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Found 178 results
510(k) Data Aggregation
(267 days)
for cataract and vitreo-retinal surgery
CFR References: 21 CFR 886.4670, 21 CFR 886.4150, 21 CFR 886.4390
HQE, HQF | HQC, HQE, HQF | Same |
| Regulation Number | 21 CFR 886.467021 CFR 886.415021 CFR 886.4390
| 21 CFR 886.467021 CFR 886.415021 CFR 886.4390 | Same |
| Device Class | II | II | Same |
|
The Bausch + Lomb Stellaris Elite™ vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations.
The Bausch + Lomb Stellaris Elite™ vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.
The Bausch + Lomb Anterior Vitrectomy Cutter Packs are intended for use with a Bausch + Lomb Microsurgical System for vitrectomy during anterior segment surgery. The Posterior Vitrectomy Cutter Packs are intended for use with a Bausch + Lomb Microsurgical System for vitrectomy during posterior segment surgery. The Combined Vitrectomy Cutter Packs are intended for use with a Bausch + Lomb Microsurgical System for both vitrectomy during posterior segment surgery and for phacoemulsification of an opacified crystalline lens during anterior segment surgery.
The Bausch + Lomb Stellaris Elite™ vision enhancement system is comprised of an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation, vitreous aspirating, cutting, and endoillumination. Additionally, the Stellaris Elite™ vision enhancement system may be configured with a laser module intended for retinal photocoagulation and laser trabeculoplasty.
A selection of disposable single-use procedure packs is available for use with the system. These packs contain the necessary tubing to facilitate delivery and removal of air and fluids to and from the patient as well as a selection of components (cannulas, cutters, probes, drapes, etc.) that facilitate the surgical procedure. The items are arranged for physician convenience and may be presented as a group intended to support all the needs of a procedure or packaged singularly to allow the physician greatest flexibility.
The Bi-Blade™+ vitrectomy cutters are powered by a pneumatic pulse that operates the guillotine style cutter. The cutter has dual side ports and an aspiration channel that allows for aspiration during surgery. Each Bi-Blade™+ vitrectomy cutter is packaged and sterilized by gamma radiation.
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(266 days)
, Massachusetts 02180
Re: K251507
Trade/Device Name: INTEGRE LIO
Regulation Number: 21 CFR 886.4390
Name**
Ophthalmic laser
Product Codes:
HQF
Device Classification
Class II
21 C.F.R. §886.4390
equivalent |
| Product code | HQF | HQF | Substantially equivalent |
| Regulation number | 886.4390
| 886.4390 | Substantially equivalent |
| Classification | II | II | Substantially equivalent |
The INTEGRE LIO is indicated to be used in ophthalmic laser procedures including retinal photocoagulation.
The INTEGRE LIO is a laser photocoagulator using visible green diode laser (532nm) technology and provide a compact design to be incorporated in a lightweight headset worn by the physician.
The INTEGRE LIO is composed of:
- a battery powered headset based on an indirect ophthalmoscope including a laser enclosure and a Head-Up Display (HUD)
- a wireless battery powered footswitch.
INTEGRE LIO is controlled by the wireless footswitch that allows the physician to set the desired parameters for treatment. The physician uses the headset to locate the area to be treated and, after setting the appropriate parameters, targets the desired tissue utilizing a visible red aiming beam. The physician presses the footswitch to deliver therapeutic green laser light to the targeted tissue. In case the battery is discharged, and the user needs to continue treatment, there is a cable available that connects the footswitch to the headset and an external power supply to connects the footswitch to an electrical outlet.
The INTEGRE LIO includes laser safety filters that will prevent a laser beam reflection to user's eye. The laser unit must be used with a focusing lens which allows retinal visualization.
Ancillary personnel must wear appropriate laser safety eyewear to protect their eyes from laser beam
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(267 days)
Number | §886.4670 Phacofragmentation System §886.4150 Vitreous aspiration and cutting instrument §886.4390
The System Sophi is an integrated phacoemulsification lens removal device designed for use in intraocular ophthalmic surgery in the anterior chamber. System Sophi is intended for liquid irrigation and aspiration, lens fragmentation and ultrasonic phacoemulsification, anterior vitrectomy, and bipolar diathermy (high frequency surgical equipment).
