(90 days)
ORION is an ophthalmic camera that is indicated for use in capturing images of the retina.
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).
The provided text describes the ORION fundus camera, but it does not contain information about specific acceptance criteria or a study that evaluates the device against such criteria. The document is a 510(k) premarket notification for the ORION device, focusing on demonstrating substantial equivalence to predicate devices, rather than detailed performance evaluations against predefined clinical endpoints.
Here's a breakdown of what the document does state and what it lacks in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Lacking. The document states: "The performance data indicate that the fundus camera ORION device meets all specified requirements, and is substantially equivalent to the predicate device." However, it does not elaborate on what those "specified requirements" are, nor does it present any specific performance metrics or data in a table format. The assessment is qualitative and focuses on equivalence rather than meeting numerical criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Lacking. The document makes no mention of a test set, sample sizes, or data provenance for any performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Lacking. No information is provided regarding experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Lacking. No adjudication method is mentioned.
5. 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
- Lacking. The device is a fundus camera, not an AI-powered diagnostic tool for interpretation. Therefore, an MRMC study related to AI assistance for human readers is not applicable to this device as described. The document focuses on the camera's ability to capture images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Lacking/Not Applicable. This is a hardware device (ophthalmic camera) with accompanying software for image management (NAVIS). It is not an algorithm that operates in a "standalone" diagnostic capacity or replaces human interpretation. Its performance is related to image acquisition quality, not automated diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Lacking. No ground truth information is provided as no detailed performance study results are presented.
8. The sample size for the training set
- Lacking. No training set is mentioned for any algorithm as the device itself is an image acquisition system, not explicitly an AI/ML diagnostic algorithm.
9. How the ground truth for the training set was established
- Lacking. Not applicable, as no training set is mentioned.
In summary: The provided 510(k) document for the ORION fundus camera primarily demonstrates substantial equivalence to existing predicate devices based on technological characteristics and intended use. It does not provide detailed performance data, acceptance criteria, or information on specific clinical studies that would fulfill the requested categories. The statement "The performance data indicate that the fundus camera ORION device meets all specified requirements" is a high-level declaration without supporting evidence in this document.
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K0702
ORION
SUBMITTER INFORMATION
APR 2 4 2007
| A. | Company Name: | Nidek Technologies Srl |
|---|---|---|
| B. | Company Address: | Via Dell'Artigianato, 6/AAlbignasego (Padova), Italy 35020 |
| C. | Company Phone:Company Fax: | +39 049 86 29 200+39 049 86 26 824 |
| D. | Contact Person: | Mr. Aldo CocchigliaManaging DirectorNidek 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 |
.
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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. | DateCleared |
|---|---|---|---|
| MP-1 MICRO PERIMETER | NIDEK TECHNOLOGIES SRL | K023719K061768 | 12 / 23 / 200209 / 28 /2006 |
| NON-MYDRIATIC FUNDUSCAMERA, 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.
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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
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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.
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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
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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 |
§ 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.