The NAVILAS Laser System is a retinal photocoagulator integrated with a digital fundus camera. The NAVILAS is indicated for use in retinal photocoagulation, as well as for the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color, fluorescein angiography and infra-red imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segments of the eye.

Device Description

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

The NAVILAS Laser System is comprised of a laser photocoagulation module, digital imaging camera, computer hardware, and a software platform intended to be used to capture display, store and manipulate images captured by the fundus camera.

Like the predicate devices, laser photocoagulation with the NAVILAS is performed using single shot (Single Spot Mode), repeated shots (Repeat Mode), and scanned patterns (Pattern Mode). All treatment-related information and images are continuously displayed on the monitor to provide the physician an optimal platform for the photocoagulation procedure.

AI/ML Overview

The provided 510(k) summary for the NAVILAS Laser System primarily focuses on demonstrating substantial equivalence to predicate devices and verifying that the device complies with specifications through internal testing. It does not present a clinical study with detailed acceptance criteria and reported device performance metrics typically found in AI/ML device submissions.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study for this device, nor can I answer questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the document.

The document discusses "Performance Data" in a general sense:

Performance Data Summary (as per the document):
"Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the NAVILAS Laser System. This was accomplished by software and hardware verification & validation testing, along with system level bench testing of the NAVILAS Laser System. All criteria for this testing were met and results demonstrate that laser photocoagulation performed with the NAVILAS Laser System meets all performance specifications and requirements."

This statement indicates that internal engineering and bench testing was performed to ensure the device met its design specifications, but it does not detail specific acceptance criteria for a human-interpretable performance metric (like sensitivity, specificity, accuracy) derived from a clinical trial or expert review.

Here's what can be extracted based on the provided text, with many fields noted as "Not Applicable" or "Not Provided" due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study.	"All criteria for this testing were met and results demonstrate that laser photocoagulation performed with the NAVILAS Laser System meets all performance specifications and requirements." (This refers to internal verification and validation testing, not clinical performance metrics.)

2. Sample Size and Data Provenance for Test Set:

Sample Size: Not provided. The testing described appears to be internal engineering and bench testing, not a clinical study with a patient test set.
Data Provenance: Not provided.

3. Number of Experts and Qualifications for Ground Truth:

Number of Experts: Not applicable/Not provided. The submission focuses on device engineering specifications and functionality, not diagnostic accuracy requiring expert ground truth in a clinical context.
Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for Test Set:

Adjudication Method: Not applicable/Not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Was an MRMC study done? No.
Effect size of human reader improvement with AI vs. without AI assistance: Not applicable. (The NAVILAS Laser System is a photocoagulator and imaging system, not an AI-diagnostic assistant that would typically be evaluated in an MRMC study for reader improvement.)

6. Standalone (Algorithm Only) Performance Study:

Was a standalone study done? Not in the sense of an algorithm's diagnostic performance. The document describes "software and hardware verification & validation testing, along with system level bench testing," which functions as a standalone performance evaluation of the device's operational specifications, but not its diagnostic or clinical efficacy in terms of specific performance metrics against a clinical ground truth.

7. Type of Ground Truth Used:

Type of Ground Truth: Not applicable for a clinical performance evaluation. The "ground truth" for the verification and validation testing would be the engineering specifications and functional requirements of the device itself (e.g., laser power output accuracy, image resolution, software functionality).

8. Sample Size for Training Set:

Sample Size: Not applicable/Not provided. This device is not described as involving machine learning or AI that would require a 'training set' in the modern sense.

9. How Ground Truth for Training Set was Established:

How Ground Truth was Established: Not applicable/Not provided.

Summary

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091064

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 00 OCT 2009

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	OD-OS GmbHWarthestr. 2114513 TeltowGermanyPhone: +49 3328 312 82-100Fax: +49 3328 312 82-999
OFFICIALCORRESPONDENT:	Judy F. Gordon, D.V.M.Regulatory Consultant to OD-OS GmbH733 Bolsana DriveLaguna Beach, CA 92563Tel: (949) 715-0609Fax: (949) 715-0610judy@clinregconsulting.com
DATE PREPARED:	April 10, 2009
TRADE NAME:	NAVILAS Laser System
COMMON NAME:	Retinal Photocoagulator with a Digital Fundus Camera
DEVICECLASSIFICATION:	Laser Instrument, Surgical, Powered(Class II, per 21 CFR §878.4810)
	Camera, OphthalmicClass II, per 21 CFR §886.1120
	Device, Storage, Images, OphthalmicClass I per 21 CFR §892.2010
	Device, Communication, Images, OphthalmicClass I per 21 CFR §892.2020
	CFX, HKI, NEE, NEG

ﺎﺯ

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SUBSTANTIAL EQUIVALENCE

The NAVILAS Laser System is substantially equivalent to the following devices listed in Table 1.

510(k) #	TRADE NAME	MANUFACTURER
Laser Photocoagulation
K072823	MERILAS 532nm Laser	Meridian AG
K043486	Pascal Photocoagulator	Optimedica Corporation
Retinal Imaging
K053044	OPTO Global Digital FundusCamera System	OPTO Global, Inc.
K052268	VISUCAM PR NM Digital Camera	Carl Zeiss Meditec AG
K011877	FF450 Plus VISUPAC System	Carl Zeiss Jena GmbH

TABLE 1
PREDICATE DEVICES FOR THE NAVILAS LASER SYSTEM

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

INDICATION FOR USE

The NAVILAS is indicated for use in retinal photocoagulation, as well as for the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color, fluorescein angiography and red-free imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segments of the eye.

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BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The NAVILAS Laser System has the same intended use, indications, and very similar principles of operation as for the cleared predicate devices, the MERILAS 532nm Laser System (K072823) and the Optimedica Pascal Photocoagulator (K043486) for laser photocoagulation. Imaging functionalities are similar to those of the OPTO Digital Fundus Camera (K053044), the Visucam PR NM Digital Camera (K052268), and the FF450 Visupac System (K011877), which are also indicated for use for the capture, display and storage of digital images of the retina and fundus. The minor differences between the NAVILAS Laser System and the listed predicate devices do not raise any new questions of safety or of effectiveness in comparison to the predicate devices.

PERFORMANCE DATA

, r

Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the NAVILAS Laser System. This was accomplished by software and hardware verification & validation testing, along with system level bench testing of the NAVILAS Laser System. All criteria for this testing were met and results demonstrate that laser photocoagulation performed with the NAVILAS Laser System meets all performance specifications and requirements.

CONCLUSIONS

As described in this 510(k) Summary, all testing deemed necessary was conducted on the NAVILAS Laser System to ensure that the device is safe and effective for its intended use and is substantially equivalent to legally marketed devices intended for laser photocoagulation and retinal imaging to aid in the diagnosis and treatment of diseases of the eve.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

ClinReg Consulting Services, Inc. c/o Judy F. Gordon, D.V.M. Regulatory Consultant to OD-OS 733 Bolsana Dr. Laguna Beach, CA 92651

OCT 2 7 2009

Re: K091064

Trade/Device Name: NAVILAS Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: II Product Code: HOF Dated: October 14, 2009 Received: October 16, 2009

Dear Ms. Gordon:

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. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov//AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Elkham

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K091064

510(k) Number (if known): K09 | 064

Device Name: NAVILAS Laser System

Indications for Use:

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bruce Drum

Page 1 of 1

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices

510(k) Number K091064

Regulation Number and Section

§ 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.