MDK MULTI-APPLICATIONS PLATFORM

{0}------------------------------------------------ # K130256 # 7. 510(K) SUMMARY # JUL 0 2 2013 ### Introduction: This document contains the 510(k) Summary for the MDK Multi-Applications Platform. The content of this summary is based on the requirements of 21 CFR 807.92(c). | Applicant / Manufacturer Name and Address: | Quanta System SPA<br>Via IV Novembre, 116<br>Solbiate Olona (VA)<br>Italy, 21058 | |--------------------------------------------|-----------------------------------------------------------------------------------------| | 510(k) Contact Person: | Maurizio Bianchi<br>Regulatory Affairs Manager<br>Quanta System SPA | | | Email: maurizio.bianchi@quantasystem.com | | | Phone: +39 0331 376797 | | | Fax: +39 0331 367815 | | Date Prepared: | November 20 ^th , 2012 | | Device Name: | MDK Multi-Applications Platform | | Classification: | Class II | | Classification Name: | Laser surgical instrument for use in general and<br>plastic surgery and in dermatology. | | Regulation Number: | 21 CFR 878.4810 | | Product Code: | GEX | ### Predicate Devices: The MDK Multi-Applications Platformis claimed to be substantially equivalent to the following legally marketed predicate devices: - Ultrawave II (K070805) Quanta System SpA ﮯ - -Ultrawave III (K083207) - Quanta System SpA - Q-Plus T (K073549) Quanta System SpA - - Q-Plus T +IPL (K123168) Quanta System Spa - {1}------------------------------------------------ ### Performance Standards: There are no mandatory performance standards for this device. ## General Device Description: The MDK Multi-Applications Platform is laser surgical instrument for use in general and plastic surgery and in dermatology (GEX). The device includes a Q-Switched Nd:YAG laser source emitting at 1064 nm and 532 nm wavelengths, and/or an Nd:YAG laser source emitting at 1064 nm (short and long pulse) and/or at 1320 nm and/or at 532 nm, and/or an Alexandrite laser source emitting at 755 nm (long pulse) and/or an intense pulsed light (Twain IPL Handpiece). The optical delivery system for the Q-Switched Nd:YAG laser source (1064nm and 532nm) is an articulated arm with fixed handpieces. The optical delivery system for the Nd:YAG laser source ( 1064nm long/short pulse, 755 nm long pulse, 532 nm long pulse and 1320 nm long pulse) is an optical fiber with focusing handpieces up to 12mm spot size. The optical delivery system for the IPL system is an handpiece (Twain IPL) with interchangeable light filter at different wavelengths. IMPORTANT NOTE: The MDK Multi-Applications Platform control software allows to work only one laser source or IPL at time: it means that the laser sources works separately and indipendently. Moreover the Intense Pulse Light cannot work with any laser sources. Combined (simultaneously or sequentially) operations of different laser sources and/or IPL is not allowed. The MDK Multi-Applications Platform architecture is based on the following main subsystems: (1) an high voltage power supply, which converts and rectifies the AC mains current to provide requlated power for the flash-lamps, simmer current and main triggering pulse; (2) a cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger; (3) a Q-switched Nd:YAG laser source, capable of generating very short pulses at 1064nm and at 532 nm through a suitable (4) KTP SGH crystal. capable of converting light pulses at 1064nm into light pulses at 532nm: (5) a Nd:YAG laser source, capable of generating laser pulses at 1064nm or 1320nm wavelength and at 532 nm through a suitable (6) KTP SGH crystal, capable of converting light pulses at 1064nm into light pulses at 532nm: (7) an Alexandrite laser source, capable of generating laser pulses at 755nm with frequency up to 1,5 Hz; (8) an Intense Pulsed Light handpiece system (Twain IPL), capable of generating light pulses at a frequency of 0.5 Hz; (9) the microprocessor based controller, which requilates the functions of the laser and allows parameter selection by the user; (10) an optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing hand piece; (11) an optical delivery system, interfacing the energy from the laser to the patient via an optical fiber and focusing hand piece: and (12) an integral skin cooler. {2}------------------------------------------------ The MDK Multi-Applications Platform is controlled via a touch screen display hosted in the front of the device where are also located the key switch, the emergency