(168 days)
Not Found
No
The document describes a laser system for surgical procedures and does not mention any AI or ML components or functionalities.
No.
The device is a surgical laser used to create incisions and facilitate surgical procedures in the eye, not to treat a condition therapeutically.
No
The device description clearly states its purpose is for "producing cuts in ocular tissue" in various surgical procedures, not for identifying the presence, absence, or risk of a disease or condition.
No
The device description explicitly states it is a "solid state femtosecond laser" and lists multiple hardware components like a Base Station, Handpiece, Laser Cavity, and OCT Box. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the FEMTO LDV™ Z8 Femtosecond Surgical Laser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is an "ophthalmic surgical laser intended for use in the creation of corneal incisions" and other surgical procedures on the eye (cornea and crystalline lens). This involves direct interaction with living tissue within the patient's body.
- Device Description: The description details a surgical laser system that produces laser energy to cut ocular tissue through photodisruption. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Anatomical Site: The device operates on "Ocular tissue, cornea, crystalline lens," which are parts of the living patient.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on samples.
In summary, the FEMTO LDV™ Z8 is a surgical device used for therapeutic procedures on the eye, not a diagnostic device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OOE
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 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)
The following components are mandatory accessories for the FEMTO LDV™ Z8 Femtosecond Surgical Laser:
- Procedure Pack (PP) with Liquid Patient Interface (LPI) for Cataract surgery.
- Procedure Pack (PP) with Applanating Patient Interface (API) for Corneal surgery
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ocular tissue (cornea, crystalline lens).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed including Safety testing and electromagnetic compatibility (EMC), Biocompatibility, Cytotoxicity, Microbiological and Sterilization testing, Software Verification and Validation testing, and Bench Testing.
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
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.
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".
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
The changes described in section IV did not require clinical performance data to demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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".
510(k) Summary
510(k) Number K213559 l.
.. SUBMITTER
| Applicant: | SIE AG, Surgical Instrument Engineering
Allmendstrasse 11
CH-2502 Port
Switzerland
Frank Ziemer, CEO
Phone: +41 32 332 70 70
Fax: +41 32 332 70 71
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. |
| 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. |
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:
-
- 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.
-
- 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.
-
- Improved Vacuum System: The vacuum design was slightly changed for a more reliable and robust vacuum check.
-
- 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.
-
- Small Esthetic changes: Changes to color and design of monitor, table and panels.
-
- 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".
| 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 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, la- | ||||
| mellar keratoplasty, penetrating keratoplasty or | ||||
| other treatment requiring lamellar resection of the | ||||
| cornea at a varying depth with respect to the cor- | ||||
| neal surface. | ||||
| In addition, the FEMTO LDV™ Z8 Surgical Laser | ||||
| is intended for use in the creation of capsulo- | ||||
| tomy, 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 under- | ||||
| going cataract surgery for removal of the crystal- | ||||
| line lens. | 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, la- | ||||
| mellar keratoplasty, penetrating keratoplasty or | ||||
| other treatment requiring lamellar resection of the | ||||
| cornea at a varying depth with respect to the cor- | ||||
| neal surface. | ||||
| In addition, the FEMTO LDV™ Z8 Surgical Laser | ||||
| is intended for use in the creation of capsulo- | ||||
| tomy, 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 under- | ||||
| going cataract surgery for removal of the crystal- | ||||
| line lens. | No difference | |||
| FEMTO LDV™ Z8 Femtosecond Surgical Laser Device | ||||
| Base Station | ||||
| 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: | |
| Because of the changed dimension and shape of | ||||
| the table plate, the footprint has changed slightly | ||||
| Base station | ||||
| design | Black panels | White panels and changed table plate | Minor difference: |
-
Color changes
-
Table plate was slightly changed in
dimension and shape for better usability | |
| Touchscreen
Monitor | 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 and
round 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 for
compatibility 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. | |
| Operating
Principle | 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 Pulse
Energy | 4 Lamellar Keratoplasty -
6 Capsulotomy
7 Lens Fragmentation
5 Penetrating Keratoplasty
9
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".
Page 7/8
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.
10
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.