Leos Laser and Endoscopy System

{0} FDA U.S. FOOD & DRUG ADMINISTRATION April 3, 2025 Beaver-Visitec International, Inc. Christopher Brady Manager, Regulatory Affairs 500 Totten Pond Rd, 10 CityPoint Waltham, Massachusetts 02451 Re: K240615 Trade/Device Name: Leos Laser and Endoscopy System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: February 28, 2024 Received: February 28, 2024 Dear Christopher Brady: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K240615 – Christopher Brady Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. {2} K240615 – Christopher Brady Page 3 For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, CLAUDINE H. KRAWCZYK -S Claudine Krawczyk Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K240615 | | | Device Name Leos Laser and Endoscopy System | | | Indications for Use (Describe) The Leos system is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, retinal detachment, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do not allow a posterior view. Glaucoma - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or cyclocryotherapy or other cyclodestructive procedures. Vitreoretinal Surgery - The endoscopically controlled endophotocoagulation that is possible with the ophthalmic laser endoscope is also useful for endophotocoagulation: - During vitreous surgery to produce chorioretinal scar around retinal breaks or retinotomy sites. - To perform intraoperative panretinal photocoagulation (PRP) in proliferative retinopathies. - To perform intraoperative retinal photocoagulation on a scleral buckle. - To perform intraoperative photocoagulation around focal neovascularization. | | | Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | 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." | | {4} 510(k) Summary Leos Laser and Endoscopy System, K240615, Page 1 of 9 BVI # I. Submitter Information | Date Prepared | April 2, 2025 | | --- | --- | | Applicant | Beaver-Visitec International, Inc. 500 Totten Pond Rd - 10 CityPoint Waltham, MA 02451 | | Primary Correspondent | Christopher Brady Senior Manager, Regulatory Affairs cbrady@bvimedical.com 1-617-888-0007 | | Alternate Correspondent | Mattia Ronchetti Senior Director, Global Clinical and Regulatory Affairs mronchetti@bvimedical.com (+39) 3667597049 | # II. Subject Device | Device Common Name | Ophthalmic Laser and Endoscopy System | | --- | --- | | Trade/Proprietary Name | Leos Laser and Endoscopy System | | Device Class | Class 2 | | Regulation Number | 886.4390 – Ophthalmic Laser | | Product Code | HQF – Laser, Ophthalmic | # III. Predicate Devices | Primary Predicate | | | --- | --- | | Device Common Name | Ophthalmic Laser and Endoscopy System | | Trade/Proprietary Name | Uram Ophthalmic Laser Endoscope | | 510(k) Number | K910532 | | Device Class | Class 2 | | Regulation Number | 886.4390 – Ophthalmic laser | | Product Code | HQF – Ophthalmic laser | | Secondary Predicate | | | Device Common Name | Ophthalmic Laser and Endoscopy System | | Trade/Proprietary Name | E2 Microprobe Laser and Endoscopy System | | 510(k) Number | K042918 | | Device Class | Class 2 | | Regulation Number | 878.4810 – Laser surgical instrument for use in general and plastic surgery and in dermatology | | Product Code | GEX – Powered Laser Surgical Instrument | # IV. Device Description Summary The Leos Laser and Endoscopic System is a next generation ophthalmic laser and endoscopy system used for the treatment of glaucoma, vitreoretinal diseases, and intraocular visualization. The system contains an $810\mathrm{nm}$ powered diode laser delivered by the stainless-steel endoscopic laser probe (trade name: VueProbe), which is placed into eye tissue to illuminate and visualize the target tissue and deliver laser energy under direct visualization. The console is a fully integrated {5} 510(k) Summary Leos Laser and Endoscopy System, K240615, Page 2 of 9 BVI portable device, containing a laser module assembly, viewing and control monitors, and a wireless footswitch for activating the laser. The larger passive monitor is for viewing the endoscopic video image and key treatment information, while the smaller touchscreen is used for parameters selection, rotation and viewing. The camera chip uses CMOS technology and is located at the tip of the probe. The LED light source is located within the plastic handpiece of the probe and illumination fibers carry the light to the tip. Additionally, the probe contains a laser fiber within its full length. # V. Indications for Use The Leos system is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, retinal detachment, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do not allow a posterior view. Glaucoma - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or cyclocryotherapy or other cyclodestructive procedures. Vitreoretinal Surgery - The endoscopically controlled endophotocoagulation that is possible with the ophthalmic laser endoscope is also useful for endophotocoagulation: - During vitreous surgery to produce chorioretinal scar around retinal breaks or retinotomy sites. - To perform intraoperative panretinal photocoagulation (PRP) in proliferative retinopathies. - To perform intraoperative retinal