PRIMUS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 21, 2017 Carl Zeiss Suzhou Co., Ltd. % Dong Hua Sr. Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 Re: K163195 Trade/Device Name: PRIMUS Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: Mav 8. 2017 Received: May 9, 2017 Dear Dong Hua: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. {1}------------------------------------------------ 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 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Kesia Alexander for 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K163195 Device Name PRIMUS Indications for Use (Describe) The PRIMUS instrument is a non-contact, high resolution tomographic imaging device. It is indicated for in-vivo viewing of axial cross sections and measurement of posterior ocular structures, including retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 510(k) Summary (Revised) ## 510(k) SUMMARY (per 21 CFR §807.92) PRIMUS ## GENERAL INFORMATION | Applicant: | | Carl Zeiss Suzhou Co., Ltd.<br>Modern Industrial Square 3b<br>No. 333 Xing Pu Road Sip<br>Suzhou, Jiangsu 215126 China<br>+ 86-512-8227-3436 (phone)<br>+ 86-512-6287-1366 (fax)<br>Establishment Registration Number: 3008564898 | | | | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--| | Contact Person: | | Dong Hua<br>Sr. Regulatory Affairs Specialist<br>Carl Zeiss Meditec, Inc.<br>5160 Hacienda Drive<br>Dublin, CA 94568<br>(925) 557-4204 Phone<br>(925) 557-4259 Fax<br>E-mail: dong.hua@zeiss.com | | | | | Date Prepared: | | June 09, 2017 | | | | | Common Name: | | Tomography, Optical Coherence | | | | | Classification Name: | | Ophthalmoscope | | | | | Product Code and Class: | | OBO - Class II | | | | | Classification Number: | | 21 CFR 886.1570 | | | | | Trade/Proprietary Name: | | PRIMUS | | | | | Model: | | 200 | | | | | PREDICATE DEVICE | | | | | | | Company: | | Carl Zeiss Meditec, Inc. | | | | | Device: | Cirrus HD-OCT with Retinal Nerve Fiber Layer (RNFL), Macular, Optic<br>Nerve Head and Ganglion Cell Normative Databases (K111157) | | | | | {4}------------------------------------------------ It is the opinion of Carl Zeiss Suzhou Company, Limited that the PRIMUS instrument is substantially equivalent to the predicate Cirrus HD-OCT with Retinal Nerve Fiber Layer (RNFL), Macular, Optic Nerve Head and Ganglion Cell Normative Databases Model 4000 (K111157) for the intended use for imaging and measurements of posterior ocular structures. The PRIMUS device is an ophthalmic diagnostic instrument that provides only the essential performance and functionality compared to Cirrus™ HD-OCT, e.g. with a separate manual-controlled patient interface and basic analysis features. ## INDICATIONS FOR USE (21 CFR §807.92(a)(5)) The PRIMUS instrument is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing of axial cross sections and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration and glaucoma. ## DEVICE DESCRIPTION SUMMARY (21 CFR §807.92(a)(4)) The PRIMUS device is an ophthalmic instrument that provides the essential performance and functionality compared to the Carl Zeiss Meditec CIRRUS™ HD-OCT Model 4000 (K11157), with a separate manually-controlled patient interface and simplified analysis features. PRIMUS uses the same SD-OCT technology from the CIRRUS and offers a simplified user interface. In addition, the camera in the PRIMUS instrument operates at a reduced speed to acquire OCT images at comparable resolution in approximately the same amount of time. #### Device Overview The PRIMUS device is a computerized ophthalmologic instrument that acquires and allows visualization of cross-sectional tomograms of the eye using spectral domain optical coherence tomography (SD-OCT). The instrument is designed to scan the eye in a non-contact manner to acquire detailed cross-sectional images of various posterior ocular structures such as the retina and the optic nerve head. Various retinal structures of the eye from the internal limiting membrane to the retinal pigment epithelium (including layers such as the ganglion and retinal nerve fiber) can be imaged. The PRIMUS instrument is available in one model, Model 200, which has a manually controlled patient interface and separate enclosure with components used in OCT scanning. The operator utilizes a keyboard, monitor and mouse to interface with the computer. Data acquired can be saved to the computer; PDFs of the reports may be saved to a USB-connected storage device. The principle of operation is identical in that both devices employ a non-invasive, non-contact low-coherence interferometry technique [spectral domain optical coherence tomography (SD-OCT) to generate high-resolution cross-sectional images of internal ocular tissue microstructures by measuring optical reflections from tissue. Both provide cross sectional images of the posterior structures of the eye (i.e., retina, including the ganglion and retinal {5}------------------------------------------------ nerve fiber layers). The device consists of two main parts: a manually controlled separate patient interface and an imaging engine box. The system is composed of a number of electrical, mechanical, and optical subsystems that are required to facilitate measurements and aid in patient alignment: - Optical head modules - SD-OCT engine modules - Patient module - Support modules As part of its report driven workflow, at the completion of scan acquisition, PRIMUS presents the pre-ordered report(s) to the user in a sequential manner. The visualization and analysis reports that available in PRIMUS are as follows: - Macular Thickness Analysis (MTA) Based on 512 X 32 Macular Cube Scan - Optic Nerve Head (ONH) & Retinal Nerve Fiber Layer (RNFL) Analysis Based on 128 X 128 ONH & RNFL Cube Scan - HD 5-line Analysis Based on 5 line HD Raster Scan - HD 1-line Analysis Based on 1 line HD Raster Scan ## Description of Software Software version 2.0 at Release 1 (R1) provides functions of patient management, image acquisition, visualization and analysis capabilities that are categorized into the following groups: - Patient Management and Administration - Acquisition - Analysis CZSC has implemented a software development process according to IEC 62304. With software version 2.0 at Release 1 (R1), PRIMUS offers automatic retinal thickness measurement and quantitative analysis reports. Risk Management and General Safety and Effectiveness The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software means, user instructions, verification of requirements and validation of the clinical workflow to ensure that the product meets its intended uses. To minimize electrical, mechanical and radiation hazards, ZEISS adheres to recognized and established industry practice and relevant international standards. {6}------------------------------------------------ #### Technological Characteristics and Substantial Equivalence (21 CFR §807.92(a)(6)): It is the opinion of Carl Zeiss Meditec, Incorporated that the proposed device, the PRIMUS 200, is substantially equivalent to the CIRRUS HD-OCT with Software Version 6.0. The indications for use for the PRIMUS 200 is similar to the indications for the predicate device CIRRUS HD-OCT with Software Version 6.0. A technological comparison and clinical testing demonstrate that the PRIMUS 200 system is functionally equivalent to the primary predicate CIRRUS HD-OCT (K111157) and does not raise new questions regarding safety and effectiveness. #### Summary of Verification and Validation Activity (21 CFR §807.92(b)): #### Bench Testing (21 CFR §807.92(b)(1)) Bench testing in the form of Unit, Integration and System Integration testing was performed to evaluate the performance and functionality of the software version 2.0. The System level software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the Test Plans. PRIMUS is designed and tested to applicable standards for electrical and optical safety with established specifications. Performance testing conducted on the PRIMUS instrument was consistent to the intended use claim. The verification testing demonstrates that the device performance complies with specifications and requirements. Results of verification and validation demonstrate safety and effectiveness as the predicate device, tests can be categorized into the following groups: - Device System Verification - Verification According to Harmonized/Recognized Standards - . Electrical Safety and Electromagnetic Compatibility - Environmental Simulation . - . Usability - Biocompatibility - Software Verification and Validation - Product Validation #### Testing to Consensus Standards (21 CFR §807.92(b)(1)) The PRIMUS 200 system has been tested (as needed) to meet the requirements for conformity (where applicable) to multiple industry standards. The R&D evaluation of the relevant testing to consensus standards is documented. #### Substantial Equivalence to Predicates (21 CFR §807.92(b)(1)) Verification testing to the system requirements (SRS) for the PRIMUS 200 system and the validation of the intended use is intended to support the claim of substantial equivalence to the following Substantial Equivalence table: {7}------------------------------------------------ | Device | PRIMUS<br>(Proposed Device K163195) | Cirrus HD-OCT with Retinal Nerve Fiber