red push button and the operation led. On the rear panel the footswitch connector, the remote interlock and the power switch are located. ### Indications for Use The MDK Multi-Applications Platform is laser surgical instrument for use in general and plastic surgery and in dermatology (GEX). The MDK Multi-Applications Platform is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation the medical specialties of dermatology, general and plastic surgery, in endoscopic/laparoscopic general surgery, gastroenterology, gynecology, neurosurgery, otorhinolaryngology (ENT), oculoplastic, oral surgery, ophthalmology (skin around eyes), orthopedics, podiatry, pulmonary/thoracic surgery and urology for surgical and aestetic applications. For intended use in Dermatology for the coagulation and hemostasis of benign vascular leasion such as, but not limited to, rosacea, poikiloderma of civatte, and treatment of benign cutaneous lesions such as warts, scars and straie. Also intended for treatment of wrinkles as, but not limited to, periocular and perioral wrinckles. For intended use on all skin types (Fitzpateick I-VI), including tanned skin. ### Comparison of Technological Characteristics: The specifications for the MDK Multi-Applications Platform is substantially equivalent to the specifications for its identified predicate devices with respect to the laser and IPL sources, wavelengths, maximum energy, spot size, fluence, pulse width, repetition rate, beam delivery, power monitor, actuator, and aiming beam. ### Comparison of Intended Use: The intended use of the MDK Multi-Applications Platform is the same as the intended use of its previously cleared devices. ### Substantial Equivalence: The Quanta System MDK Multi-Applications Platform is as safe and effective as the predicate devices. The MDK Multi-Applications Platform has the same intended use and similar technological characteristics and principles of operation as its predicate devices. The {3}------------------------------------------------ minor technological differences between the MDK Multi-Applications Platform and its predicate devices raise no new issues of substantial equivalence or safety and effectiveness. . . Thus, MDK Multi-Applications Platform is substantially equivalent to its identified predicate devices. . {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure embracing a bird. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002 July 2, 2013 Quanta System SpA % Mr. Maurizio Bianchi Via IV Novembre No 116 21058 Solbiate Olona (VA), Italy Re: K130256 Trade/Device Name: MDK Multi-Applications Platform Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general surgery and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: June 01, 2013 Received: June 05, 2013 Dear Mr. Bianchi: 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 {5}------------------------------------------------ Page 2 - Mr. Maurizio Bianchi 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 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/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 Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Peter D. Rumm -S Enclosure {6}------------------------------------------------ 510(k) Number (if known): K130256 #### Device Name: MDK Multi-Applications Platform ### Indications for Use: The MDK Multi-Applications Platform is is in assthetic and surgical applications requiring incision, extision ablation, vaporization and coagulation of body soft tissues In the modical specialites of demations plastic surgery, endoscopic/lapercecopic general surgery, gastroenlerology, gynecology, otorhinolaryngology (ENT), neurosurgery, oral surgery as follows: #### Nd:YAG 1064nm Q-switched and 632nm Q-switched The MDK Mull-Applications Platform is intention of vacular lesions, pigmented teslons, and for hair, tattoo removel and the incision, excision, ablation, vaporization of soft tissue. #### General dermatology (attation, vaportzation, incision, excision and coagulation of set tissue) indicated for treatment such as but not limited to treatment of: Tatloo removal - 1064nm: suggested for dark blue and black ink - 532nm: suggested for red, orange, yellow, and purple ink 0 - Pigmented lesion removal (benign) - Caté au lait spot 0 - Ephalides, solar lentigo (lentigines - Becker News - Ota Nevus - Nevus sodus Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR Over-The-Counter Use (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) Neil R Ogden .... Neil R Ogden 2013.06.27 15:13:32 -04'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130256 Pag_1_of_6 {7}------------------------------------------------ ### 510(k) Number (if known): K130256 #### Device Name: MDK Multi-Applications Platform Indications for Use: continued #### Nd: YAG 1064nm (long & ghort RH&D) The MDK Multi-Applications Platorn is interest surgical applications; dermatoryplastic surgen; andoscopic - laprosecopic surgery; general surgery; gynecology; ENT; hemostmaly; occuloplasios; putmonary surgery; thoracle surgery; and orthopsdics. #### General Sumical Appl .: Incision, excision, cosgulation, hemostation, andor abletion of soft ilsue in dermatology & plastic surgery, endoscopic laparoscopic general surgery, ganeel surgery, gynecdogy, head and neck-obrhindlaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery and urology. #### Dermatology/Plastic Surgery; Coaguation and hemostasis of beline such as, but not limited to, port wine stains, hemantionas, werb, telangiectass rosacea, venus lake, leg and spieler veins and civate and treatmant of benign cutuneous lesions such as wards, scars, strae and psodasis. It addition, the laser is intention of benign pigmented lessins such as but not limited to, lentigos (goe spots), solar laniaca (sun socies, seborteic keraloses, nevi, chossme, verruce, skip lace, kerabeas, tattoor (significant reduction in the intensity of blue and/or black tattoos), and plaques. The laser is also indicated for pigments lesion size, for palients with testins that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The laser is also indicated for the treatment of facial wrinkles. It is indicated for the removal of unwanted half for the stable long-larm, or permanent, hair reduction of melario in hair follices, and for the treatment of people (PFB). Pormanent hair reduction is delined as the bonglarm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. It is indicated for the reduction of red pigmentation in hypertophic and kebid scars where vascularity is an integral part of the scar. It is indicated for use on all skin types (Fitzpatic) 1-1) } including tanned akin, and the removal and permanent reduction of unwarded hair in Fitzpatrick I-VI, including suntanned skin types. #### Orthopedics: Cutting, ablation, and/or hemostasis of intro-articular tissue in orthopedic surgical and arthroscopic applications, #### Pulmonary Sumary Paliative treatment of beign and meilight postousions, including squartous cell carcinoma, adenocarcinoma carcinoid, benign turnors, granulomas, and benign strictures. Over-The-Counter Use Prescription Use AND/OR (Part 21 C.F.R. 801 Subpart D) (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) Neil R Ogden -- 3 2013.06.27 15:14:00 =04'00' (Division Sign-Off) for MXM Division of Surgical Devices 510{k) Number K130256 {8}------------------------------------------------ ### 510(k) Number (if known): K130256 Device Name: MDK Multi-Applications Platform ### Indications for Use: continued #### Nd:YAG 1064nm (long & short pulse) - Continued Thoracis Sumary Including excision, coegulation of set lissue. Thoracic applications, including but not limited to, isotation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractor of pacemaker pockets; vaporization, coaghation, incisionexcision, debuiking, and ablation of lung tissue (thoracoscopy). Urology: All applications including supericial urnors, invasire bladder carcinoma, uretoral strictures and lealins of the orternal genitalia (including condyloma acuminate). #### Nd:YAG_1320mm Indicated for use in general surgery and dematology for the incision, ablation, vaporization, coagulation and haemostasis of soft tosue. It is also indicated for the treatment of perioral wrinkles, fine lines and wrinkles, and the beathers of back acne and strophic acne scars. #### Alexandrite 766 mm Intention for coagulation and hemostasions and the removal and permanent reduction of unwanted hair in Fitzpatick skin types I-VI, beluding suntamed skin indicated for pigmented tesions and writtings. Parmanent hair roduction is defined as the long-larm, stable reduction in the number of halm measured at 6. 9, and 12 months after the campletion of a treatment regime. Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR ### Over-The-Counter Use (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) Neil R Ogden. 