RS-1000 ZOOM SLITLAMP WITH OPTION

K060869 · Rightmedical Products, LLC · HJO · May 11, 2006 · Ophthalmic

Device Facts

• Record ID: K060869
• Device Name: RS-1000 ZOOM SLITLAMP WITH OPTION
• Applicant: Rightmedical Products, LLC
• Product Code: HJO · Ophthalmic
• Decision Date: May 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The RS-1000 Zoom Slitlamp with 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

RS-1000 Zoom Slitlamp is a diagnostic illumination microscope; uses halogen lamp to illuminate anterior eye segment; enables visualization of cornea epithelium through posterior capsule. Operated by eye care professionals in clinical settings. Optional attachments allow for photographic or video documentation. Device aids clinicians in diagnosing diseases or trauma affecting anterior eye structures by providing magnified, illuminated view of ocular tissues.

Clinical Evidence

Bench testing only. Device tested for safety and electromagnetic compatibility per IEC 60601-1 and IEC 60601-1-2 standards. No clinical data provided.

Technological Characteristics

AC-powered slitlamp biomicroscope; halogen lamp illumination source; zoom magnification optics; optional photographic/video attachment. Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).

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

• Marco Ophthalmic branded Ultra G5 zoom slitlamp (K930438)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K' followed by the numbers '060869'. The characters are written in a bold, dark ink, which contrasts with the white background. The handwriting style appears somewhat cursive, especially in the connection between the digits.

Image /page/0/Picture/1 description: The image shows the logo for RIGHTmedical. The logo has the word "RIGHTmedical" in bold, black letters. Below the word is the phone number 1-888-224 6012, followed by a black dot and the website address www.rightmedical.com. There are also some geometric shapes on the right side of the logo.

MAY 11 2006

200 Expressway Court Virginia Beach, Virginia 23462, USA

## 510(k) Summary

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

| Submitter: | Right Medical Products LLC.<br>200 Expressway Court,<br>Virginia Beach, VA. USA<br>23462 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Harumi Kumahara<br>Regulatory Affairs Coordinator<br>Phone: [phone] X244<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | February 2006 |
| Trade Name: | RS-1000 Zoom Slitlamp with option |
| Common Name: | AC-Powered Slitlamp Biomicroscope |
| Product Code: | HJO |
| Class: | Class II |
| Classification panel: | 86/ Ophthalmic |
| Predicate Device: | Substantial Equivalence is claimed based on the<br>Marco Ophthalmic branded Ultra G5 zoom slitlamp<br>(K930438), |
| Device Description: | The RS-1000 Zoom slitlamp microscope consists of<br>a microscope with a halogen lamp which<br>illuminates the inner eye for examination with an |

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Image /page/1/Picture/0 description: The image shows the logo for Right Medical. The logo has the word "RIGHTmedical" in bold, black letters. Below the word is the phone number 1-888-224-6012 and the website www.rightmedical.com.

200 Expressway Court Virginia Beach, Virginia 23462, USA

optional attachment for photographic or video capabilities and an illumination power supply.

The RS-1000 Zoom slitlamp is a diagnostic Intended Uses: illumination microscope intended to examine 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 affects the structural properties of the anterior eve segment.

Technological Characteristics: The technological characteristics with option are the same or similar to those found with the predicate devices where the eye is examined by projecting light onto it.

Performance testing: The RS-1000 Zoom slitlamp was tested in accordance to IEC 60601-1 and IEC 60601-1-2 was found to meet all safety and electromagnetic compatibility requirements of the standards.

Conclusion: Based on non-clinical testing results, the RS-1000 Zoom slitlamp with option has demonstrated that it is 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 2006

Right Medical Products, LLC. c/o Harumi Kumahara 200 Expressway Court Virginia Beach, VA 23462

Re: K060869

Trade/Device Name: RS-1000 Zoom Slitlamp with option Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: March 20, 2006 Received: March 30, 2006

Dear Ms. Kumahara:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

1f you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

MB Eychhus MD

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): __

Device Name: RS-1000 Zoom Slitlamp with option

Indications for Use:

The RS-1000 Zoom Slitlamp with 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 V (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)

Denis L. McCarthy

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

510(k) Number K060869

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