The System Sophi is an integrated phacoemulsification lens removal device designed for use in intraocular ophthalmic surgery in the anterior chamber. System Sophi is intended for lens fragmentation and ultrasonic phacoemulsification, liquid irrigation and aspiration, anterior vitrectomy, and bipolar diathermy (high frequency surgical equipment).
A cassette is the interface between the System Sophi device and the surgical handpiece. It is used to regulate the balanced saline solution (BSS) irrigating fluid to the handpiece, to aspirate lens fragments and liquids from the handpiece, to monitor irrigation and aspiration flow and pressure and deposition of lens fragments and fluid into the waste bag for disposal. The cassette ports and tube connectors are coded to ensure proper connections at any time.
The system is controlled with a foot pedal (surgeon) and a graphical user interface (assistant). System Sophi is powered by mains voltage (AC-powered) or through a battery.
Only company-validated and recommended disposable sterile equipment and designated instruments and hand pieces are allowed.
The Sophi system is offered in three configurations: Sophi Premium, Sophi Eco and Sophi A, differing in the included options and accessories.
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(141 days)
Re: K251772*
Trade/Device Name: Navilas Laser System 577sl (156691)
Regulation Number: 21 CFR 886.4390
Laser System 577SL
Common Name: Photocoagulator
Regulation Name: Ophthalmic Laser (21 CFR 886.4390
)
Device Classification: Class II
Product Code(s): HQF, Ophthalmic Laser (21 CFR §886.4390)
assigned to product code HQF (ophthalmic lasers), which is more specific. |
| Regulation Number | 21 CFR 886.4390
| 21 CFR 886.4390 | 21 CFR 878.4810 | 21 CFR 886.4390 | Same to Primary Predicate and Predicate 3<br
The Navilas® Laser System is an ophthalmic laser integrated with a digital camera. The Navilas® Laser System is indicated for the treatment of ocular pathology in the anterior and posterior segment of the eye, with supporting imaging functions (capture, display, storage and annotation) of the retina of the eye via color and infrared imaging.
The Navilas® Laser System is intended for use in the posterior segment to perform Retinal Photocoagulation, Panretinal photocoagulation, focal photocoagulation or grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
- Proliferative and non-proliferative diabetic retinopathy
- Macular edema
- Choroidal neovascularization associated with wet age-related macular degeneration
- Age-related macular degeneration
- Central and branch retinal vein occlusion
- Lattice degeneration
- Retinal tears and detachments
Intended for use in the treatment of ocular pathology in the anterior segment including:
- Iridotomy
- Iridoplasty
- Trabeculoplasty
The Navilas Laser System 577SL is a laser photocoagulator with an integrated digital fundus camera. The Navilas Laser System 577SL combines imaging technologies (color and infra-red imaging) with established laser photocoagulation treatment methods by providing the physician a system for imaging and treatment planning prior to the photocoagulation procedure.
The Navilas Laser System 577SL is comprised of:
- A semiconductor laser source that operates at 577nm wavelength. The laser can operate with Continuous Wave (CW) or Micro-Second Pulsing (MSP).
- An integrated delivery system that directs the laser beam through an ophthalmoscope using motorized mirrors.
- A digital camera that provides continuous real-time imaging in color with white light illumination of the fundus, or in monochrome using infrared illumination.
- A software platform that is based on an embedded Windows operating system, that controls the startup, use, calibration, monitoring, and shutdown of the system.
The Navilas Laser System 577SL supports the user during multiple steps of a laser treatment procedure with digital imaging, image storage, planning and laser treatment options including:
Digital imaging - Provided by a color image with white light, supporting mydriatic and nonmydriatic image acquisition (with and without dilated pupils), or a monochrome IR image. Images are presented using a digital display. An illumination mode is selected where images are acquired and either stored, exported or discarded after viewing on the touch sensitive digital display.
Image Storage - Captured images can be digitally stored in the Navilas Laser System 577SL database along with other patient related data to create a complete patient record for future reference. Images from other devices may also be imported and stored.
