(81 days)
Not Found
No
The summary describes automated precision control and integration with pre-op analysis devices, but does not mention AI or ML algorithms for decision-making, image analysis, or treatment planning. The performance studies focus on accuracy and quality of cuts, not on the performance of any AI/ML component.
No
The device is described as an ophthalmic surgical laser used for cutting and fragmentation, which are surgical procedures, not therapeutic treatments in themselves, but rather a means to achieve a therapeutic outcome.
No
The LENSAR Laser System - fs 3D is described as an ophthalmic surgical laser used for cutting and fragmentation procedures within the eye, not for diagnosing conditions. While it integrates with "pre-op analysis devices" and has "treatment planning tools," its primary function, as detailed in the "Intended Use" and "Device Description," is therapeutic (surgical), not diagnostic.
No
The device description explicitly states it "utilizes a pulsed laser" and is a "medical device for use in ophthalmic surgery," indicating it is a hardware device that performs physical actions (cutting and fragmentation) using a laser. While it includes software components for control and planning, it is not solely software.
Based on the provided information, the LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical laser system used for performing procedures on the eye (creating capsulotomies, fragmenting lenses, making corneal incisions, creating flaps and tunnels). This is an in vivo application, meaning it's used on a living organism.
- Device Description: The description reinforces its use as a surgical tool for cutting and manipulating tissues within the eye.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform such functions.
Therefore, the LENSAR Laser System - fs 3D is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use: · in the creation of an anterior capsulotomy; - · in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens; - · in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea; - · in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/ incisions in the cornea; - · in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea; - · in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and - · in the creation of partial thickness single-plane radial cuts/incisions in the cornea.
Product codes (comma separated list FDA assigned to the subject device)
OOE
Device Description
The LLS-fs 3D with Streamline™ is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The device is also intended for use in the creation of pocket cuts/incisions in the cornea in patients undergoing ophthalmic surgery, in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea, and in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments, each of which may only be performed individually. Additionally, the device is also intended for use in the creation of partial thickness single-plane radial cuts/incisions in the cornea which may be performed individually or consecutively with arcuate incisions.
Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser fragmentation treatment within the lens; the size, architecture, and location of full thickness incisions within the cornea; the size, architecture, location, depth, and quantity of partial thickness incisions within the cornea; and the size, architecture, and depth of pocket. flap, and tunnel cuts.
The LLS-fs 3D with Streamline™ includes the integration with pre-op analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis-C™ (corneal) and IntelliAxis-L™ (lens) markers for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scheimpflug Camera-based Imaging System with 3D Confocal Structured Illumination (3D-CSI)
Anatomical Site
anterior lens capsule, lens, cornea
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
- The accuracy of the depth of the corneal tunnel was tested using a porcine ex vivo eve model.
- For both the corneal tunnel and radial incisions in combination with arcuate incisions an assessment of the incision quality was conducted using porcine eyes.
- The accuracy of the depth of the radial incisions in combination with arcuate incisions was tested using a porcine ex vivo eye model.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Evaluation:
Verification and validation testing were completed to demonstrate that the proposed device performance complies with specifications and requirements identified for the LENSAR Laser System - fs 3D. Each function and/or feature was verified through unit testing and system testing by means of the appropriate test case or test specification. The unit/system verification test reports provide the test cases, expected results for each test case, and the actual results obtained. All criteria for this testing were met and the results demonstrate that the LENSAR System with the new indications and other software changes meets all performance specifications and requirements. The objectives defined in the validation plan were achieved according to the validation results. The software on the proposed LLS-fs 3D System has been updated in support of the changes outlined above.
Performance data supporting substantial equivalence is summarized as follows:
- The accuracy of the depth of the corneal tunnel was tested using a porcine ex vivo eve model. The depth of the tunnel was measured using an optical coherence tomographer over various depths and compared to the intended depth. The study showed that the achieved depth was well within the established requirements for depth of the corneal tunnel.
- For both the corneal tunnel and radial incisions in combination with arcuate incisions an assessment of the incision quality was conducted. The study consisted of using the laser to cut corneal tunnel and radial incisions (individually or in combination with arcuate incisions) at various depths in porcine eyes. A trained biomedical scientist, using standard instruments, assessed the acceptability for each as it relates to ease of opening and incision quality. The results showed that the proposed device showed ease of opening and quality of incision quality that was acceptable.
