GDX VCC WITH ECC SOFTWARE

{0}------------------------------------------------ # SECTION 5. 5. 510(K) SUMMARY K082016 AUG 1 0 2009 ### 510(k) SUMMARY (per 21 CFR §807.92) ## GDx with ECC Retinal Nerve Fiber Layer Normative Database #### GENERAL INFORMATION Manufacturer: Carl Zeiss Meditec Inc. 5160 Hacienda Drive Dublin, California 94568 (925) 557-4616 (phone) (925) 557-4481 (fax) Est. Reg. No. 2918630 Contact Person: Judith A. Brimacombe, MA Director, Regulatory/Clinical Affairs Carl Zeiss Meditec Inc. 5160 Hacienda Drive Dublin, California 94568 (925) 557-4616 (phone) (925) 557-4481 (fax) Class II (acc. 21 CFR 886.1570) Classification name: ↑ Ophthalmoscope Classification: MYC, HLI Product Code: Trade/Proprietary name: GDx with ECC Retinal Nerve Fiber Layer Normative Database ### PREDICATE DEVICE | Company: | Carl Zeiss Meditec, Inc. | |----------|--------------------------------| | Device: | Nerve Fiber Analyzer (K941705) | | Company: | Carl Zeiss Meditec, Inc. | | Device: | Stratus OCT (K030433) | {1}------------------------------------------------ ## SECTION 5. ### INTENDED USE The GDx is a confocal polarimetric scanning laser ophthalmoscope that is intended for imaging and three-dimensional analysis of the fundus and retinal nerve fiber layer (RNFL) in vivo. The GDx and its GDx Variable Corneal Compensation (VCC) and GDx Enhanced Corneal Compensation (ECC) RNFL Normative Databases aid in the diagnosis and monitoring of diseases and disorders of the eye that may cause changes in the polarimetric retinal nerve fiber layer thickness. The GDx is to be used in patients who may have an optic neuropathy. #### DEVICE DESCRIPTION The GDx with ECC Retinal Nerve Fiber Layer Normative Database is a confocal scanning laser ophthalmoscope comprising an opto-mechanical scanning laser head unit and a computer. The device employs Scanning Laser Polarimetry (SLP) to measure the Retinal Nerve Fiber Layer (RNFL) thickness using polarized light. #### SUBSTANTIAL EQUIVALENCE The GDx with ECC Retinal Nerve Fiber Layer Normative Database is substantially equivalent to the predicate devices identified previously. The GDx with ECC Retinal Nerve Fiber Layer Normative Database is substantially equivalent to the predicate devices with regards to intended use, operating principle, function, and materials. Clinical evaluation performed on the GDx supports the expanded indications for use statement and demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness with respect to ophthalmoscopes. #### CLINICAL EVALUATION A clinical study was conducted at ten sites to gather data for the ECC normative database, to train the nerve fiber indicator (NFI), and to compare two GDx algorithms, variable corneal compensation (VCC) and enhanced corneal compensation (ECC). The GDx ECC RNFL thickness normative database was created using GDx ECC scan data from 251 subjects. 18 to 82 years of age, who were deemed representative of the normal population. The normative database has an even distribution of right and left eves, as well as gender, and has a wide representation of the general population with regard to refractive error, intraocular pressure, axial length, corneal curvature and thickness measurement spectrum. Data from 215 subjects with early, moderate and late stage glaucoma were also collected for the purpose of training the ECC NFI. Two-thirds of the normal and {2}------------------------------------------------ ## SECTION 5. glaucoma study eyes were randomly selected by statistical programs as the model building subset for the development of the ECC NFI. The other one-third of the study eyes was used for model validation. Results revealed that the ECC and VCC algorithms correlated well, and their ability to measure the RNFL thickness was similar. The ECC algorithm generated a lower atypical scan rate than the VCC algorithm and the ECC algorithm compensated for the anterior segment birefringence better than the VCC algorithm. #### SUMMARY As described in this 510(k) Summary, all testing deemed necessary was conducted on the GDx with ECC Retinal Nerve Fiber Layer Database to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion. The logo is black and white. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002 Carl Zeiss Meditec Incorporated c/o Judith A. Brimacombe, M.A. Director, Clinical/Regulatory Affaires 5160 Hacienda Drive Dublin, CA 94568 AUG 1 0 2009 Re: K082016 Trade Name: GDx VCC with ECC Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: MYC, HLI Dated: June 4, 2009 Received: June 9, 2008 Dear Ms. Brimacombe: 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, Or to 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 1011, 1 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbanding 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, {4}------------------------------------------------ Page 2 - Judith A. Brimacombe, M.A. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Kesia Alexander for Kesia R. Felder, MD 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 {5}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K082016 Device Name: ## GDx with ECC Retinal Nerve Fiber Layer Normative Database Indications for Use: The GDx is a confocal polarimetric scanning laser ophthalmoscope that is intended for imaging and three-dimensional analysis of the fundus and retinal nerve fiber layer (RNFL) in vivo. The GDx and its GDx Variable Corneal Compensation (VCC) and (DDx Enhanced Corneal Compensation (ECC) RNFL Normative Databases aid in the diagnosis and monitoring of diseases and disorders of the eye that may cause changes in the polarimetric retinal nerve fiber layer thickness. The GDx is to be used in patients who may have an optic neuropathy. Prescription Use x (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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Sexyhe 8/7/2009 (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number.