(129 days)
Not Found
No
The provided text does not mention AI, ML, deep learning, or any related terms. The description focuses on the laser technology and imaging system.
Yes
The device is described as an ophthalmic surgical laser used in procedures for cataract treatment and corneal incisions, which directly addresses medical conditions and aims to restore health.
No
The ALLY™ System is described as an ophthalmic surgical laser used for procedures like creating capsulotomies and fragmenting lenses, not for diagnosing conditions.
No
The device description explicitly states it is a "medical device intended for use in ophthalmic surgery" and utilizes a "dual-pulse-width laser" and a "Scheimpflug Camera-based Imaging System with 3D Confocal Structured Illumination (3D-CSI)". These are hardware components, not solely software.
Based on the provided information, the ALLY™ Adaptive Cataract Treatment System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The system is indicated for use in surgical procedures on the eye (anterior capsulotomy, lens fragmentation, corneal incisions). These are direct surgical interventions on a living patient.
- Device Description: The description clearly states it's a "medical device intended for use in ophthalmic surgery" and describes its function as a "femtosecond laser used to cut" and "laser-assisted fragmentation." This is a surgical tool.
- Anatomical Site: The anatomical site is the "Ophthalmic / anterior segment of the eye (lens, cornea)," which are parts of the living body.
- Intended User/Care Setting: It's used by a "surgeon in a surgical setting."
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. The ALLY™ System operates directly on the body during surgery.
N/A
Intended Use / Indications for Use
- The ALLY™ Adaptive Cataract Treatment System 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.
Product codes (comma separated list FDA assigned to the subject device)
OOE
Device Description
The ALLY" Adaptive Cataract Treatment System (ALLY" System) is a medical device intended for use in ophthalmic surgery. The ALL Y™ System brings the precision of femtosecond laser to the cataract procedure. The ALL Y™ System allows for an initial femtosecond laser procedure using a dual-pulse-width laser used to cut a precision capsulotomy in the anterior lens capsule; laser-assisted fragmentation of the cataractous lens for removal during cataract surgery; and 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.
Mentions image processing
Not Found
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, cataractous lens, cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmic surgical laser (implies professional use in a clinical setting)
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)
Design verification and validation testing was completed to demonstrate that the proposed device performance complies with specifications and requirements identified for the ALLY" Adaptive Cataract Treatment System. 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 ALLY™ Adaptive Cataract Treatment System meets all performance specifications and requirements. The objectives defined in the validation plan were achieved according to the validation results.
Eye Safety Analysis Testing: A detailed analysis of the retinal and corneal burn hazard analysis for capsulotomy, fragmentation, clear corneal and arcuate incisions under worst-case normal and single failure conditions was performed in accordance with ANSI Z-136.1:2014, with the conclusion that the ALLY™ Adaptive Cataract Treatment System laser is safe with regards to retinal and corneal illumination for the defined indications.
Biocompatibility Testing: Minor changes to materials used in the ALLY™ System Patient Interface Device (PID) and the addition of the PVC alignment card that is temporarily placed on the patient's head to facilitate system alignment underwent biocompatibility testing per ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (3 ed.). Test results indicated that the PVC alignment card and the minor materials changes met all biocompatibility requirements.
Sterilization Validation: There have been no changes to the ALLY™ System PID or PID Ring Arm as detailed and previously cleared with the LLS-fs 3D (K182795) to the sterilization provider, sterilization methodology, profile/chamber, or sterility assurance level. The ALL Y™ System includes a sterile drapes kit (used for monitors, handles, joystick, tray; and an alignment card). This drapes kit has the same packaging as the drapes kit previously cleared for the predicate device in K182795. The drapes for the ALLY 100 System have been updated and were adopted into the family of products already validated.
Sterile Device Packaging: Packaging for the sterile Patient Interface Device (PID) and Drapes Kit has been performed. Test results satisfied the acceptance criteria as defined by the recognized standards (ISTA 3A, ASTM F2096, ASTM F88) and found to be in compliance with the recognized standards.
Electromagnetic Compatibility and Electrical Safety: The ALLY™ Adaptive Cataract Treatment System has undergone electromagnetic compatibility and electrical safety testing to support this premarket notification. Test results satisfied the acceptance criteria as defined by the recognized standards (ANSI/AAMI/IEC 60601-1-2:2014, ANSV/AAMI/ES 60601-1:2005 A1:2012) and found to be in compliance with the applicable recognized safety standards.
