HyPHo Laser System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 23, 2017 Hyper Photonics Srl % Mark Job Regulatory Technology Services. LLC 1394 25th Street. Nw Buffalo, Minnesota 55313 Re: K163449 Trade/Device Name: HyPHo Laser System 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: June 9, 2017 Received: June 12, 2017 Dear Mark 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) 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 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. Image /page/1/Picture/8 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, bold font. The text is black and appears to be against a white background. There is a faint watermark in the background that says "FDA". 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 510(k) Number (if known) K163449 Device Name HyPHo Surgical Laser System #### Indications for Use (Describe) The Hyper Photonics's HYPHO (Ho:YAG) Surgical Laser and Delivery Devices and Accessories (Hyper Photonics optical fibers) is intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery. The HYPHO Laser System and its delivery system (Hyper Photonics optical fibers) are indicated for use in the performance of specific surgical applications as follows: Urology - Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH) - Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of: = bladder; ■ superficial and invasive bladder, urethral and ureteral tumors; ▪ condylomas: · lesions of external genitalia; · ureteral and penile hemangioma; · ureteral strictures; ■ bladder neck obstructions Urinary Lithotripsy including: o endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones; o treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed. Arthroscopy o Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including: meniscectomy; plica removal; ligament and tendon release; contouring and sculpting of articular surfaces; debridemnent of inflamed synovial tissue (synovectomy); loose body debridement; chondromalacia and tears; lateral retinecular release: capsulectomy in the knee; {3}------------------------------------------------ chondrornalacia ablation. o Discectomy including: percutaneous vaporization of the L4-5 and L5-SI lumbar discs of the vertebral spine; open and arthroscopic spine procedures; foraminotomy. General Surgery o Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including: cholecystectomy: lysis of adhesions; appendectomy; biopsy. pylorostenotomy, and removal of polyps of the sigmoid colon; 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; hemniorrhaphy: tonsillectomy; lymphadenectomy; partial nephrectomy; pilonidal cystectomy; resection of lipoma: debridement of decubitus ulcer; hemorrhoids: debridenment of statis ulcer; biopsy. ENT Surgery o Endoscopic endonasal/ sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including: partial turbinectomy; ethmoidectorny; polypectomy: maxillary antrostomy; frontal sinusotomy; sphenoidotomy; dacryocystorhinostomy (DCR); functional endoscopic sinus surgery (FESS). Gynecological Surgery o Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue). Gastroenterology Surgery o Open and endoscopic gastroenterology surgery (ablation, vaporization, incision, excision, resection, coagulation and hemostasis, including: gall bladder calculi: biliary /bile duct calculi; benign and malignant neoplasm; polyps: {4}------------------------------------------------ colitis; ulcers: angiodysplasia; hemorrhoids: varices: esophagitis: esophageal ulcer; Mallory-Weiss tear; gastric ulcer; duodenal ulcer; non-bleeding ulcer; gastric erosions: colorectal cancer; gastritis: bleeding tumnors; pancreatitis: vascular malformations: telangiectasis; telangiectasias of the Osler-Weber-Renu disease. Pulmonary Surgery o Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue. Dermatology and plastic surgery Incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft, mucosal, fatty and cartilaginous tissues, intherapeutic plastic, dermatologic and aesthetic surgical procedures. including: scars; tattoo removal: vascular lesions: port wine stains; hemangioma; telangiectasia of the face and leg; rosacea: corns: papillomas: basal cell carcinomas; lesions of skin and subcutaneous tissue; plantar warts: periungual and subungual warts; debridement of decubitus ulcer; skin tag vaporization. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {5}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {6}------------------------------------------------ # 510(k) SUMMARY Hyper Photonics S.r.l. Hyper Photonics HYPHO Laser system ### Introduction: The basis of this submission is New Device The content of this summary is based on the requirements of 21CFR 807.92 #### Applicant name: Hyper Photonics S.r.l. Via Lecco 61 20871 Vimercate MB Italy #### Contact person: Isabella Carrer Tel +39 039 89086512 Fax +39 039 89086513 #### Date prepared: May 31, 2017 #### Common name: Hyper Photonics S.r.1. HYPHO Laser System ## Product Code: GEX ## Device Class: Class II Regulation Number: 21 CFR 878.4810 #### Panel: General & Plastic Surgery #### Predicate Devices: Modified Lumenis VersaPulse PowerSuite Holmiumn (Ho:YAG) Surgical Lasers and - Delivery Devices and Accessories - Lumenis Pulse 120H (K140388); Modified Quanta System LITHO Laser System (K141101). - #### Intended use/ Indications for Use: {7}------------------------------------------------ The Hyper Photonics's HYPHO (Ho:YAG) Surgical Laser and Delivery Devices and Accessories (Hyper Photonics optical fibers) is intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery. The HYPHO Laser System and its delivery system (Hyper Photonics optical fibers) are indicated for use in the performance of specific surgical applications as follows: Urology - Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH) - Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of: - = bladder; - . ■ superficial and invasive bladder, urethral and ureteral tumors; - 트 ▪ condylomas; - I · lesions of external genitalia; - 트 · ureteral and penile hemangioma; - I · ureteral strictures; - bladder neck obstructions . Urinary Lithotripsy including: - o endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones; - treatment of distal impacted fragments of