NAVILAS LASER SYSTEM

K141851 · Od-Os GmbH · GEX · Jan 2, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K141851
• Device Name: NAVILAS LASER SYSTEM
• Applicant: Od-Os GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Navilas Laser System/Navilas Laser System 532+/ Navilas Laser System 577+ are indicated for use: · 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 eve, including via color. fluorescein angiography 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 Story

Navilas Laser System integrates ophthalmic laser photocoagulation with digital fundus imaging (color, infrared, fluorescein angiography). System captures, displays, stores, and manipulates retinal images for treatment planning. Physician operates system to deliver laser energy via motorized mirrors through ophthalmoscope optics. Laser modes include single shot, repeat, and scanned patterns. Imaging uses slit illumination panned at 25 Hz. Device aids clinicians in visualizing ocular pathology and precisely targeting retinal tissue for photocoagulation or glaucoma procedures. Benefits include improved treatment planning and documentation through integrated imaging and automated laser delivery.

Clinical Evidence

Bench testing only. Performance verification and validation testing, including software and hardware testing and system-level bench testing, confirmed the device meets all performance specifications and requirements.

Technological Characteristics

Laser sources: frequency-doubled Nd:YVO4 (532nm) or optically-pumped semiconductor (532nm or 577nm). Delivery: motorized mirrors through ophthalmoscope optics. Imaging: digital camera, slit illumination (25 Hz). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 62366, IEC 60825-1, ISO 15004-2, ISO 14971, 21 CFR 1040.

Indications for Use

Indicated for patients requiring retinal photocoagulation for diabetic macular edema, proliferative diabetic retinopathy, choroidal neovascularization, retinal vein occlusion, lattice degeneration, retinal tears, or detachments; and for patients requiring laser trabeculoplasty, iridotomy, or iridoplasty for glaucoma. Includes imaging for ocular pathology diagnosis and treatment.

Regulatory Classification

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.

Predicate Devices

• Navilas Laser System (K091064)
• PASCAL® Synthesis Ophthalmic Scanning Laser System (K123542)
• Iridex IQ Family (K071687)
• Quantel Supra 577 (K091581)

Submission Summary (Full Text)

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

January 2, 2015

OD-OS GMBH c/o Judy F. Gordon ClinReg Consulting Services, Inc. 733 Bolsana Drive Laguna Beach, CA 92651

Re: K141851

Trade/Device Name: Navilas Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: HGF, GEX, HKI, NFF, NFG Dated: November 29, 2014 Received: December 1, 2014

Dear Dr. 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, 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.

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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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Deborah L. Falls -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K141851

Device Name Navilas Laser System

### Indications for Use (Describe)

The Navilas Laser System/Navilas Laser System 532+/ Navilas Laser System 577+ are indicated for use:

· 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 eve, including via color. fluorescein angiography 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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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### 4.0 510(K) SUMMARY

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

### 4.1 SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED

| APPLICANT: | OD-OS GmbH<br>Warthestr. 21<br>14513 Teltow<br>Germany |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Judy Gordon, D.V.M.<br>ClinReg Consulting Services, Inc.<br>733 Bolsana Drive<br>Laguna Beach, CA 92651<br>[e-mail]<br>Tel: [phone]<br>Fax: [phone] |

DATE SUMMARY PREPARED: December 22, 2014

### 4.2 NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME

| COMMON NAME: | Photocoagulator with a Digital Camera |
|-------------------------|---------------------------------------------------------------------------|
| DEVICE CLASSIFICATION: | Laser Instrument, Surgical, Powered<br>(Class II, per 21 CFR §878.4810 |
| | Camera, Ophthalmic<br>Class II, per 21 CFR §886.1120 |
| | Device, Storage, Images, Ophthalmic<br>Class I per 21 CFR §892.2010 |
| | Device, Communication, Images, Ophthalmic<br>Class I per 21 CFR §892.2020 |
| PRODUCT CODES: | GEX; HKI, NFF, NFG |
| TRADE/PROPRIETARY NAME: | Navilas® Laser System |

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### K141851

### 4.3 PREDICATE DEVICES

| 510(K) # | TRADE NAME | MANUFACTURER |
|----------|-------------------------------------------------------|------------------------|
| K091064 | Navilas Laser System | OD-OS |
| K123542 | PASCAL® Synthesis Ophthalmic<br>Scanning Laser System | Topcon Medical Systems |
| K071687 | Iridex IQ Family | Iridex |

