(107 days)
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No
The summary describes a digital camera for taking retinal images and its technical specifications. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an ophthalmic camera for taking digital images of the retina, which is a diagnostic function, not a therapeutic one.
No
The device is described as taking digital images of the human retina. There is no mention of the device analyzing these images or providing a diagnosis based on them. The "Summary of Performance Studies" focuses on image quality metrics, not diagnostic accuracy.
No
The device description explicitly states that the DRS is an ophthalmic camera with physical components like an optical head, head-rest, chin rest, and base, in addition to the integrated computer and software. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "taking digital images of a human retina." This describes an imaging device used to capture visual information from a living patient.
- Device Description: The description details an "ophthalmic camera" and its components, all of which are consistent with an in-vivo imaging system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are specifically designed to perform tests on samples taken from the body.
This device is clearly an in-vivo imaging device used to visualize the retina directly in a patient.
N/A
Intended Use / Indications for Use
The CenterVue Digital Retinography System DRS is intended for taking digital images of a human retina without the use of a mydriatic agent.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
The DRS is an ophthalmic camera used to take colored digital images of a human retina without use of a mydriatic agent. The instrument body includes: optical head, head-rest, chin rest and a base. The device integrates a dedicated computer and a touch-screen display and operates as a standalone unit, running a dedicated software application. The device is provided with a front lens cap, a power cord and spare fuses.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Colored digital images of a human retina
Anatomical Site
Human retina
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The DRS has undergone extensive performance testing before release to ensure that the device and its software meet the functional requirements and to demonstrate equivalence to the predicate devices.
Summary of the results:
Sensor resolution: 48.15 pixels / degree (Requirement: 48 pixels / degree)
Resolution on retina:
≥ 60 line pairs/mm at the center of the field: Yes
≥ 40 line pairs/mm at the mid field (r/2): Yes
≥ 25 line pairs/mm at the periphery of the field (r): Yes
Field of view: 42.95° horizontal x 40.3° vertical (Requirement: 45° horizontal x 40° vertical)
Pixel pitch: 6.39 μm (Requirement: 6 μm)
Range of focus: -15 D to + 15 D (Requirement: -15 D to + 15 D)
Minimum pupil size: 4.0 mm (Requirement: 4.0 mm)
Position of internal fixation targets for central and peripheral fields: Actual position (for normally fixating subjects) within ±1° from expected position (Requirement: Specific angular positions for central, nasal, temporal, supero-temporal, peri-central, superior, inferior fields)
OD/OS detection: Yes (tested on multiple subjects) (Requirement: Device captures OD or OS or both based on operator's selection)
Auto-alignment: Yes (tested on multiple subjects) (Requirement: Device automatically aligns to the center of the pupil prior to auto-focusing and capture)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 886.1120 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.
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Image /page/0/Picture/0 description: The image is a logo for "centerview at the center of vision". The logo features the word "centerview" in a sans-serif font, with the tagline "at the center of vision" in a smaller font below it. Above the text is a stylized eye symbol, which is composed of a circle and a series of curved lines that create a sense of depth and dimension.
APPENDIX B
OCT 2 7 2010
510(k) Summary of safety and effectiveness
510(k) OWNER INFORMATION
| A. Company name: | CenterVue SpA |
|---|---|
| B. Company address: | via Tommaseo 77, 35131, Padova, ITALY |
| C. Company phone: | +39 049 781 1828 |
| C. Company fax: | +39 049 781 1899 |
| D. Contact person: | Giuliano Barbaro, Managing Director |
| E. Revised summary date: | September 21st 2010 |
SUBMITTER INFORMATION
| A. Company name: | Donawa Lifescience Consulting Srl | |
|---|---|---|
| B. Company address: | Piazza Albania, 10, 00153 Rome, ITALY | |
| C. Company phone: | +39 06 578 2665 | |
| D. Company fax: | +39 06 574 3786 | |
| E. Contact person: | Roger Gray, VP Quality and Regulatory |
DEVICE IDENTIFICATION
- Camera, ophthalmic, ac-powered Generic Device name: A.
- B. Trade/proprietary name: Digital Retinography System DRS
- Classification: ll C.
- HKI Product code: D.
DEVICE DESCRIPTION
The DRS is an ophthalmic camera used to take colored digital images of a human retina without use of a mydriatic agent. The instrument body includes: optical head, head-rest, chin rest and a base. The device integrates a dedicated computer and a touch-screen display and operates as a standalone unit, running a dedicated software application. The device is provided with a front lens cap, a power cord and spare fuses.
tel. +39 049 781 1828 fax +39 049 781 1899 e-mail: info@centervue.com
REA: 378243 CCIAA PD C.F./P. IVA: 04296580287
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Image /page/1/Picture/0 description: The image shows a logo for "centerview at the center of vision". The logo features a stylized eye design above the word "centerview", with the tagline "at the center of vision" written in a smaller font below. The eye design is abstract and appears to be made up of several geometric shapes.
