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.

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.

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
Handpiece (HP) integrating the Cutting Lens and Topview Camera
Disposable accessories

AI/ML Overview

The provided document is a 510(k) Summary for the FEMTO LDV™ Z8 Femtosecond Surgical Laser, which is a medical device. This document does not describe a study involving an AI/Machine Learning component, nor does it provide acceptance criteria and performance metrics typically associated with such studies.

Specifically, the document focuses on demonstrating substantial equivalence of a modified version of an existing ophthalmic laser device to its predicate device. The changes are primarily hardware and minor software updates (bug fixes, not new algorithms with performance metrics).

Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types, etc.) because the document does not contain this type of data related to an AI/ML device study.

The document states: "The changes described in section IV did not require clinical performance data to demonstrate substantial equivalence to the predicate device." This indicates that no new clinical studies were performed to assess the performance of the modified device in terms of efficacy or diagnostic accuracy, which would be the typical context for the acceptance criteria and study details you've asked for. The studies mentioned are focused on safety, EMC, biocompatibility, sterilization, and software verification/validation, rather than a performance study of an AI algorithm.

Summary

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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. 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.

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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 of medical device-related 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-regulatory-information/postmarketing-safety-reportingcombination-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 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-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

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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)

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)

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Image /page/3/Picture/1 description: The image shows the logo for Ziemer Ophthalmology. The logo consists of the word "ziemer" in a sans-serif font, with the word "OPHTHALMOLOGY" in a smaller font below it. To the right of the word "ziemer" is a stylized red swoosh. Below the logo is the text "Page 1/8".

K213559

510(k) Summary

510(k) Number K213559 l.

.. SUBMITTER

Applicant:	SIE AG, Surgical Instrument EngineeringAllmendstrasse 11CH-2502 PortSwitzerlandFrank Ziemer, CEOPhone: +41 32 332 70 70Fax: +41 32 332 70 71Email: frank.ziemer@ziemergroup.com
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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

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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.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.A base station drape completes the PP for Corneal surgery.

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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.
1. 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.
1. Improved Vacuum System: The vacuum design was slightly changed for a more reliable and robust vacuum check.
1. 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.
1. Small Esthetic changes: Changes to color and design of monitor, table and panels.
1. 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.

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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 &Indication for Use	The FEMTO LDV™ Z8 Femtosecond SurgicalLaser is an ophthalmic surgical laser intended foruse in the creation of corneal incisions indicatedfor use in patients undergoing LASIK surgery,tunnel creation for implantation of rings, pocketcreation for implantation of corneal implants, la-mellar keratoplasty, penetrating keratoplasty orother treatment requiring lamellar resection of thecornea at a varying depth with respect to the cor-neal surface.In addition, the FEMTO LDV™ Z8 Surgical Laseris intended for use in the creation of capsulo-tomy, phacofragmentation and the creation ofsingle plane, multi-plane, arc cuts/incisions in thecornea, each of which may be performed eitherindividually or consecutively during the sameprocedure indicated for use in patients under-going cataract surgery for removal of the crystal-line lens.	The FEMTO LDV™ Z8 Femtosecond SurgicalLaser is an ophthalmic surgical laser intended foruse in the creation of corneal incisions indicatedfor use in patients undergoing LASIK surgery,tunnel creation for implantation of rings, pocketcreation for implantation of corneal implants, la-mellar keratoplasty, penetrating keratoplasty orother treatment requiring lamellar resection of thecornea at a varying depth with respect to the cor-neal surface.In addition, the FEMTO LDV™ Z8 Surgical Laseris intended for use in the creation of capsulo-tomy, phacofragmentation and the creation ofsingle plane, multi-plane, arc cuts/incisions in thecornea, each of which may be performed eitherindividually or consecutively during the sameprocedure indicated for use in patients under-going cataract surgery for removal of the crystal-line lens.	No difference
FEMTO LDV™ Z8 Femtosecond Surgical Laser Device
Base Stationfootprint	102 cm (L) x 56 cm (W) x 77 cm (H).	102 cm (L) x 53 cm (W) x 78 cm (H).	Minor difference:Because of the changed dimension and shape ofthe table plate, the footprint has changed slightly
Base stationdesign	Black panels	White panels and changed table plate	Minor difference:- Color changes- Table plate was slightly changed indimension and shape for better usability
TouchscreenMonitor	Black Touchscreen Monitor with straight edges	White Touchscreen Monitor with round edges	Minor difference:Touch screen monitor (from a different supplier)
Characteristics	Cleared Device	Proposed Device	Difference
			with same functionality but different color andround edges.
Power Sensors	Power sensor 4 & 5	Power sensor 4 & 5 with Ulbricht sphere	Minor difference:Slight design modification for better reliability.
Suction Unit(Vacuum System)	Single tube system	Twin tube system	Minor difference:Different connector and tube system forcompatibility with Twin tube PP (see below).
Handpiece	Handpiece HP 6.3	Handpiece HP 6.4	Minor difference:- Slightly changed geometry- Adapted design of laser exit window.
OperatingPrinciple	Photodisruption	Photodisruption	No difference
Laser Parameters
Laser Type	Solid state mode locked, diode pumped	Solid state mode locked, diode pumped	Minor difference:Second source laser cavities with identical requi-rement and function.
Laser wavelength	1020 - 1060nm	1020-1060nm	No difference
Pulse with	200-500 fs	200-500 fs	No difference
Max PulseEnergy	< 6 μJ	< 6 μJ	No difference
Max PulseFrequency	< 10 MHz with ±10% tolerance	< 10 MHz with ±10% tolerance	No difference
Spot Size	< 2 μm	< 2 µm	No difference
Software	LASIKCorneal Incisions including CCI $^{2}$ and ARC $^{3}$Pocket	LASIKCorneal Incisions including CCI and ARCPocket	Minor difference:Bug fixes and improvements that did not requirea 510(k) for each single change according to the
Characteristics	Cleared Device	Proposed Device	Difference
	RingKeratoplasty including LKP4, PKP5 andKeraKlearCataract including CAPS6 and LF7	RingKeratoplasty including LKP, DALK, PKP, LiquidPKP and KeraKlearCataract including CAPS, LF, CCI and ARCCataract TrainingSurgery Report Tool	Guideline "Deciding When to Submit a 510(k) fora Software Change to an Existing Device datedOctober 25, 2017".
Material	The device does not contain or dispense any me-dicinal substances, tissues of animal origins, orany other materials requiring special considera-tions.	The device does not contain or dispense any me-dicinal substances, tissues of animal origins, orany other materials requiring special considera-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:Slight geometry modificationsSlight Material change: Same bulk material,but different trade name version
Patient Interface	Applanating patient interfaceLiquid patient interface	SLIM Applanating patient interfaceSLIM Liquid patient interface	Minor difference:Slight geometry modificationsSlight Material change: Same bulk material,but different trade name version
Suction Tubing	Suction tubing with one tube	Suction tubing with two tubes	Minor difference:Two tubes instead of one and different connectorwithout any material change.
Drape Set orDrape	PP Cataract: Drape set consisting of four drapes.PP Cornea: One base station drape.	PP Cataract SLIM: Drape set consisting of fourdrapes.PP Cornea SLIM: One base station drape.	No difference
Characteristics	Cleared Device	Proposed Device	Difference
Packaging
PrimaryPackaging	PP Cornea: Blister	PP Cornea SLIM: Blister	No difference
	PP Cataract: Blister and pouch with drape set	PP Cataract SLIM: Blister and pouch with drapeset
SecondaryPackaging	PP Cornea: Sales Unit (Box of 10)	PP Cornea SLIM: Sales Unit (Box of 10)	No difference
	PP Cataract: Sales Unit (Box of 10)	PP Cataract SLIM: Sales Unit (Box of 10)
SterilizationMethod	EO (Ethylene oxide) Sterilization	EO (Ethylene oxide) Sterilization	No difference
Shelf life	3 years	3 years	No difference

