STATIC VESSEL ANALYZER

K082196 · Imedos GmbH · HKI · Jun 16, 2009 · Ophthalmic

Device Facts

• Record ID: K082196
• Device Name: STATIC VESSEL ANALYZER
• Applicant: Imedos GmbH
• Product Code: HKI · Ophthalmic
• Decision Date: Jun 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended 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.

Device Story

Static Vessel Analyzer (SVA) captures, displays, stores, and manipulates retinal images; utilizes fundus camera and digital image sensor. SVA software comprises VisualIS (imaging management) and VesselMap2 (analysis add-on). User selects veins and arteries on images; software estimates vessel diameters and calculates arterial-venous ratio. Used in clinical settings by healthcare providers to aid in diagnosis or monitoring of eye diseases. Semi-automated measurement improves repeatability and reduces reader-to-reader bias compared to manual methods. Output assists clinicians in assessing retinal vascular health.

Clinical Evidence

Method comparison study (bench testing) compared VesselMap2 semi-automated analysis to manual methods. Results demonstrated agreement between methods, smaller intra- and intergrader variability for the semi-automated method, and elimination of systematic reader-to-reader bias observed in manual analysis. Appropriate intravisit and intervisit reproducibility confirmed.

Technological Characteristics

Fundus imaging system; includes digital image sensor. Software components: VisualIS (image management) and VesselMap2 (semi-automated analysis). Connectivity: standalone or integrated with fundus camera. Software algorithm: semi-automated vessel diameter estimation and ratio calculation.

Indications for Use

Indicated for patients requiring diagnostic imaging or monitoring of eye and retinal diseases. Used for semiautomated measurement and calculation of retinal artery/vein diameter ratios.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*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.

Predicate Devices

• Carl Zeiss FF450plus VISUPAC System (K011877)

Submission Summary (Full Text)

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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 .: [phone] Fax .: [phone]

Date Prepared: June 12, 2009

Contact Person: Dr. Hans Stromever Stromeyer & Partners Consulting 317 Shore Breeze Lane League City. TX 77573 Phone: [phone] Email: [e-mail]

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:

- 1. Agreement between manual and semi-automatic (VesselMap2) retinal vessel analysis, without any indication of statistically significant differences between methods;
- 2. Smaller intragrader variability) and intergrader variability (reproducibility) for the semi-automatic method (VesselMap2) than for the manual method;
- 3. 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;
- 4. 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

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#### 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.

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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 [phone] or [phone] 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 _____________________________________________________________________________________________________________________________________________________________

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# 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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