Search Results

LEONI™ Laser Fibers (BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable) are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors and are indicated for use in laser-based surgical applications and procedures that are performed with compatible lasers operating at wavelengths between 500nm and 2200nm, which have been cleared.

The fiber optic delivery systems are accessories designed to deliver optical energy to soft or fibrous tissue in general surgical applications, in combination with any SMA-compatible laser system also indicated for the same applications.

They are composed of silicon, polyimide, acrylate, and polyamide.

The device systems are available in multiple sizes and with multiple tip shapes and handpiece configurations.

The fiber optics are available in reusable, and single use disposable devices that are prepackaged sterile. The reusable fiber optic systems may be reused only after the optical fiber tip is cleaned according to the Instructions for Use.

This document is a 510(k) premarket notification for LEONI™ Laser Fibers. It confirms that the device is substantially equivalent to legally marketed predicate devices and does not contain information about acceptance criteria or specific study outcomes that would typically be found in a performance study report for AI/ML devices.

Therefore, I cannot provide the requested information from the provided text. The document outlines the regulatory approval process for a medical device (laser fibers) and focuses on demonstrating substantial equivalence to existing devices rather than presenting the results of a novel performance study with acceptance criteria.

Specifically, the document states:

• No animal testing or human clinical testing was required for this product category.
• Laboratory testing was conducted on technological characteristics such as laser power, pull testing, optical performance, and mechanical performance. However, these are general categories of tests, and specific acceptance criteria or detailed results of these tests (e.g., performance metrics, sample sizes, ground truth) are not provided in this summary.
• Sterilization and biocompatibility testing were also performed but again, the detailed acceptance criteria and specific outcomes from these tests are not present in this summary.

Ask a specific question about this device

The Holinwon 30 laser system is indicated for superficial incision, 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 dermatological and aesthetic surgical procedures, including: scars, basal cell carcinomas, tattoo removal, lesions of skin and subcutaneous tissue, vascular lesions (including port wine stains, hemangioma, telangiectasia (facial, leg), and rosacea), plantar warts, periungual and subungual warts, coms, debridement of decubitus ulcer, papillomas and skin tag vaporization.
2. Gastroenterological/Gastrointestinal Surgery, including: Cholecystectomy, varices, lysis of adhesions, esophagitis, appendectomy, esophageal ulcer, biopsy Mallory-Weiss tear, pylorostenotomy, gastric ulcer, benign and malignant lesions, duodenal ulcer, rectal polyps of sigmoid colon, non-bleeding ulcer, gall bladder calculi, gastric erosions, biliary/ bile duct calculi, colorectal cancer, benign and malignant neoplasm, gastritis, polyps, bleeding turnors, colitis, pancreatitis, ulcers, vascular malformations, angiodysplasia, telangiectasias, hemorthoids and telangiectasias of the Osler-Weber-Rendu disease.
3. General Surgery of soft tissue, including; skin incision, herniorrhaphy, tissue dissection, tonsillectomy, excision of external tumors and lesions, lymphadenectomy, complete or partial resection of internal organs, partial nephrectomy, tumors and lesions, pilonidal cystectomy, tissue ablation, resection of lipoma, mastectomy, pelvic adhesiolysis, hepatectomy, debridement of decubitus ulcer, pancreatectomy, pilodidal cyst removal and repair, thyroidectomy, debridement of statis ulcer, parathyroidectomy and biopsy.
4. Genitourinary Surgery/Urology, including: superficial urinary bladder tumors, urethral and penile hemangioma, invasive bladder carcinoma, bladder neck obstructions, holmium laser incision/excision/resection/ ablation, hemoastasis, vaporization, and enucleation in the treatment of benign prostatic (BPH), lesions of the external genitalia, bladder, urethral and ureteral tumors and condylomas.
5. Gynecological Surgery during open and endoscopic procedures, including: condyloma acuminata
6. Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of kidney calculi, fragmentation of urethral 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, ligament and tendon release, knee synovectomy, contouring of articular surfaces, chondromalacia and tears, debridement of inflamed synovial tissue, loose body debridement, capsulectomy in the knee, lateral retinacular release, chondroplasty in the knee, debridement of the degenerative knee, chondromalacia ablation and plica removal
8. Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, polypectomy, functional endoscopic sinus surgery, maxillary antrostomy, turbinate procedures (e.g.. turbinectomy), frontal sinusotomy, dacryocystorhinostomy (DCR), sphenoidotomy and ethmoidectomy
9. Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectorny: Superficial incision, excision, resection, ablation, coagulation, hemostasis and vaporization, with or without an endoscope, in the following: -Percutaneous Lumbar Disc Decompression/Discectomy 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 symptom, 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/Discectomy 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 CTmyelography, 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)