Planning - Areas identified on acquired or imported images by the user that are selected for future treatment consideration can be marked through the use of treatment planning tools available. The physician has the ability to highlight areas on acquired images (called Points of Interest). These locations are created and manipulated using the touch sensitive digital display.
Laser Treatment - Treatment options are also unchanged from the predicate device with Pre-planned and Ad-hoc Modes available on all Navilas laser models. Pre-positioning of the aiming beam onto locations which are selected by the physician during planning is also facilitated. The position of the aiming beam can be monitored on the real-time image that is displayed on the touch sensitive digital display.
Report generation - Information collected in the database includes images obtained before, during and after treatment. This information can be used for the generation of patient reports for documentation purposes.
The Navilas Laser System 577SL can emit a 577 nm wavelength beam for photocoagulation with power up to 1700 mW and pulse duration up to 4000 ms.
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(30 days)
K252682**
Trade/Device Name: LenSx Laser System (8065000944)
Regulation Number: 21 CFR 886.4390
System (8065000944) |
|---|---|
| Regulation Number and Name (Product Code in Parentheses) | 21 CFR 886.4390
510(k) Number** | K243896 |
| Regulation Number and Name (Product Code in Parentheses) | 21 CFR 886.4390
-|
| Administrative | | |
| 510(k) | K243896 | K252682 |
| Regulation Number | 21 CFR 886.4390
| 21 CFR 886.4390 |
| Regulatory Class | Class II | Class II |
| Product Code | OOE; HNO; HQC
The LenSx Laser system is indicated for use:
- In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
- In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery.
- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
- In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.
The LenSx Laser system is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create vapor bubbles which disrupts/separates tissue (photodisruption) within the lens capsule, crystalline lens, and the cornea. A computer-guided delivery system places the laser pulses in a pattern to produce an incision/cut.
The laser pulses are delivered through a sterile, disposable applanating lens and suction ring that contacts the cornea and fixes the eye with respect to the laser delivery system.
The interface between the laser and patient is the Patient Interface that connects to the delivery system which is docked to the patient's cornea. Two models of the Patient Interface accessory are offered for use with the LenSx Laser: the LenSx Laser Patient Interface and the LenSx Laser SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly. The LenSx Laser SoftFit Patient Interface also comes with a soft contact lens that is positioned against the external surface of the Patient Interface glass. For cataract procedures, the LenSx Laser SoftFit Patient Interface is used. The LenSx Laser Patient Interface is used for corneal, flap, tunnel, and pocket incisions. Refer to the Instructions for Use supplied with the LenSx Laser Patient Interface for preparation and application.
The LenSx Laser system is for prescription use and should only be operated by a trained physician. The LenSx Laser system is intended to be used within a clinic(s)/hospital(s)/surgical practice network.
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(264 days)
Nevada 89521
Re: K243014
Trade/Device Name: EyeQ nanoECP
Regulation Number: 21 CFR 886.4390
The EyeQ nanoECP System is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do not allow a posterior view.
Glaucoma - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or cyclocryotherapy or other cyclodestructive procedures.
Not Found
The provided FDA 510(k) clearance letter for the EyeQ nanoECP describes the device's indications for use and regulatory classification but does not contain any information regarding acceptance criteria or the study that proves the device meets specific performance criteria.
This document is a clearance letter, which means the FDA has already reviewed the submitted data and determined substantial equivalence. The detailed performance data and study design (including acceptance criteria, sample sizes, ground truth establishment, etc.) are typically part of the 510(k) submission, which is not fully disclosed in the public clearance letter.
Therefore,Based on the provided text, I cannot extract the information required to populate the table or answer the questions about the study design that proves the device meets the acceptance criteria. The clearance letter only states that the device has been found substantially equivalent for its stated indications for use.
To answer your request, I would need access to the actual 510(k) submission summary or a more detailed performance study report for the EyeQ nanoECP.
