QUANTA CYBER TM 150W

{0}------------------------------------------------ | Title: | 510(k) SUMMARY<br>Quanta System Cyber Tm 150W | K102749<br>DEC 10 2010 | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | Submitter: | Quanta System SpA<br>via IV Novembre,116<br>21058 Solbiate<br>Olona VA / Italy | | | Contact: | Dr. Isabella Carrer<br>Medical Division Manager | | | Date Prepared: | October 5, 2009 | | | Device Trade Name: | Quanta System Cyber Tm 150W | | | Common Name: | Laser surgical instrument for use in general surgery and<br>dermatology | | | Classification Name: | Instrument, surgical, powered, laser | | | Predicate Devices: | - Quanta System Cyber Surgical Laser Family<br>(K090962); | | | Intended Use / | 2.01μm Applications: | | | Indications for Use: | The Cyber Tm 150W and its fiber optic delivery system<br>are intended for use in surgical procedures using open,<br>laparoscopic and endoscopic incision, excision, resection,<br>ablation, vaporization, coagulation and hemostasis of<br>soft tissue in use in medical specialties including:<br>Urology, Gastroenterology, Thoracic and Pulmonary,<br>Gynecology, ENT, Dermatology, Plastic Surgery,<br>General Surgery.and Arthroscopy | | | | <b>Urology</b> | | | | Open and endoscopic surgery (incision, excision, | | resection, ablation, vaporization, coagulation and hemostasis) including: - Urethral Strictures - -Bladder Neck Incisions (BNI) {1}------------------------------------------------ - 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 a - 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 {2}------------------------------------------------ #### 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 #### General Surgery Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: - Cholecystectomy - - Lysis of adhesion - - Appendectomy 1 - Biopsv - - Skin incision - - Tissue dissection - {3}------------------------------------------------ - Excision of external tumors and lesions - Complete or partial resection of internal organs, tumors and lesions - Mastectomy - - Hepatectomy - - Pancreatectomy - - Splenectomy - - Thyroidectomy - - Parathyroidectomy - - Herniorrhaphv - - Tonsillectomy . - Lymphadenectomy - - Partial Nephrectomy - - Pilonidal Cystectomy ﺳ - 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 Cyber Tm 150W is a surgical laser instrument for use in general surgery and dermatology. The Cyber Tm 150W is: | Technological | |------------------| | Characteristics: | | Models | Wavelength | Laser Power | |----------|------------|-------------| | Cyber Tm | 2.01μm | 150W | - Cyber Tm is intended for use in surgical procedures using open, laparoscopic and {4}------------------------------------------------ endoscopic incision, excision, resection, ablation, vaporization, coagulation 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 The device consists of a rack that houses the cooling units (2 chillers), the laser source and the power supply. Above the rack, into a cover-proof light, the laser head and optical bench with the beam delivery optics and the power meter are housed. The Cyber Tm includes a Tm:YAG Laser Source that emit a Cw laser light at 2.01pm wavelength with power adjustable from 5 to 150W. An SMA connector allows the connection of an optical fiber in which the main beam and the 650nm aiming beam are launched. Sidefire fibers (600pm) and bare fibers (200, 365, 400, 550, 600, 800 and 1000um) are available for both laser source. The emergency red push button , the key-switch and the operation status led are housed in the front part of the system. The footswitch connector is housed in the back side of the system. A metal door closes the lower rack. On the back panel are housed the magneto-thermal switch (circuit braker), the line cable with IEC309 /32A plug and a safety interlock connector. The rear panel also contains the power supply and chiller outlet grids cooling . The device is controlled by a touch-screen PC mounted on a orientable arm. Animal tests were performed to demonstrate the Performance Data consistent and predictable ablation and coagulation of different tissues used in the study. > Quanta System Cyber Tm 150W is as safe and effective as the predicate devices. The Cyber Tm 150W has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Cyber Tm 150W and its predicate devices raise no new issues of safety or effectiveness. From a clinical point of view, comparing 120W vs 150W application on animal tissue it has been showed that: > > lateral coagulation width and axial coagulation depth do not show any Substantial Equivalence: {5}------------------------------------------------ significant difference – therefore the remaining tissue is affected in the same amount - depth of the ablation crater: no significant differences when velocities of 5 and 10mm/s were used, while a significant increase of ablation depth at 1mm/s at 150W compared to 120W - carbonisation of Tm:YAG laser power occurred at 150W in the same manner as could be observed at 120W Thus, the Cyber Tm 150W is substantially equivalent. {6}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Quanta System SPA % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313 DEC 1 0 2010 Re: K102749 Trade/Device Name: Quanta System Cyber Tm 150W Regulation Number: 21 CFFR 878.4810 Regulation Name: Lase surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 27, 2010 Received: December 01, 2010 Dear Mr. Job: 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 (Act to not require approval of the Federal Food, Drug, You may, therefore, market the device, subject to the secure approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of PMA). general controls provisions of the Act include recorders 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 mistranding and adulteration. Please note: CDRH does not evaluate information related to contract ing and warranties. We remind vou: bowever, that design is hat 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. {7}------------------------------------------------ Page 2 – Mr. Mark Job Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that substantial equivalence detemination does not mean that FDA has made a determination administers leavith other requirements of the Act or any Federal statutes and regulations administered by other requirements of for comply with all the Act's requirements, including, but not limited to: registration and listing (21) CFR Part 807); labeling (21 CFR Part 801); modical 10: registration and l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting and listing); CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as and forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, e the election of the of Schild (QS) regulation (21 CFR Part 820); and if applicable, the elect product radiation control provisions (Sections 531-542 of the Act); 21 CFR 10 If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm/11/2/2/2/2 the Center for Devices and Radiological Health CDRH/CDRH/Offices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Offices/ucm 115809.htm for note the regulation entitled "Misbranding by references of Compliance. Also, please note the regulation entitled than is (CDRH s) Office of Compliance. Also, please 807.97). For questions regarding the reporting of cl 807.97). For question reporting of ference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation ( 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 Small Manufacturers, International and Consumer Assistance at its toll the manner (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, A B reta Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ | | Indications for Use Statement | | |---------------------------|-------------------------------|--| | 510(k) Number (if known): | K102749 | | Device Name: Cyber Tm 150W DEC 1 0 2010 Indications for Use: ## 2.01um Applications: The Cyber Tm 150W and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation 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 ## Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: - Urethral Strictures - - Bladder Neck Incisions (BNI) ー - 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 - - 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 - (Division Sign-Off) (Division Sign-Off) Division of Surgicel, Orthopedic, Orthopedic, Devices and retive Devices Division of Surgers and Restorative Devices and Restorative Devices 510(k) Number K1027 {9}------------------------------------------------ - 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 I - Colitis - Mallory-Weiss tear - Gastric Erosions ## 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 - tissue) including: (Division Sign-Off) (Division Sign of Surgical, Orthopedic, and Restorative Devices 510(k) Number K102749 {10}------------------------------------------------ A. - Dacrvocystorhinostomy - Frontal Sinusotomy - Ethmoidectomy - Maxillary antrostomy - - Functional endoscopic sinus surgery - - Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal - Tonsillectomy - Adenoidectomy ## 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 ﮯ - Parathvroidectomy a - Herniorrhaphy . - Tonsillectomy - - Lymphadenectomy - - Partial Nephrectomy ﮯ - Pilonidal Cystectomy - Resection of lipoma - Debridement of Decubitus Ulcer - Hemorrhoids - Debridement of Statis Ulcer - Biopsy Mark A. Milburn (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K102749 Arthroscopy 20 {11}------------------------------------------------ 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. - Prescription Use X Use (Part 21 C.F.R. 801 Subpart D) AND/OR Over-The-Counter (21 C.F.R. 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mula A. Millican (Division Sign-Off) Division of Surgical, Orthopedic, Division of Surgices Division of Surges and Restorative Devices K102749 510(k) Number