), COLIS, papillomas, basal cell carcinomas, lesions of skin and subcutaneous tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, skin tag vaporization
2. Gastroenterological/Gastrointestinal Surgery, including: cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, telangiectasias of the Osler-Weber-Rendu disease
3. General Surgery of soft tissue, including: skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, mastectomy, hepatectomy, pancreatectomy, splenectomy, thyroidectomy, parathyroidectomy, hemiorrhaphy, tonsillectomy, lymphadenectomy, partial nephrectomy, pilonidal cystectomy, resection of lipoma, pelvic adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilodidal cyst removal and repair, debridement of statis ulcer, biopsy
4. Genitourinary Surgery/Urology, including: superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, lesions of the external genitalia, bladder, urethral and ureteral tumors, condylomas, urethral and penile hemangioma, bladder neck obstructions, holmium laser incision, excision, resection, ablation, hemostasis, vaporization, and enucleation in the treatment of benign prostatic hyperplasia (BPH)
5. Gynecological Surgery during open and endoscopic procedures, including: condyloma acuminata
6. Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of urethral calculi, fragmentation of kidney calculi, treatment of distal impacted fragment of steinstrasse when guide wires cannot be passed
7. Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including: knee meniscectomy, knee synovectomy, chondromalacia and tears, loose body debridement, lateral retinacular release, debridement of the degenerative knee, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridement of inflamed synovial tissue, capsulectomy in the knee, chondroplasty in the knee, chondromalacia ablation
8. Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g., turbinectorny), dacryocystorhinostomy (DCR), ethmoidectomy, polypectomy, maxillary antrostomy, frontal sinusotomy, sphenoidotomy
9. Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectomy: Superficial incision, excision, resection, ablation, coagulation, hemostasis and vaporization, with or without an endoscope, in the following: Percutaneous Lumbar Disc Decompression/Discectorny in soft, cartilaginous, and bony tissue, including: foraminoplasty; Percutaneous Cervical Disc Decompression/Discectorny in soft tissue, in patients with: uncomplicated ruptured or herniated discs, neck pain with radiation down the arm, symptoms and signs of sensory loss, tingling, numbness, muscle weakness, and/or decreased deep tendon reflexes, MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms, positive electromyography and/or nerve conduction studies, no improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication); Percutaneous Thoracic Disc Decompression/Discectorny in soft tissue, in patients with: uncomplicated ruptured or herniated discs, thoracic and intercostal intractable pain, paresthesias at levels appropriate to the herniated discs visualized on MRI and CT-myclography, MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms, no improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication)

Interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications; interstital applications should only be performed using the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices.

Device Description

The Trimedyne Holmium Laser System is a medical grade, Class IV, pulsed, solid state Holmium: YAG laser system designed to deliver pulsed infrared laser energy with a wavelength of 2.1 um and 350 microseconds pulsewidth. Menu-driven control options allow the users to select pulse repetition rate, output energy, and lasing duration.

AI/ML Overview

This document is a 510(k) premarket notification for the Trimedyne Holmium Laser System. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies, based solely on the text provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not report any specific acceptance criteria or performance metrics for the Trimedyne Holmium Laser System in relation to clinical or non-clinical studies. Instead, it states that:

• "No non-clinical data were submitted in this Premarket Notification."
• "No clinical tests were submitted in this Premarket Notification."

The basis for this 510(k) clearance is "substantial equivalence" to a predicate device, not fulfillment of specific performance criteria demonstrated through new testing.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided text.

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not applicable. No new clinical or non-clinical data/tests were submitted.
• Data provenance: Not applicable. No new clinical or non-clinical data/tests were submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No new clinical or non-clinical data/tests were submitted, and therefore no ground truth was established by experts for such tests.

4. Adjudication method for the test set:

• Not applicable. No new clinical or non-clinical data/tests were submitted.

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:

• Not applicable. This device is a medical laser system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned or performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a medical laser system, not an algorithm.

7. The type of ground truth used:

• Not applicable. No new clinical or non-clinical data/tests were submitted for which ground truth would be established. The document relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

• Not applicable. This document is for a medical device (laser system), not a machine learning or AI algorithm that would require a training set.

9. How the ground truth for the training set was established:

• Not applicable. As above, this document is not for an AI/ML algorithm.

Conclusion from the Document:

The Trimedyne Holmium Laser System received clearance based on substantial equivalence to an already legally marketed predicate device (also referred to as "Trimedyne Holmium Laser System"). This means the manufacturer demonstrated that the new device has the same intended use and technological characteristics as the previously cleared device, or if there are differences, that those differences do not raise new questions of safety or effectiveness. As such, the submission did not include any new non-clinical or clinical data/tests to prove performance against specific acceptance criteria.

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.