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(131 days)
2099
Re: K243896
Trade/Device Name: LenSx Laser System (8065998162)
| Regulation Number: 21 CFR 886.4390 |
|---|
| Regulation Number and Name (Product Code in Parentheses) |
| 510(k) Number** |
| Regulation Number and Name (Product Code in Parentheses) |
| --------- |
| Administrative |
| 510(k) |
| Regulation Number |
| 21 CFR 886.4390 |
| Regulatory Class |
| Product Code |
The LenSx Laser system is indicated for use:
- In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
- In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery.
- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
- In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.
The LenSx Laser system is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create vapor bubbles which disrupts/separates tissue (photodisruption) within the lens capsule, crystalline lens, and the cornea. A computer-guided delivery system places the laser pulses in a pattern to produce an incision/cut.
The laser pulses are delivered through a sterile, disposable applanating lens and suction ring that contacts the cornea and fixes the eye with respect to the laser delivery system.
The interface between the laser and patient is the Patient Interface that connects to the delivery system which is docked to the patient's cornea. Two models of the Patient Interface accessory are offered for use with the LenSx Laser: the LenSx Laser Patient Interface and the LenSx Laser SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly. The LenSx Laser SoftFit Patient Interface also comes with a soft contact lens that is positioned against the external surface of the Patient Interface glass. For cataract procedures, the LenSx Laser SoftFit Patient Interface is used. The LenSx Laser Patient Interface is used for corneal, flap, tunnel, and pocket incisions. Refer to the Instructions for Use supplied with the LenSx Laser Patient Interface for preparation and application.
The LenSx Laser system is for prescription use and should only be operated by a trained physician. The LenSx Laser system is intended to be used within a clinic(s)/hospital(s)/surgical practice network.
Based on the provided FDA 510(k) Clearance Letter for the LenSx Laser System, this document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for a new AI or novel diagnostic device.
The clearance is for a modified version of an existing device (LenSx Laser System) with software updates and an expanded indication for Implantable Collamer Lens (ICL) surgery. The general approach taken is to show that these modifications do not raise new questions of safety or efficacy and that the device remains substantially equivalent to its predicate. Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria (especially in the context of an AI/diagnostic device) is not explicitly detailed in this 510(k) summary.
However, I can extract the relevant information presented, acknowledging that it's framed within the context of demonstrating substantial equivalence for a modified device, rather than a de novo clearance for a completely new technology with novel performance claims.
Here's an attempt to answer the questions based on the provided text, highlighting where the information is not applicable or not detailed in this type of submission:
Acceptance Criteria and Device Performance Study (as inferred from the 510(k) Summary)
The 510(k) summary indicates that the modifications to the LenSx Laser System are minor and do not introduce new safety or efficacy concerns. The "acceptance criteria" are implied by the successful completion of various non-clinical tests demonstrating that the device continues to meet its intended design specifications and functional requirements, performing as intended and being equivalent to the predicate. There are no specific numerical performance metrics provided in the summary that would typically be seen for a new diagnostic or AI device (e.g., sensitivity, specificity, accuracy against a gold standard).
Table of Acceptance Criteria and Reported Device Performance
Since this is a modification to an existing device, the "acceptance criteria" are generally about maintaining the performance and safety profiles of the predicate. The "reported device performance" refers to the successful completion of the tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-Clinical Testing: | |
| Biocompatibility requirements per ISO 10993-1. | No further testing required; materials are common and widely used. |
| Sterilization and Shelf Life. | Console provided non-sterile; intended for use with sterile accessories. |
| Electromagnetic Compatibility (EMC) according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60601-4-2, and FDA guidance. | Met all requirements and followed FDA recommendations. |
| Electrical/Mechanical Safety according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60601-4-2. | Met all requirements. |
| Optical Radiation Safety according to ANSI Z80.36-2021. | Retinal exposures in compliance with limits for Group 1 devices. |
| Software Verification and Validation. | Successfully completed and met all requirements; documentation provided as recommended by FDA guidance ("Enhanced Documentation Level"). |
| Cybersecurity compliance per FDA guidance. | Fulfilled FDA's cybersecurity recommendations. |
| Performance Testing (bench testing, design specifications, functional requirements). | Successfully completed bench testing; demonstrated ability to meet all intended design specifications. Features (including new ones like arcuate nomogram, phacofragmentation patterns, capsulorhexis markers, ICL setting) function as intended and meet applicable design requirements. Performance regression and toric markings capsular bag pull tests were successful. |
| Equivalence Criteria: | |
| No new questions of safety and efficacy compared to predicate. | Determined to be substantially equivalent to the predicate device. |
| Risk profile equivalent to the predicate device. | Risk profiles are equivalent. |
| Maintain functional requirements. | Functional requirements were met. |
Study Details (as applicable)
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of clinical cases or patient data, as no animal or clinical testing was deemed necessary for this submission. The "test set" primarily refers to bench testing, software verification/validation, and regulatory compliance checks.
