SUPRA SCAN DELIVERY SYSTEM

{0}------------------------------------------------ K100678 JUL 2-1 2010 ### Executive Summary 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS f This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h). ### I. General information | Applicant: | Quantel Medical | |------------|-----------------| |------------|-----------------| Address: QUANTEL MEDICAL 21 rue Newton Z.I. du Brezet 63039 Clermont-Ferrand Cedex 2 FRANCE +33 (0)473 745 745 +33 (0)473 745 700 (Fax) | Contact Person: | Mr. Patrick QUERO | |---------------------------|--------------------------------------| | | Quality Director & Regulatory Affair | | | (+33) 473 74 57 45 | | | (+33) 473 74 57 00 | | Summary Preparation Date: | July 2009 | ### II. Name Name: SUPRA SCANTM Delivery System Device Name: Common Name: SUPRA SCANTM Delivery System Classification Laser instrument, surgical, powered (see 21CFR 878.4810) Product Code: GEX ; Panel: 79 ### III. Predicate Device OptiMedica PASCAL Synthesis™ Delivery System (K081744) ### IV. Product Description SUPRA SCAN™ Delivery System is a scanning laser delivery system that enables the use of proprietary pattern scanning technology when coupling with laser platforms. This offers existing commercially available laser platform the ability to deliver a full spectrum of pattern scanning options. The SUPRA SCAN™ Delivery System is intended for use by trained ophthalmologist for diagnosis and treatment of ocular pathology. The Quantel Medical SUPRA SCAN™ Delivery System consists of the following system components: - 1) Scanning Laser Delivery System adapter with scanner controls that may be coupled to a slit lamp type Haag Streit or similar models, and connected to a currently cleared Quantel Medical 532nm retinal photocoagulator (SUPRA 532). - 2) Scanner control module with LCD/Touch screen, power supply, electronics and electrical connections. Image /page/0/Picture/23 description: The image shows the number 052 in a bold, slightly distorted font. The numbers are black against a white background. The digits are closely spaced, giving the impression of a single unit. {1}------------------------------------------------ #### V. Indications for Use The SUPRA SCAN™ Delivery System when connected to a compatible laser system is indicated for use in the treatment of ocular pathology of anterior segments including, retinal photocoagulation, pan retinal photocoagulation for vascular and structural abnormalities of the retina and choroids including: - · Proliferative and nonproliferative diabetic retinopathy; - · Choroidal neovascularization; - · Branch retinal vein occlusion; - · Age-related macular degeneration; - · Retinal tears and detachments - · Macular edema - · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma. ### VI. Device Technological Characteristics and comparison to Predicate Device ### Predicate Product Comparison Table: | Manufacturer | QUANTEL MEDICAL | OPTIMEDICA Corporation | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | Model | SUPRA SCAN™ Delivery System | PASCAL Synthesis™ Delivery System | | 510 (K) Number | | K081744 | | Intended Use | Photocoagulation of both anterior and posterior<br>segments of the eye by generation of patterns of<br>laser spots. | Photocoagulation of both anterior and posterior<br>segments of the eye by generation of patterns of<br>laser spots. | | Type of Delivery System | Slit lamp adaptor with optical fiber connected to a<br>laser | Slit lamp with laser integrated | | Laser Energy source | Frequency doubled Nd : YAG | Frequency doubled Nd : YAG | | Laser Energy Delivery | Single spot & Multi spot | Single spot & Multi spot | | Spot placement | Centered on Guide Beam | Centered on Guide Beam | | Laser energy Intensity | Selected by Physician | Selected by Physician | | Pulsing System | Continuous | Continuous | | Power requirements : Current | 1 A | --- | | Computer control | Yes | Yes | | Can user change computer<br>program ? | No | No | #### VI - 1 - GENERAL SPECIFICATIONS COMPARISON TABLE - {2}------------------------------------------------ | Manufacturer | QUANTEL MEDICAL | OPTIMEDICA Corporation | |---------------------------------------|-------------------------------------------------------------------|-----------------------------------------------| | Model | SUPRA 532 | Pascal ™ Photocoagulator | | 510 (K) Number | K070776 | K043486 | | Lasing Medium | Frequency doubled Nd : YAG | Frequency doubled Nd : YAG | | Pulsing System | Continuous | Continuous | | Output Wavelength | 532 nm | 532 nm | | Average Power (AP) | 2W with SUPRA Scan | 2 W | | Laser Safety Class | 4/IV | 4/IV | | Exposure Selections (t) | 0.007s to continuous | 0.01s to continuous | | Cooling Method | Solid State Cooling with<br>thermoelectric<br>(Peltier) heat pump | Air cooled | | Aiming Beam : | Coaxial with treatment beam | | | Aiming Beam : Type | Red diode | Red diode | | Aiming Beam : Wavelength | 635 nm | 635 nm | | Aiming laser power | < 1mW | < 1mW | | Laser Safety Class | 2/II | 2/II | | Power requirements :<br>Voltage | 100 to 240 Vac | 100 to 240 Vac | | Power requirements : Current | | 5 A | | Computer control | Yes | Yes | | Can user change computer<br>program ? | No | No | | Safety measures | Conform to standard 60601-2-22<br>and 60825-1 | Conform to standard 60601-2-22 and<br>60825-1 | . . : and the comments of the comments of the comments of ## VI -2 - LASER ENERGY SOURCE COMPARISON TABLE . . . . . : {3}------------------------------------------------ | Manufacturer | QUANTEL MEDICAL | OPTIMEDICA Corporation | |---------------------------------------------------|----------------------------------------------------------|--------------------------------------| | Model | SUPRA SCAN™ Delivery<br>System connected to<br>SUPRA 532 | PASCAL Synthesis™ Delivery<br>System | | 510 (K) Number | | K081744 | | User interface | Touchscreen | Touchscreen | | Dimensions | 5,8in H x 13in W x 12,1in D | --- | | Power calibration | YES | YES | | Laser Energy Delivery | Multi-Spot Mode | Multi-Spot Mode | | Mini focal spot size diameter | 100μm | 100μm | | Exposure Selections (Multi spot mode) | 0.01s to continuous | 0.01s to continuous | | Mini focal spot size : (area) | $7.8539 x 10^{-5} cm^2$ | $7.8539 x 10^{-5} cm^2$ | | Average Power Density (APD=AP/area) | $0.2546 x10^{5} W/cm^2$ | $0.2546 x10^{5} W/cm^2$ | | Energy max at minimum exposure<br>(APx t) | 20mJ | 20mJ | | Max energy density at min exposure<br>(APxt/area) | $0.254 x10^{3} J/cm^2$ | $0.254 x10^{3} J/cm^2$ | | Mini focal spot size diameter | 500 µm | 400 μm | | Mini focal spot size : (area) | $1,9635 x 10^{-3} cm^2$ | $1,256 x 10^{-3} cm^2$ | | Average Power Density (APD=AP/area) | $1,02 x10^{3} W/cm^2$ | $1,59 x10^{3} W/cm^2$ | | Energy max at minimum exposure<br>(APx t) | 20mJ | 20mJ | | Max energy density at min exposure<br>(APxt/area) | 102 mJ/cm² | 159 mJ/cm² | | Laser Energy Delivery | Single spot Mode | Single spot Mode | | Mini focal spot size diameter | 50μm | 60 μm | | Exposure Selections (Single spot mode) | 0.007s to continuous | 0.01s to continuous | | Mini focal spot size : (area) | $1,9635 x 10^{-5} cm^2$ | $2,8274 x 10^{-5} cm^2$ | | Average Power Density (APD=AP/area) | $1,02 x10^{5} W/cm^2$ | $0,7073 x10^{5} W/cm^2$ | | Energy max at minimum exposure (APx t) | 14mJ | 20mJ | | Max energy density at min<br>exposure(APxt/area) | 71 mJ/cm² | 71 mJ/cm² | . # VI - 3 - LASER CHARACTERISTICS COMPARISON TABLE ・・・・・・ 055 {4}------------------------------------------------ | Manufacturer | QUANTEL MEDICAL | OPTIMEDICA Corporation | |-------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------| | Model | SUPRA SCAN™ Delivery System | PASCAL Synthesis™ Delivery System | | 510 (K) Number | --- | K081744 | | User interface | Touch screen + manual zoom | Touch screen | | Dimensions | Screen : 20cm H x 12cm W x 4cm D<br>Adaptor : 25cm H x 20cm W x 13cm D | 122cm H x 76cm W x 122cm D | | Weight | 2 kg | 137 kg | | Focal spot size diameters available | Continuously adjustable with parafocal<br>zoom from 50μm to 500μm | 4 sizes available : 60μm - 100μm – 200μm -<br>400μm | | Spot size adjustment | Manually on the zoom | From touch screen | | Type of patterns available | Square - Triple arc - Circle - Macular grid | Square - Triple arc - Circle - Macular grid -<br>Octant | | Repetition rate between two spots | 8ms | 8ms | | Type of scanning system | scanners | scanners | | Filter protection integrated | YES | YES | ### VI-4-SYSTEM CHARACTERISTICS COMPARISON TABLE ### VII. Performance Standard SUPRA SCAN™ Delivery System is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including: - IEC 60825-1:2007, Safety of laser products Part 1 : Equipment classification, requirements and . user's guide. - . IEC 60601-2-22: Ed 1995, Medical electrical Equipment - Part 2 : Particular requirements for the safety of diagnostic and therapeutic laser equipment. - . IEC 60601-1: 1988 + A1:1991 + A2:1995, Medical Electrical equipment - Part 1 : gencral requirement for safety. - . IEC 60601-1-2: 2001, Medical Electrical equipment - Part 1 : General requirements for safety-2. Collateral