- Evaluation (from a previous study) of the effect of the laser partial thickness incisions on endothelial cells of ex vivo eyes showed that the laser method results in no loss of endothelial cell density when a sufficiently large residual corneal bed is maintained.
- The accuracy of the depth of the radial incisions in combination with arcuate incisions was tested using a porcine ex vivo eye model. The depth of the radial and arcuate incisions was measured using an optical coherence tomographer over various depths and compared to the intended depth. The study showed that the achieved depth was well within the established requirements for depth of the radial incision individually or in combination with the arcuate incision.
- A review of the hazard analysis of all potential hazards to the patient, surgeon and other system operators was performed to consider all changes to the proposed LLS-fs 3D device. The hazard analysis demonstrates that all potential hazards have acceptable levels of probability/severity characteristics.
In all cases, the test results showed that the new indications and other minor changes meet the performance specifications and requirements.
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 contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
December 21, 2018
Lensar, Inc. Keith Peck Director, Quality Assurance 2800 Discovery Drive. Suite 100 Orlando, FL 32826
Re: K182795
Trade/Device Name: LENSAR Laser System - fs 3D (LLS-fs 3D) Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: September 28, 2018 Received: October 1, 2018
Dear Keith Peck:
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/cdrl/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. 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bradley S. Cunningham -S
for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182795
Device Name LENSAR Laser System - fs 3D
Indications for Use (Describe)
The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use: · in the creation of an anterior capsulotomy;
- · in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens;
- · in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea;
- · in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/ incisions in the cornea;
- · in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea;
- · in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and
- · in the creation of partial thickness single-plane radial cuts/incisions in the cornea.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
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3
510(K) SUMMARY
This 510(k) Summary has been prepared in accordance with the requirements of 21 CFR 807.92.
SUBMITTER INFORMATION 1.0
The submitter of this 510(k) Summary is:
| Company: | Contact Person: |
|---|---|
| LENSAR, Inc. | |
| 2800 Discovery Drive, Suite 100 | |
| Orlando, FL 32826 | Keith Peck |
| (888) 575-6412 (Office | |
| (407) 386-7228 (Fax) |
Summary Preparation Date: December 21, 2018
DEVICE INFORMATION 2.0
| Trade/Proprietary Name: LENSAR Laser System - fs 3D (LLS-fs 3D) | |
|---|---|
| Common/Usual Name: | Ophthalmic Femtosecond Laser |
| Classification Name(s): | Ophthalmic Femtosecond Laser (21 CFR 886.4390) |
| Product Code(s): | OOE |
| Review Panel: | Ophthalmic |
| Regulatory Class: | II |
3.0 PREDICATE DEVICE
The legally marketed (predicate) device to which LENSAR is claiming substantial equivalence to is:
| 510(k) Number | Device Name | Manufacturer |
|---|---|---|
| K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | |
| (for use in radial cuts/incisions) | LENSAR, Inc. | |
| K141476 | WaveLight® FS200 Laser System (for use in | |
| tunnels for corneal ring segments) | Alcon Laboratories, Inc. |
4.0 DEVICE DESCRIPTION
The LLS-fs 3D with Streamline™ is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The device is also intended for use in the creation of pocket cuts/incisions in the cornea in patients undergoing ophthalmic surgery, in the creation of a corneal flap in patients undergoing treatment requiring
4
initial lamellar resection of the cornea, and in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments, each of which may only be performed individually. Additionally, the device is also intended for use in the creation of partial thickness single-plane radial cuts/incisions in the cornea which may be performed individually or consecutively with arcuate incisions.
Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser fragmentation treatment within the lens; the size, architecture, and location of full thickness incisions within the cornea; the size, architecture, location, depth, and quantity of partial thickness incisions within the cornea; and the size, architecture, and depth of pocket. flap, and tunnel cuts.
The LLS-fs 3D with Streamline™ includes the integration with pre-op analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis-C™ (corneal) and IntelliAxis-L™ (lens) markers for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments.
