(266 days)
Not Found
No
The summary describes a standard ophthalmoscope for image capture and angiography, with no mention of AI or ML capabilities for image analysis or diagnosis.
No
The device is described as capturing and recording images for diagnosis, which is a diagnostic function, not a therapeutic one. It does not exert any direct therapeutic effect on the patient.
No
The device is an ophthalmoscope, which is used for capturing images of the fundus. While these images can be used for diagnosis, the device itself is an imaging tool and not a diagnostic device that performs the diagnosis.
No
The device description explicitly states it is a "confocal laser scanning ophthalmoscope" and describes its hardware components (laser scanning, selection of laser colors). It also mentions compliance with hardware-related standards (IFC 60601-1, 60601-1-1, 60601-1-2, 60825-1, ISO 15004-2:2007, 21 CFR Parts 1010 and 1040).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- Device function: The Ophthalmoscope F-10 is used to capture images of the fundus directly from the patient's eye. This is an in vivo (within a living organism) procedure, not an in vitro (in glass, outside the body) procedure.
- Intended Use: The intended use is to capture images for the diagnosis of fundus diseases, which is based on visual examination of the images, not on the analysis of biological specimens.
Therefore, based on the provided information, the Ophthalmoscope F-10 is a medical device used for imaging the eye, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ophthalmoscope F-10 is intended for use in capturing images of the fundus which can be used for diagnosis of fundus diseases.
Product codes
MYC
Device Description
The Ophthalmoscope F-10 is categorized as a Class 1 confocal laser scanning ophthalmoscope. The F-10 captures and records confocal images of the fundus by laser scanning using a selection of laser colors: IR (infrared), blue, green, and red and affords Indocyanine green (ICG) and fluorescein (FAG) angiography.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Confocal laser scanning
Anatomical Site
fundus
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)
Nidek Company Ltd. has verified and validated that the Ophthalmoscope F-10 meets its functional specifications, performance requirements and complies with applicable U.S. and international standards (IFC 60601-1, 60601-1-1, 60601-1-2, 60825-1 and ISO 15004-2:2007) for products of its kind. This device complies with 21 CFR Parts 1010 and 1040, with the exception of those allowable performance deviations noted in FDA's Laser Notice 50.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY - 6 2008
Pre-Market Notification 510(k) Summary
1. Sponsor Information:
l
Company Name & Address: NIDEK Company, Ltd. 34-14 Maehama, Hiroishicho Gamagori, Aichi, 443-0038 Japan Contact Person: Yoneji Mizuno Contact Title: Manager Regulatory Affairs Contact Phone Number: +81-533-67-8901 Contact Fax Number: +81-533-67-6610
Date of Summary:
May 5, 2008
2. Device Name and Classification:
| Common and Usual Name: | Ophthalmoscope |
|---|---|
| Proprietary Name: | Ophthalmoscope F-10 |
| Classification Name: | Ophthalmoscope, AC-Powered (21 CFR § 886.1570) |
| Product Code: | MYC |
| Class: | II |
| Performance Standards: | No applicable performance standards have been issued under section 514 or under section 513(b) of the Food, Drug and Cosmetic Act. |
Performance Standards issued for Light Emitting Products: 21CFR Part 1040, Section 1040.10 and 1040.11 (Laser Products).
3. Predicate Device(s):
| K971671: | Heidelberg Engineering |
|---|---|
| Heidelberg Retina Angiograph FA/ICGA (HRA/C) | |
| K871268: | G. Rodenstock Instrumente, GMBH |
| Rodenstock Scanning Laser |
Ophthalmoscope F-10 510(k) Summary
NIDEK COMPANY, LTD.
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4. Description of Device:
The Ophthalmoscope F-10 is categorized as a Class 1 confocal laser scanning ophthalmoscope. The F-10 captures and records confocal images of the fundus by laser scanning using a selection of laser colors: IR (infrared), blue, green, and red and affords Indocyanine green (ICG) and fluorescein (FAG) angiography.
న్. Indications for Use:
The Ophthalmoscope F-10 is intended for use in capturing images of the fundus which can be used for diagnosis of fundus diseases.
6. Comparison with Predicate Device(s):
The Ophthalmoscope F-10 is substantially equivalent to the predicate devices identified and other commercially available SLO products. It is similar in characteristics, materials, features, has similar technological features, intended use and indications for use as the predicates, and do not raise any new questions of safety and effectiveness.
7. Non-Clinical Performance Summary:
Nidek Company Ltd. has verified and validated that the Ophthalmoscope F-10 meets its functional specifications, performance requirements and complies with applicable U.S. and international standards (IFC 60601-1, 60601-1-1, 60601-1-2, 60825-1 and ISO 15004-2:2007) for products of its kind. This device complies with 21 CFR Parts 1010 and 1040, with the exception of those allowable performance deviations noted in FDA's Laser Notice 50.
8. Conclusions:
In summary, Nidek Company Ltd., is of the opinion that the Ophthalmoscope F-10 docs not introduce any new potential safety risks, is as effective, and performs as well as devices currently on the market, and concludes that the Ophthalmoscope F-10 is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three curved lines that resemble a human figure or a symbol representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 6 2008
NIDEK Co., Ltd. c/o Mr. Paul Sumner Vice President of Regulatory, Clinical & & Quality Systems Arkin Consulting Group, LLC 1733 Canton Lane Marietta, GA 30062
Re: K072259
Trade/Device Name: Ophthalmoscope F-10 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC Dated: April 16, 2008 Received: April 18, 2008
Dear Mr. Sumner:
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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Page 2- Mr. Paul Sumner
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M. B. Egelston, m.d.
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 Statement
510(k) Number (if known):
Device Name:
OPHTHALMOSCOPE F-10
Indications For Use:
The Ophthalmoscope F-10 is intended for use in capturing images of the fundus, which can be used for the diagnosis of fundus diseases.
Prescription Use XX (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Derick
Page 1 of 1
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K072259
NIDEK COMPANY, LTD.