Standard : electromagnetic compatibility - requirements and tests. - . IEC 60601-1-4: 2000, Medical electrical equipment - Part 1 : General requirements for safety -4 -Collateral standard : Programmable electrical medical systems, edition 1.1 The device also complies with European Medical Directive 93/42/EEC + Amendment 2007/47/EEC and the US Federal Performance Standards 21 CFR 1002.10 Requirements (21 CFR 1040.10 and 21CFR 1040.11 for Class IV Laser Products with permissible deviations defined in Laser Notice 50, dated July 26, 2001.), Part 1010.2 and 1010.3, Part 820 - Quality System Regulation, and have passed ISO 9001 and 13485 System Certification. {5}------------------------------------------------ ### VIII. Discussion of similarities and Differences with the Predicate Product SUPRA SCANT" Delivery System share the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate device , the PASCAL Synthesis™ Delivery System (K081744). In addition a review of the predicate device demonstrate that the SUPRA SCAN™ Delivery System is safe and effective as the predicate device as they share equivalent specifications / characteristics and are used to perform the same indicated surgical procedures. The only differences in the specifications/characteristics of the SUPRA SCAN ™ Delivery System and its predicate PASCAL Synthesis™ Delivery System (K081744) is that : - 1. The SUPRA SCAN™ Delivery System has a maximum spot size of 500 microns instead of 400 microns for PASCAL Synthesis™ Delivery System. This difference is not viewed as being clinically significant. SUPRA SCAN 100 Delivery System offers to treat at 400 microns with equivalent energy output performance. ### Conclusion: SUPRA SCAN™ Delivery System use the same fundamental technology features as the PASCAL Synthesis The Delivery System (K081744) and delivers the same level of effectiveness. Therefore, it is concluded that there is no significant difference in the basic function, safety and effectiveness between the PASCAL Synthesis" Delivery System (Predicate Device) and the SUPRA SCAN 100 Delivery System. ### IX. Non-clinical performance data and conclusions from non-clinical tests Laboratory testing was conducted to validate and verify that the proposed device, SUPRA SCAN™ Delivery System met all design specifications and was substantially equivalent to the predicate device. Clinical Conclusion: No Clinical information is required. ### X. Conclusion Based on the information in this notification Quantel Medical concludes that the SUPRA SCAN™ Delivery System is substantially equivalent (SE) to the cited legally marketed predicate. The potential hazards. e.g. are controlled by a risk management plan including : - A hazard identification (Section 9) t - -A Risk evaluation (Section 9) - A software Development and Validation Process (Section 10). l {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in a simple, abstract style, with three curved lines representing the snakes and a horizontal line representing the staff. The text is in uppercase letters and is evenly spaced around the circle. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 ### JUL 21 2010 Quantel Medical % TUV Rheinland of North America, Inc. Mr. Tamas Borsai 12 Commerce Road Newton, Connecticut 06470 Re: K100678 Trade/Device Name: Supra Scan™ Delivery 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: July 19, 2010 Received: July 19, 2010 Dear Mr. Borsai: 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. {7}------------------------------------------------ Page 2 - Mr. Tamas Borsai 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 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. http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Mark A. Melkerson 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): _ K Device Name: SUPRA SCAN™ Delivery System Indications for Use Statement: The SUPRA SCAN™ Delivery System when connected to a compatible laser system is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation, pan retinal photocoagulation for vascular and structural abnormalities of the retina and choroids including: - · Proliferative and nonproliferative diabetic retinopathy; - · Choroidal neovascularization; - · Branch retinal vein occlusion; - · Age-related macular degeneration; - · Retinal tears and detachments - · Macular edema - · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation Prescription Use X (Per 21 CFR 801.109) OR Over-The Counter Use Mark A. Millerson (Division Sigr. Oft) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number ***_*** 020