5.0 INDICATIONS FOR USE
The LENSAR Laser System – fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use:
- in the creation of an anterior capsulotomy; ●
- in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens:
- . in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea;
- in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/ incisions in the cornea;
- in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea;
- . in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and
- in the creation of partial thickness single-plane radial cuts/incisions in the cornea
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6.0 PREDICATE DEVICE
All elements of the proposed device remain unchanged from that cleared under K181430 except for the following technological difference:
- addition of a new indication for use in patients undergoing surgery or other treatments . requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments: and
- . addition of a new indication for the creation of partial thickness single-plane radial cuts/incisions in the cornea.
5
Other changes unrelated to the requested change for the addition of the new indications are as follows:
- . allowing arcuate incisions that are currently cleared to be completed with the curved contact patient interface device (PID) that is already cleared;
- . the ability to manually adjust the location of the capsulotomy without compromising the safety limits to the iris that already exist; and
- . the ability to fragment the lens closer to the anterior capsule only within the boundaries of the capsulotomy diameter.
The following table provides a comparative between the proposed LLS-fs 3D laser device with the addition of the new indications and the predicate laser devices.
| Table 1: Summary of Technological Characteristics | |||
|---|---|---|---|
| Characteristics | Proposed Device | ||
| LLS-fs 3D Laser System | |||
| 510(k) K182795 | Predicate Device | ||
| (Radial Cuts/Incisions) | |||
| LLS-fs 3D Laser System | |||
| 510(k) K181430 | |||
| Cleared: 08/09/2018 | Predicate Device | ||
| (Tunnels for Corneal Ring | |||
| Segments) | |||
| WaveLight FS200 Laser System | |||
| 510(k) K141476 | |||
| Cleared: 09/30/2014 | |||
| Indication for | |||
| Use | The LENSAR Laser | ||
| System - fs 3D (LLS-fs | |||
| 3D) with Streamline™ is | |||
| an ophthalmic surgical | |||
| laser indicated for use: | |||
| in the creation of an | |||
| anterior capsulotomy;in patients undergoing | |||
| surgery requiring | |||
| laser-assisted | |||
| fragmentation of the | |||
| cataractous lens;in the creation of full | |||
| and partial thickness | |||
| single-plane and multi- | |||
| plane arc cuts/ | |||
| incisions in the | |||
| cornea;in patients undergoing | |||
| ophthalmic surgery or | |||
| other treatments | |||
| requiring pocket | |||
| cuts/incisions in the | |||
| cornea;in the creation of a | |||
| corneal flap in patients | |||
| undergoing treatment | |||
| requiring initial | |||
| lamellar resection of | |||
| the cornea; | The LENSAR Laser | ||
| System - fs 3D (LLS-fs | |||
| 3D) with Streamline™ is | |||
| an ophthalmic surgical | |||
| laser indicated for use: | |||
| in the creation of an | |||
| anterior capsulotomy;in patients undergoing | |||
| surgery requiring | |||
| laser-assisted | |||
| fragmentation of the | |||
| cataractous lens;in the creation of full | |||
| and partial thickness | |||
| single-plane and multi- | |||
| plane arc cuts/ | |||
| incisions in the | |||
| cornea;in patients undergoing | |||
| ophthalmic surgery or | |||
| other treatments | |||
| requiring pocket | |||
| cuts/incisions in the | |||
| cornea;in the creation of a | |||
| corneal flap in patients | |||
| undergoing treatment | |||
| requiring initial | |||
| lamellar resection of | |||
| the cornea. | The WaveLight FS200 Laser | ||
| System is an ophthalmic surgical | |||
| laser indicated for use: | |||
| In the creation of a corneal flap | |||
| in patients undergoing LASIK | |||