photocoagulation on a scleral buckle. - To perform intraoperative photocoagulation around focal neovascularization # VI. Substantial Equivalence Comparison The Leos System is designed to provide the same clinical therapy using the same treatment laser and aiming laser technologies and wavelengths as the predicate devices. The primary differences for the Leos System are updated endoscopy technology and new form factors for the console, footswitch and probe. A comparison table is provided below. {6} 510(k) Summary Leos Laser and Endoscopy System, K240615, Page 3 of 9 BVI | Characteristic | Uram Ophthalmic laser Endoscope and E2 Microprobe Laser and Endoscopy System (Predicate Devices) K910532, K042918 | Leos Laser and Endoscopy System (Subject Device) | Same or Equivalent | | --- | --- | --- | --- | | Generic Device Description | 810 nm Laser Endoscopy System | 810 nm Laser Endoscopy System | Same | | Indications | The ophthalmic laser endoscope is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, retinal detachment, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do allow a posterior view. Glaucoma - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or cyclocryotherapy or other cyclodestructive procedures. The endophotocoagulation of ciliary processes under direct endoscopic view is highly controllable, i.e. titratable, and has been demonstrated to be effective in the treatment of glaucoma. Vitreoretinal Surgery - The endoscopically controlled endophotocoagulation that is possible with the ophthalmic laser endoscope is also useful for endophotocoagulation: | The Leos System is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, retinal detachment, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do not allow a posterior view. Glaucoma - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or cyclocryotherapy or other cyclodestructive procedures. Vitreoretinal Surgery - The endoscopically controlled endophotocoagulation that is possible with the ophthalmic laser endoscope is also useful for endophotocoagulation: • During vitreous surgery to produce chorioretinal scar around retinal breaks or retinotomy sites. • To perform intraoperative panretinal photocoagulation (PRP) in proliferative retinopathies. | Same, with minor changes (changes underlined) 1. Specify system 2. Correction at the end of first paragraph 3. Removal of third paragraph based on FDA feedback to remove performance claim | {7} 510(k) Summary Leos Laser and Endoscopy System, K240615, Page 4 of 9 BVI | Characteristic | E2 System (Predicate Device) K042918, K910532 | Leos System (Subject Device) | Same or Equivalent | | --- | --- | --- | --- | | | · During vitreous surgery to produce chorioretinal scar around retinal breaks or retinotomy sites. · To perform intraoperative panretinal photocoagulation (PRP) in proliferative retinopathies. · To perform intraoperative retinal photocoagulation on a scleral buckle. · To perform intraoperative photocoagulation around focal neovascularization | · To perform intraoperative retinal photocoagulation on a scleral buckle. · To perform intraoperative photocoagulation around focal neovascularization | | | **Camera Characteristics** | | | | | **Visualization Delivery System** | In probe - Fiberoptic Endoscope Video Camera Imaging | In probe - Direct Endoscope Video Camera Imaging | Same | | **Camera Location** | Console | Endoscopic Probe | Equivalent Different location and camera signal | | **Camera Type** | Analog, CCD | Digital, CMOS | Equivalent Different camera technologies | {8} 510(k) Summary Leos Laser and Endoscopy System, K240615, Page 5 of 9 BVI | Characteristic | E2 System (Predicate Device) K042918, K910532 | Leos System (Subject Device) | Same or Equivalent | | --- | --- | --- | --- | | Image Resolution | 10,000 pixels (limited by fiber count) | 40,000 pixels | Equivalent Leos System performance exceeds the E2 System | | Laser Characteristics | | | | | Treatment Laser Source and Type | Double hetero-structure, Gallium-Arsenide (GaAs), Semiconductor Diode (near-infrared spectra), Class IV | Double hetero-structure, Gallium-Arsenide (GaAs), Semiconductor Diode (near-infrared spectra), Class IV | Same | | Treatment Laser Beam Nominal Wavelength (λ) | 810 nm (subvisible) | 810 nm (subvisible) | Same | | Treatment Beam | Continuous Wave | Continuous Wave | Same | | Treatment Modality | Continuous or Duration-Timed Modes | Continuous or Duration-Timed Modes | Same | | Treatment Laser Power Range | 0 – 1.2 Watts | 0.05 – 1.2 Watts | Equivalent Removed lower setting of 0 Watts | | Laser Power Settings | 50 mW increments | 50 mW increments | Same | | Laser Power Accuracy | +/- 20% | +/- 20% | Same | | Laser Duration Cycle Settings | Duration increments in seconds as follows: 0.05, 0.07, 0.10, 0.20, 0.30, 0.50, 1.0, 2.0, Continuous | Duration increments in seconds as follows: 0.05, 0.07, 0.10, 0.20, 0.30, 0.50, 1.0, 2.0, Continuous | Same | {9} 510(k) Summary Leos Laser and Endoscopy System, K240615, Page 6 of 9 BVI | Characteristic | E2 System (Predicate Device) K042918, K910532 | Leos System (Subject Device) | Same or Equivalent | | --- | --- | --- | --- | | Repetition Mode | No | No | Same | | Adjustable