(316 days)
Not Found
No
The description mentions "semiautomated measurement" and the software estimating vessel diameters, but there is no mention of AI, ML, or related terms, nor is there a description of training or test sets typically associated with such technologies. The performance study focuses on method comparison and reproducibility, not AI/ML performance metrics.
No
The device is intended to aid in diagnosing or monitoring diseases of the eye by capturing, displaying, storing, and manipulating images, and performing semi-automated measurements. It does not provide treatment or therapy.
Yes
The device is intended to aid in diagnosing or monitoring diseases of the eye by capturing, displaying, storing, and manipulating images of the eye, and specifically, the VesselMap2 software is intended to be used for semi-automated measurement and calculation of the retinal artery/vein diameter ratio, which are diagnostic indicators.
No
The device description explicitly states that the IMEDOS SVA unit is designed as a complete Fundus Imaging system, which includes hardware components (fundus camera and digital image sensor) in addition to the software. While the software can be sold separately, the overall device as described in the context of the 510(k) summary is a system with both hardware and software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The Static Vessel Analyzer (SVA) with VesselMap2 analyzes images of the eye, specifically the retina. It does not perform tests on biological samples taken from the body. It is an imaging and image analysis device.
- Intended Use: The intended use is to capture, display, store, and manipulate images of the eye to aid in diagnosing or monitoring eye diseases. This is consistent with an imaging device, not an IVD.
- Device Description: The description details a fundus imaging system and software for image analysis, not a system for analyzing biological samples.
Therefore, the SVA with VesselMap2 falls under the category of a medical imaging device and associated image analysis software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Static Vessel Analyzer (SVA) with VesselMap2 is intended to capture, display, store, and manipulate images of the eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed. Specifically, the VesselMap2 software is intended to be used for semiautomated measurement and calculation of the retinal artery/vein diameter ratio.
Product codes
HKI, NFF, NFG
Device Description
The IMEDOS SVA unit is designed as a complete Fundus Imaging system or the software can be sold separately as a standalone product. The SVA software consist of two components - VisualIS, an imaging software for capture, display, storage and manipulation of images of the eye and VesselMap2, an add-on for enhanced analysis of retina images.
VisualIS captures the images which are provided by the fundus camera and the connected digital image sensor. Together with an image set the data of the patient are recorded and stored. The complete examination can be stored and opened for follow-up examination purposes.
The add-on VesselMap2 offers a semi-automated measurement for Arterial -- Venous Ratio of retinal vessels. The software allows the user to select veins and arteries. Vessel diameters are estimated by the software and the ratio of the analyzed arteries to veins is calculated. The image is not altered in any way during this calculation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fundus Camera
Anatomical Site
Eye, especially the retina area, as well as surrounding areas.
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
Imedos completed a comprehensive method comparison study assessing the VesselMap software function compared to an accepted, manual method for determining arterial-venous ratios. This study assessed agreement, reproducibility, and repeatability. The completed study demonstrated:
- Agreement between manual and semi-automatic (VesselMap2) retinal vessel analysis, without any indication of statistically significant differences between methods;
- Smaller intragrader variability) and intergrader variability (reproducibility) for the semi-automatic method (VesselMap2) than for the manual method;
- In the manual method, a systematic bias between the two graders exists, which is not the case in the semi-automatic method. Thus, the comparison study demonstrated that the VesselMap software does not introduce reader-to-reader bias;
- Appropriate intravisit and intervisit reproducibility for the semi-automatic method. The visit-to-visit variability (whether for manual or semi-automated analysis) was shown to be much higher than the variability in results associated with the device.
Key Metrics
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.