| surgery or other surgery or | |||
| treatment requiring initial | |||
| lamellar resection of the | |||
| cornea.In patients undergoing surgery | |||
| or other treatment requiring | |||
| initial lamellar resection of the | |||
| cornea to create tunnels for | |||
| placement of corneal ring | |||
| segments.In the creation of a lamellar | |||
| cut/resection of the cornea for | |||
| lamellar keratoplasty.In the creation of a penetrating | |||
| cut/incision for penetrating | |||
| keratoplasty and for corneal | |||
| harvesting.In patients undergoing | |||
| ophthalmic surgery or other | |||
| treatment requiring arcuate | |||
| cuts/ incisions in the cornea.In patients undergoing | |||
| ophthalmic surgery or other | |||
| treatment requiring pocket | |||
| cuts/ incisions in the cornea. | |||
| Table 1: Summary of Technological Characteristics | |||
| Characteristics | Proposed Device | ||
| LLS-fs 3D Laser System | |||
| 510(k) K182795 | Predicate Device | ||
| (Radial Cuts/Incisions) | |||
| LLS-fs 3D Laser System | |||
| 510(k) K181430 | |||
| Cleared: 08/09/2018 | Predicate Device | ||
| (Tunnels for Corneal Ring | |||
| Segments) | |||
| WaveLight FS200 Laser System | |||
| 510(k) K141476 | |||
| Cleared: 09/30/2014 | |||
| in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and in the creation of partial thickness single-plane radial cuts/incisions in the cornea. | |||
| Operating | |||
| Principle | Photodisruption and | ||
| plasma mediated ablation | Photodisruption and | ||
| plasma mediated ablation | Photodisruption and plasma | ||
| mediated ablation | |||
| Lens | |||
| Fragmentation | |||
| Removal | Provided by commercially | ||
| available separate | |||
| system of ultrasound; | |||
| irrigation/ aspiration | Provided by commercially | ||
| available separate | |||
| system of ultrasound; | |||
| irrigation/ aspiration | Provided by commercially | ||
| available separate system of | |||
| ultrasound; irrigation/ aspiration | |||
| Class/ Product | |||
| Code/ | |||
| Regulation | Class II/ OOE/ 886.4390 | Class II/ OOE/ 886.4390 | Class II/ OOE/ 886.4390 |
| Patient Contact | |||
| Portion of | |||
| Device | Disposable | ||
| polycarbonate/ silicone | |||
| patient interface | |||
| accessory; suction ring | |||
| assembly | Disposable | ||
| polycarbonate/ silicone | |||
| patient interface | |||
| accessory; suction ring | |||
| assembly | Disposable patient contact | ||
| consumable accessory; suction | |||
| ring assembly and applanating | |||
| cone. | |||
| Sterilization | |||
| Method (patient | |||
| interface | |||
| accessory) | Gamma irradiation (not | ||
| including Curved Contact | |||
| PID) or Ethylene Oxide | |||
| (EO) | Gamma irradiation (not | ||
| including Curved Contact | |||
| PID) or Ethylene Oxide | |||
| (EO) | Ethylene Oxide (EO) | ||
| Laser Type | Yb:YAG | Yb:YAG | Nd:Glass* |
| Wavelength | 1030 nm | 1030 nm | 1030 nm |
| Pulsing | Mode-locked | Mode-locked | Mode-locked |
| Mode | Fundamental (TEM00) | Fundamental (TEM00) | Fundamental (TEM00) |
| Pulse Duration | $1.5 x10^{-12}$ sec | $1.5 x10^{-12}$ sec | $0.35 x 10^{-12}$ sec |
| Repetition Rate | 20-80 kHz, adjustable | 20-80 kHz, adjustable | 200 kHz |
| Maximum Pulse | |||
| Energy | 15 µJ | 15 µJ | 2.4 µJ |
| Maximum Peak | |||
| Power | 9 MW | 9 MW | 7 MW |
| Table 1: Summary of Technological Characteristics | |||
| Characteristics | Proposed Device | ||
| LLS-fs 3D Laser System | |||
| 510(k) K182795 | Predicate Device | ||
| (Radial Cuts/Incisions) | |||
| LLS-fs 3D Laser System | |||
| 510(k) K181430 | |||
| Cleared: 08/09/2018 | Predicate Device | ||
| (Tunnels for Corneal Ring | |||
| Segments) | |||
| WaveLight FS200 Laser System | |||
| 510(k) K141476 | |||
| Cleared: 09/30/2014 | |||
| Biometrics | Scheimpflug Camera- | ||
| based Imaging System | |||
| with 3D Confocal | |||
| Structured Illumination | |||
| (3D-CSI) | Scheimpflug Camera- | ||
| based Imaging System | |||
| with 3D Confocal | |||