2013.06.27 15:14:24 -04'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130256 {9}------------------------------------------------ 510(k) Number (if known): K130256 Device Name: MDK Multi-Applications Platform ### Indications for Use: continued #### Nd:YAG_532nm (Long puke) For the coagulation and hemostasis of vascular lesions. #### Dermatology/Plastic Surgery: For photocogniation and hemostasis of vasular and colaneous including but not limited to, the following general categories: vascular lesions (engiomas (port wine), telangiecasia (facial or ex-tremities telangiectasias, venous anomalios, leg veinst, benign pigmanted lastons, chlossma, cate au- lat, tattoos (red and green ink), vernucae, skin tags, keraloses, plaques, cutaneous lesion treatment (hemostasis, color lightening, flattening, reduction of lesion size. #### General Surgery: Vaporizing, Caagulating, Incising, Debulking, and Ablating of Soll Tissue as well as in Endoscopic (e.g., laparecopic) or open surgeries. #### Gastroenterology: Tissue ablation and hemostals in the gastronities track Esophaged necknown , including squamous call carcinoma and adenocarcherna; Gastrontestinal hemosas, Esophagitis, Esophageal Ucor, Mallory-Weiss taar, Gastic Ucer, Anglodysplassa, Stomal Ucers, Non-bleeding Ulcors, Gestrontastinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids). #### Head and Otorhinolaryngology (ENT); Tissue incluin, excision, ablation, and vessel hernostasis #### Hemostasis during Surgery Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g., laparoscopic) and open surgery #### Neurosurgery: Hemostasis for: Pituitary Tumor, Memagioblastoms; AVMs; Globlasbona; Astrocytoma; Ollyodendroglioma. ### Qphthalmology: Post-vitrectorny endophotocoagulation of the retina. Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR ### Over-The-Counter Use (21 C.F.R. 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Connerrence of CDRH, Office of Device Evaluation (ODE) Neil R Ogden 2013.06.27 115:15:03 -04'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number_K130256 {10}------------------------------------------------ 510(k) Number (if known): K130256 Device Name: MDK Multi-Applications Platform ### Indications for Use: continued ### Nd:YAG_632nm (long_pulse) - continued #### Pulmonary Surgery, Pallative treatment of benign and malling sistery obstructions, including Squamous Coll Carcinoma, Adenocarcinoma; Carcinoid: Benign Tumors; Granulomas; Banign Strictures. #### Thoracic Surgery, Cuting (incision and excision), coagueling of soft tissue Thoracic applications including, but not limited to: Isolation of vessels for endartecetony and/or by-pass grafts, Wedge Resections, Formation of Pacemation pockets. Vaporization, coagulation, incision and excision, debulking, and ablation offing tissue (Thoracoscopy). #### Urology: All applications including: Superficial urinary bladder carcinoma; Urethrol Stricture; Lesions of the external genitalia (including condyloma acuminata). #### IPL 590-1200nm: 626-1200nm: 660-1200nm Indicated for permanent hair removal, Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. #### IPL 560-1200nm;670-1200nm Indicated for phoboxagulation of dermanlogical vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (restment of facial and leg veins), and treatment of benign pigmented lesions #### IPL 400-1200mm Indicated for inflammatory acne (acne vulgaris). Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR ### Over-The-Counter Use (21 C.F.R. 807 Subpart C) ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Commirrence of CDRH, Office of Device Evaluation (ODE) Neil R Ogden ... . . . . . 2013.06.27 15:15:34 -04'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130256 {11}------------------------------------------------ 510(k) Number (if known): K130256 Device Name: · MDK Multi-Applications Platform #### Indications for Use: continued #### Integrated Skin Cooler The intended use of the integrated cooling system in the MDK Multi-Applications Platorm hand-piece is to provide cooling of the skin prior to laser treatment, for the reduction of painting laser treatment, to allow for the use of higher flucinces such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect. · Prescription Use _ × (Part 21 C.F.R. 801 Subpart D) AND/OR Over-The-Counter Use (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) Neil R Ogden ( 4) 2013.06:27 11:5:16:01 -04'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130256 Pag 6 of 6