U.S. Laser Worx Patriot 1 family of lasers

K162334 · U.S. Laser Worx · GEX · Apr 27, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K162334
• Device Name: U.S. Laser Worx Patriot 1 family of lasers
• Applicant: U.S. Laser Worx
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 encountered in urology, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery general surgery and arthroscopy.

Device Story

The Patriot 1 Family consists of Thulium (Tm:Fiber) surgical lasers delivering 1.94-micron wavelength radiation via fiber optics. The device operates in continuous mode with adjustable power outputs (5W to 120W, 150W, 180W, or 200W). It is used by physicians in clinical settings (OR, endoscopic suites) for soft tissue management across multiple specialties. The laser energy is delivered to the target tissue via sterile, single-use fibers (400, 600, 1000 microns). The physician uses an adjustable blue diode aiming beam to guide the laser. The device enables precise tissue removal or coagulation, facilitating surgical procedures and potentially reducing patient recovery time through minimally invasive endoscopic or open surgical approaches.

Clinical Evidence

Bench testing only. Performance data includes power verification, energy transmission measurements, and software accuracy testing. Compliance with IEC safety standards (60601-1, 60601-1-2, 60601-2-22, 60825-1) was demonstrated.

Technological Characteristics

Tm:Fiber laser source; 1.94-micron wavelength; continuous operating mode; 5-200W power output; 400/600/1000 micron fiber delivery; 450nm blue diode aiming beam; closed-cycle internal cooling; 230 VAC electrical supply. Software-controlled power output. Meets IEC 60601-1, 60601-1-2, 60601-2-22, and 60825-1 standards.

Indications for Use

Indicated for soft tissue incision, excision, resection, ablation, vaporization, and coagulation in urology (including BPH, tumors, strictures), gastroenterology, thoracic/pulmonary, gynecology, ENT, dermatology, plastic surgery, general surgery, and arthroscopy/orthopedic surgery. Patriot 1 180 and 200 models are indicated for BPH only when using >150W.

Regulatory Classification

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.

Predicate Devices

• AllMed Systems, Inc. Revolix 120 (K070476)
• Quanta System Cyber Tm 120, Tm 150, Tm 180 and the Tm 200 (K131081)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 27, 2017

U.S. Laser Worx Frank Ford CEO 13423 Blanco Rd #162 San Antonio, Texas 78216

Re: K162334

Trade/Device Name: U.S. Laser Worx Patriot 1 Family of Lasers 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: February 9, 2017 Received: February 13, 2017

Dear Mr. 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 (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. 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.

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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

## Indications for Use Statement

#### 510(k) Number (if known): K162334

Device Name: Patriot 1 Family of Lasers and Accessories

#### Indications for Use:

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 encountered in urology, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery general surgery and arthroscopy.

#### 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. 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

Prescription Use: X AND/OR Over the Counter Use: (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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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

AND/OR Over the Counter Use: Prescription Use: X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Thoracic and Pulmonary

Open and endoscopic thoracic and pulmonary surgery (incision, 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, coaqulation 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 Tonsillectomv Adenoidectomy

Prescription Use: X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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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

#### Prescription Use: X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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General Surgery

Open laparoscopic and endoscopic surgery (incision, excision, 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

Prescription Use: _ X AND/OR Over the Counter Use: (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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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

## Note: The Patriot 1 180 and 200 are only cleared for BPH when using over 150 W

Prescription Use: __ X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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# 510K SUMMARY

| Title: | U. S. Laser Worx, Inc. Patriot 1 Family of Lasers and Accessories | | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------|--|--|
| Submitter: | U. S. Laser Worx, Inc. | | |
| Contact: | Timothy J. Shea<br>189 Winding Oaks Lane<br>Oviedo, FL 32765<br>Phone: [phone]<br>Email: [e-mail] | | |
| Date Prepared: | August 6, 2016 | | |
| Device Trade Name: | Patriot 1 Family of Lasers and Accessories | | |
| Common Name: | Tm:Fiber Laser | | |
| Classification Name | 21 CFR Part 878.4810<br>Laser Surgical instrument for use in general and plastic surgery as well as<br>Dermatology | | |
| Predicate Devices: | AllMed Systems, Inc. Revolix 120 (K07046) and the Quanta System Cyber<br>Tm 120, Tm 150, Tm 180 and the Tm 200 (K131081) | | |
| Review Panel: | General and Plastic Surgery (GEX) | | |
| PRODUCT CODE: | GEX | | |
| Device Description: | General Description- Thulium Laser/ Patriot 1 family of lasers | | |

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### Indications for use

### Indications for Use Statement:

510(k) Number (if known): K162334

Device Name: Patriot 1 Family of Lasers and Accessories

#### Indications for Use:

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 coaqulation of soft tissue encountered in urology, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery general surgery and arthroscopy.