- Data Provenance: Not applicable as no clinical or animal data was collected for this submission. The data provenance for compliance testing is internal Alcon laboratories.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this 510(k) submission does not rely on expert-adjudicated ground truth from a clinical test set. The ground truth for engineering and software tests is based on design specifications, recognized standards, and regulatory guidance. For clinical ground truth, the submission relies on the established safety and efficacy of the predicate device and the assessment that the modifications do not alter this.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical test set requiring expert adjudication.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was performed or required. The device is a surgical laser, not an AI-assisted diagnostic tool that would typically involve human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an AI algorithm. However, the device itself, including its software, undergoes standalone functional and safety testing as part of the "Non-Clinical Testing" detailed in Section 7.1, such as "Software verification and validation testing" and "Performance Testing." These tests ensure the device (algorithm and hardware) performs its functions correctly according to specifications, independent of operator interaction after initial surgical planning.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the non-clinical and software testing, the "ground truth" is defined by:
- Engineering Specifications: The pre-defined technical and functional requirements for the laser system.
- International and National Standards: Compliance with standards like IEC 60601 series, ANSI Z80.36-2021 for safety and performance.
- FDA Guidance Documents: Compliance with FDA recommendations for software documentation and cybersecurity.
- Predicate Device Performance: The established safety and effectiveness of the existing LenSx Laser System serves as the clinical benchmark.
- For the non-clinical and software testing, the "ground truth" is defined by:
-
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that relies on a "training set" of data in the typical sense for a new diagnostic algorithm. The software modifications are deterministic or rule-based enhancements (e.g., embedded calculator, new cut patterns).
-
How the ground truth for the training set was established:
- Not applicable for the same reason as above. If there were internal development/optimization processes for the new features (e.g., nomogram calculations), their accuracy and "ground truth" would be established through mathematical validation, simulation, and bench testing against known physical principles or desired outcomes, rather than a data-driven training set.
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(394 days)
02451
Re: K240615
Trade/Device Name: Leos Laser and Endoscopy System
Regulation Number: 21 CFR 886.4390
Proprietary Name | Leos Laser and Endoscopy System |
| Device Class | Class 2 |
| Regulation Number | 886.4390
Ophthalmic Laser Endoscope |
| 510(k) Number | K910532 |
| Device Class | Class 2 |
| Regulation Number | 886.4390
The Leos system is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, retinal detachment, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do not allow a posterior view.
Glaucoma - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or cyclocryotherapy or other cyclodestructive procedures.
Vitreoretinal Surgery - The endoscopically controlled endophotocoagulation that is possible with the ophthalmic laser endoscope is also useful for endophotocoagulation:
- During vitreous surgery to produce chorioretinal scar around retinal breaks or retinotomy sites.
- To perform intraoperative panretinal photocoagulation (PRP) in proliferative retinopathies.
- To perform intraoperative retinal photocoagulation on a scleral buckle.
- To perform intraoperative photocoagulation around focal neovascularization
The Leos Laser and Endoscopic System is a next generation ophthalmic laser and endoscopy system used for the treatment of glaucoma, vitreoretinal diseases, and intraocular visualization. The system contains an 810 nm powered diode laser delivered by the stainless-steel endoscopic laser probe (trade name: VueProbe), which is placed into eye tissue to illuminate and visualize the target tissue and deliver laser energy under direct visualization. The console is a fully integrated portable device, containing a laser module assembly, viewing and control monitors, and a wireless footswitch for activating the laser. The larger passive monitor is for viewing the endoscopic video image and key treatment information, while the smaller touchscreen is used for parameters selection, rotation and viewing. The camera chip uses CMOS technology and is located at the tip of the probe. The LED light source is located within the plastic handpiece of the probe and illumination fibers carry the light to the tip. Additionally, the probe contains a laser fiber within its full length.
