AMICO DH-W35 OPHTHALMOSCOPE SERIES

K131939 · Amico Diagnostic Incorporated · HLI · Mar 26, 2014 · Ophthalmic

Device Facts

• Record ID: K131939
• Device Name: AMICO DH-W35 OPHTHALMOSCOPE SERIES
• Applicant: Amico Diagnostic Incorporated
• Product Code: HLI · Ophthalmic
• Decision Date: Mar 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.

Device Story

Amico DH-W35 Ophthalmoscope Series is an AC-powered, hand-held diagnostic device. It utilizes internal illumination and viewing optics to allow clinicians to visualize the internal structures of the eye, including the cornea, aqueous, lens, vitreous, and retina. The device is intended for use in clinical settings by healthcare professionals. By providing a magnified view of the ocular fundus, the device assists the clinician in diagnosing and monitoring ocular health. It functions as a standard optical instrument without automated analysis or digital processing.

Clinical Evidence

Bench testing only. Performance testing was conducted per ISO 10942 (ophthalmoscope optical requirements) and ISO 15004-2 (light hazard protection). Electrical safety and electromagnetic compatibility testing were performed per IEC 60601-1 and UL60601-1-2.

Technological Characteristics

AC-powered hand-held ophthalmoscope. Optical illumination and viewing system. Complies with ISO 10942 and ISO 15004-2 for optical performance and light safety. Electrical safety per IEC 60601-1 and UL60601-1-2.

Indications for Use

Indicated for the examination of the cornea, aqueous, lens, vitreous, and retina of the eye in patients requiring ophthalmic evaluation.

Regulatory Classification

Identification

An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Special Controls

*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, 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

• Welch Allyn Ophthalmoscope (K950461)

Submission Summary (Full Text)

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## MAR 2 0 2014

# K131939

### 510(k) SUMMARY (as required by 807.92)

| Regulatory Correspondent: | AJW Technology Consultants, Inc<br>445 Apollo Beach Blvd<br>Apollo Beach, FL 33572<br>Lauren Chrapowitzky<br>[e-mail]<br>813-645-2855<br>813-645-2856 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Amico Diagnostic Incorporated<br>55 East Wilmot St.<br>Richmond Hill, ON L4B 1A3 CANADA<br>Eric Charron<br>[e-mail] |
| Date of Summary: | 30 August 2013 |
| Trade/Proprietary Name: | Amico DH-W35 Ophthalmoscope Series |
| Common/Usual Name: | Ophthalmoscope, Ac-Powered |
| Classification Name: | Ophthalmoscope |
| Product Code: | HLI |
| Indications for Use: | An ophthalmoscope is intended to be used to<br>examine the cornea, aqueous, lens, vitreous and<br>retina of the eye. |
| Device Description: | The ophthalmoscope is an AC powered hand-held<br>device containing illumination and viewing optics<br>to examine the cornea, aqueous, lens, vitreous, and<br>the retina of the eye. |
| Predicate Device: | K950461 - Welch Allyn Ophthalmoscope |
| Substantial Equivalence: | The applicant device has the same fundamental<br>technological characteristics as the predicate device.<br>Performance testing between the predicate device<br>and the subject device have verified substantial<br>equivalence in design, materials and intended use, |

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and confirmed there are no significant differences between the proposed and predicate devices that raise new questions of safety or efficacy. A comparison chart has been included in Section 12 of this submission.

.

#### Performance Testing:

The FDA Ophthalmoscope Guidance Document [Ophthalmoscope Guidance (Direct and Indirect) Version 1.0, July 8. 1998] was utilized to determine performance testing requirements. Performance testing was completed per ISO 10942 and ISO 15004-2 requirements. Additionally, electrical safety testing was performed per IEC 60601-1 and UL60601-1-2. Results of these tests (included in Sections 17 and 18 of the submission) demonstrate that the Amico Ophthalmoscope is as safe as or safer than the predicate device for its intended use.

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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 stylized depiction of an eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol.

March 26. 2014

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G600 Silver Spring MD 20093-0002

Amico Diagnostics Incorporated % Ms. Lauren Chrapowitzky Regulatory Consultant AJW Technology Consultants, Inc. 445 Apollo Beach Blvd. Apollo Beach, FL 33572

Re: K131939

Trade/Device Name: Amico DH-W35 Ophthalmoscope Series (Models DH-W35 and DH- W35-CH-L) Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLI Dated: February 6, 2014 Received: February 10, 2014

Dear Ms. Chrapowitzky:

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 10 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. Ilisting 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 elass 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.

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Page 2 -Ms. Lauren Chrapowitzky

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 (OS) regulation (21 CFR Parl 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part

807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

Sincerely yours,

### Kesia Y. Alexander -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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

#### 510(k) Number (if known) K131939

#### Device Name

Amico DH-W35 Ophthalmoscope Series

Indications for Use (Describe)

An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

## Marsha L. Burke Nicholas -S

Digitally signed by Marsha L. Burke Nicholas -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300014022, cn=Marsha L. Burke Nicholas -S Date: 2014.03.25 12:31:33 -04'00'

FORM FDA 3881 (1/14)