ELITA™ Femtosecond Laser System, ELITA™ Patient Interface

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION". The logo is clean and professional, reflecting the organization's role in regulating food and drugs. April 14, 2023 Johnson & Johnson Surgical Vision, Inc. Amanda Houston Senior Regulatory Affairs Project Lead 31 Technology Drive Irvine, CA 92618 Re: K223566 Trade/Device Name: ELITA™ Femtosecond Laser System, ELITA™ Patient Interface Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: March 14, 2023 Received: March 15, 2023 ## Dear Amanda Houston: 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. 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 located 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. 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. {1}------------------------------------------------ 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 devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-device-advice-comprehensive-regulatoryassistance/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, J Angelo Green -S Image /page/1/Picture/6 description: The image shows the logo of the Food and Drug Administration (FDA). The logo consists of the letters "FDA" in a large, sans-serif font. The letters are light blue and appear to be slightly transparent. The background is white. for Tieuvi Nguyen, Ph.D., 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223566 Device Name ELITA™ Femtosecond Laser System, ELITA™ Patient Interface Indications for Use (Describe) The ELITA™ Femtosecond Laser System is an ophthalmic femtosecond laser indicated in the creation of corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea. The ELITA™ Femtosecond Laser System is used in conjunction with a sterile disposable Patent Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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." {3}------------------------------------------------ # 510(k) SUMMARY The following 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92: | 510(k) Summary: | K223566 | | |-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | [807.92(a)(1)] Submitter Information | | | | Sponsor/Submitter: | AMO Manufacturing USA, LLC<br>510 Cottonwood Drive<br>Milpitas, CA 95035 USA<br>Phone 408-273-5166<br>Fax:408 273-5966 | | | Contact Person: | Amanda Houston<br>Senior RA Program Lead<br>Email: ahousto1@its.jnj.com<br>Phone: 562-774-8122 | | | Date Summary Prepared: | April 6, 2023 | | | [807.92(a)(2)] Name of Device | | | | Device Trade Name: | ELITA™ Femtosecond Laser System, ELITA™ Patient Interface | | | Common Name: | Ophthalmic laser | | | Device Classification: | Class II | | | Regulation Number: | 21 CFR 886.4390 | | | Classification Name: | Ophthalmic Laser | | | Product Code: | OOE | | | [807.92(a)(3)] Legally Marketed Devices | | | | Primary Predicate:<br>Secondary Predicate: | Femto LDV Z8 Femtosecond Surgical Laser - K213559, Cleared<br>April 21, 2022 (specific to Regulation # 886.4390)<br>iFS Advanced Femtosecond Laser System - K141852; cleared<br>January 16, 2015 (specific to intended use and technology) | | | Device Description: | The ELITATM Femtosecond Laser System is an ophthalmic laser<br>for corneal surgical operation. The system accurately cuts cornea<br>tissue through a high pulse repetition rate and ultra-fast scanner to<br>place pulses tightly next to each other, generating a continuous<br>cutting surface. The system is controlled by the graphical user<br>interface and software real-time controls. The optical delivery<br>system determines a 3-dimensional position in the cornea at which<br>the laser focuses. When the laser is emitted, the energy delivered is<br>sufficient to photo-disrupt a small volume of tissue. The process of<br>cutting involves repetitively setting a focus point and translating the<br>laser cutting line generated by the resonant scanner.<br>The ELITATM Femtosecond Laser System is a CDRH Class IV<br>laser per 21 CFR 1040.10 and 1040.11 due to intentional laser<br>exposure of the eye. | | | | [807.92(a)(5)] Intended Use | | | Indications for Use: | The ELITATM Femtosecond Laser System is an ophthalmic<br>femtosecond laser indicated in the creation of corneal flap in patients<br>undergoing LASIK surgery or other surgery or treatment requiring<br>initial lamellar resection of the cornea.<br>The ELITATM Femtosecond Laser System is used in conjunction<br>with a sterile disposable ELITATM Patient Interface, consisting of a<br>pre-sterilized suction ring assembly and pre-sterilized applanation<br>cone, intended for single-use. | | | Difference in<br>Indications from<br>Predicate Device | The ELITATM Femtosecond Laser System maintains a similar,<br>more concise Indications for Use statement as that of the FEMTO<br>LDVTM and iFS Systems. This reduction does not impact the<br>intended use, and the main indication (corneal lamellar resection<br>and flap creation) remains the same. There are no new<br>indications/intended use introduced with the ELITATM<br>Femtosecond Laser System and ELITATM Patient Interface.