| Structured Illumination | |||
| (3D-CSI) | Opto-Mechanical referencing | ||
| Beam Targeting | |||
| and Delivery | Computer-controlled | ||
| scanner with F-theta lens | Computer-controlled | ||
| scanner with F-theta lens | Computer-controlled scanner with | ||
| F-theta lens | |||
| Photodisruptive | |||
| Fluence | |||
| Threshold in | |||
| Lens Tissue | 4 J/cm² | 4 J/cm² | 3 J/cm²* |
| Intended Use for | |||
| Iris Registration | |||
| Feature | • System provides a | ||
| means to assist the | |||
| surgeon during anterior | |||
| segment ophthalmic | |||
| surgical procedures, to | |||
| make an incision. | |||
| • Using standard pre- | |||
| operative clinical data, | |||
| together with surgeon- | |||
| driven, onscreen | |||
| templates and guides, | |||
| the System provides | |||
| graphical assistance to | |||
| the surgeon as desired | |||
| during the surgery. | |||
| • The system utilizes | |||
| surgeon confirmation at | |||
| each step for planning | |||
| and positioning of | |||
| guidance for incision | |||
| placement. | |||
| • The ocular rotation | |||
| difference between the | |||
| upright position (as | |||
| observed during | |||
| preoperative | |||
| measurements) and the | |||
| supine position (as | |||
| observed during the | |||
| surgical event) is | |||
| determined either by | |||
| manually marking the | |||
| eye in the upright | |||
| position and allowing | |||
| the surgeon to line up | • System provides a | ||
| means to assist the | |||
| surgeon during anterior | |||
| segment ophthalmic | |||
| surgical procedures, to | |||
| make an incision. | |||
| • Using standard pre- | |||
| operative clinical data, | |||
| together with surgeon- | |||
| driven, onscreen | |||
| templates and guides, | |||
| the System provides | |||
| graphical assistance to | |||
| the surgeon as desired | |||
| during the surgery. | |||
| • The system utilizes | |||
| surgeon confirmation at | |||
| each step for planning | |||
| and positioning of | |||
| guidance for incision | |||
| placement. | |||
| • The ocular rotation | |||
| difference between the | |||
| upright position (as | |||
| observed during | |||
| preoperative | |||
| measurements) and the | |||
| supine position (as | |||
| observed during the | |||
| surgical event) is | |||
| determined either by | |||
| manually marking the | |||
| eye in the upright | |||
| position and allowing | |||
| the surgeon to line up | • Not Applicable. | ||
| Table 1: Summary of Technological Characteristics | |||
| Characteristics | Proposed Device | ||
| LLS-fs 3D Laser System | |||
| 510(k) K182795 | Predicate Device | ||
| (Radial Cuts/Incisions) | |||
| LLS-fs 3D Laser System | |||
| 510(k) K181430 | |||
| Cleared: 08/09/2018 | Predicate Device | ||
| (Tunnels for Corneal Ring | |||
| Segments) | |||
| WaveLight FS200 Laser System | |||
| 510(k) K141476 | |||
| Cleared: 09/30/2014 | |||
| the pre-marked eye in | |||
| the upright position to | |||
| that of the supine | |||
| position by way of | |||
| software reticules, or by | |||
| the System's ability to | |||
| analyze and match iris | |||
| features between | |||
| images acquired in | |||
| each position. | the pre-marked eye in | ||
| the upright position to | |||
| that of the supine | |||
| position by way of | |||
| software reticules, or by | |||
| the System's ability to | |||
| analyze and match iris | |||
| features between | |||
| images acquired in | |||
| each position. | |||
| Intended Use for | |||
| the Cataract | |||
| Density Imaging | |||
| Feature | • The imaging system of | ||
| the LENSAR Laser | |||
| System finds lens | |||
| surfaces in order to | |||
| correctly place pulses | |||
| into the lens. Upon | |||
| finding the lens | |||
| surfaces, the imaging | |||
| system also determines | |||
| the location and degree | |||
| of the nuclear cataract | |||
| within the lens. The | |||
| surgeon then has the | |||
| ability to pick from a | |||
| variety of fragmentation | |||
