(136 days)
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.
N/A
FDA 510(k) Clearance Letter - Patriot Duo Laser System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.08.00
Silver Spring, MD 20993
www.fda.gov
October 27, 2025
Patriot Laser, LLC
Frank Ford
Official Applicant
13423 Blanco Road #162
San Antonio, Texas 78216
Re: K251824
Trade/Device Name: Patriot Duo
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: GEX
Dated: June 3, 2025
Received: June 13, 2025
Dear Frank Ford:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2
K251824 - Frank Ford Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.
Page 3
K251824 - Frank Ford Page 3
See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
TANISHA L. HITHE -S [Digitally signed by TANISHA L. HITHE -S Date: 2025.10.27 18:05:38 -04'00']
Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 3
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K251824
Device Name: Patriot Duo Laser System
Indications for Use (Describe)
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,
Page 5
FORM FDA 3881 (8/23) Page 2 of 3
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
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Page 6
FORM FDA 3881 (8/23) Page 3 of 3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 7
Patriot Duo 510k Summary K251824
510(k) number: K251824
Device Name: Patriot Duo Laser System
510(k) Type: Traditional
Applicant: Patriot Laser, LLC
23030 N 15th Street
Phoenix, AZ 85207
October 22nd, 2025
Applicant Contact Name: Frank Ford
Phone: 210-885-7679
Email: fford1@satx.rr.com
Medical Specialty: General and Plastic Surgery
Regulation: § 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
Product Code: GEX (Class 2) – Powered Laser Surgical Instrument
Predicate Devices: K162334, Patriot 1
K183647, SOLTIVE™ Premium
Page 8
Patriot Duo 510k Summary K251824
| 510(k) number | K251824 |
|---|---|
| Device Name | Patriot Duo Laser System |
| 510(k) Type | Traditional |
| Applicant | Patriot Laser, LLC23030 N 15th StreetPhoenix, AZ 85207October 22nd, 2025 |
| Applicant Contact | Name: Frank FordPhone: 210-885-7679Email: fford1@satx.rr.com |
| Medical Specialty | General and Plastic Surgery |
| Regulation | § 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology. |
| Product Code | GEX (Class 2) – Powered Laser Surgical Instrument |
| Predicate Devices | K162334, Patriot 1K183647, SOLTIVE™ Premium |
Page 1 of 16
Page 9
Patriot Duo 510k Summary K251824
Device Description
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.
Page 2 of 16
Page 10
Patriot Duo 510k Summary K251824
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.
Page 3 of 16
Page 11
Patriot Duo 510k Summary K251824
Summary of Non-Clinical Testing
- Risk analysis activities, in compliance with the requirements of ISO 14971 Third Edition 2019-12. Medical devices - Application of risk management to medical devices
- IEC 60825-1:2014, Safety of laser products – Part 1: Equipment classification and requirements.
- IEC 60601-1:2005, Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance; IEC 60601-1:2005/AMD1:2012/AMD2:2020
- IEC 60601-1-2:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- Software verification and validations, with Basic Documentation, in compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005 and Content of Premarket Submissions for Device Software Functions, June 2023.
The tests confirmed that the subject device operates in alignment with its specifications and complies with international consensus standards and FDA guidance.
Page 4 of 16
Page 12
Patriot Duo 510k Summary K251824
Indications for Use
CW Mode:
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
Page 5 of 16
Page 13
Patriot Duo 510k Summary K251824
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
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Patriot Duo 510k Summary K251824
Quasi-CW (SuperPulse) Mode:
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
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Patriot Duo 510k Summary K251824
Technological Comparison
Comparison with predicate - CW Mode
| Specifications | Patriot Duo (K251824) | Patriot 1 (K162334) | Comparison |
|---|---|---|---|
| Indications for Use | 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:UrologyOpen 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 genitaliaGastroenterologyOpen and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy, Polyps, Biopsy | The Patriot 1 Family of Lasers, 400, 600 and 1000 micron sterile, disposable, single use fibers are indicated for incision, excision, resection, ablation, vaporization and coagulation of soft tissue including:UrologyOpen 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. 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 Lesions of external genitalia.GastroenterologyOpen and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: | Same |
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Patriot Duo 510k Summary K251824
| Specifications | Patriot Duo (K251824) | Patriot 1 (K162334) | Comparison |
|---|---|---|---|
| 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 ErosionsThoracic and PulmonaryOpen 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 treeGynecologyOpen 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 | 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 PulmonaryOpen 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 treeGynecologyOpen and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) |
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Patriot Duo 510k Summary K251824
| Specifications | Patriot Duo (K251824) | Patriot 1 (K162334) | Comparison |
|---|---|---|---|
| ENTEndoscopic 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, AdenoidectomyDermatology and Plastic SurgeryIncision, 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 wartsGeneral SurgeryOpen 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 | 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 cervixENTEndoscopic 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, AdenoidectomyDermatology and Plastic SurgeryIncision, 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 wartsGeneral SurgeryOpen laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, |
