(248 days)
K07046, K131081
Not Found
No
The summary describes a laser surgical instrument and its intended uses. There is no mention of AI, ML, image processing, or any data-driven algorithms that would suggest the incorporation of such technology. The performance studies focus on safety standards and bench testing of power and energy transmission.
Yes.
The device is a surgical instrument for various procedures involving soft tissues, which are therapeutic interventions.
No
The device is described as a "surgical instrument" intended for incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue, which are all therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is a "Thulium Laser/ Patriot 1 family of lasers" and describes hardware components like a "Tm:Fiber Laser Source" and "fiber optics" for delivering laser radiation. It also mentions bench tests involving "power verifications, measurements, accuracy of software and energy transmission," indicating a hardware component is being tested.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states the device is for "incision, excision, resection, ablation, vaporization and coagulation of soft tissue" in various surgical specialties. This describes a surgical tool used directly on the patient's body for treatment.
- Device Description: The description reinforces this by calling it a "surgical instrument" that delivers laser radiation to "tissue to be treated."
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a surgical laser intended for direct therapeutic intervention on soft tissue within the body.
N/A
Intended Use / 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
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, 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
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, 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
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
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
General Description- Thulium Laser/ Patriot 1 family of lasers
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethral, Bladder, Uretheral, Prostate, external genitalia, Appendectomy, Polyps, Gall Bladder, Biliary/Bile duct, Ulcers (Gastric, Duodenal, Non Bleeding, Esophageal), Pancreatitas, Hemorrhoids, Cholecystectomy, Colorectal, Telangiectasias, Osler-Weber-Renu disease, Vascular, Gastritis, Esophagitis, Varices, Colitis, Mallory-Weiss tear, Gastric, Laryngeal, Airway, tracheobronchial, Intra-uterine, fibroids, endometrial, uterus, cervix, Endonasal/sinus, oral, nasal, glossal, pharyngeal, laryngeal, Tonsillectomv, Adenoidectomy, skin, subcutaneous tissue, Achilles, Plantar, Adhesion, internal organs, tumors, Mastectomy, Hepatectomy, Pancreatectomy, Splenectomy, Thyroidectomy, Parathyroidectomy, Herniorrhaphy, Lymphadenectomy, Nephrectomy, Pilonidal, lipoma, Decubitus Ulcer, Statis Ulcer, Spinal Disc, Foramen.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K07046, K131081
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
3
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)
4
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)
5
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)
6
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)
7
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)
8
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 | ||
| 189 Winding Oaks Lane | |||
| Oviedo, FL 32765 | |||
| Phone: 407-590-2050 | |||
| Email: tsheabo@aol.com | |||
| 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 | ||
| Laser Surgical instrument for use in general and plastic surgery as well as | |||
| Dermatology | |||
| Predicate Devices: | AllMed Systems, Inc. Revolix 120 (K07046) and the Quanta System Cyber | ||
| 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 |
9
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)
10
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)
11
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)
12
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)
13
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)
14
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)
15
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 |
| 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 |
| L: 29.3 | |
| W: 19.8 | |
| Weight: | TBD Pounds |
16
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.
17
SUBSTANTIAL EQUIVALENCE SUMMARY
| Company/
Specifications | US. Laser Worx, Inc.
Patriot 1 Family of
Lasers | AllMed Systems Inc.
Revolix 120 | Quanta System SPA
Cyber Tm 120, 150,
180 and 200 |
|--------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Concurrence:
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
200 Watts | 5 to 120 Watts | 1 to 120, 150, 180 and
200 Watts |
| Operating
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
micron fibers. Specialty
fibers also available | 200, 400, 600 and 1000
micron fibers. Specialty
fibers also available | 600, 800 and 1000
micron fibers. Specialty
fibers also available |
| Aiming Beam: | 450 nm, Blue Diode,
adjustable | 635 nm Red Diode, 1
mW
Adjustable | 635 nm Red Diode
adjustable |
| Electrical
Supply: | 230 VAC, 30 Amps,
50/60 Hz, | 230 VAC, 2.4 kVA,
50/60 Hz | 200-240, 50/60 Hz, 16
Amps |
| Cooling: | Closed cycle, internal | Closed cycle, internal | Closed cycle, internal |
| Dimensions: | H: 35.3"
W: 19.8"
L: 29.3″ | H: 38"
W: 17"
L: 35" | H: 43.3"
W: 21.6"
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
18
- 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