Based on the provided FDA 510(k) Clearance Letter for the Leos Laser and Endoscopy System, here's an analysis of the acceptance criteria and study that proves the device meets them:
It's important to note that the provided document is a 510(k) clearance letter, which focuses on substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria from a clinical trial. Therefore, explicit acceptance criteria are not detailed in this document in the way they would be for a clinical study report. Instead, the "acceptance" is based on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
The "study" in this context is primarily a non-clinical bench testing regimen designed to ensure the device performs within acceptable parameters and is comparable to predicate devices. Clinical studies were explicitly stated as not applicable and not required for this clearance.
Here's the breakdown of the information requested, as extractable from the provided document:
Acceptance Criteria and Device Performance Study (Based on 510(k) Substantial Equivalence)
The "acceptance criteria" for a 510(k) clearance are primarily met by demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and performance. The performance data presented are primarily from non-clinical bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since specific quantitative clinical "acceptance criteria" are not given in a 510(k) clearance letter (which relies on equivalence, not novel performance claims), this table will reflect the performance characteristics demonstrating equivalence as described in the document. The "criteria" are implicitly that the performance is comparable or superior to the predicate and meets relevant safety standards.
| Characteristic | Acceptance Criteria (Implicitly: Comparable to Predicate & Meets Standards) | Reported Device Performance (Leos System) |
|---|---|---|
| Indications for Use | Same as predicate devices | Same as predicate devices (minor wording changes, removal of performance claim) |
| Treatment Laser Wavelength | 810 nm | 810 nm |
| Treatment Laser Type | Double hetero-structure, GaAs, Semiconductor Diode (Class IV) | Double hetero-structure, GaAs, Semiconductor Diode (Class IV) |
| Treatment Laser Power Range | 0 – 1.2 Watts (Predicate) | 0.05 – 1.2 Watts (Leos System) - Implicit acceptance: within safe and effective range, slight change noted. |
| Laser Power Accuracy | +/- 20% | +/- 20% |
| Aiming Beam Wavelength | 640 nm (red/orange) | 640 nm (red/orange) |
| Aiming Beam Power | up to 1500uW (Predicate) | up to 60 uW (Leos System) - Implicit acceptance: sufficient for aiming, lower power due to improved camera sensitivity. |
| Image Resolution | 10,000 pixels (Predicate, limited by fiber count) | 40,000 pixels (Leos System) - Implicit acceptance: performance exceeds predicate, deemed equivalent or better. |
| EMC and Electrical Safety | Compliant with IEC 60601-1 and IEC 60601-1-2 | Compliant with IEC 60601-1 and IEC 60601-1-2 |
| Laser Safety and Optical Safety | Compliant with IEC 60825-1, IEC 60601-2-22, ANSI Z80.36 | Compliant with IEC 60825-1, IEC 60601-2-22, ANSI Z80.36 |
| Software Level of Concern | "Major" (V&V per FDA guidance & IEC 62304) | "Major" (V&V completed successfully per FDA guidance & IEC 62304) |
| Biocompatibility | Compliant with ISO 10993 | Confirmed compliant to FDA recognized standards per ISO 10993 |
| Sterilization & Shelf Life | Confirmed per FDA recognized standards | Confirmed per ASTM D4169-22, ISO 11135, ISO 10993-7, AAMI TIR 28, and ISO 11607-1 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of patients or cases. The "test set" in this context primarily refers to bench testing of the device and its components. The document indicates:
- Design Verification and Validation Testing: Confirms product meets requirements.
- Software Verification and Validation: Completed successfully.
- Biocompatibility, Sterilization, Shelf life testing.
- Data Provenance: Not applicable in terms of patient data. The provenance is from internal lab bench testing and verification activities. The study is non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. For non-clinical bench testing, "ground truth" is established by engineering specifications, regulatory standards (e.g., IEC, ISO, ASTM), and validated test methods. Human expert review of data is inherent but not quantified in this summary.