Hazard Analysis: A hazard analysis was conducted to identify all potential hazards to the patient, surgeon, and other system operators resulting from differences between the ALL Y" Adaptive Cataract Treatment System and the predicate device, LLS-fs 3D (K182795). The identified hazards were duly evaluated in the risk analysis, and mitigation measures were defined and tested. After the implementation and testing of mitigation measures, the benefit of the ALLY™ Adaptive Cataract Treatment System prevails over the residual risks and all potential hazards have acceptable levels of probability/severity characteristics.
Software Verification and Validation Testing: A complete software verification and validation testing of the ALLY™ Adaptive Cataract Treatment System was conducted. The results demonstrate that the ALLY™ Adaptive Cataract Treatment System is in compliance with the following recognized standard: IEC 62304. Documentation was provided as recommended in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: Guidance for Industry and FDA Staff (May 11, 2005). 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.
Animal Studies Performance Data: No animal studies were performed to support substantial equivalence of this premarket notification.
Clinical Performance Data: No clinical studies were deemed necessary to demonstrate the safety and effectiveness or substantial equivalence of the ALLY™ Adaptive Cataract Treatment System to the predicate device. The non-clinical performance data demonstrated that the device performs as intended.
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.
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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 and 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.
June 9, 2022
LENSAR, Inc. Mr. Keith Peck Director, Quality Assurance 2800 Discovery Drive, Suite 100 Orlando, Florida 32826
Re: K220259
Trade/Device Name: ALLY Adaptive Cataract Treatment System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: April 29, 2022 Received: May 2, 2022
Dear Mr. 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/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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 medical devices and radiation-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) K220259
Device Name
ALLYTM Adaptive Cataract Treatment System
Indications for Use (Describe)
- The ALL Y™ Adaptive Cataract Treatment System 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.
| 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/0 description: The image contains the logo for LENSAR. The logo consists of a spherical, web-like design on the left, followed by the word "LENSAR" in a simple, sans-serif font. The color scheme is primarily light blue or teal, giving the logo a clean and modern appearance.
510(k) Summary
This 510(k) Summary has been prepared in accordance with the requirements of 21 CFR 807.92.
1.0 SUBMITTER INFORMATION
| Company/Owner: | LENSAR, Inc.
2800 Discovery Drive, Suite 10
Orlando, FL 32826
Phone: (407) 641-4889
Fax: (407) 386-7228 |
|-----------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Keith Peck
Phone: (888) 575-6412
Fax: (407) 386-7228 |
Date Summary Prepared: June 8, 2022
2.0 DEVICE INFORMATION
| Trade/Proprietary Name: | ALLY™ Adaptive Cataract Treatment System |
|---|---|
| Regulation Number: | 21 CFR 886.4390 |
| Regulation Name: | Ophthalmic Laser |
| Regulatory Classification: | Class II |
| Product Code: | OOE |
| Review Panel: | Ophthalmic |
3.0 LEGALLY MARKETED DEVICES
The legally marketed devices to which LENSAR is claiming equivalence to are:
| 510(k) Number | Device Name | Manufacturer |
|---|---|---|
| K182795 | LENSAR Laser System – fs 3D (LLS-fs 3D) | LENSAR, Inc. |
DEVICE DESCRIPTION 4.0
The ALLY" Adaptive Cataract Treatment System (ALLY" System) is a medical device intended for use in ophthalmic surgery. The ALL Y™ System brings the precision of femtosecond laser to the cataract procedure. The ALL Y™ System allows for an initial femtosecond laser procedure using a dual-pulse-width laser used to cut a precision capsulotomy in the anterior lens capsule; laser-assisted fragmentation of the cataractous lens for removal during cataract surgery; and 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.
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Image /page/4/Picture/1 description: The image shows the logo for LENSAR. The logo consists of a blue, spherical graphic on the left, followed by the word "LENSAR" in a light gray, sans-serif font. The graphic appears to be a stylized representation of a lens or a globe, with intersecting lines forming a mesh-like pattern.
Use of the ALLY"" System provides automated precision and 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; and the size, architecture, location, depth, and quantity of partial thickness incisions within the cornea.
The ALLY"" System uses Streamline® to integrate pre-op analysis devices, automated iris registration with automatic cyclorotation adjustment, IntelliAxis-C® (corneal), and IntelliAxis Refractive Capsulorhexis® (lens) markers for alignment of toric IOLs, as well as treatment planning tools for precision-guided laser treatments.
