(272 days)
No
The summary describes a standard ophthalmoscope with illumination and viewing optics, and there is no mention of AI, ML, image processing, or any related technologies. The performance studies reference established standards for ophthalmoscopes and electrical safety, not AI/ML performance metrics.
No.
The intended use of an ophthalmoscope is to examine the structures of the eye, which is a diagnostic purpose, not a therapeutic one. It does not treat or cure any condition.
Yes
Explanation: An ophthalmoscope is used to examine anatomical structures of the eye, which is a diagnostic function because it involves the identification of normal or abnormal conditions.
No
The device description explicitly states it is an "AC powered hand-held device containing illumination and viewing optics," indicating it is a hardware device with physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Ophthalmoscope Function: The description clearly states that the ophthalmoscope is used to examine the eye directly. It does not involve the analysis of specimens taken from the body.
The device is used for direct examination of the eye's internal structures, which falls under the category of in vivo (within the living body) diagnostic devices, not in vitro.
N/A
Intended Use / Indications for Use
An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.
Product codes
HLI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea, aqueous, lens, vitreous and retina of the eye.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K950461 - Welch Allyn Ophthalmoscope
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
MAR 2 0 2014
K131939
510(k) SUMMARY (as required by 807.92)
| Regulatory Correspondent: | AJW Technology Consultants, Inc
445 Apollo Beach Blvd
Apollo Beach, FL 33572
Lauren Chrapowitzky
laurenc@ajwtech.com
813-645-2855
813-645-2856 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Amico Diagnostic Incorporated
55 East Wilmot St.
Richmond Hill, ON L4B 1A3 CANADA
Eric Charron
echarron@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 to
examine the cornea, aqueous, lens, vitreous and
retina of the eye. |
| Device Description: | 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. |
| Predicate Device: | K950461 - Welch Allyn Ophthalmoscope |
| Substantial Equivalence: | The applicant device has the same fundamental
technological characteristics as the predicate device.
Performance testing between the predicate device
and the subject device have verified substantial
equivalence in design, materials and intended use, |
1
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.
2
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.
3
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)