RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION

K110129 · Rightmedical Products, LLC · HJO · Aug 30, 2011 · Ophthalmic

Device Facts

• Record ID: K110129
• Device Name: RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
• Applicant: Rightmedical Products, LLC
• Product Code: HJO · Ophthalmic
• Decision Date: Aug 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The Righton Zoom Slit Lamp NS-2D with photo option is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

Device Story

Righton Zoom Slit Lamp NS-2D is a converging-type (Greenough) stereoscopic zoom microscope for ophthalmic observation and microphotography. Device consists of main unit and illumination power supply. Operates via manual zoom magnification (5.9x-39x) and variable slit width/aperture settings. Used by eye care professionals in clinical settings to visualize anterior eye segment structures. Includes optional data collection and image manipulation software for capturing and processing images. Provides magnified view of eye to assist clinicians in diagnosing ocular diseases or trauma. Benefits include enhanced visualization of anterior segment anatomy for improved diagnostic accuracy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Converging-type (Greenough) zoom microscope; 12.5x/15.0x eyepieces; 12V 30W halogen illumination; LED fixation light (Class 1); manual zoom magnification 5.9x to 39x; slit width 0-16mm; diopter adjustment -8D to +8D; working distance 100mm. Includes optional image capture/manipulation software. Not suitable for use in flammable atmospheres.

Indications for Use

Indicated for patients requiring examination of the anterior eye segment (cornea epithelium to posterior capsule) to aid in the diagnosis of diseases or trauma affecting structural properties.

Regulatory Classification

Identification

An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

Special Controls

*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• Appasamy A1A-11 Zoom Slit Lamp (K082031)
• EyeCap Imaging System (K000368)
• Nidek Navis Software (K013694)

Submission Summary (Full Text)

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K110129

AUG 3 0 2011

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## 510(k) Summary

The information contained in this premarket notification 510(k) summary is submitted as required by 21 CFR 807.92(c):

| Submitter: | RIGHTMEDICAL Products LLC.<br>5325 Cleveland Street,<br>Virginia Beach, VA. USA<br>23462 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mélanie Deslauriers<br>Regulatory Affairs Coordinator<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | August 2011 |
| Trade Name: | Righton Zoom Slit Lamp NS-2D with option |
| Common Name: | AC-Powered Slit lamp Biomicroscope |
| Product Code: | HJO |
| Class: | Class II |
| Regulation: | 21 CFR 886.1850 |
| Predicate Device: | Substantial Equivalence of the Slit Lamp is claimed based<br>on the Appasamy A1A-11 Zoom Slit Lamp (K082031).<br>Substantial Equivalence of the data collection and image<br>manipulation software is claimed based on the EyeCap<br>Imaging System (K000368) and on the Nidek Navis Software<br>(K013694). |
| Device Description: | The NS-2D zoom slit lamps are designed for ophthalmic<br>observation and microphotography. These slit lamps feature<br>zoom stereoscopic converging microscopes that can be<br>used for ophthalmic observation. Each instrument consists<br>primarily of the main unit and the illumination power supply<br>unit. |

:

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## Substantial Equivalence Tables:

| | Righton NS-2D Zoom | Appasamy A1A 11 Zoom<br>(K082031) |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used in examination of the anterior<br>eye segment, from the cornea<br>epithelium to the posterior capsule.<br>It is used to aid in the diagnosis of<br>diseases or trauma which affect the<br>structural properties of the anterior<br>eye segment. | Used in examination of the anterior<br>eye segment, from the cornea<br>epithelium to the posterior capsule.<br>It is used to aid in the diagnosis of<br>diseases or trauma which affect the<br>structural properties of the anterior<br>eye segment. |
| Method of operation | Converging-type Zoom Microscope<br>(12.5°)<br>(Greenough Type) | Converging-type Zoom Microscope<br>(Galilean Type) |
| Exposure parameters | Magnification Change: Continuous<br>by manual zoom<br>Eyepiece: 12.5x and 15.0x<br>PD Range: 52mm to 75mm<br>Slit Width: 0mm to 16mm<br>continuously variable<br>Slit Apertures: ø0.2, 1, 2, 5, 10, 14,<br>16 mm, 0 to 12 mm continuously<br>variable<br>Slit Inclination: 0°, 5°, 10°, 15° and<br>20°<br>Slit Rotation: 90° to right and left<br>Diopter adjustment: -8D to +8D for<br>the 12.5x eyepiece and<br>-6D to +6D for the 15x eyepiece<br>Working Distance: 100mm | Magnification Change: Continuous<br>by manual zoom<br>Eyepiece: 12.5x<br>PD Range: 55mm to 75mm<br>Slit Width: 0mm to 14mm<br>Slit Apertures: 0mm to 14mm,<br>ø0.2, 1, 3, 4, 6, 10, 14mm<br>Slit Inclination: 0°, 5°, 10°, 15° and<br>20°<br>Slit Angles: 0° to 180°<br>Diopter adjustment: -6D to +6D<br>Working Distance: 100mm |
| Total Magnification | 5.9x to 32.5x for 12.5x eyepiece<br>7.1x to 39x for 15.0x eyepiece | 5.5x to 35.0x |
| Filters | Transparent<br>Heat Absorption<br>ND (28%)<br>Green<br>Cobalt Blue | Transparent<br>Heat Absorption<br>Green<br>Cobalt Blue |
| Fixation Light | LED (Class 1) | LED |
| Data collection and/or<br>display system | Yes | NAV |
| Flammability of<br>materials | This instrument is not suitable for<br>use in a flammable atmosphere.<br>Do not use this instrument if any<br>flammable gases are present. | This instrument is not suitable for<br>use in a flammable atmosphere.<br>Do not use this instrument if any<br>flammable gases are present. |
| Max. temperature of<br>parts of the device held<br>by the operator or<br>accessible to the patient | No parts of device with<br>patient/operator contact is<br>energized and remains at ambient<br>temperature | No parts of device with<br>patient/operator contact is<br>energized and remains at ambient<br>temperature |
| Brightness Control | 12V 30W halogen bulb | 12V 30W halogen bulb |

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Conclusion:

Based on non-clinical testing results, the Righton Zoom Slit Lamp NS-2D with option and the data collection and image manipulation software have demonstrated that they are equivalent to the predicate devices with respect to intended uses, technological characteristics and safety and effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the border of the circle.

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

Right Medical Products LLC c/o Ms. Mélanie Deslauriers, B.Sc., MBA Regulatory Affairs Manager 5325 Cleveland Street, Suite 303 Virginia Beach, VA 23462

AUG 3 0 2011

Re: K110129

Trade/Device Name: Righton Zoom Slit Lamp with Photo Option, Model NS-2D Regulation Number: 21 CFR 886.1850 Regulation Name:, AC-Powered Slit-Lamp Biomicroscope Regulatory Class: Class II Product Code: HJQ Dated: August 5, 2011 Received: August 10, 2011

Dear Ms. Deslauriers:

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, Trug 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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Page 2 - Ms. Mélanie Deslauriers, B.Sc., MBA

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 thream 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 eltectronic 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm far 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" (21 CFR Pact 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

for

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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## Indications for Use

510(k) Number (if known): K110129

Device Name: Righton Zoom Slit Lamp NS-2D with photo option

Indications for Use:

The Righton Zoom Slit Lamp NS-2D with photo option is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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)

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

510(k) Number K110129

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