INDICATIONS FOR USE 5.0
The ALLY™ Adaptive Cataract Treatment System 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.
TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES 6.0
The following table provides a comparative between the ALLY™ System and the predicate device.
| Summary of Technological Characteristics | ||
|---|---|---|
| Subject Device | ||
| ALLY™ Adaptive Cataract Treatment | ||
| System, 510(k) K220259 | Predicate Device | |
| LLS-fs 3D Laser System | ||
| 510(k) K182795 | ||
| Characteristic | ||
| Class / Product Code / | ||
| Regulation No. | Class II / OOE / 886.4390 | Class II / OOE / 886.4390 |
| Intended Type of Use | Prescription Use | Prescription Use |
| Indications for Use | The ALLY™ Adaptive Cataract Treatment | |
| System 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. | 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. in patients undergoing surgery or other | ||
| treatment requiring initial lamellar | ||
| Summary of Technological Characteristics | ||
| Subject Device | Predicate Device | |
| Characteristic | ALLY™ Adaptive Cataract Treatment | |
| System, 510(k) K220259 | LLS-fs 3D Laser System | |
| 510(k) K182795 | ||
| resection of the cornea to create tunnels | ||
| for placement of corneal ring segments. | ||
| • 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 | ||
| Patient Contact | ||
| Portion of Device (PID) | Disposable polycarbonate/silicone patient | |
| interface accessory; suction ring assembly | Disposable polycarbonate/silicone patient | |
| interface accessory; suction ring assembly | ||
| Sterilization Method | ||
| (Accessories) | Ethylene Oxide (EO) | Gamma irradiation (not including Curved |
| Contact PID) or Ethylene Oxide (EO) | ||
| Laser Type | Yb:YAG | Yb:YAG |
| Wavelength | 1030 nm | 1030 nm |
| Pulsing | Mode-locked | Mode-locked |
| Mode | Fundamental (TEM00) | Fundamental (TEM00) |
| Pulse Duration | 320 - 1500 fs | $1.5 x10^{-12}$ sec |
| Repetition Rate | Variable (320 kHz max) | 20-80 kHz, adjustable |
| Maximum Pulse | ||
| Energy | 15 μJ | 15 μJ |
| 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) | ||
| Beam Targeting and | ||
| Delivery | 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 |
| Intended Use for Iris | ||
| Registration Feature | Same as predicate device (K182795). | • 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 the pre-marked eye in the upright | ||
| position to that of the supine position by | ||
| Summary of Technological Characteristics | ||
| Characteristic | Subject Device | Predicate Device |
| ALLY™ Adaptive Cataract Treatment | ||
| System, 510(k) K220259 | LLS-fs 3D Laser System | |
| 510(k) K182795 | ||
| Intended Use for the | ||
| Cataract Density | ||
| Imaging Feature | Same as predicate device (K182795). | System's ability to analyze and match iris features between images acquired in each position. |
| The imaging 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 density/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. | ||
| The 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 fragmentation (CustomFrag). | ||
| The system utilizes surgeon confirmation for planning and positioning of guidance for laser shot placement. | ||
| Intended Use for the | ||
| IntelliAxis Refractive | ||
| Capsulorhexis® | ||
| Feature | Same as predicate device (K182795). | 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. |
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Image /page/5/Picture/1 description: The image contains the logo for LENSAR. The logo consists of a blue, spherical, grid-like design on the left, followed by the word "LENSAR" in a light gray, sans-serif font. The text is aligned horizontally with the spherical design.
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Image /page/6/Picture/1 description: The image shows the logo for LENSAR. The logo consists of a blue, spherical, geometric design on the left, resembling a stylized globe or network. To the right of the design is the word "LENSAR" in a light gray, sans-serif font. The logo appears clean and modern.
7.0 DETERMINATION OF SUBSTANTIAL EQUIVALENCE
7.1 Non-Clinical Performance Data
Design verification and validation testing was completed to demonstrate that the proposed device performance complies with specifications and requirements identified for the ALLY" Adaptive Cataract Treatment System. 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 ALLY™ Adaptive Cataract Treatment System meets all performance specifications and requirements. The objectives defined in the validation plan were achieved according to the validation results.
The comparison to the predicate device shows that the ALLY™ Adaptive Cataract Treatment System is substantially equivalent. The minor differences between the additional ALLY" Adaptive Cataract Treatment System device features and the predicate device do not raise any new questions of safety or effectiveness.
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Image /page/7/Picture/1 description: The image contains the logo for LENSAR. The logo consists of a spherical graphic to the left of the company name. The spherical graphic is made up of many small squares. The company name, LENSAR, is written in a sans-serif font.
7.2 Eye Safety Analysis Testing
A detailed analysis of the retinal and corneal burn hazard analysis for capsulotomy, fragmentation, clear corneal and arcuate incisions under worst-case normal and single failure conditions was performed in accordance with ANSI Z-136.1:2014, with the conclusion that the ALLY™ Adaptive Cataract Treatment System laser is safe with regards to retinal and corneal illumination for the defined indications.
7.3 Biocompatibility Testing
Minor changes to materials used in the ALLY™ System Patient Interface Device (PID) and the addition of the PVC alignment card that is temporarily placed on the patient's head to facilitate system alignment underwent biocompatibility testing per ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (3 ed.). Test results indicated that the PVC alignment card and the minor materials changes met all biocompatibility requirements.
7.4 Sterilization Validation
There have been no changes to the ALLY™ System PID or PID Ring Arm as detailed and previously cleared with the LLS-fs 3D (K182795) to the sterilization provider, sterilization methodology, profile/chamber, or sterility assurance level.
The ALL Y™ System includes a sterile drapes kit (used for monitors, handles, joystick, tray; and an alignment card). This drapes kit has the same packaging as the drapes kit previously cleared for the predicate device in K182795. The drapes for the ALLY 100 System have been updated and were adopted into the family of products already validated.
7.5 Sterile Device Packaging
Packaging for the sterile Patient Interface Device (PID) and Drapes Kit has been performed. Test results satisfied the acceptance criteria as defined by the recognized standards (ISTA 3A, ASTM F2096, ASTM F88) and found to be in compliance with the recognized standards.
7.6 Electromagnetic Compatibility and Electrical Safety
The ALLY™ Adaptive Cataract Treatment System has undergone electromagnetic compatibility and electrical safety testing to support this premarket notification. Test results satisfied the acceptance criteria as defined by the recognized standards (ANSI/AAMI/IEC 60601-1-2:2014, ANSV/AAMI/ES 60601-1:2005 A1:2012) and found to be in compliance with the applicable recognized safety standards.
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Image /page/8/Picture/0 description: The image shows the logo for LENSAR. The logo consists of a blue, spherical, geometric design on the left, resembling a stylized globe or network. To the right of the design is the word "LENSAR" in a light blue, sans-serif font. The overall impression is modern and corporate.
7.7 Hazard Analysis
A hazard analysis was conducted to identify all potential hazards to the patient, surgeon, and other system operators resulting from differences between the ALL Y" Adaptive Cataract Treatment System and the predicate device, LLS-fs 3D (K182795). The identified hazards were duly evaluated in the risk analysis, and mitigation measures were defined and tested. After the implementation and testing of mitigation measures, the benefit of the ALLY™ Adaptive Cataract Treatment System prevails over the residual risks and all potential hazards have acceptable levels of probability/severity characteristics.
7.8 Software Verification and Validation Testing
A complete software verification and validation testing of the ALLY™ Adaptive Cataract Treatment System was conducted. The results demonstrate that the ALLY™ Adaptive Cataract Treatment System is in compliance with the following recognized standard: IEC 62304. Documentation was provided as recommended in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: Guidance for Industry and FDA Staff (May 11, 2005). 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.
7.9 Animal Studies Performance Data
No animal studies were performed to support substantial equivalence of this premarket notification.
7.10 Clinical Performance Data
No clinical studies were deemed necessary to demonstrate the safety and effectiveness or substantial equivalence of the ALLY™ Adaptive Cataract Treatment System to the predicate device. The non-clinical performance data demonstrated that the device performs as intended.
8.0 CONCLUSIONS FROM NON-CLINICAL AND CLINICAL DATA
The ALLY" Adaptive Cataract Treatment System has the same intended use, indications for use, and similar design and fundamental and scientific technology as the predicate device. The non-clinical performance data demonstrate that the ALLY™ Adaptive Cataract Treatment System is substantially equivalent to the predicate device and does not raise any new issues of safety or effectiveness. Thus, the ALLY " Adaptive Cataract Treatment System is substantially equivalent to the predicate device.