Table 2: Comparison between the cleared and the proposed device

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K213559

² Clear Corneal Incision
3 Arcuate Incision

³Arcuate Incision

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Image /page/8/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".

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K213559

4 Lamellar Keratoplasty

6 Capsulotomy
7 Lens Fragmentation
5 Penetrating Keratoplasty

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Image /page/9/Picture/1 description: The image contains the logo for Ziemer Ophthalmology. The word "ziemer" is written in lowercase letters in a dark gray color. Below the word "ziemer" is the word "OPHTHALMOLOGY" in smaller, uppercase letters. To the right of the word "ziemer" is a red, stylized letter "S".

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K213559

The other components of the FEMTO LDV™ Z8 Femtoseond Surgical Laser as Fixed Mirror Articulated Arm, Power Supply, Computer, OCT Box and Safety System did not change.

All changes are minor and have no effect on effectiveness; therefore, these two devices are considered substantially equivalent.

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Image /page/10/Picture/1 description: The image shows the logo for Ziemer Ophthalmology, with the word "ziemer" in gray and the word "OPHTHALMOLOGY" in a smaller font below it. To the right of the word "ziemer" is a red abstract shape. Below the logo is the text "Page 8/8" in black.

VIII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Non-clinical testing

Safety testing and electromagnetic compatibility (EMC)

The following safety and EMC tests were conducted with the modified device including the changes above:

IEC 60601-1-2 .
IEC 60601-1
IEC 60601-1-6 .
IEC 60601-1-2-22 ●
. IEC 60825-1

Biocompatibility, Cytotoxicity, Microbiological and Sterilization testing

A risk-based decision was made to test only in vitro for EO/ECH residuals and cytotoxicity due to the only minor material and geometry adjustments of the SLIM Procedure Packs. A repetition of in vivo tests was deliberately omitted, as these had already been extensively tested with the substantially equivalent predecessor products.

Although primary packaging for the modified SLIM Procedure Packs are the same as for the current 510(k)-cleared Procedure Packs, the sterilization was retested. The outcome of the re-validation showed that all acceptance criteria were achieved and proved compliance with ISO 11135:2014.

Software Verification and Validation testing

Every change was verified and validated according to ISO 62304 and documentation was provided as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Bench Testing

All bench testing results demonstrated equivalent performance between the modified and the cleared device according to the changes summarized in chapter VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES. The bench testing comprises the following tests:

Sterilization validation of the disposable accessories ●
Shelf-life testing of the disposable accessories ●
Verification of the different Resection Geometries ●
. System verification

Clinical Studies

The changes described in section IV did not require clinical performance data to demonstrate substantial equivalence to the predicate device.

VIII. CONCLUSIONS

The modified FEMTO LDV™ Z8 Femtosecond Surgical Laser is substantially equivalent to the cleared FEMTO LDV™ Z8 Femtosecond Surgical Laser as all changes do not affect safety and effectiveness.

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.