The ophthalmoscope is an AC powered hand-held device containing illumination and viewing optics to examine the cornea, aqueous, lens, vitreous, and the retina of the eye.

AI/ML Overview

This K131939 submission describes a traditional ophthalmoscope, which is a manually operated viewing device, not an AI or algorithm-driven device. Therefore, many of the requested categories related to AI performance, ground truth, and training sets are not applicable.

Here's an analysis based on the provided text, focusing on the device's technical performance and regulatory acceptance:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Substantial Equivalence to Predicate	The applicant device has the same fundamental technological characteristics as the predicate device (K950461 - Welch Allyn Ophthalmoscope). Performance testing verified substantial equivalence in design, materials, and intended use, with no significant differences raising new questions of safety or efficacy. A comparison chart was included in Section 12 (not provided in this excerpt).
Ophthalmoscope Performance Testing	Performance testing was completed per ISO 10942 and ISO 15004-2 requirements, as determined by the FDA Ophthalmoscope Guidance Document (Direct and Indirect) Version 1.0, July 8, 1998. The results (included in Sections 17 and 18, but not provided) demonstrated that the Amico Ophthalmoscope is as safe as or safer than the predicate device for its intended use. (Specific quantitative performance metrics from these ISO standards are not provided in the excerpt.)
Electrical Safety Testing	Electrical safety testing was performed per IEC 60601-1 and UL60601-1-2. The results (included in Sections 17 and 18, but not provided) demonstrated that the Amico Ophthalmoscope is as safe as or safer than the predicate device for its intended use.
Indications for Use	An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous, and retina of the eye. The device met this intended use.
Regulatory Classification and Compliance	Classified as Class II device under 21 CFR 886.1570 (Ophthalmoscope) with Product Code HLI. Received 510(k) clearance based on substantial equivalence, subject to general controls provisions of the Act (e.g., annual registration, device listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration), and potentially additional controls for Class II devices.

Study Details (Non-Applicable/Not Provided for AI Device):

Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI algorithm tested on a dataset. The "test set" would refer to the physical devices themselves and their performance characteristics. The provenance refers to the testing standards (ISO, IEC, UL) and comparison to a legally marketed predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic algorithms (e.g., expert consensus on image findings) is not relevant here. Device functionality and safety are evaluated against technical standards.
Adjudication method for the test set: Not applicable. This is not a study assessing diagnostic accuracy of an algorithm requiring adjudication of results.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a standalone physical ophthalmoscope, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical hand-held direct ophthalmoscope, which is inherently used with a human in the loop. There is no "algorithm only" component.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic performance "ground truth." The "ground truth" for this device's acceptance is its conformity to established performance standards (ISO 10942, ISO 15004-2) and electrical safety standards (IEC 60601-1, UL60601-1-2), and its substantial equivalence to a predicate device.
The sample size for the training set: Not applicable. There is no training set for a non-AI physical device.
How the ground truth for the training set was established: Not applicable.

Summary of Acceptance and Study:

The acceptance criteria for the Amico DH-W35 Ophthalmoscope Series were primarily based on demonstrating substantial equivalence to a previously cleared predicate device (K950461 - Welch Allyn Ophthalmoscope) and compliance with relevant performance and safety standards.

The study that proves the device meets these criteria involved:

A performance comparison of the subject device against the predicate device to ensure "the same fundamental technological characteristics" and no "significant differences... that raise new questions of safety or efficacy."
Performance testing conducted according to:
- FDA Ophthalmoscope Guidance Document (Direct and Indirect) Version 1.0, July 8, 1998.
- ISO 10942 (Ophthalmic instruments — Direct ophthalmoscopes)
- ISO 15004-2 (Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection)
Electrical safety testing conducted according to:
- IEC 60601-1 (Medical electrical equipment — Part 1: General requirements for basic safety and essential performance)
- UL 60601-1-2 (Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests)

The results of these tests, as reviewed by the FDA, demonstrated that the Amico Ophthalmoscope is "as safe as or safer than the predicate device for its intended use," leading to its 510(k) clearance based on substantial equivalence. Specific quantitative data from the performance and electrical safety tests are not provided in this summary but were included in Sections 17 and 18 of the original submission.

Summary

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MAR 2 0 2014

K131939

510(k) SUMMARY (as required by 807.92)

Regulatory Correspondent:	AJW Technology Consultants, Inc445 Apollo Beach BlvdApollo Beach, FL 33572Lauren Chrapowitzkylaurenc@ajwtech.com813-645-2855813-645-2856
Submitter of 510(k):	Amico Diagnostic Incorporated55 East Wilmot St.Richmond Hill, ON L4B 1A3 CANADAEric Charronecharron@amico.com
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 toexamine the cornea, aqueous, lens, vitreous andretina of the eye.
Device Description:	The ophthalmoscope is an AC powered hand-helddevice containing illumination and viewing opticsto examine the cornea, aqueous, lens, vitreous, andthe retina of the eye.
Predicate Device:	K950461 - Welch Allyn Ophthalmoscope
Substantial Equivalence:	The applicant device has the same fundamentaltechnological characteristics as the predicate device.Performance testing between the predicate deviceand the subject device have verified substantialequivalence 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
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.(b)
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.