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Patriot Duo 510k Summary K251824
| Specifications | Patriot Duo (K251824) | Patriot 1 (K162334) | Comparison |
|---|---|---|---|
| Pancreatectomy, Splenectomy, Thyroidectomy, Parathyroidectomy, Herniorrhaphy, Tonsillectomy, Lymphadenectomy, Partial Nephrectomy, Pilonidal Cystectomy, Resection of lipoma, Debridement of Decubitus Ulcer, Hemorrhoids, Debridement of Statis Ulcer, BiopsyArthroscopyArthroscopy/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 surgeryNote: The Patriot Duo in CW mode is only cleared for BPH when using over 150 W | 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, BiopsyArthroscopyArthroscopy/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 surgeryNote: The Patriot 1 is only cleared for BPH when using over 150 W | ||
| Laser Medium: | Tm:Fiber | Tm:Fiber | Same |
| Wavelength: | 1930 – 1950 nm | 1940 nm | Same |
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Patriot Duo 510k Summary K251824
| Specifications | Patriot Duo (K251824) | Patriot 1 (K162334) | Comparison |
|---|---|---|---|
| Power to Tissue: | 30 to 200 Watts | 10 to 200 Watts | Within Range |
| Operating Modes: | Continuous (CW) | Continuous (CW) | Same |
| Pulsed Mode: | CW | CW | Same |
| Beam Delivery: | 200 - 1000 micron and side-fire fibers. Specialty fibers also available | 200 - 1000 micron fibers. Specialty fibers also available | Same |
| Aiming Beam: | 520 nm Green diode power adjustable 0-5 mW | 450 nm Blue diode adjustable | Similar |
| Electrical Supply: | 220V~ at 5000VA 50/60 Hz | 230 VAC, 2.4 kVA , 50/60 Hz, | Similar |
| Cooling: | Closed cycle, internal | Closed cycle, internal | Same |
| Dimensions: | H: 45.5W: 22.5L: 44 | H: 35.3W: 19.8L: 29.3 | Similar |
| Weight: | Approx. 350 lbs | Approx. 300 Pounds | Similar |
Technological Differences:
Power to Tissue: The power to tissue for the subject device is 30-200 W, while the predicates is 10-200 W. Even though there is a difference, our power is within the range of the predicate, therefore, there are no safety concerns.
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Patriot Duo 510k Summary K251824
Comparison with predicate - Quasi CW Mode
| Specification | Patriot Duo (K251824) | SOLTIVE™ Premium (K183647) | Comparison |
|---|---|---|---|
| Indications for Use | The Patriot Duo in the Quasi-CW (SuperPulse) mode is intended for:UrologyAblation 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. | The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) 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.Urology•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 | Similar |
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Patriot Duo 510k Summary K251824
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.
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 •Endoscopic fragmentation of calculi •Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, 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
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Patriot Duo 510k Summary K251824
| Specification | Patriot Duo (K251824) | SOLTIVE™ Premium (K183647) | Comparison |
|---|---|---|---|
| Laser Classification: | Class 4 | Class 4 | Same |
| Laser Type: | Thulium Fiber Laser | Thulium Fiber Laser | Same |
| Wavelength: | 1930 – 1950 nm | 1920 nm – 1960 nm | Same |
| Laser Energy: | 0.025 J – 6.0 J | 0.025 J – 6 J | Within Range |
| Laser Frequency: | 1 Hz – 2,400 Hz | 1 Hz – 2,400 Hz | Same |
| Average Power: | 2 W – 60 W adjustable ±20% | 2 W – 60 W adjustable | Same |
| Pulse Duration: | 200 μs and up to 50 ms | 200 μs – 50 ms | Same |
| Fiber Delivery: | 200 - 1,000 micron and Side-Fire | 200 - 1,000 micron | Same |
| Aiming Beam: | 520 nm Green power adjustable 0-5 mW | Green, 500 – 550 nm, power adjustable 0-5 mW | Similar |
| Product Category: | Surgical laser for medical use | Surgical laser for medical use | Same |
| Class of Medical Device Directive: | Class IIb | Class IIb | Same |
| Electrical requirements: | 230V~ at 3000VA 50/60 Hz | 100-240V~ at 1200VA 50/60 Hz | Similar |
| Dimensions H x W x D: | 45.5 x 22.5 x 44 inches | 25.5 x 37.0 x 56.0 inches | Similar |
| Weight: | Approx. 350 lbs | 73 lbs | Similar |
| Laser Cooling System: | Closed cycle, internal, air | Air | Same |
| Protection against electric shock: | Class 1 / Type BF | Class 1 / Type BF | Same |
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Patriot Duo 510k Summary K251824
Note: For Lithotripsy and Percutaneous Urinary Lithotripsy Indications, the SOLTIVE™ Premium is indicated for "Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed". This indication is not included in for the Patriot Duo; however, the indications for use of the Patriot Duo still fall within the range of the SOLTIVE™ Premium predicate device. Therefore, this difference does not impact safety nor effectiveness of the device.
Technological Differences:
Wavelength: The wavelength for the subject device is 1930 – 1950 nm, while for the predicate it's 1920 nm – 1960 nm. In both cases the center frequency is identical; both lasers are 1940 nm lasers, therefore, there are no safety concerns.
Aiming Beam: The aiming beam for the predicate and the subject device are identical in the power class and center frequency, therefore, there are no safety concerns.
Conclusion
Based upon the intended use and known technical information provided in this pre-market notification, the device is substantially equivalent to the predicate Patriot 1 Family of Lasers and the SOLTIVE™ Premium SuperPulse Laser, as it shares similar intended uses, technological characteristics, and principles of operation. Comprehensive non-performance testing demonstrated that any technological differences in optical and energy outputs are clinically insignificant. Coupled with verification testing results showing equivalence and evidence of safe and effective operation, it has been determined that the Patriot Duo Laser and its associated accessories meet all necessary requirements and specifications without raising new safety or effectiveness concerns.
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§ 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.