steinstrasse when guide wires o cannot be passed. Arthroscopy - O Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including: - . meniscectomy; - 트 plica removal: - 트 ligament and tendon release: - 트 contouring and sculpting of articular surfaces; - 트 debridemnent of inflamed synovial tissue (synovectomy); - loose body debridement; - chondromalacia and tears: - 트 lateral retinecular release; - capsulectomy in the knee; {8}------------------------------------------------ - chondroplasty in the knee; - 트 chondrornalacia ablation. - o Discectomy including: - percutaneous vaporization of the L4-5 and L5-SI lumbar discs of 트 the vertebral spine; open and arthroscopic spine procedures; - foraminotomy. # General Surgery - O Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including: - cholecystectomy; - 트 lysis of adhesions; - appendectomy; - 트 biopsy. pylorostenotomy, and removal of polyps of the sigmoid colon: - skin incision; - 트 tissue dissection; - excision of external tumors and lesions; ■ - complete or partial resection of internal organs, tumors and lesions; - 트 mastectomy: - hepatectomy; - 트 pancreatectomy; - splenectomy: - 트 thyroidectomy; - parathyroidectomy; - 트 hemniorrhaphy: - 트 tonsillectomy; - lymphadenectomy; - 트 partial nephrectomy; - 트 pilonidal cystectomy; - 트 resection of lipoma; - 트 debridement of decubitus ulcer; - hemorrhoids; - debridenment of statis ulcer; - 트 biopsy. # ENT Surgery - o Endoscopic endonasal/ sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including: - partial turbinectomy; I - ethmoidectorny; - 트 polypectomy; - maxillary antrostomy; {9}------------------------------------------------ - frontal sinusotomy; - 트 sphenoidotomy; - dacryocystorhinostomy (DCR); I - 트 functional endoscopic sinus surgery (FESS). # Gynecological Surgery - O Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue). Gastroenterology Surgery - O Open and endoscopic gastroenterology surgery (ablation, vaporization, incision, excision, resection, coagulation and hemostasis, including: - gall bladder calculi; - biliary /bile duct calculi; - I benign and malignant neoplasm; - 트 polyps: - 트 colitis: - ulcers; - angiodysplasia; - 트 hemorrhoids: - varices; - 트 esophagitis; - esophageal ulcer; - 트 Mallory-Weiss tear; - gastric ulcer; - 트 duodenal ulcer; - 트 non-bleeding ulcer; - gastric erosions: - 트 colorectal cancer; - 트 gastritis: - 트 bleeding tumnors; - 트 pancreatitis; - 트 vascular malformations: - 트 telangiectasis; - 트 telangiectasias of the Osler-Weber-Renu disease. #### Pulmonary Surgery - O Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue. Dermatology and plastic surgery - Incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft, mucosal, fatty and cartilaginous tissues, in {10}------------------------------------------------ therapeutic plastic, dermatologic and aesthetic surgical procedures. including: - scars: - 트 tattoo removal; - 트 vascular lesions: - port wine stains; - 트 hemangioma; - I telangiectasia of the face and leg: - rosacea: - 트 corns: - 트 papillomas: - 트 basal cell carcinomas; - 트 lesions of skin and subcutaneous tissue; - 트 plantar warts: - 트 periungual and subungual warts: - 트 debridement of decubitus ulcer; - I skin tag vaporization. ## Device Description: The device includes a Ho:Yag laser source with 35W max output power at 2100 nm wavelength. The optical delivery system is an optical fiber. The HYPHO Laser System is designed with six major sub-systems, including: (1) Power Supply: a high voltage power supply, which converts and rectifies the AC mains current to provide regulated power for the flash lamp simmer current and main triggering pulse; (2) Cooling System: a cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger; (3) Laser System: a Ho:YAG laser rod, capable of generating laser pulses at 2100 nm wavelength and a frequency up to 30 Hz; (4) Delivery System: an optical delivery system, interfacing the energy from the laser to the patient via an optical fiber and surgical hand piece. A RFID recognition system is included to read the fiber diameter and the number of reuses directly from the fiber equipped with the suitable transponder; (5) PC embedded with 7" display and Control Electronics which regulates the functions of the laser and allows parameter selection by the user, (6) Optical fibers (Hyper optical fibers) equipped with the transponder for recognition of core diameter and for the management of number of reuses. In addition to the six subsystems, the HYPHO Laser System incorporates several safety features, including a remote interlock, an emergency red push button, a footswitch and a key switch. Moreover, the system features two laser emission indicators: a Led stripe located on the top of the frontal panel and a buzzer. The led stripe is green in READY mode and blue in EMISSION mode. The buzzer sounds during laser emission. {11}------------------------------------------------ The HYPHO Laser System is operated via proprietary FW and SW. The SW communicates with embedded FW in the main processor and manages Graphical User Interface (GUI) running on the PC embedded. ### Substantial Equivalence: The intended use and indications for use of the HYPHO Laser System are identical to the intended use and indications for use of its predicate devices. In addition the same technological characteristics and principles of operations apply for all systems. Performance testing was conducted in order to demonstrate the performance of the HYPHO Laser System and to verify that no questions of safety and effectiveness have been raised. The following performance activities were carried out: - o risk analvsis: - o electrical and laser safety and electromagnetic compatibility testing; - o Software verification and validation; - o System testing (e.g. footswitch, emission indicator, emergency button, ON/OFF button). Test results indicated that the subject HYPHO Laser system performs in accordance with its requirements and specifications, in similarity with its predicate devices. Consequently, it is Hyper Photonics belief that the HYPHO Laser System is as safe as effective for its intended use as its predicates and is substantially equivalent to its predicate devices without raising any safety and/or effectiveness issues.