REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200

{0}------------------------------------------------ FEB 1 9 2013 ## Attachment V ## 510(k) Summary ### 1.General Information ### Submitter: AllMed Systems Inc. 9232 Klemetson Drive Pleasanton CA 94588 24th March 2011 Phone: 925-468-0433 925-399-5984 Fax Contact Person Peter Allen Date Prepared ### 2. Names | Device Name | Revolix Family of Laser Systems including the RevoLix Jr<br>30, RevoLix Jr 50 RevoLix 160 and RevoLix 200 | |---------------------|-----------------------------------------------------------------------------------------------------------| | Common Name | 2.01micron Laser System | | Classification Name | Laser Surgical Instrument and accessories | ### 3. Predicate Device RevoLix Jr, RevoLix 120 watt and Quanta Cyber TM 150 ### 4. Product Description The RevoLix Family of diode pump solid state ( that include the RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200) are part of a family of surgical laser systems operating at a wavelength of 2.01 micron. The purpose of these lasers is to ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic surgical applications and procedures in an aqueous and non-aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a hand piece. endoscopic or laparoscopic surgical instrument. {1}------------------------------------------------ It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch ### 5. Indications for Use The RevoLix Jr 30, RevoLix 160 and RevoLix 200 laser systems and their 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) 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 Note: The RevoLix 160 and 200 are only approved for the treatment of BPH when used at power levels greater than 120 watts ### Gastroenterology Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: > Appendectomy Polyps Biopsv Gall Bladder calculi Biliary/Bile duct calculi Ulcers {2}------------------------------------------------ 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 Esophaqitis 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 > 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 coaqulation Soft tissue excision procedures such as excisional conization of the cervix ## ENT Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coaqulation and hemostasis of soft tissue) including: > Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy {3}------------------------------------------------ Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal . Tonsillectomy Adenoidectomy {4}------------------------------------------------ ### Dermatology and Plastic Surgerv Incision, excision, resection, ablation, vaporization, coaqulation and hemostasisof 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 Appendectomv Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs, tumors and lesions Mastectomy Hepatectomy Pancreatectomv Splenectomv Thyroidectomy Parathyroidectomy Herniorrhaphy Tonsillectomy Lymphadenectomy Partial Nephrectomy Pilonidal Cystectomy Resection of lipoma Debridement of Decubitus Ulcer Hemorrhoids Debridement of Statis Ulcer Biopsv ### 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 {5}------------------------------------------------ ### 6. Rationale for Substantial Equivalence The Revolix Jr 30. RevoLix Jr 50. RevoLix 160 and RevoLix 200 laser systems and their fiber optic delivery devices share the same intended use, indications for use, similar design features and functional features and therefore are substantially equivalent to the RevoLix Jr, RevoLix 120 and Quanta Cyber TM 150. ### Testing and Clinical Evaluation. All necessary bench testing was conducted on the proposed family of RevoLix lasers to support a determination of substantial equivalence to the predicate device. The depth of thermal injury and coagulation were measured and compared to the RevoLix 120 and did not show significant differences. The ablation depth was also measured and found to be of comparable depth, with an adjustment in the translation speed depended on the power level. Other tissue effects such as carbonization were also found to be comparable. All clinical data provided in this submission supporting the RevoLix 200 at a setting of 200 watts is provided ONLY for the indication of use in the treatment of BPH. ### 7. Conclusion The Revolix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 Laser Systems with fiber optic delivery devices was found to be safe and effective and therefore substantially equivalent to the predicate surgical laser systems and delivery devices. Note: The RevoLix 160 and 200 are only approved for the treatment of BPH when used at power levels greater than 120 watts {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. ### DEPARTMENT OF HEALTH & HUMAN SERVICES ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 AllMed Systems, Incorporated % Mr. Peter Allen 495 Main Street Wilbraham, Massachusetts 01095 February 19, 2013 Re: K110941 Trade/Device Name: RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLiz 200 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: March 24, 2011 Received: December 31, 2012 Dear Mr. Allen: 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. Isting 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {7}------------------------------------------------ Page 2 - Mr. Peter Allen 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours, FOR Peter D. Rumm -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ #### 510(k) Number: K110941 Device Name: RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 Indications For Use: The Revolix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 laser systems and their 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) 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 Note: The RevoLix 160 and 200 are only approved for the treatment of BPH when used at power levels greater than 120 watts Neil R Ogden R 2013.02.15 15:28:29 :05 100' for MXM (Division Sign-Off) Division of Surgical Devices 510(k) Number K110941 Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 6 {9}------------------------------------------------ #### K110941 510(k) Number: Device Name: RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 Indications For Use: ### 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 Neil R Ogden= Neil R Ogden - 30:00 -05'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K110941 . Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 2 of 6 {10}------------------------------------------------ #### 510(k) Number: K110941 Device Name: RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 Indications For Use: 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 Laryngeal Lesions Airway obstructions including carcinoma Polyps and Granulomas Palliation of obstructing carcinomas of the tracheobronchial tree ### Gynecology ﺮ 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 coaqulation Soft tissue excision procedures such as excisional conization of the cervix Neil R Ogdenz 2013.02.15 5 3 11-2 -05'00' (Division Sian-Off) for MXM Division of Surgical Devices K110941 510(k) Number Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 3 of 6 {11}------------------------------------------------ #### K110941 510(k) Number: Device Name: RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 Indications For Use: ### 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 ### Neil R Ogdens 2013.02.15 1 32-19-05'00' for MXM (Division Sign-Off) Division of Surgical Devices K110941 510(k) Number Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 4 of 6 {12}------------------------------------------------ #### 510(k) Number: K110941 Device Name: RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 Indications For Use: ### 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 Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs, tumors and lesions Mastectomv Hepatectomy Neil R Ogder 33-26 -05'00' 2013.02.15 15 (Division Sign-Off) for MXM Division of Surgical Devices K110941 510(k) Number Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 5 of 6 {13}------------------------------------------------ #### 510(k) Number: K110941 Device Name: RevoLix Jr 30, RevoLix Jr 50; RevoLix 160 and RevoLix 200 Indications For Use: Pancreatectomy Splenectomy Thyroidectomy Parathvroidectomy 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 Foraminoplastv Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery. Neil R Ogdens 2013.02.15 11:34:26 -05'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K110941 Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use . (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 6 of 6