The Holinwon 30 Laser System is a pulsed solid-state Holmium:YAG laser system is designed to deliver infrared laser energy with a wavelength of 2100 nm and a nominal pulse width of 600 microseconds. Menu driven control options allows the operator to select the pulse energy and the pulse repetition rate(frequency).

The provided document is a 510(k) Premarket Notification for the Holinwon 30 laser system. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with pre-defined acceptance criteria and statistically significant results.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of typical clinical performance studies for novel devices (e.g., diagnostic accuracy studies for AI). Instead, it focuses on non-clinical bench testing and comparison to a predicate device.

Here's an explanation of why the requested information is not present and what is reported in the document:

1. A table of acceptance criteria and the reported device performance: This document does not present clinical performance acceptance criteria or report performance data against such criteria. The "performance" reported are the results of non-clinical bench tests (electrical safety, EMC, software validation, biocompatibility) demonstrating compliance with recognized standards.

   However, for the sake of illustrating the comparison to the predicate device, which is the core of a 510(k) submission for substantial equivalence, a table can be constructed from page 7:

   Feature	Proposed Device (Holinwon 30)	Predicate Device (OmniPulse Jr.™)
   K Number	K183563	K041660
   Manufacturer	WON TECH Co., Ltd.	Trimedyne.Inc.
   Model	Holinwon 30	OmniPulse Jr.™
   Product Code	GEX	GEX
   Intended Use/Ind. for Use	Superficial incision, excision, etc. in multispecialty applications (detailed list provided)	Superficial incision, excision, etc. in multispecialty applications (same as proposed)
   Laser Type	Holmium: YAG laser	Holmium: YAG laser
   Wavelength	2100 nm	2100 nm
   Pulse Energy	0.1 - 3 J	0.2 - 3.5 J
   Pulse Duration	600 microseconds ± 10%	350 microseconds
   Repetition Rate	2 - 15 Hz	5 - 20 Hz
   Output Power	0.2 - 30 W	1.4 - 30 W
   Aiming Beam	Green, 532 nm ± 10%, < 5 mW, Class 3R	Red, 3 mW maximum, Class 3R
   Electrical Consumption	230 VAC, 5.0 kVA (21 A), 50 Hz, single phase	230 VAC, 3.5 kVA, 15 A, 50/60 Hz, single phase
   Dimensions (W x L x H)	37 cm x 71.4 cm x 89.4 cm	53 cm x 50 cm x 91 cm
   Weight	70 kg	104 kg
   Cooling	Self-contained air/water	Self-contained air/water

   The "acceptance criteria" here is that the differences in these characteristics "do not raise any new safety and effectiveness issues."

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of submission. The "tests" mentioned are non-clinical bench tests (electrical safety, EMC, software validation, biocompatibility), not clinical studies with patient data.

3. 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. "Ground truth" in the clinical sense (e.g., diagnosis from expert consensus or pathology) is not established or used as part of this 510(k) submission, as no human-in-the-loop or standalone AI performance study was conducted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there is no clinical test set to adjudicate.

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 document is for a laser surgical instrument, not an AI-powered diagnostic device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a physical laser surgical instrument, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth was established or used for performance evaluation in this 510(k) submission.

8. The sample size for the training set: Not applicable. The device is a physical laser system, not an AI model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary from the document:

• Clinical Studies: "No clinical studies were considered necessary and performed." (Page 9)
• Proof of meeting acceptance criteria: The device demonstrates compliance with relevant international and national standards for electrical safety (ES60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60601-2-22, IEC 60825-1), and biocompatibility (ISO 10993 series). Software validation was also performed for the "MODERATE level of concern software." These non-clinical tests serve as the basis for demonstrating safety and performance.
• Basis for Clearance: Substantial equivalence to a predicate device (OmniPulse Jr.™) by demonstrating that technological differences (pulse duration, aiming beam) do not raise new safety or effectiveness issues.

Ask a specific question about this device