#### Urology

Open and endoscopic surgery (incision, excision, 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

#### Prescription Use: X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Gastroenterology

Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coaqulation 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

Prescription Use: X AND/OR Over the Counter Use: (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Thoracic and Pulmonary

Open and endoscopic thoracic and pulmonary surgery (incision, 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, resection, ablation, vaporization, coaqulation 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

Prescription Use: _ X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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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

Prescription Use: X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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General Surgery

Open laparoscopic and endoscopic surgery (incision, excision, ablation, vaporization, coaqulation 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

Prescription Use: __X _________________AND/OR Over the Counter Use: (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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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

Note: The Patriot 1 180 and 200 are only cleared for BPH when using over 150 W

Prescription Use: __ X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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# SPECIFICATIONS

# Patriot 1 Family of Lasers Technical Specifications

| Laser Type: | Tm:Fiber |
|--------------------|----------------------------------------------------------------------|
| Wavelength: | 1.94 microns |
| Power to Tissue: | 5 to 120, 150, 180, 200 Watts |
| Operating Modes: | Continuous |
| Beam Delivery: | 400, 600 and 1000 micron fibers. Specialty<br>fibers also available. |
| Aiming Beam: | 450, Blue Diode, Adjustable |
| Electrical Supply: | 230 VAC, 2.4 kVA, 50/60 Hz |
| Cooling: | Closed cycle, internal |
| Dimensions: | H: 35.3<br>L: 29.3<br>W: 19.8 |
| Weight: | TBD Pounds |

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General Device Description (unmodified predicate devices vs new modified devices):

The U. S. Laser Worx Family of lasers are surgical instrument for use in general and plastic surgery and in dermatology (GEX).

The Patriot 1 Family of lasers are installed with a single Tm:Fiber Laser Source with CW emission at 1.94 microns with adjustable power from 5 W to the maximum output power (as given below). The laser radiation is delivered to the tissue to be treated through fiber optics.

The Patriot 1 Family (that includes 120, 150, 180 and the 200) and its accessories are intended for use in surqical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coaqulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.

Note: the Patriot 1 180 and 200 are only approved for the treatment of BPH when used at power levels greater than 150W.

The Patriot 1 Family has the following models (and related main characteristics):

| Patriot 1 120 | 5 to 120 Watts to tissue |
|---------------|--------------------------|
| Patriot 1 150 | 5 to 150 Watts to tissue |
| Patriot 1 180 | 5 to 180 Watts to tissue |
| Patriot 1 200 | 5 to 200 Watts to tissue |

All models of the Patriot 1 Family share the same structure, the same components and the same software. The differentiation of the models derives only from the factory set of the maximum output power of the laser resonator.

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# SUBSTANTIAL EQUIVALENCE SUMMARY

| Company/<br>Specifications | US. Laser Worx, Inc.<br>Patriot 1 Family of<br>Lasers | AllMed Systems Inc.<br>Revolix 120 | Quanta System SPA<br>Cyber Tm 120, 150,<br>180 and 200 |
|--------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Concurrence:<br>510(k) Number: | Pending | K070476 | K131081 |
| Laser Medium: | Tm:Fiber | Tm:Fiber | Tm:Fiber |
| Wavelength: | 1.94 microns | 2.01 microns | 2.01 microns |
| Power to Tissue: | 5 to 120, 150, 180 and<br>200 Watts | 5 to 120 Watts | 1 to 120, 150, 180 and<br>200 Watts |
| Operating<br>Modes: | Continuous | Continuous and Pulsed | Continuous and Pulsed |
| Pulsed Mode: | CW | 50 ms to CW | 10 to 1,000 ms, CW |
| Beam Delivery: | 400, 600 and 1000<br>micron fibers. Specialty<br>fibers also available | 200, 400, 600 and 1000<br>micron fibers. Specialty<br>fibers also available | 600, 800 and 1000<br>micron fibers. Specialty<br>fibers also available |
| Aiming Beam: | 450 nm, Blue Diode,<br>adjustable | 635 nm Red Diode, 1<br>mW<br>Adjustable | 635 nm Red Diode<br>adjustable |
| Electrical<br>Supply: | 230 VAC, 30 Amps,<br>50/60 Hz, | 230 VAC, 2.4 kVA,<br>50/60 Hz | 200-240, 50/60 Hz, 16<br>Amps |
| Cooling: | Closed cycle, internal | Closed cycle, internal | Closed cycle, internal |
| Dimensions: | H: 35.3"<br>W: 19.8"<br>L: 29.3″ | H: 38"<br>W: 17"<br>L: 35" | H: 43.3"<br>W: 21.6"<br>L: 29.5" |
| Weight: | TBD Pounds | 330 Pounds | 352 Pounds |

## NOTE: The Patriot 1 180 and 200 are only cleared for BPH when using over 150 Watts

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- From a design and clinical perspective, the predicate and candidate laser devices, Summary: are the same technology and have the same intended uses. Based upon the fact that the devices are extremely similar, the Patriot 1 Family of Lasers and Accessories should not raise any concerns regarding its overall safety and/or effectiveness.
Non-Clinical Performance Data:

Performance Standards: THERE ARE NO PERFORMANCE STANDARDS NECESSARY/REQUIRED FOR THIS DEVICE.

IEC safety standards met:

60601-1 ED 3.1(2012)

60601-1-2:2014 4th Ed

60601-2-22 Ed 3.1(2012)

60601-1:2005

60601-1 ED3 (2007) AMENDMENT 1(2013)

60601-1:14(2014) —CANADA

60825-1 2007

ADDITIONALLY, WE PERFORMED NUMEROUS BENCH TESTS INVOVING POWER VERIFICATIONS, MEASUREMENTS, ACCURACY OF SOFTWARE AND ENERGY TRANSMISSION