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The Patriot Duo in the CW mode is intended for Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, Coagulation and hemostasis) of soft tissues including:

Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, Coagulation and hemostasis) including: Urethral Strictures, Bladder Neck Incisions (BNI), Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors, Ablation of Benign Prostatic Hypertrophy (BHP), Transurethral incision of the prostate (TUIP), Laser Resection of the Prostrate (HoLRP), Laser Enuculeation of the Prostate (HoLEP), Laser Ablation of the Prostate (HoLAP), Condylomas and Lesions of external genitalia.

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy, Polyps, Biopsy, Gall Bladder calculi, Biliary/Bile duct calculi, Ulcers, Gastric ulcers, Duodenal ulcers, Non Bleeding Ulcers, Pancreatitas, Hemorrhoids, Cholecystectomy, Benign and Malignant Neoplasm, Angiodysplasia, Colorectal cancer, Telangiectasias, Telangiectasias of the Osler-Weber-Renu disease, Vascular Malformation, Gastritis, Esophagitis, Esophageal ulcers, Varices, Colitis, Mallory-Weiss tear, Gastric Erosions

Thoracic and Pulmonary
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue including: Laryngeal Lesions, Airway obstructions including carcinoma, Polyps and Granulomas, Palliation of obstructing carcinomas of the tracheobronchial tree

Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis), Intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation and or vessel coagulation, Soft tissue excision procedures such as excisional conization of the cervix

ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation,vaporization, coagulation and hemostasis of soft tissue) including: Endonasal/sinus Surgery, Partial turbinectomy, Polypectomy, Dacryocystorhinostomy, Frontal Sinusotomy, Ethmoidectomy, Maxillary antrostomy, Functional endoscopic sinus surgery, Lesions or tumors of the oral, nasal, glossal, pharyngeal and, laryngeal, Tonsillectomy, Adenoidectomy

Dermatology and Plastic Surgery
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas, Lesions of skin and subcutaneous tissue, Skin tags, Plantar warts

General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Cholecystectomy, Lysis of adhesion, Appendectomy Biopsy, Skin incision, Tissue dissection, Excision of external tumors and lesions, Complete or partial resection of internal organs, tumors and lesions, Mastectomy, Hepatectomy Pancreatectomy, Splenectomy, Thyroidectomy, Parathyroidectomy, Herniorrhaphy, Tonsillectomy, Lymphadenectomy, Partial Nephrectomy, Pilonidal Cystectomy, Resection of lipoma, Debridement of Decubitus Ulcer, Hemorrhoids, Debridement of Statis Ulcer, Biopsy

Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue), Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including: Percutaneous Laser Disc Decompression/Discectomy, Foraminoplasty, Ablation and coagulation of soft vascular and non vascular tissue, In minimally invasive spinal surgery

The Patriot Duo in the Quasi-CW (SuperPulse) mode is intended for:

Urology
Ablation of Benign Prostatic 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 urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones.

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including: Appendectomy, Polyps, Biopsy, Gall Bladder calculi, Biliary/Bile duct calculi, Ulcers, Gastric ulcers, Duodenal ulcers, Non Bleeding Ulcers, Pancreatitis, Haemorrhoids, Cholecystectomy, Benign and Malignant Neoplasm, Angiodysplasia, Colorectal cancer, Telangiectasias, Telangiectasias of the Osler-Weber-Renu disease, Vascular Malformation, Gastritis, Esophagitis, Esophageal ulcers, Varices, Colitis, Mallory-Weiss tear, Gastric Erosions

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

Note: The Patriot Duo for CW mode is only cleared for BPH when using over 150 W

Patriot Laser is seeking to introduce the Patriot Duo Laser, fibers and related accessories into commerce using fibers provided by InnovaQuartz, LLC, previously cleared by the FDA via the Premarket 510(k) notification process K180140, the InnovaQuartz LLC side fire fiber was previously cleared by the Premarket 510(k) notification process K233157.

The Patriot Duo Laser, fibers and related accessories are substantially equivalent to the predicate devices, The U.S. Laser Worx Patriot 1 Family of Lasers, fibers and associated accessories (K162334) and the Olympus Surgical Technologies America Soltive Preimum SuperPulse Laser, Laser fibers and accessories (K183647). The Patriot Duo is essentially the exact same device in the CW mode of operation as the as the Patriot 1 Family of Lasers. The Patriot Duo also employs a Quasi CW (SuperPulse) module allowing the Patriot Duo to operate in both the CW and Quasi CW (SuperPulse) modes to expand the Indications for Use (IFU's) to include Laser Lithotripsy and a variety of other clinical indications in the Quasi CW (SuperPulse) mode.

In the Patriot Duo each mode of operation is completely independent and may not be used at the same time or simultaneously, hence Patriot Laser LLC is simply requesting FDA Premarket Approval of two previously cleared modalities to be available in one system.

The U.S. Laser Worx Patriot 1 Family of lasers and accessories received FDA Premarket clearance April 27, 2017 (K162334) and the Olympus Surgical Technologies America Soltive Preimum SuperPulse Laser, Laser fibers and accessories received FDA Premarket clearance August 10, 2019 (K183647) for its Quasi CW (SuperPulse) Thulium Fiber Laser. Patriot Laser is simply combining two previously cleared technologies into the same console making it more beneficial for the medical community to treat more patients and a wider array of medical conditions using the same device.

The Patriot 1 Family of Lasers, 200, 400, 600 and 1000 micron sterile, disposable, single-use fibers (K162334) are indicated for incision, excision, resection, ablation, vaporization and coagulation of soft tissue encountered urology, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery general surgery and arthroscopy.

The Olympus Surgical Technologies America Soltive Preimum SuperPulse Laser (K183647) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery, and gynecological surgery.

The Patriot Duo Laser, fibers, and related accessories are indicated for incision, excision, resection, ablation, vaporization, and coagulation of soft tissue encountered in urology, lithotripsy, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery general surgery and arthroscopy.

The Patriot Duo, the Patriot 1 Family of Lasers and the Soltive Premium are medical grade, infrared devices, which provide continuous and or Quasi CW (SuperPulse) laser energy at a wavelength 1945.5 nm +/- 8 % and 1920 nm – 1960 nm respectfully. The very slight difference in wavelength is clinically negligible. The Patriot Duo has the same intended uses as the previously cleared devices by the FDA via the 510K Notification process.

A comparison matrix listing the Characteristics and Technical Data of the Patriot Laser Patriot Duo and representative predicate devices is listed below.

The intended use and indications for use of the Patriot Duo Laser, fibers and related accessories are equivalent to the intended use and indications for use of the predicate devices the Patriot 1 Family of Lasers, fibers and related accessories and The Soltive Premium Laser, Laser fibers and accessories.

In addition, similar technological characteristics and principles of operation apply for all three laser systems. The Patriot Duo Laser, fibers and related accessories, components share the same fundamental technology as the previously cleared or predicate devices.

Performance testing was conducted and demonstrated that technological differences in optical and energy outputs of the laser do not alter the safety and effectiveness when compared to the optical and energy outputs of the predicate laser systems.

In regard to safety or effectiveness whereas the Patriot Duo, the Patriot 1 Family of Lasers and the Soltive Premium are very similar products. Patriot Laser believes that the performance characteristics of the Patriot Duo raises no safety concerns.

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