| patterns as the surgeon | |||
| sees fit. Additionally, | |||
| the pattern itself can be | |||
| altered in size and | |||
| thereby the number of | |||
| shots as the surgeon | |||
| sees fit. | |||
| • LENSAR Laser System | |||
| provides a mechanism | |||
| for the doctor to change | |||
| the size and type of | |||
| pattern as the surgeon | |||
| sees fit. For | |||
| convenience, the | |||
| System is also provided | |||
| with an optional | |||
| mechanism for intra- | |||
| operatively matching | |||
| the nuclear cataract | |||
| condition to one of five | |||
| categories for surgeon | |||
| pre-selected | • The imaging system of | ||
| the LENSAR Laser | |||
| System finds lens | |||
| surfaces in order to | |||
| correctly place pulses | |||
| into the lens. Upon | |||
| finding the lens | |||
| surfaces, the imaging | |||
| system also determines | |||
| the location and degree | |||
| of the nuclear cataract | |||
| within the lens. The | |||
| surgeon then has the | |||
| ability to pick from a | |||
| variety of fragmentation | |||
| patterns as the surgeon | |||
| sees fit. Additionally, | |||
| the pattern itself can be | |||
| altered in size and | |||
| thereby the number of | |||
| shots as the surgeon | |||
| sees fit. | |||
| • LENSAR Laser System | |||
| provides a mechanism | |||
| for the doctor to change | |||
| the size and type of | |||
| pattern as the surgeon | |||
| sees fit. For | |||
| convenience, the | |||
| System is also provided | |||
| with an optional | |||
| mechanism for intra- | |||
| operatively matching | |||
| the nuclear cataract | |||
| condition to one of four | |||
| categories for surgeon | |||
| pre-selected | • Not Applicable. | ||
| Table 1: Summary of Technological Characteristics | |||
| Characteristics | Proposed Device | ||
| LLS-fs 3D Laser System | |||
| 510(k) K182795 | Predicate Device | ||
| (Radial Cuts/Incisions) | |||
| LLS-fs 3D Laser System | |||
| 510(k) K181430 | |||
| Cleared: 08/09/2018 | Predicate Device | ||
| (Tunnels for Corneal Ring | |||
| Segments) | |||
| WaveLight FS200 Laser System | |||
| 510(k) K141476 | |||
| Cleared: 09/30/2014 | |||
| fragmentation | |||
| (CustomFrag). | |||
| • The LENSAR Laser | |||
| System utilizes surgeon | |||
| confirmation for | |||
| planning and | |||
| positioning of guidance | |||
| for laser shot | |||
| placement. | fragmentation | ||
| (CustomFrag). | |||
| • The LENSAR Laser | |||
| System utilizes surgeon | |||
| confirmation for | |||
| planning and | |||
| positioning of guidance | |||
| for laser shot | |||
| placement. | |||
| Intended Use for | |||
| the Capsular | |||
| IntelliAxis | |||
| (IntelliCap) | |||
| Feature | • Using standard pre- | ||
| operative data, the | |||
| System places laser | |||
| marks onto the lens | |||
| capsule as part of the | |||
| capsulotomy to identify | |||
| the astigmatic axis as | |||
| prescribed by the | |||
| surgeon. | • Using standard pre- | ||
| operative data, the | |||
| System places laser | |||
| marks onto the lens | |||
| capsule as part of the | |||
| capsulotomy to identify | |||
| the astigmatic axis as | |||
| prescribed by the | |||
| surgeon. | • Not Applicable. |
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- LENSAR estimate only (some WaveLight® parameters were not in the public domain as of this writing and, therefore, LENSAR estimates cannot be confirmed).
The laser parameters that differ slightly from the predicate device (K141476) are Pulse Duration, Repetition Rate, and Maximum Pulse Energy (listed in the table above). The settings for these parameters are based on pre-clinical testing results. Included in this process is the optimization of additional treatment parameters. Clinical safety and effectiveness of tunnels for corneal ring segments are qualified by: a) incision depth accuracy, b) ring tunnel depth regularity, c) ring tunnel incision quality, and whether the incision after the ICRS insertion is acceptable.