- Qualifications of Experts: Not specified. This would typically be internal R&D, Quality, and Regulatory personnel with expertise in device design, testing, and regulatory compliance.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This refers to the process of resolving discrepancies among human readers or raters in clinical studies. For non-clinical bench testing, "adjudication" is achieved through adherence to specifications, standards, and robust quality control processes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: No. The device is an Ophthalmic Laser and Endoscopy System, not an AI-powered diagnostic imaging device requiring a comparative effectiveness study with human readers.
- Effect Size of Human Reader Improvement: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This refers to AI algorithm performance. The Leos system is a direct medical intervention device (laser and endoscopy), not an AI diagnostic algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical tests, the "ground truth" is based on:
- Engineering specifications: The device is designed to meet certain performance parameters (e.g., laser power, resolution).
- Regulatory standards: Compliance with international and national standards (e.g., IEC 60601 series, ISO 10993 series, ANSI Z80.36, ASTM D4169-22, ISO 11135, ISO 11607-1, AAMI TIR 28).
- Predicate device characteristics: The Leos system's performance is compared against the established characteristics of the predicate devices for substantial equivalence.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
Summary of the "Study" Proving Acceptance:
The "study" proving the device meets the (implicit) acceptance criteria for 510(k) clearance is a comprehensive non-clinical testing program that includes:
- Bench Testing: Verifying electrical safety, electromagnetic compatibility (EMC), laser and optical safety, and general design performance against engineering specifications and relevant industry standards.
- Software Verification and Validation: Ensuring the software operates correctly and safely, given its "Major" level of concern.
- Biocompatibility Testing: Confirming the materials used in the probe are safe for contact with patients.
- Sterilization and Shelf Life Testing: Validating the sterilization process and ensuring the product maintains sterility and functionality over its intended shelf life.
The conclusion drawn from this testing is that the Leos Laser and Endoscopy System is substantially equivalent to its predicate devices, performing similarly (or better in some aspects like image resolution) while not raising any new safety or effectiveness concerns. This substantial equivalence is the basis for its FDA clearance.
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(73 days)
Ballerup, 2750 Denmark
Re: K242397
Trade/Device Name: LYNX Photocoagulator Regulation Number: 21 CFR 886.4390
The Norlase LYNX Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
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I apologize, but the provided text from the FDA 510(k) clearance letter for the LYNX Photocoagulator does not contain information on the acceptance criteria and the study that proves the device meets those criteria.
This document is a clearance letter, which confirms that the FDA has found the device to be substantially equivalent to a legally marketed predicate device. It briefly touches on device classification, regulations, and mentions the intended use of the device.
To describe the acceptance criteria and the study that proves the device meets them, I would need access to the actual 510(k) submission summary or a more detailed technical report which would typically include sections on performance testing, design specifications, and clinical or non-clinical data. The provided document only details the regulatory clearance, not the underlying performance data.
Therefore, I cannot fulfill your request with the given input.
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(269 days)
Parkway Dublin, California 94568
Re: K233911
Trade/Device Name: VISULAS combi Regulation Number: 21 CFR 886.4390
VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including:
• Photocoagulation of the retina
- Trabeculoplasty
- · Iridotomy
- · Posterior capsulotomy
· Posterior membranectomy
This device is Prescription Use (Rx) only.
VISULAS combi is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength and standard photodisruption treatments of ocular tissues at a wavelength of 1064 mm. VISULAS combi is operated in the following treatment modes:
- single-spot mode (software license VERTE) -
- multi-spot mode (software license VITE)
- YAG disruption mode (software license YAG). -
VISULAS combi consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as SL Imaging Solution, contact lenses or Applanation Tonometer.
The provided text is a 510(k) premarket notification for the VISULAS combi ophthalmic laser. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new device type through clinical studies. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test sets, expert involvement for ground truth, MRMC studies, and detailed training set information, is not explicitly provided in this document.
However, based on the document, I can extract information related to the acceptance criteria in the context of demonstrating substantial equivalence and the types of studies performed.