INTENDED USE
The CenterVue Digital Retinography System DRS is intended for taking digital images of a human retina without the use of a mydriatic agent.
SUBSTANTIAL EQUIVALENCE
The DRS device is substantially equivalent to the following predicate devices with regard to intended use, operating principle, and function:
| Predicate Device | 510(k) Holder | 510(k) No. | Date cleared |
|---|---|---|---|
| EyeScan | Ophthalmic Imaging Systems | K092374 | 17 November 2009 |
| Orion | Nidek Technologies Srl | K070231 | 24 April 2007 |
TEST DATA
The DRS has undergone extensive performance testing before release to ensure that the device and its software meet the functional requirements and to demonstrate equivalence to the predicate devices.
A summary of the results of performance testing vs. the device requirements follows:
| Performance item | Requirements | Test results |
|---|---|---|
| Sensor resolution | 48 pixels / degree | 48.15 pixels / degree |
| Resolution on retina | ≥ 60 line pairs/mm at the center of the field | |
| ≥ 40 line pairs/mm at the mid field (r/2) | ||
| ≥ 25line pairs/mm at the periphery of the field (r) | Yes | |
| Yes | ||
| Yes | ||
| Field of view | 45° horizontal x 40° vertical | 42.95° horizontal x |
| 40.3° vertical | ||
| Pixel pitch | 6 μm | 6.39 μm |
| Range of focus | -15 D to + 15 D | -15 D to + 15 D |
| Minimum pupil size | 4.0 mm | 4.0 mm |
| Position of internal | ||
| fixation targets for | ||
| central and peripheral | ||
| fields | CENTRAL: field centered on the foveal pit | |
| NASAL: field centered 17° nasally to the fovea | ||
| TEMPORAL: field centered 17° temporally to the fovea | ||
| SUPERO-TEMPORAL: field centered 12° superiorly and 12° | ||
| temporally to the fovea | ||
| PERI-CENTRAL: field centered 5° nasally to the fovea | ||
| SUPERIOR: field centered 17° superiorly to the fovea | ||
| INFERIOR: field centered 17° inferiorly to the fovea | Actual position (for | |
| normally fixating | ||
| subjects) within ±1° | ||
| from expected | ||
| position | ||
| OD/OS detection | Device captures OD or OS or both based on operator's | |
| selection | Yes (tested on | |
| multiple subjects) | ||
| Auto-alignment | Device automatically aligns to the center of the pupil prior | |
| to auto-focusing and capture | Yes (tested on | |
| multiple subjects) |
via Tommaseo, 77 35131 Padova, Italy www.centervue.com tel. +39 049 781 1828 fax +39 049 781 1899 e-mail: info@centervue.com
REA: 378243 CCIAA PD C.F./P. IVA: 04296580287
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Image /page/2/Picture/0 description: The image shows a logo for "centerview at the center of vision". The logo features a stylized eye design above the text. The eye is composed of geometric shapes, with a dark circle representing the pupil. The text is in a sans-serif font and is stacked, with "centerview" on top and "at the center of vision" below.
PERFORMANCE STANDARDS
The DRS complies with the following standards: IEC 60601-1:2005; IEC 60601-1-2:2007; ISO 10940-2:2009; ISO 15004-2 2007.
CONCLUSION
As described in this 510(k) Summary, all testing deemed necessary was conducted on the DRS to ensure that the device is safe and effective for its intended use, when used in accordance with its Instructions for Use, and equivalence with the identified predicate devices has been demonstrated.
tel. +39 049 781 1828 fax +39 049 781 1899 e-mail: info@centervue.com REA: 378243 CCIAA PD C.F./P. IVA: 04296580287
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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 depiction of an eagle or bird with outstretched wings. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
CENTERVUE SpA c/o Mr. Roger Gray Vice President, Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania, 10 00153 Rome, Italy
Re: K101935
Trade/Device Name: Digital Retinography System (DRS) Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: II Product Code: HKI Dated: September 29, 2010 Received: October 4, 2010
OCT 2 7 2010
Dear Mr. Gray:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Debra Falls
Malvina B. Eydelman, M.D. Director
Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix A
Indications for Use Statement
510(k) Number (if known): K101935
Device Name: CenterVue Digital Retinography System DRS .
Indications for Use: The CenterVue Digital Retinography System DRS is intended for taking digital images of a human retina without the use of a mydriatic agent.
Prescription Use (Part 21 CFR 801 Subpart D)
ਨੇ
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sigh-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of 1 Rev.2 Apr 4, 2008
510(k) Number_k101935