PERFORMANCE DATA 7.0
The following performance data were undertaken in support of the substantial equivalence determination.
Performance Evaluation:
Verification and validation testing were completed to demonstrate that the proposed device performance complies with specifications and requirements identified for the LENSAR Laser System - fs 3D. Each function and/or feature was verified through unit testing and system testing by means of the appropriate test case or test specification. The unit/system verification test reports provide the test cases, expected results for each test case, and the actual results obtained. All criteria for this testing were met and the results demonstrate that the LENSAR System with the new indications and other software changes meets all performance specifications and requirements. The objectives defined in the validation plan were achieved
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according to the validation results. The software on the proposed LLS-fs 3D System has been updated in support of the changes outlined above.
Performance data supporting substantial equivalence is summarized as follows:
- The accuracy of the depth of the corneal tunnel was tested using a porcine ex vivo eve . model. The depth of the tunnel was measured using an optical coherence tomographer over various depths and compared to the intended depth. The study showed that the achieved depth was well within the established requirements for depth of the corneal tunnel.
- For both the corneal tunnel and radial incisions in combination with arcuate incisions an . assessment of the incision quality was conducted. The study consisted of using the laser to cut corneal tunnel and radial incisions (individually or in combination with arcuate incisions) at various depths in porcine eyes. A trained biomedical scientist, using standard instruments, assessed the acceptability for each as it relates to ease of opening and incision quality. The results showed that the proposed device showed ease of opening and quality of incision quality that was acceptable.
- . Evaluation (from a previous study) of the effect of the laser partial thickness incisions on endothelial cells of ex vivo eyes showed that the laser method results in no loss of endothelial cell density when a sufficiently large residual corneal bed is maintained.
- . The accuracy of the depth of the radial incisions in combination with arcuate incisions was tested using a porcine ex vivo eye model. The depth of the radial and arcuate incisions was measured using an optical coherence tomographer over various depths and compared to the intended depth. The study showed that the achieved depth was well within the established requirements for depth of the radial incision individually or in combination with the arcuate incision.
- . A review of the hazard analysis of all potential hazards to the patient, surgeon and other system operators was performed to consider all changes to the proposed LLS-fs 3D device. The hazard analysis demonstrates that all potential hazards have acceptable levels of probability/severity characteristics.
In all cases, the test results showed that the new indications and other minor changes meet the performance specifications and requirements. The comparison with the predicate devices shows that the proposed LENSAR Laser System – fs 3D is substantially equivalent to the WayeLight® FS200 Laser System (K141476) for the indication of use in the creation of corneal tunnels and to the LENSAR Laser System - fs 3D (LLS-fs 3D) for the indication of use in the creation of partial thickness single planed radial incisions.
The minor differences between the additional LENSAR device feature and the predicate device do not raise any new questions of safety or effectiveness.
Biocompatibility Testing:
The Patient Interface Device (PID) Kits have no changes to the material or assembly as part of this submission and thus remains unchanged from that used with the previously cleared device (K181430).
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The PID Ring Arm is multi-use and is sterilized by autoclaving. There were no changes to the material or assembly of the PID Ring Arm as part of this submission and thus remains unchanged from prior device files.
Software Verification and Validation Testing:
A complete software verification and validation testing was conducted covering all cited changes and updates since the prior clearance (K181430), and documentation was provided as recommended by FDA's "Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury to the patient or operator.
Summary of Clinical Studies:
The addition of the added indications for use and other minor changes as described in Section 6 above for use with the LENSAR Laser System did not require clinical performance data to demonstrate substantial equivalence to the predicate device.
CONCLUSIONS 8.0
The activities used to evaluate the LENSAR Laser System – fs 3D (LLS-fs 3D) and the information provided in this 510(k) submission do not identify any new issues of safety or effectiveness.
Based on the above supportive information, the proposed LENSAR Laser System - fs 3D (LLS-fs 3D) with the new indications are substantially equivalent with respect to safety and effectiveness and indication for use as cleared in: