FEMTO LDV Z8 Femtosecond Surgical Laser

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April 21, 2022 SIE AG, Surgical Instrument Engineering % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127 Re: K213559 Trade/Device Name: FEMTO LDV Z8 Femtosecond Surgical Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: March 10, 2022 Received: March 11, 2022 Dear Kevin Walls: 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. 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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-device-reportingmdr-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/medicaldevices/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. Anjana Jain, PhD 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213559 Device Name FEMTO LDV™ Z8 Femtosecond Surgical Laser (modification to old model) Indications for Use (Describe) The FEMTO LDV™ Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV™ Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px"> <span style="font-family:Arial, Helvetica, sans-serif"> </span> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <span style="font-size:16px"> <span style="font-family:Arial, Helvetica, sans-serif"> </span> </span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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SUBMITTER | Applicant: | SIE AG, Surgical Instrument Engineering<br>Allmendstrasse 11<br>CH-2502 Port<br>Switzerland<br>Frank Ziemer, CEO<br>Phone: +41 32 332 70 70<br>Fax: +41 32 332 70 71<br>Email: frank.ziemer@ziemergroup.com | |------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| - Contact Person: Mr. Kevin Walls Requlatory Insight, Inc. 33 Golden Eagle Lane Littleton, Colorado 80127 Phone: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com Date Prepared: April 21, 2022 # III. DEVICE Name of Device: FEMTO LDV™ Z8 Femtosecond Surgical Laser Common or Usual Name: Ophthalmic Laser Classification Name: Ophthalmic Femtosecond Laser Regulatory Class: Class II Product Code: OOE Regulation Number: 886.4390 # IV. PREDICATE DEVICE The legally marketed (predicate) device to which we are claiming substantial equivalence is: Device Name: FEMTO LDV™ Z8 Femtosecond Surgical Laser 510(k) Number: K150323 # V. DEVICE DESCRIPTION The FEMTO LDV™ Z8 Femtosecond Surgical Laser is a solid state femtosecond laser used in ophthalmology. It is used for producing cuts in ocular tissue and can be used in corneal and cataract surgery. The Z8 produces femtosecond laser energy that is absorbed by the tissue, resulting in plasma formation. This plasma rapidly expands, creating a cavitation bubble separating the tissue. This process is known as photodisruption. Because of its very short pulse duration, femtosecond laser technology deploys low pulse energy that virtually eliminates damage peripheral to the incision site and can therefore be used to dissect tissue on a microscopic scale. Femtosecond laser systems may use closer spot spacing to overlap these cavitation regions, producing less tissue bridges. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Ziemer Ophthalmology, with the word "ziemer" in a dark gray sans-serif font and the word "OPHTHALMOLOGY" in a smaller, lighter gray font underneath. To the right of the word "ziemer" is a red abstract shape. Below the logo is the text "Page 2/8" and "K213559". The energy needed for photodisruption can be reduced with shorter pulse duration and smaller diameters of the spot. To achieve such a focused laser spot with a smaller diameter, a lens with a higher numerical aperture is required. Smaller spots enhance the accuracy and overall precision of cuts. The strategy of low pulse energy and small overlapping spots is employed by the FEMTO LDV technology, allowing the reduction of energy used. The FEMTO LDV™ Z8 Femtosecond Surgical Laser system consists of the following functional units: - Base Station (BS), integrating the Laser Cavity, Fixed Mirror Articulated Arm (FMAA), Power -Supply, Computer, Touchscreen Monitor, Suction Unit, OCT Box, and Safety System (see Figure 1), - Handpiece (HP) integrating the Cutting Lens and Topview Camera (see Figure 1), - - -Disposable accessories (see Table 1) Image /page/4/Picture/7 description: The image shows a medical device with several labeled components. The device includes a touchscreen monitor at the top, an articulated arm connected to a handpiece, and a base station. The base station is white with the text "FEMTO Z8 NEO" printed on the side. Figure 1: Main parts of FEMTO LDV™ Z8 Femtosecond Surgical Laser The following components are mandatory accessories for the FEMTO LDV™ Z8 Femtosecond Surgical Laser: | Accessory | Description | |----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Procedure Pack (PP) with Liquid Patient Interface (LPI) for Cataract surgery. | The PP is sterile, single use kit composed of a casing, a suction tubing and a liquid patient interface which get connected with the Handpiece and enable a sterile interface to the human eye via vacuum.<br>A set of drapes for base station and articulated arm completes the PP for Cataract surgery. | | Procedure Pack (PP) with Applanating Patient Interface (API) for Corneal surgery | The PP is sterile, single use kit composed of a casing, a suction tubing and an applanating patient interface which get connected with the Handpiece and enable a sterile interface to the human eye via vacuum.<br>A base station drape completes the PP for Corneal surgery. | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Ziemer Ophthalmology, with the word "ziemer" in gray and "OPHTHALMOLOGY" in red below it. To the right of the word "ziemer" is a red abstract shape. Below the logo is the text "Page 3/8" and "K213559". # VI. INDICATIONS FOR USE The following indications for use remain unchanged from those previously cleared via K150323: The FEMTO LDV™ Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, FEMTO LDV™ Z8 Femtosecond Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. # VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES Modifications of the cleared device described in this 510(k) are the following ones: - 1. Second source Laser Cavities: Two Laser cavities with identical requirement and function are introduced as an alternate (second source) for the existing one. - Improved Power Sensors: By minor adjustments to the optic-mechanical design the sensor's ad-2. justment tolerance is improved. - 3. Structured LEW/LAF: By introducing a 3-dimensional structure in the LEW, the reliability of the zero point determination for the OCT picture is significantly increased. - 4. Improved Vacuum System: The vacuum design was slightly changed for a more reliable and robust vacuum check. - 5. SLIM Handpiece and SLIM Procedure Packs: The geometry of the Handpiece (HP) and of the Procedure Packs (PP) was slightly changed to better fit the anatomy of patients with thicker eyelids. In addition raw material trade name changes were introduced. - 6. Small Esthetic changes: Changes to color and design of monitor, table and panels. - 7. Latest software release: The changes listed above have been incorporated into various SW releases. As a consequence we decided to submit the latest software version. A comparison of the technological characteristics is listed in Table 2: ¹ LEW is an abbreviation for "Laser Exit Window". In the R&D documentation unfortunately the German term is used LAF ("Laser Austritts-Fenster") more commonly. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Ziemer Ophthalmology. The word "ziemer" is in lowercase letters and is in a dark gray color. Below the word "ziemer" is the word "OPHTHALMOLOGY" in smaller, red, capital letters. To the right of the word "ziemer" is a red, stylized letter "S". K213559 | Characteristics | Cleared Device | Proposed Device | Difference | | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--| | General | | | | | | 510(k) No | K150323 | K213559 | n/a | | | Classification | Class II, OOE | Class II, OOE | No difference | | | Intended Use &<br>Indication for Use | The FEMTO LDV™ Z8 Femtosecond Surgical<br>Laser is an ophthalmic surgical laser intended for<br>use in the creation of corneal incisions indicated<br>for use in patients undergoing LASIK surgery,<br>tunnel creation for implantation of rings, pocket<br>creation for implantation of corneal implants, la-<br>mellar keratoplasty, penetrating keratoplasty or<br>other treatment requiring lamellar resection of the<br>cornea at a varying depth with respect to the cor-<br>neal surface.<br>In addition, the FEMTO LDV™ Z8 Surgical Laser<br>is intended for use in the creation of capsulo-<br>tomy, phacofragmentation and the creation of<br>single plane, multi-plane, arc cuts/incisions in the<br>cornea, each of which may be performed either<br>individually or consecutively during the same<br>procedure indicated for use in patients under-<br>going cataract surgery for removal of the crystal-<br>line lens. | The FEMTO LDV™ Z8 Femtosecond Surgical<br>Laser is an ophthalmic surgical laser intended for<br>use in the creation of corneal incisions indicated<br>for use in patients undergoing LASIK surgery,<br>tunnel creation for implantation of rings, pocket<br>creation for implantation of corneal implants, la-<br>mellar keratoplasty, penetrating keratoplasty or<br>other treatment requiring lamellar resection of the<br>cornea at a varying depth with respect to the cor-<br>neal surface.<br>In addition, the FEMTO LDV™ Z8 Surgical Laser<br>is intended for use in the creation of capsulo-<br>tomy, phacofragmentation and the creation of<br>single plane, multi-plane, arc cuts/incisions in the<br>cornea, each of which may be performed either<br>individually or consecutively during the same<br>procedure indicated for use in patients under-<br>going cataract surgery for removal of the crystal-<br>line lens. | No difference | | | FEMTO LDV™ Z8 Femtosecond Surgical Laser Device | | | | | | Base Station<br>footprint | 102 cm (L) x 56 cm (W) x 77 cm (H). | 102 cm (L) x 53 cm (W) x 78 cm (H). | Minor difference:<br>Because of the changed dimension and shape of<br>the table plate, the footprint has changed slightly | | | Base station<br>design | Black panels | White panels and changed table plate | Minor difference:<br>- Color changes<br><br>- Table plate was slightly changed in<br>dimension and shape for better usability | | | Touchscreen<br>Monitor | Black Touchscreen Monitor with straight edges | White Touchscreen Monitor with round edges | Minor difference:<br>Touch screen monitor (from a different supplier) | | | Characteristics | Cleared Device | Proposed Device | Difference | | | | | | with same functionality but different color and<br>round edges. | | | Power Sensors | Power sensor 4 & 5 | Power sensor 4 & 5 with Ulbricht sphere | Minor difference:<br>Slight design modification for better reliability. | | | Suction Unit<br>(Vacuum System) | Single tube system | Twin tube system | Minor difference:<br>Different connector and tube system for<br>compatibility with Twin tube PP (see below). | | | Handpiece | Handpiece HP 6.3 | Handpiece HP 6.4 | Minor difference:<br>- Slightly changed geometry<br>- Adapted design of laser exit window. | | | Operating<br>Principle | Photodisruption | Photodisruption | No difference | | | Laser Parameters | | | | | | Laser Type | Solid state mode locked, diode pumped | Solid state mode locked, diode pumped | Minor difference:<br>Second source laser cavities with identical requi-<br>rement and function. | | | Laser wavelength | 1020 - 1060nm | 1020-1060nm | No difference | | | Pulse with | 200-500 fs | 200-500 fs | No difference | | | Max Pulse<br>Energy | < 6 μJ | < 6 μJ | No difference | | | Max Pulse<br>Frequency | < 10 MHz with ±10% tolerance | < 10 MHz with ±10% tolerance | No difference | | | Spot Size | < 2 μm | < 2 µm | No difference | | | Software | LASIK<br>Corneal Incisions including CCI $^{2}$ and ARC $^{3}$<br>Pocket | LASIK<br>Corneal Incisions including CCI and ARC<br>Pocket | Minor difference:<br>Bug fixes and improvements that did not require<br>a 510(k) for each single change according to the | | | Characteristics | Cleared Device | Proposed Device | Difference | | | | Ring<br>Keratoplasty including LKP4, PKP5 and<br>KeraKlear<br>Cataract including CAPS6 and LF7 | Ring<br>Keratoplasty including LKP, DALK, PKP, Liquid<br>PKP and KeraKlear<br>Cataract including CAPS, LF, CCI and ARC<br>Cataract Training<br>Surgery Report Tool | Guideline "Deciding When to Submit a 510(k) for<br>a Software Change to an Existing Device dated<br>October 25, 2017". | | | Material | The device does not contain or dispense any me-<br>dicinal substances, tissues of animal origins, or<br>any other materials requiring special considera-<br>tions. | The device does not contain or dispense any me-<br>dicinal substances, tissues of animal origins, or<br>any other materials requiring special considera-<br>tions. | No difference | | | Packaging | The device is packed in a wooden crate: | The device is packed in a wooden crate: | No difference | | | | FEMTO LDV™ Z8 Femtosecond Surgical Laser PP | | | | | Composition | | | | | | Casing | Casing | SLIM Casing | Minor difference:<br>Slight geometry modifications<br>Slight Material change: Same bulk material,<br>but different trade name version | | | Patient Interface | Applanating patient interface<br>Liquid patient interface | SLIM Applanating patient interface<br>SLIM Liquid patient interface…