<br>Therefore, the Indications for Use for these devices are<br>substantially equivalent. | | | | [807.92(a)(6)] Technical Characteristics | | | Technological<br>Characteristics: | The ELITATM Femtosecond Laser System and ELITATM<br>Patient Interface (PI) share the same design principle and mode<br>of operation with the predicate devices, in that these systems | | {4}------------------------------------------------ ## [807.92(a)(4)] Device Description {5}------------------------------------------------ deliver femtosecond pulses through a computer-controlled delivery system to produce a pattern of photo-disruption to create cuts or separation of corneal tissue, resulting in the same functionality (flap creation for LASIK surgery or other surgeries requiring lamellar resection). The ELITA™ PI characteristics are the same as the iFS PI in that the means of patient contact to the system is created via affixing a suction ring to the scleral surface of the eye prior to use, applanating the eye via vacuum, to couple the beam output to the cornea and provide a fixed reference plane for precision scanning. [807.92(b)(1)] Determination of Substantial Equivalence The ELITATM Femtosecond Laser System and ELITA™ Patient Interface successfully completed bench testing. Electromagnetic Compatibility (EMC) testing, and software and Non-Clinical design verification and validation testing. which demonstrates Performance Data: the system's ability to meet all intended design specifications. Bench testing of the iFS predicate device is directly applicable to the subject device as there are no significant changes to the subject device. Features introduced with the subject device have minor technological differences and do not adversely affect the safety and effectiveness of the device. Additional tests are performed to verify these features function as intended and meet applicable design requirements. Bench testing, when coupled with software verification and validation testing presented for the subject device, provides reasonable assurance that the system remains safe and effective for its intended use and furthermore, that it is substantially equivalent to the iFS predicate device. Clinical Data was deemed not necessary for the ELITA™ Femtosecond Laser System and ELITA™ Patient Interface. The performance data demonstrated that the device performs as intended. The subject device does not include any changes to the Clinical Performance indications for use or intended use of the primary or secondary Data: predicate devices. It does not introduce any new harms or unacceptable risks, and therefore does not require clinical testing to assess safety and performance or to demonstrate equivalence. {6}------------------------------------------------ Table 1 below provides a comparison of the predicate and subject devices and demonstrates substantial equivalence to the predicate devices for its indications for use, intended use, technological characteristics, and new features. | Attribute | Subject Device | Primary Predicate | Secondary Predicate | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K223566 | K213559 | K141852 | | Trade/ Device<br>Name | ELITATM<br>Femtosecond Laser<br>System | FEMTO LDVTM Z8<br>Femtosecond Surgical<br>Laser Device | iFS Advanced<br>Femtosecond Laser<br>System | | Manufacturer | AMO Manufacturing<br>USA, LLC | SIE AG, Surgical<br>Instrument Engineering | AMO Manufacturing<br>USA, LLC | | Regulation<br>Number | 886.4390 | Same | 878.4810 | | Regulation<br>Name | Ophthalmic Laser | Same | General & Plastic<br>Surgery | | Regulatory<br>Class | Class II | Class II | Same | | Product Code | OOE | Same | GEX, HNO | | Technological<br>Characteristics | Femtosecond pulsed<br>laser | Same | Same | | Operating<br>Principle | Cutting/resection of<br>the corneal tissue<br>within controlled<br>parameters through<br>the use of<br>femtosecond laser<br>pulses which are<br>delivered through an<br>applanation device<br>that fixates the eye<br>under a vacuum | Same | Same | | Resection<br>Method | Resection created by<br>laser micro-photo-<br>disruption | Same | Same | | Indications for<br>Use | The ELITATM<br>Femtosecond Laser<br>System is an<br>ophthalmic<br>femtosecond laser<br>indicated in the creation<br>of corneal flap in<br>patients undergoing<br>LASIK surgery or other<br>surgery or treatment<br>requiring initial | The FEMTO LDVTM Z8<br>Femtosecond Surgical<br>Laser is an ophthalmic<br>surgical laser intended for<br>use in the creation of<br>corneal incisions<br>indicated for use in<br>patients undergoing<br>LASIK surgery, tunnel<br>creation for implantation<br>of rings, pocket creation | • In patients undergoing<br>surgery or other treatment<br>requiring initial lamellar<br>resection of the cornea<br>• In patients undergoing<br>surgery or other treatment<br>requiring initial lamellar<br>resection of the cornea to<br>create tunnels for<br>placement of corneal ring<br>segments | | | | | | | | lamellar resection of the<br>cornea. | corneal implants, lamellar<br>keratoplasty, penetrating<br>keratoplasty or other<br>treatment requiring<br>lamellar resection of the<br>cornea at a varying depth<br>with respect to the corneal<br>surface. | • In patients undergoing<br>ophthalmic surgery or<br>other treatment requiring<br>arcuate cuts/incisions in<br>the cornea, penetrating<br>and/or intrastromal<br>• In lamellar IEK and<br>corneal harvesting<br>• In the creation of a<br>corneal flap in patients<br>undergoing LASIK<br>surgery or other treatment<br>requiring initial lamellar<br>resection of the cornea<br>• In the creation of a<br>lamellar cut/resection of<br>the cornea for lamellar<br>IEK and for the creation<br>of a penetrating<br>cut/incision for<br>penetrating IEK<br>• In patients undergoing<br>ophthalmic surgery or<br>other treatment<br>requiring the creation<br>of corneal channels for<br>placement/insertion of | | Beam Delivery<br>Device | Zoom lens controls the<br>depth of resection<br>Motorized gantry<br>positioning<br>Electrical gantry motors<br>lock the position of the<br>delivery assembly<br>Magnified video image<br>provides a view of the<br>surgical field<br>Contact light and<br>maximum applanation<br>light; light that<br>indicates increased<br>applanation contact<br>pressure within the<br>acceptable range.<br>Cone illumination | None listed | Same as Subject Device | | | Focusing objective<br>focuses the beam into<br>the resection plane<br>Motorized mirrors and<br>focusing objective scan<br>the laser beam through<br>the fixed objective to<br>create an X-Y resection<br>plane | | | | Laser Type | Mode locked, diode<br>pumped, Ytterbium-<br>doped fiber laser | Solid state mode<br>locked, diode pumped | Mode-locked, diode-<br>pumped Nd:glass<br>oscillator with a diode-<br>pumped regenerative<br>amplifier | | Treatment Laser<br>Wavelength<br>(nm) | 1040 nm | 1020-1060nm | 1053 nm | | Output Power,<br>Max | 2.0 W | None listed | 0.400 W | | Pulse Energy<br>Range | 45-90 nJ | None listed | 300-2000 nJ | | Maximum Pulse<br>Energy (µJ) | 0.2 µJ | < 6 µJ | 2.5 µJ | | Repetition Rate<br>(MHz) | 10 MHz | < 10 MHz with ±10%<br>tolerance | 0.15 MHz | | Pulse Duration<br>(fs) | 100-200 fs | 200-500 fs | 600-800 fs | | Spot size | < 2 µm | < 2 µm | < 3 µm | | System controls | FPGA and<br>Microprocessors, with<br>Graphical User<br>Interface | None listed | Microprocessor with<br>Graphical User Interface | | Patient Interface | | | | | Patient Contact<br>Interface | Suction-ring type<br>interface device | Same | Same | | Patient Interface<br>Usage | Single Use | Same | Same | | Patient Contact<br>Portion of the<br>Device | Contact Lens - Fused<br>Silica<br>Suction Ring – TPE<br>Versaflex | None listed | Contact Lens - Same as<br>Subject Device<br>Suction Ring - C - Flex | | Sterilization<br>Method of<br>Disposable | Radiation (Gamma) | EO | Same as Subject Device | Table 1: Substantial Equivalence Table {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ | Source of<br>Vacuum | Automatic | None listed | Manual | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Operating<br>System | Windows 10, Linux | None listed | QNX operating system<br>running proprietary iFS<br>software | | Available<br>Resection<br>Patterns | The ELITA™ Laser<br>provides a single five-<br>part resection for flap<br>creation (using a raster<br>pattern with multi-layer<br>side cut); a pocket cut is<br>also available for<br>management of opaque<br>bubble layer | None listed | Surgeon can choose from<br>the following patterns to<br>create a flap:<br>· Spiral<br>· Raster<br>• Double Raster<br>• Side Cut Only<br>• Pocket<br>• Flap Well<br>· Flap + Oval<br>• Inlay | ## [807.92(b)(3)] Conclusion Conclusions from Non-Clinical and Clinical Tests: The ELITATM Femtosecond Laser System and ELITA™ Patient Interface are substantially equivalent to the currently cleared FEMTO LDV™ Femtosecond Surgical Laser (specific to regulation number) and iFS Advanced Laser System (specific to intended use and technology). The subject device and its accessory have a similar intended use, indications for use, and fundamental scientific technology compared to the predicate devices. The subject devices were determined to be substantially equivalent based on successful completion of non-clinical bench testing, Electromagnetic Compatibility (EMC) testing, software and design verification and validation testing. Based on the similarities between the subject devices and the predicates, no new risks were introduced; therefore, animal and clinical testing was not required. The successful results from the aforementioned testing were obtained using well-recognized international standards including several FDA recognized consensus standards. In addition, AMO has demonstrated through risk analysis and performance testing that the subject devices are substantially equivalent and are at least as safe and effective as the predicate devices.