FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

In Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser). Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Latice Degeneration, Retinal Tears and Detachments (Laser Retinopexy).
For the imaging (capture, display, storage and manipulation) of the retina of the eve, including via color and infrared imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segment of the eye.
In Laser Trabeculoplasty for Primary Open Angle Glaucoma, as well as Iridotomy and Iridoplasty for Closed Angle Glaucoma.

Device Description

The Navilas Laser 577s is a laser photocoagulator with an integrated digital fundus camera. The Navilas 577s Laser System combines imaging technologies (fundus live imaging, and infra-red imaging) with established laser photocoagulation treatment methods by providing the doctor a system for imaging and treatment planning prior to the photocoagulation.

The Navilas Laser 577s is comprised of:

A semiconductor laser source that operates at 577nm. The semiconductor laser . source for the Navilas 577s is identical to the laser source used with the Navilas 577+ cleared under K141851.
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 intended to be used to capture display, store and manipulate . images captured by the fundus camera.

The Navilas Laser System 577s supports the user during multiple steps of a laser treatment procedure with digital imaging, image storage, planning and laser treatment options including:
Digital imaging as provided by a color image with white light, supporting mydratic and non-mydratic 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 or discarded after viewing on the touch sensitive digital display.
Image Storage - Captured images can be digitally stored in the Navilas Laser System 577s 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 Single Pulse Mode. Repeat Mode and Scanned Pattern Mode 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 may be used for the generation of patient reports for documentation purposes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Navilas® Laser System 577s." This document primarily focuses on demonstrating substantial equivalence to a predicate device (Navilas Laser System 577+), rather than presenting a detailed independent study with specific acceptance criteria and performance data for a new AI/algorithm-driven device.

Therefore, many of the requested elements (e.g., acceptance criteria for a new clinical study, sample size for test set with data provenance, number of experts for ground truth, adjudication methods, MRMC study, standalone performance, training set details) are not present in this document because it is a submission for a device change that is functionally identical to the predicate with some hardware improvements and elimination of a feature. The "Performance Data" section discusses engineering and software testing, not clinical performance against specific metrics for diagnostic accuracy or efficacy.

However, I can extract and present the information that is available:

Summary of Device and Context:

Device Name: Navilas® Laser System 577s
Device Type: Laser photocoagulator with an integrated digital fundus camera.
Purpose of Submission: 510(k) premarket notification to demonstrate substantial equivalence to the Navilas Laser System 577+ (K141851).
Key Differences from Predicate: Elimination of fluorescein angiography imaging capability; hardware design improvements (new GUI, relocation of scanner controls, conversion to manual base height adjustment, designation of table as optional accessory, inclusion of combination objective element). The core laser and imaging technology are stated as the same.
Indications for Use: (Identical to predicate, except for the removed angiography feature)
- Retinal Photocoagulation for various conditions (Diabetic Macular Edema, Proliferative Diabetic Retinopathy, Sub-retinal Neovascularization, Retinal Vein Occlusion, Lattice Degeneration, Retinal Tears and Detachments).
- Imaging (capture, display, storage, manipulation) of the retina (color, infrared) for aiding diagnosis and treatment of ocular pathology in the posterior segment.
- Laser Trabeculoplasty for Primary Open Angle Glaucoma, and Iridotomy/Iridoplasty for Closed Angle Glaucoma.

Regarding the Requested Information:

Since this document describes a 510(k) submission for substantial equivalence based on functional identity and engineering testing rather than a new clinical performance study for an AI/algorithm, most of the specific questions about acceptance criteria for clinical performance, ground truth, expert consensus, and reader studies are not applicable or not detailed in this document.

Here's what can be inferred or directly stated from the provided text, with a clear note when information is absent:

A table of acceptance criteria and the reported device performance

Acceptance Criteria: For substantial equivalence, the primary acceptance criterion is that the new device (Navilas 577s) is as safe and effective as the predicate device (Navilas 577+). This is demonstrated through engineering and software verification and validation, showing that the minor changes do not negatively impact performance or safety. No specific quantitative clinical performance acceptance criteria (e.g., accuracy thresholds) are listed, as this isn't a de novo clinical study establishing such criteria. Instead, it's about meeting specifications and requirements.
Reported Device Performance: The document states: "All criteria for this testing were met and results demonstrate that laser photocoagulation performed with the Navilas Laser 577s meets all performance specifications and requirements." This is a qualitative statement of success in the engineering and software tests.

Criterion Type	Description / Test Performed	Reported Performance / Outcome
Substantial Equivalence	Device maintains functional identity to predicate (Navilas 577+) with minor changes (no fluorescein angiography, hardware updates).	Determined to be substantially equivalent by FDA.
Illumination Safety	ISO 15004-2 Ophthalmic Instruments - Fundamental Requirements and Test Methods - Part 2: Light Hazard Protection	Criteria met.
Software Life Cycle Process	IEC 62304 Medical Device Software Software Life Cycle Process (Software LOC "Major")	Criteria met. (Implies adherence to process adequate for software with potential for serious injury/death)
Human Factors & Usability	IEC 62366 (Usability Engineering), IEC 60601-1-6 (General requirements for basic safety and essential performance - Usability)	Criteria met.
Laser Product Safety	IEC 60601-1 (General safety), IEC 60601-1-2 (EMC), IEC 60601-2-22 (Therapeutic Laser Equipment), IEC 60825-1 (Laser classification)	Criteria met.
Laser Bench Testing	Verify spot and pattern placement accuracy.	Criteria met.
Software Verification & Validation	General V&V for the "Major" LOC software.	Criteria met.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This document describes engineering and software testing ("bench testing") rather than a clinical study with a patient "test set". There is no mention of patient data (images or otherwise) used for testing in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: No clinical test set or ground truth establishment by experts is described in this submission summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No clinical test set or adjudication method is described.
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: This document does not describe an MRMC study or any study involving human readers with or without AI assistance. The device is a laser system with imaging capability, not an AI diagnostic assistant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: While the device has an imaging and software component ("aiding in the diagnosis"), the focus of this submission is on the laser safety, performance, and the integrated system's function, not a standalone diagnostic algorithm. No such standalone performance study is mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: For the engineering and software tests, "ground truth" would likely refer to established engineering specifications and requirements (e.g., laser power, spot size accuracy, software functionality conforming to design), rather than clinical ground truth like pathology or expert consensus on disease states.
The sample size for the training set
- Not Applicable / Not Provided: This is not a submission for a machine learning or AI device that typically requires a distinctive "training set" for an algorithm. The software is described as a platform for image capture, display, storage, and manipulation, and planning tools, not a learning algorithm.
How the ground truth for the training set was established
- Not Applicable / Not Provided: As noted above, training sets and their associated ground truth methodology are not discussed in this substantial equivalence submission.

Summary

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.