Layer<br>(RNFL), Macular, Optic Nerve Head and<br>Ganglion Cell Normative Database (K111157)<br>[Model: 4000] | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | The CirrusTM HD-OCT with Retinal Nerve Fiber | | Intended Use | The PRIMUS is used for in-vivo<br>viewing of axial cross-sectional<br>imaging and measurement of<br>posterior ocular structures. | Layer (RNFL), Macular, Optic Nerve Head and<br>Ganglion Cell Normative Databases is indicated<br>for in-vivo viewing, axial cross-sectional, and<br>three-dimensional imaging and measurement<br>of anterior and posterior ocular structures. | | Indication for Use | The PRIMUS instrument is a non-<br>contact, high resolution<br>tomographic and biomicroscopic<br>imaging device. It is indicated for<br>in-vivo viewing of axial cross<br>sections and measurement of<br>posterior ocular structures,<br>including retina, retinal nerve<br>fiber layer, macula, and optic<br>disc. It is intended for use as a<br>diagnostic device to aid in the<br>detection and management of<br>ocular diseases including, but not<br>limited to, macular holes, cystoid<br>macular edema, diabetic<br>retinopathy, age-related macular<br>degeneration and glaucoma | The CirrusTM HD-OCT is a non-contact, high<br>resolution tomographic and biomicroscopic<br>imaging device. It is indicated for in-vivo<br>viewing, axial cross-sectional, and three-<br>dimensional imaging and measurement of<br>anterior and posterior ocular structures,<br>including cornea, retina, retinal nerve fiber<br>layer, ganglion cell plus inner plexiform layer,<br>macula, and optic nerve head. The Cirrus<br>normative databases are quantitative tools for<br>the comparison of retinal nerve fiber layer<br>thickness, macular thickness, ganglion cell plus<br>inner plexiform layer thickness, and optic<br>nerve head measurements to a database of<br>normal subjects. The Cirrus HD-OCT is<br>intended for use as a diagnostic device to aid<br>in the detection and management of ocular<br>diseases including, but not limited to, macular<br>holes, cystoid macular edema, diabetic<br>retinopathy, age-related macular<br>degeneration, and glaucoma | | Device Classification | Optical Coherence Tomography | Optical Coherence Tomography (OCT) | | Name<br>Generic Common Name | (OCT)<br>Optical Coherence Tomography<br>(OCT) | Optical Coherence Tomography (OCT) | | Classification Product<br>Code | OBO | OBO | | Class | II | II | | Technology | Spectral Domain OCT (SD-OCT) | Spectral Domain OCT (SD-OCT) | | OCT Imaging | | | | Methodology | Spectral Domain OCT (SD-OCT) | Spectral Domain OCT (SD-OCT) | | Optical Source | Super Luminescent Diode, 840nm | Super Luminescent Diode, 840nm | | Optical Power | ≤ 725 µW at the cornea | < 725 µW at the cornea | | Scan Speed | 12,000 (±10%) A-scans per second | 27,000 A-scans per second | | A-Scan Depth | 2.0 mm (in tissue), 1,024 points | 2.0 mm (in tissue), 1,024 points | | Axial Resolution | 5 µm ±1 (in tissue) | 5 µm (in tissue) | | Transverse Resolution | < 20µm (in tissue, FWHM*) | 15 µm (in tissue) | | | | | | Device | PRIMUS<br>(Proposed Device K163195) | Cirrus HD-OCT with Retinal Nerve Fiber Layer<br>(RNFL), Macular, Optic Nerve Head and<br>Ganglion Cell Normative Database (K111157)<br>[Model: 4000] | | Scan Pixels | 1024 axial x (128-1024) transverse | 1024 axial × (200-4096) transverse | | Acquisition Time | Up to 2.5 seconds (depending on #<br>of pixels scanned) | Up to 2.9 sec (depending on # of pixels<br>scanned) | | Scan Patterns | 5-line raster scan, 1-line HD scan,<br>Macular Cube scan (512x32),<br>ONH/RNFL cube scan (128x128) | Line, circle, cross-hair, raster (a series of<br>closely spaced lines), radial scans and<br>combinations of the above. Includes Macular<br>Cube Scan (512x128); ONH/RNFL Cube Scan<br>(200x200); HD 5-line raster; HD Single line scan | | Fundus Imaging | | | | Methodology | Confocal Scanning "Laser"<br>Ophthalmoscope (cSLO) | Line Scanning Ophthalmoscope | | Optical Source | Super Luminescent Diode (SLD),<br>840nm | Super Luminescent Diode (SLD), 750 nm | | Optical Power | ≤ 725µW at the cornea | < 1.5 mW at the cornea | | Field of View | 29 × 21 degrees (W × H) | 36 × 30 degrees (W × H) | | Frame Rate | Alignment: ≥ 4.0 Hz | > 20 Hz | | Transverse Resolution | Alignment : ≤ 80µm (in Tissue) | 25 µm (in tissue) | | Fixation | | | | Internal Fixation Source | Consistently displayed 525 nm Green<br>colored LED | LCD (green pixels) | | Internal Fixation Focus<br>Adjustment | -23D to +17D (diopters) Focus of<br>Internal Fixation will change<br>according to different refractive<br>error adjustment | -20D to +20D (diopters) | | External Fixation Source | Mechanically adjustable arm with<br>blinking LED at the tip | Mechanically adjustable arm with blinking<br>LED at the tip | # Table 1: Substantial Equivalence Table {8}------------------------------------------------ # Table 1: Substantial Equivalence Table {9}------------------------------------------------ #### CLINICAL EVALUATION Clinical evaluation performed on the PRIMUS supports the indications for use statement and demonstrates that the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness. A prospective study was conducted to support the indication for use statement for the PRIMUS with software version 2.0 at Release 1 (R1) and to determine comparability of the measurements obtained from both the PRIMUS 200 and the Cirrus HD-OCT Model 4000 instruments. Clinical data was collected and analyzed to determine the repeatability and reproducibility of the measurements of the PRIMUS 200. The study enrolled normal eyes, eyes with retinal disease and glaucoma. #### Comparative analysis for the PRIMUS 200 and CIRRUS Model 4000 A study was performed on total 127 subjects, which included 45 normal subjects, 39 retinal disease subjects and 43 glaucoma subjects were analyzed in the study to evaluate equivalence of the means of 19 measurement parameters: retinal nerve fiber layer (RNFL) thickness (5 parameters), optic nerve head (ONH) (5 parameters), and macular thickness (9 parameters) between the PRIMUS 200 and Cirrus HD-OCT Model 4000. Two study devices, PRIMUS 200 & Cirrus HD-OCT Model 4000 and each measurement parameter, the mean of the available measurements was calculated for each study eye. The difference in each of the 19 measurement parameters between the PRIMUS 200 and Cirrus HD-OCT Model 4000 was calculated for each study eye. The mean difference, the corresponding 95% confidence intervals, and 95% limits of agreement were calculated for each measurement parameter. The comparative analyses utilized on one PRIMUS 200 device, and the results are presented in Tables 2, 3 and 4 for the normal, retinal disease and glaucoma disease eye studies, respectively. Additionally 95% Cls for the lower and upper limits of agreement are provided in Table 2a (normal eyes), Table 3a (retinal disease eyes) and Table 4a (glaucomatous eyes). The mean values of the 19 thickness parameters were very similar between the two devices. The results of the study parameters demonstrate substantial equivalence between the PRIMUS 200 and Cirrus HD-OCT Model 4000. {10}------------------------------------------------ ## Table 2: Mean difference in macular thickness, RNFL thickness and ONH measurements between PRIMUS 200 and CIRRUS 4000 (Normal eyes) | | Primus 200<br>Mean (SD) | Cirrus 4000<br>Mean (SD) | Difference<br>Mean (SD) | 95%<br>Confidence<br>Interval of<br>Mean<br>Difference | 95% Limits of<br>Agreement for<br>Differences<br>Between<br>Subject Means | |----------------------------------|-------------------------------------|--------------------------|-------------------------|--------------------------------------------------------|---------------------------------------------------------------------------| | | Macular Thickness Parameters (N=45) | | | | | | Central Subfield (µm) | 236.1 (19.87) | 236.0 (20.77) | 0.1 (5.36) | (-1.5, 1.7) | (-10.4, 10.6) | | Inner Nasal (µm) | 315.1 (17.16) | 316.2 (18.14) | -1.1 (6.74) | (-3.1, 0.9) | (-14.3, 12.1) | | Inner Superior (µm) | 311.9 (16.11) | 315.6 (16.47) | -3.8 (6.30) | (-5.6, -2.0) | (-16.1, 8.5) | | Inner Temporal (µm) | 299.4 (16.59) | 301.5 (16.49) | -2.1 (6.25) | (-3.9, -0.3) | (-14.3, 10.2) | | Inner Inferior (μm) | 309.6 (16.80) | 312.4 (16.96) | -2.8 (6.44) | (-4.7, -0.9) | (-15.4, 9.8) | | Outer Nasal (μm) | 291.0 (13.47) | 293.9 (14.08) | -3.0 (4.96) | (-4.4, -1.6) | (-12.7, 6.7) | | Outer Superior (µm) | 273.5 (11.67) | 274.1 (10.37) | -0.6 (6.71) | (-2.6, 1.4) | (-13.8, 12.6) | | Outer Temporal (µm) | 252.7 (12.81) | 255.6 (12.02) | -2.9 (5.11) | (-4.4, -1.4) | (-12.9, 7.1) | | Outer Inferior (µm) | 258.0 (12.18) | 262.8 (13.37) | -4.8 (3.78) | (-5.9, -3.7) | (-12.2, 2.6) | | RNFL Thickness Parameters (N=45) | | | | | | | Average RNFL<br>Thickness (µm) | 90.6 (10.03) | 92.8 (10.00) | -2.3 (4.05) | (-3.5, -1.1) | (-10.2, 5.6) | | Temporal (µm) | 58.4 (6.11) | 59.7 (8.65) | -1.2 (5.49) | (-2.8, 0.4) | (-12.0, 9.6) | | Superior (µm) | 115.5 (16.88) | 118.0 (16.64) | -2.5 (7.41) | (-4.7, -0.3) | (-17.0, 12.0) | | Nasal (µm) | 71.7 (9.86) | 74.2 (10.93) | -2.5 (5.06) | (-4.0, -1.0) | (-12.4, 7.4) | | Inferior (µm) | 116.6 (17.20) | 119.5 (16.31) | -2.8 (7.14) | (-4.9, -0.7) | (-16.8, 11.2) | | ONH Parameters (N=45) | | | | | | | Rim Area (mm²) | 1.29 (0.194) | 1.31 (0.1…