(90 days)
No
The description focuses on standard ophthalmic imaging technology (CCD cameras, Xenon light, IR LEDs) and mentions basic software (NAVIS) running on older operating systems. There is no mention of AI, ML, image processing beyond basic capture, or any performance metrics typically associated with AI/ML algorithms.
No
The device is described as an ophthalmic camera for capturing images of the retina and an instrument for the diagnosis of retinal diseases, not for treatment.
Yes
The 'Device Description' explicitly states, "The Nidek Technologies Srl ORION is an instrument for the diagnosis of retinal diseases."
No
The device description explicitly states it is an "instrument" that includes "CCD cameras," "Xenon light and IR LEDs sources," and is a "fundus camera." These are hardware components, indicating it is not a software-only device, even though it includes dedicated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "captur[e] images of the retina." This is a diagnostic imaging device, not a device that performs tests on biological samples in vitro (outside the body).
- Device Description: The description confirms it's an "instrument for the diagnosis of retinal diseases" that captures images. It doesn't mention analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or analysis of biological specimens like blood, urine, or tissue, which are characteristic of IVD devices.
The device is an ophthalmic camera used for capturing images for diagnostic purposes, which falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
ORION is an ophthalmic camera that is indicated for use in capturing images of the retina.
Product codes
HKI
Device Description
The Nidek Technologies Srl ORION is an instrument for the diagnosis of retinal diseases. It is able to capture color images of the patient retina through CCD cameras.
The fundus camera ORION is supplied with Xenon light and IR LEDs sources suitable for performing the above described examinations.
The system includes also the dedicated NAVIS software (running with Windows XP e 2000 operative system).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical (color images, IR)
Anatomical Site
Retina / 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)
The performance data indicate that the fundus camera ORION device meets all specified requirements, and is substantially equivalent to the predicate device.
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
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
K0702
ORION
SUBMITTER INFORMATION
APR 2 4 2007
| A. | Company Name: | Nidek Technologies Srl |
|---|---|---|
| B. | Company Address: | Via Dell'Artigianato, 6/A |
| Albignasego (Padova), Italy 35020 | ||
| C. | Company Phone: | |
| Company Fax: | +39 049 86 29 200 | |
| +39 049 86 26 824 | ||
| D. | Contact Person: | Mr. Aldo Cocchiglia |
| Managing Director | ||
| Nidek Technologies Srl | ||
| E. | Date Summary Prepared: | January 18, 2007 |
.
DEVICE IDENTIFICATION
| A. | Generic Device Name: | Ophthalmic camera, AC-powered |
|---|---|---|
| B. | Trade/Proprietary Name: | ORION |
| C. | Classification: | Class II |
| D. | Product Code: | HKI |
.
1
ORION
DEVICE DESCRIPTION
The Nidek Technologies Srl ORION is an instrument for the diagnosis of retinal diseases. It is able to capture color images of the patient retina through CCD cameras.
The fundus camera ORION is supplied with Xenon light and IR LEDs sources suitable for performing the above described examinations.
The system includes also the dedicated NAVIS software (running with Windows XP e 2000 operative system).
INTENDED USE
ORION is intended for use as Fundus Camera. The color image of the fundus obtained in nonmydriatic conditions, using an IR sensible camera as a visible flash for illuminating the retina at picture taking.
SUBSTANTIAL EQUIVALENCE
The Nidek Technologies Srl ORION device is of comparable type and is substantially equivalent to the following predicate devices:
| Predicate Device | 510(K) Holder | 510(k) No. | Date
Cleared |
|-----------------------------------------------|------------------------|--------------------|---------------------------------|
| MP-1 MICRO PERIMETER | NIDEK TECHNOLOGIES SRL | K023719
K061768 | 12 / 23 / 2002
09 / 28 /2006 |
| NON-MYDRIATIC FUNDUS
CAMERA, MODEL NM-1000 | NIDEK, INC | K014274 | 04/17/2002 |
In further support of a substantial equivalence determination, Section 5 provides a comparison chart of the fundus camera ORION and the predicate devices.
2
510(k) NOTIFICATION
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of ORION and the predicate devices has been performed. The results of this comparison demonstrate that the fundus camera ORION is equivalent to the marketed predicate devices.
PERFORMANCE DATA
The performance data indicate that the fundus camera ORION device meets all specified requirements, and is substantially equivalent to the predicate device.
ORION
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nidek Technologies, srl c/o Aldo Cocchiglia Via dell'Artigianato, 6/A 35020 Albignasego (Padova) Italy
Re: K070231
APR 2 4 2007
Trade/Device Name: ORION™ Regulation Number: 21 CFR 886.1120 Regulation Name: AC-Powered Ophthalmic Camera Regulatory Class: II Product Code: HKI Dated: April 2, 2007 Received: April 5, 2007
Dear Mr. Cocchiglia:
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 misbrandi, no 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 – Aldo Cocchiglia
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 Office of Compliance at (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
MB Egelman, 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
5
INDICATIONS FOR USE
510(k) Number (if known):
KO70231
Device Name:
.
ORION
.
Indications for Use:
ORION is an ophthalmic camera that is indicated for use in capturing images of the retina.
Prescription Use
(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)
ORION 510(k)
| (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises | |
|---|---|
| 510(k) Number | K070231 |