Laser Spot Size | Not adjustable | Not adjustable | Same | | Laser Footswitch Control | Wired control to activate laser and (optional) illumination intensity | Wireless control to activate laser and rotation | Equivalent The Leos footswitch does not include an option for illumination control and is wireless. Rotation control is an additional feature to be used based on user preference | | Aiming Beam Laser Source and Type | Multi-quantum well structure, Aluminum Gallium Indium Phosphide (AlGaInP) Semiconductor Diode (visible spectra), Class III | Multi-quantum well structure, Aluminum Gallium Indium Phosphide (AlGaInP) Semiconductor Diode (visible spectra), Class III | Same | | Aiming Beam Nominal Wavelength (λ) | 640 nm (red/orange) | 640 nm (red/orange) | Same | | Aiming Beam Laser Power | up to 1500uW | up to 60 uW | Equivalent Less power required for equivalent aiming beam visibility due to new camera sensitivity, aperture and location. | | Aiming Beam Laser Intensity Setting | 10 – 250 in increments of 10 | up to 100%, 11 settings between 5 and 100% | Equivalent | {10} 510(k) Summary Leos Laser and Endoscopy System, K240615, Page 7 of 9 BVI | Characteristic | E2 System (Predicate Device) K042918, K910532 | Leos System (Subject Device) | Same or Equivalent | | --- | --- | --- | --- | | | | | Settings changed to percentage scale and number of settings reduced | | **Illumination Characteristics** | | | | | **Light Source** | Xenon lamp [to probe from console] | LED illumination [in probe] | Equivalent New light source location and technology | | **Light Power** | 175 W | 0.36 W LED driver | Equivalent Change due to difference in light source | | **Light Intensity** | Mechanical shutter-wheel control knob (fully open to fully closed) | Touchscreen adjustable from 0 to 100% (manually or via an automatic adjustment algorithm) | Equivalent Change due to difference in light source and technology | | **Other Characteristics** | | | | | **Interface** | Table-top Console | Integrated standing control modules with console, touchscreen control screen, and passive view screen for surgeon | Equivalent Updated user interface | | **Communications – User Access** | N/A | USB 2.0 Type A for video image recording and an HDMI port for a second passive viewing screen | Equivalent New features | {11} 510(k) Summary Leos Laser and Endoscopy System, K240615, Page 8 of 9 BVI | Characteristic | E2 System (Predicate Device) K042918, K910532 | Leos System (Subject Device) | Same or Equivalent | | --- | --- | --- | --- | | System Power | 115 or 240 V AC, 60-50Hz | 120 or 240 V AC, 60-50Hz | Same Both are standard US and worldwide power supply voltages | | Probe Use Description | Reusable, non-sterile | Single use, sterile | Equivalent Probe will be provided sterile | | Probe Options | 20G, straight | 19G, straight and curved | Equivalent Slight increase in size and curved option added based on user preference. No clinical/therapy difference | {12} 510(k) Summary Leos Laser and Endoscopy System, K240615, Page 9 of 9 BVI ## VII. Non-Clinical Tests Summary ### Bench Testing The following non-clinical testing was performed to support the substantial equivalence of the Leos System and VueProbe to the legally marketed predicate devices: **Electromagnetic Compatibility and Electrical Safety** - The Leos System was evaluated for EMC and electrical safety and found to be compliant with IEC 60601-1 for electrical safety and IEC 60601-1-2 for EMC. **Laser Safety and Optical Safety** - The Leos System was evaluated for laser and optical safety and found to be compliant with IEC 60825-1, IEC 60601-2-22, ANSI Z80.36. **Design Verification and Validation Testing** - Design verification testing confirms that the product meets its product requirements. **Software Verification and Validation** - The software level of concern is "Major". Software verification and validation testing was completed successfully following FDA's guidance "Guidance for the Content of premarket Submissions for Software Contained in Medical Devices" and IEC 62304. **Biocompatibility Testing** - Biocompatibility testing was performed per ISO 10993 and the sterile, single use probes were confirmed to be compliant to FDA recognized standards. **Sterilization and Shelf Life** - Sterilization, shelf life, and packaging/transport testing was performed to support the stated shelf life of the probes per FDA recognized standards ASTM D4169-22, ISO 11135, ISO 10993-7, AAMI TIR 28, and ISO 11607-1. ### Animal Testing Not applicable. Animal studies were not required to establish substantial equivalence. ### Clinical Testing Not applicable. Clinical studies were not required to establish substantial equivalence. ## VIII. Conclusion The Leos Laser and Endoscopy System is substantially equivalent to the predicate devices, Uram Ophthalmic Laser Endoscope (K910532) and E2 Microprobe Laser and Endoscopy System (K042918). The Leos system has identical indications for use as the predicate devices and is similar in technological characteristics, performance, and principles of operation. The differences between the subject device and the predicate devices do not raise any new safety or effectiveness concerns.