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JUN 1 6 2009
510(k) SUMMARY
Imedos GmbH's Static Vessel Analvzer
· 510(k) Number: K082196
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
IMEDOS GmbH Am Nasstal 4 D-07751 Jena GERMANY Tel .: +49-3641-6396-0 Fax .: +49-3641-6396-12
Date Prepared: June 12, 2009
Contact Person: Dr. Hans Stromever Stromeyer & Partners Consulting 317 Shore Breeze Lane League City. TX 77573 Phone: +1.281.467.3424 Email: hans@stromeyerconsulting.com
Trade/Device Name: Static Vessel Analyzer (SVA) Classification Name: Opthalmic camera Regulation Number: 21 CFR 886.1120 Product Code: HKI, Class II
Classification Name: Medical image communications device. Regulation Number: 21 CFR 892.2010 Product Code: NFF, Class I 510(k) exempt
Classification Name: Medical image storage device Regulation Number: 21 CFR 892.2020 Product Code: NFG, Class I 510(k) exempt
Indications for Use:
Static Vessel Analyzer (SVA) with VesselMap2 is intended to capture, display, store, and manipulate images of the eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed. Specifically, the VesselMap2 software is intended to be used for semiautomated measurement and calculation of the retinal artery/vein diameter ratio.
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Technological Characteristics:
The IMEDOS SVA unit is designed as a complete Fundus Imaging system or the software can be sold separately as a standalone product. The SVA software consist of two components - VisualIS, an imaging software for capture, display, storage and manipulation of images of the eye and VesselMap2, an add-on for enhanced analysis of retina images.
VisualIS captures the images which are provided by the fundus camera and the connected digital image sensor. Together with an image set the data of the patient are recorded and stored. The complete examination can be stored and opened for follow-up examination purposes.
The add-on VesselMap2 offers a semi-automated measurement for Arterial -- Venous Ratio of retinal vessels. The software allows the user to select veins and arteries. Vessel diameters are estimated by the software and the ratio of the analyzed arteries to veins is calculated. The image is not altered in any way during this calculation.
The manual and semi-automatic calculation were compared and verified on representative retina images and the results show improved repeatability of the semi-automated calculations based on the uncertainty and precision of manual vessel diameter determination based on the user's subjective perception of vessel edges.
Performance Data
Imedos completed a comprehensive method comparison study assessing the VesselMap software function compared to an accepted, manual method for determining arterial-venous ratios. This study assessed agreement, reproducibility, and repeatability. The completed study demonstrated:
-
- Agreement between manual and semi-automatic (VesselMap2) retinal vessel analysis, without any indication of statistically significant differences between methods;
-
- Smaller intragrader variability) and intergrader variability (reproducibility) for the semi-automatic method (VesselMap2) than for the manual method;
-
- In the manual method, a systematic bias between the two graders exists, which is not the case in the semi-automatic method. Thus, the comparison study demonstrated that the VesselMap software does not introduce reader-to-reader bias;
-
- Appropriate intravisit and intervisit reproducibility for the semi-automatic method. The visit-tovisit variability (whether for manual or semi-automated analysis) was shown to be much higher than the variability in results associated with the device.
Substantial Equivalence
The Imedos SVA System has the same intended use, principles of operation and technological characteristics as the Carl Zeiss FF450plus VISUPAC System (K011877). The minor differences between the Carl Zeiss FF450plus VISUPAC System and the Imedos SVA system do not raise new questions of safety or effectiveness. Performance data demonstrate that the SVA System is as safe and effective its predicates. Thus, the SVA System is substantially equivalent.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three thick, curved lines forming the body and wings of the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Imedos GmbH c/o Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004
JUN 1 6 2009
Re: K082196
Trade Name: Static Vessel Analyzer (SVA) Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI, NFF, NFG Dated: May 22, 2009 Received: May 26, 2009
Dear Mr. Kahan:
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 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.
3
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Kesia Alexander for
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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Indications for Use
510(k) Number: K082196
Device Name: Static Vessel Analyzer (SVA)
Indications For Use:
Static Vessel Analyzer (SVA) with VesselMap2 is intended to capture, display, store, and manipulate images of the eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed. Specifically, the VesselMap2 software is intended to be used for semiautomated measurement and calculation of the retinal artery/vein diameter ratio.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) vision of Ophthalmic and Ear, ose and Throat Devices
510(k) Number K082196
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