## PREDICATE DEVICES FOR NAVILAS LASER SYSTEM

## PREDICATE DEVICES FOR NAVILAS LASER SYSTEM 532+

| 510(K) # | TRADE NAME | MANUFACTURER |
|----------|-------------------------------------------------------|------------------------|
| K091064 | Navilas Laser System | OD-OS |
| K123542 | PASCAL® Synthesis Ophthalmic<br>Scanning Laser System | Topcon Medical Systems |
| K071687 | Iridex IQ Family | Iridex |

## PREDICATE DEVICES FOR NAVILAS LASER SYSTEM 577+

| 510(K) # | TRADE NAME | MANUFACTURER |
|----------|-------------------------------------------------------|------------------------|
| K091064 | Navilas Laser System | OD-OS |
| K123542 | PASCAL® Synthesis Ophthalmic<br>Scanning Laser System | Topcon Medical Systems |
| K071687 | Iridex IQ Family | Iridex |
| K091581 | Quantel Supra 577 | Quantel |

#### 4.4 DEVICE DESCRIPTION

The NAVILAS Laser System combines imaging technologies (fundus live imaging, infra-red imaging and fluorescein angiography) with established retinal laser photocoagulation treatment methods, providing the doctor with a system for image capture, display, storage and manipulation for treatment planning and documentation.

The primary components of the Navilas Laser System include:

- . One of three optional ophthalmic laser sources:
- a frequency doubled ND:YVO4 laser source that operates at 532nm, or -
- an optically-pumped semiconductor laser source that also operates at the same -532nm, or
- an optically-pumped semiconductor laser source that operates at 577nm -

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- An integrated delivery system that directs the laser beam through ophthalmoscope optics using motorized mirrors,
- A digital camera and computer hardware that provides continuous real-time imaging ● using slit illumination that is projected through the ophthalmoscope optics and panned automatically at a rapid rate of 25 Hz across the subject area using the motorized mirrors. Imaging can be in color (using white light illumination) or in monochrome (using infrared illumination or blue light illuminations).

Laser photocoagulation with the NAVILAS can be performed using single shot (Single Spot Mode), repeated shots (Repeat Mode), and scanned patterns (Pattern Mode).

### 4.5 STATEMENT OF INTENDED USE

The Navilas Laser System/Navilas Laser System 532+/ Navilas Laser System 577+ are indicated for use:

- 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), Lattice Degeneration, Retinal Tears and Detachments (Laser Retinopexy).
- . For the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color, fluorescein angiography 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.

### TECHNOLOGICAL CHARACTERISTICS COMPARISON 4.6

The Navilas Laser System has the same indications for use, similar design and functional features and is therefore substantially equivalent to the predicate devices.

#### 4.7 PERFORMANCE STANDARDS

The Navilas is designed, manufactured and tested in accordance with both mandatory and voluntary standards including:

- . IEC 60601-1 Medical Electric Equipment, Part 1: General requirements for safety Medical Electrical Equipment - Part 1-2: General requirements ● IEC 60601-1-2 for safety (Collateral standard: electromagnetic compatibility requirements and tests)

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| • IEC 60601-2-22 | Medical Electrical Equipment, Part 2: Particular requirements for<br>the safety and diagnostic and therapeutic laser equipment |
|------------------|--------------------------------------------------------------------------------------------------------------------------------|
| • IEC 62366 | Medical Devices – Application of usability engineering to medical<br>devices |
| • IEC 60825-1 | Safety of Laser Products, Part 1: Equipment classification and<br>requirements |
| • ISO 15004-2 | Ophthalmic Instruments – Fundamental requirements and test<br>methods – Part 2: Light hazard protection |
| • ISO 14971 | Application of risk management to medical devices |

This device also complies with European Medical Device Directive 93/42/EEC and U.S. Federal Performance Standards per 21 CFR Part 1040 for light emitting products.

### SUMMARY OF PERFORMANCE TEST RESULTS 4.8

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 the Navilas Laser System meets all performance specifications and requirements.

#### 4.9 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 treatment and imaging of the eye.