Here's an analysis of the provided text:
1. A table of acceptance criteria and the reported device performance
The document primarily focuses on demonstrating substantial equivalence to predicate devices, VISULAS green (K232051) for photocoagulation and VISULAS yag (K230350) for photodisruption. The "acceptance criteria" are implied by the similarity to these predicate devices in terms of indications for use, technological characteristics, and principle of operation.
| Criteria Category | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (VISULAS combi) |
|---|---|---|
| Indications for Use | Same as predicate devices | - Photocoagulation of the retina- Trabeculoplasty- Iridotomy- Posterior capsulotomy- Posterior membranectomy (combines indications of both predicates) |
| Laser Type | Solid state laser, frequency-doubled (for photocoagulation) Q-switched Nd:YAG laser (for photodisruption) | - Photocoagulation: solid state laser, frequency-doubled- Photodisruption: Q-switched Nd:YAG laser |
| Wavelength | 532 nm (for photocoagulation) 1064 nm (for photodisruption) | - Photocoagulation: 532 nm- Photodisruption: 1064 nm |
| Power/Energy | 50 to 1500 mW (photocoagulation) 9.0 mJ to 45.0 mJ (photodisruption) | - Photocoagulation: 50 to 1500 mW- Photodisruption: Pulse Mode 1 (Single Pulse): 9.0 mJ to 13.0 mJPulse Mode 2 (Double Pulse): 18.0 mJ to 28.0 mJPulse Mode 3 (Triple Pulse): 29.0 mJ to 45.0 mJ |
| Pulse Duration/Length | 10 - 2500 ms and cw (photocoagulation) < 4 ns (photodisruption) | - Photocoagulation: 10 - 2500 ms and cw- Photodisruption: < 4 ns |
| Laser Spot Size | 50 μm to 1000 μm (photocoagulation) 6.5 µm ± 20% in air (photodisruption) | - Photocoagulation: 50 μm to 1000 μm (continuously adjustable)- Photodisruption: 6.5 µm ± 20% in air |
| Safety Standards | Compliance with relevant IEC and ANSI standards | - ANSI/AAMI ES60601-1:2005/(R) 2012- ANSI Z80.36-2016- IEC 60601-1-2:2014- IEC 60825-1:2007- IEC 60601-2-22:2012- IEC 62133: 2012- IEC 60601-4-2 |
| Biocompatibility | Meets ISO 10993-1 requirements | Biocompatibility testing on patient-contacting accessories conducted in accordance with ISO 10993-1, evaluating cytotoxicity and sensitization. Demonstrated equivalency to the predicate device. |
| Software | Verification and validation of software as per FDA guidance | Software verification and validation testing conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Demonstrated that the product works as designed. |
| Functional Performance | Meets defined specifications | Non-clinical system testing evaluated system relevant to each specification. Functional and system-level testing showed the system met the defined specifications and demonstrated non-clinical equivalency to the predicate device. |
2. Sample size used for the test set and the data provenance
The document does not describe specific clinical test sets with patient samples. The studies are primarily non-clinical: biocompatibility testing, laser safety, electrical safety, EMC, software V&V, and bench testing. These types of tests do not typically involve patient samples and thus, information on data provenance like "country of origin of the data" or "retrospective/prospective" is not applicable in the context of this submission. The device is being cleared based on substantial equivalence to existing devices through comparison of design and non-clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not detail clinical studies involving experts to establish ground truth for a test set. This type of information is typically required for AI/CADe devices or those relying on human interpretation of images/data. The current submission is for a medical laser, and its performance is evaluated based on technical specifications and safety standards, not clinical diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as there is no described clinical test set requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The VISULAS combi is an ophthalmic laser for direct treatment (photocoagulation and photodisruption), not an AI-assisted diagnostic or interpretative device. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a treatment laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's acceptance is primarily based on compliance with established technical specifications, international safety standards (e.g., IEC, ANSI, ISO), and performance equivalence to predicate devices, as demonstrated through engineering tests (bench testing). For biocompatibility, the ground truth is established by the results of standardized biological evaluation tests (ISO 10993-1).
8. The sample size for the training set
Not applicable. This device is a hardware-based medical laser, not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, for the same reason as above.
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