EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER

{0}------------------------------------------------ JAN 1 3 2012 #### 510(k) Summary Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser # Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 Phone: (413) 525-0600 Facsimile: (413) 525-0611 Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant Date prepared: July 5, 2011 #### Name of Device and Name/Address of Sponsor Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser; Evolve® HPD Dual Biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 #### Classification Name Surgical laser (21 CFR 878.4810, Product Code GEX) #### Predicate Devices Ceralas 150W 980/ 1470nm Multiwavelength Diode Laser, (K090164) Ceralas 180W 980nm Diode Laser, (K083682) Ceralas 980nm Diode Laser Family, (K100726 & K112324) #### Intended Use/Indication for Use The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Evolve HPD Multiwavelength 980/ 1470 Diode Laser (up to 150W) is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the saphenous veins in patients with superficial vein reflux. The Multiwavelength laser is further indicated for laser assisted lipolysis. Power from 151W to 200W is indicated in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH). The device is specifically indicated for use as follows: {1}------------------------------------------------ # K112013 Ear, Nose and Throat and Oral Surgery (Otolaryngology) Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include: Removal of benign lesions from the ear, nose and throat Excision and vaporization of vocal cord nodules and polyps Incision and excision of carcinoma in situ Ablation and vaporization of hyperkeratosis Excision of carcinoma of the larynx Laryngeal papillomectomy Excision and vaporization of herpes simplex I and II Neck dissection Arthroscopy Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include: Menisectomy Synovectomy Chondromalacia Gastroenterology Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include: Hemostasis of upper and lower GI bleeding Excision and vaporization of colorectal carcinoma Excision of polyps General Surgery, Dermatology, Plastic Surgery and Podiatry Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of keloids Liver resection {2}------------------------------------------------ K 112013 pg 3 of 5 Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcers Hepatobiliary tumors Mastectomy Dermabrasion Laser Assisted Lipolysis Vaporization and hemostasis of capillary hemangioma Excision, vaporization and hemostasis of abdominal tumors Excision, vaporization and hemostasis of rectal pathology Pilonidal cystectomy Herniorapphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystectomy Thyroidectomy Resection of organs Debridement of wounds Photocoagulation of teleangectasia of the legs and face Photocoagulation of vascular lesions of the face and extremities Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities Treatment of reticular veins and branch varicosities Urology Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia Vaporization of the prostate to treat benign prostatic (BPH). Note: powers from 151W to 200W should only be applied in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH). Gynecology Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include: Endometrial ablation Excision or vaporization of condylomata acurninate Vaporization of cervical intraepithelial neoplasia {3}------------------------------------------------ K112013 874 af's #### Cervical conization Menorrhagia Neurosurgery Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas Cardiac Surgery Hemostasis and coagulation of soft tissue, including cardiac tissue. Pulmonary Surgery Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include: Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction Endoscopic pulmonary applications Dental Applications Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival); frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening. Powers from 151W to 200W Powers from 151W to 200W should only be applied in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH). {4}------------------------------------------------ K112013 pg 5 of 5 #### Technological Characteristics The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser contains the same basic components as the cleared Ceralas 150W 980/ 1470mm Diode Laser (K090164). The purpose of this submission is to increase the energy from 150W to 200W for application in the vaporization of the prostate to treat Benign Prostatic Hyperplasia. (BPH) #### Performance Data The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7. Published clinical data supplied quantifies ablation rates on a per Watt basis for a 980nm laser versus a 1470nm laser, which together with studies using 200W 980nm lasers on human cadaver prostates and 50W 1470nm lasers on prostates of patients with bladder outlet obstruction along with its predicate devices support the conclusion that the device is safe and effective and substantially equivalent to its predicate devices. #### Substantial Equivalence The Evolve HPD 980/ 1470mm Multiwavelength Diode Laser is as safe and effective for these Indication for Use as the cleared Ceralas 150W 980/ 1470mm Diode Laser. The Evolve HPD 980/ 1470mm Multiwavelength Diode Laser has the same intended uses, indications, technological characteristics, and principles of operation as its predicate device. Thus, the Evolve HPD 980/ 1470nm Multiwavelength Diode Laser is substantially equivalent to its predicate devices. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JAN 1 3 2012 Biolitec, Incorporated % Genmarhay BDA Harry Hayes, Ph.D. 515 Shaker Road East Longmeadow, Massachusetts 01028 Re: K112013 Trade/Device Name: Evolve HPD 980/1470nm Multiwavelength Diode Laser 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: January 5, 2012 Received: January 10, 2010 Dear Dr. Hayes: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assessment to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of prior of ring 2011 - 12:00 accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mains 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 adultier. Thease noter Obras set, 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 If your device is elaborition (000 aron). 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 r load be action of a determination that your device complies with other requirements of the Act that I Drivias intatutes and regulations administered by other Federal agencies. You must or any I oderar statute and securements, including, but not limited to: registration and listing (21 compy with an all love (21 CFR Part 801); medical device reporting (reporting of medical CI K Far 607), adoming (21 CFR 803); good manufacturing practice requirements as set {6}------------------------------------------------ Page 2 - Harry Hayes, Ph.D. 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 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 1cgallanon (21 CFA Part 1007) process 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/Resourcesfor You/Industry/defaulf.htm. Sincerely yours, Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ pq 1 of 4 Indications for Use Statement 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ # Device Name: Evolve® HPD 980/ 1470nm Multiwavelength Diode Laser #### Indications for Use: The device is intended for delivery of laser light to soft tissue in the contact and non The active is included a recedures including via endoscopes. The Evolve HPD contact article attring of 1470 Diode Laser (up to 150W) is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear. nose and throat and oral surgery (otolaryngology), arthroscopy, m car, nooo and the surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the saphenous veins in patients with surger); action approacted Multiwavelength laser is further indicated for laser assisted lipolysis. Bapernelar 151W to 200W is indicated in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH). The device is specifically indicated for use as follows: ## Ear, Nose and Throat and Oral Surgery (Otolaryngology) Har, I woo una rizion, ablation, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include: Removal of benign lesions from the ear, nose and throat Excision and vaporization of vocal cord nodules and polyps Incision and excision of carcinoma in situ Ablation and vaporization of hyperkeratosis Excision of carcinoma of the larynx Laryngeal papillomectomy Excision and vaporization of herpes simplex I and II Neck dissection #### Arthroscopy Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include Menisectomy Synovectomy Chondromalacia Neil R. Ogden for mkn (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K112013 {8}------------------------------------------------ K.11 2013 1 2 of 4 #### Gastroenterology Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include: Hemostasis of upper and lower GI bleeding Excision and vaporization of colorectal carcinoma Excision of polyps # General Surgery, Dermatology, Plastic Surgery and Podiatry Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcers Hepatobiliary tumors Mastectomy Dermabrasion Laser Assisted Lipolysis Vaporization and hemostasis of capillary hemangioma Excision, vaporization and hemostasis of abdominal tumors Excision, vaporization and hemostasis of rectal pathology Pilonidal cystectomy (Division Sign-C Herniorapphy Division of Surgical, Orthopedic, Adhesiolysis and Restorative Devices Parathyroidectomy Laparoscopic cholecystectomy 112013 Thyroidectomy 510(k) Number. Resection of organs Debridement of wounds Photocoagulation of teleangectasia of the legs and face Photocoagulation of vascular lesions of the face and extremities I novenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities Treatment of reticular veins and branch varicosities {9}------------------------------------------------ 1/2013 pg 3 of 4 #### Urology Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia Vaporization of the prostate to treat benign prostatic hyperplasia (BPH). Note: powers from Vaporization of the procuse to applied in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH). #### Gynecology Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include: Endometrial ablation Excision or vaporization of condylomata acurninate Vaporization of cervical intraepithelial neoplasia Cervical conization Menorrhagia ### Neurosurgery Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas #### Cardiac Surgery Hemostasis and coagulation of soft tissue, including cardiac tissue. #### Pulmonary Surgery Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue nitred. in the pulmonary system. Examples include: Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction Endoscopic pulmonary applications cision and ablation of soft tissue Nilk for mam (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices **Dental Applications** 510(k) Number K112013 Indicated for the following applications on intraoral and extraoral soft tissue thatcated or the tonewal gingival and epithelial lining of free gingival). frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, {10}------------------------------------------------ K 11 2013 Pg 4 of 4 gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/ partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening. #### Powers from 151W to 200W x owers from 151 W to 200W should only be applied in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH). (PLEASE DO NOT WRITE BELOW THIS LINE … CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _ V (Per 21 C.F.R. 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96) Neil RPOschelen for mxc Division of Surnical, Orthopedic, and Restorative Devices 510(k) Number K112013.