Tomey Cornea/Anterior Segment OCT CASIA2

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date May 11, 2022. The text is in a clear, serif font. The date is written out in full, with the month, day, and year clearly visible. The image is simple and straightforward, with the focus on the date itself. Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Tomey Corporation % Ryan Bouchard Consultant ORA, Inc. 300 Brickstone Square Andover, Massachusetts 01801 Re: K213265 Trade/Device Name: Tomey Cornea/Anterior Segment OCT CASIA2 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dear Mr. Bouchard: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 27, 2022. Specifically, FDA is updating the 510(k) Summary as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Elvin Ng. OHT1: Office of Ophthalmic. Anesthesia, Respiratory. ENT and Devices, 240-402-4662. Elvin.Ng(a)fda.hhs.gov. Sincerely, Elvin Y. Ng -S Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ April 27, 2022 Image /page/1/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Tomey Corporation % Ryan Bouchard Consultant ORA, Inc. 300 Brickstone Square Andover, Massachusetts 01801 Re: K213265 Trade/Device Name: Tomey Cornea/Anterior Segment OCT CASIA2 Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: March 25, 2022 Received: March 28, 2022 Dear Mr. Bouchard: 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 Mav 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. 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. 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 {2}------------------------------------------------ 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Elvin Y. Na -S Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213265 Device Name Tomey Cornea/Anterior Segment OCT CASIA2 Indications for Use (Describe) The Tomey Corneal Anterior Segment OCT CASIA2 is a non-contact, high resolution tomographic and biomicrosopic device indicated for the in vivo imaging of ocular structures in the anterior segment. The Tomey Corneal Anterior Segment OCT CASIA2 is indicated as an aid in the visualization of anterior segment findings. Type of Use (Select one or both, as applicable) | <div><span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | |------------------------------------------------------------------------------------------------| | <div><span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ## 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 required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ This summary of the 510(k) premarket notification for the Tomey Cornea/Anterior Segment OCT CASIA2 is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR\$807.92. Submitter Information: ## Owner/Company name, address Tomey Corporation 2-11-33 Noritakeshinmachi Nishi-ku, Nagoya 451-0051 Japan Contact person Yuko Matsushita Regulatory Telephone: [+81] 52-581-5327 E-mail: ymatsushita@tomey.co.jp ## Contact/Application Correspondent Ryan Bouchard Ora, Inc. 300 Brickstone Square Andover, MA 01810 Telephone: (978) 332-9574 Facsimile: (978) 689-0020 E-mail: rbouchard@oraclinical.com ## Date Prepared April 27, 2022 #### Device Information 1. | Trade Name: | Tomey Cornea/Anterior Segment OCT CASIA2 | |----------------------------|------------------------------------------| | Common Name: | OCT (Optical Coherence Tomography) | | Classification Name: | Tomography, optical coherence | | Product Code: | OBO | | Classification Regulation: | 21 CFR 886.1570 | #### Predicate Device 2. The CASIA2 is substantially equivalent to the following legally marketed device: | 510(k) Number | Trade name | Product code | |---------------|--------------------------------------------|--------------| | K180660 | RTVue XR OCT Avanti with AngioVue Software | OBO, HLI | The predicate device is hereinafter called the Avanti. {5}------------------------------------------------ #### Description of the Device 3. The Tomey Cornea/Anterior Segment OCT CASIA2 (CASIA2) is a non-contact, high resolution tomographic and biomicroscopic device indicated for in vivo imaging of ocular structures in the anterior segment. The Tomey Cornea/Anterior Segment OCT CASIA2 is indicated as an aid in the visualization of anterior segment findings. CASIA2 consists of several components: the main unit, AC input power source, a touch panel LCD monitor, an external hard drive (HDD), a mouse and a keyboard. There are two types of OCT, which are based on different measurement principles: time domain (TD) and Fourier domain (FD). In the TD, the reference mirror is moved mechanically in the direction of depth; in the FD, the depth-wise tissue data is obtained without moving the reference mirror. With the FD, since the reference mirror does not need to be moved mechanically, images can be obtained at a higher speed compared to the TD. The FD is further classified into spectral-domain OCT Idetected in Fourier space using broadband light source and spectroscope (grating) without moving the reference mirror] and swept-source OCT (optical interference performed in the Fourier space by changing the wavelength of the light source at a high speed). CASIA2 is an anterior segment OCT that obtains images by A-scanning with swept-source OCT. OCT images are created by the intensity of the light (backscattered light) that returns in the same path as that of incident light among the scattered light of each tissue. Thus, it is created with higher intensity in the tissues that generate strong backward scattering. The various structures which are imaged, and the related scans include the following: - . Cornea - 0 AS Global scan - 0 AS H+V Scan - O AS Single - Lens ● - Lens scan O - Lens Raster O - Lens Global scan O - o Lens H+V Scan - Lens Single O - Iridocorneal Angle ● - Angle HD N (nasal) O - Angle HD T (temporal) O - Angle HD S (superior) O - Angle HD I (inferior) O #### 3.1 Performance specification - Scan speed: 50,000 A scans/second - Scan Range: ● - o Depth: 13mm - Radial: 16mm in diameter O - Transverse: Raster: 12 x 12 mm O {6}------------------------------------------------ #### Indications for Use 4. The Tomey Cornea/Anterior Segment OCT CASIA2 is a non-contact, high resolution tomographic and biomicroscopic device indicated for the in vivo imaging of ocular structures in the anterior segment. The Tomey Cornea/Anterior Segment OCT CASIA2 is indicated as an aid in the visualization of anterior segment findings. #### 5. Statement of substantial equivalence For its indications, the Tomey Cornea/Anterior Segment OCT CASIA2 has the same intended use as the RTVue XR OCT Avanti for the anterior segment as shown in the comparison table below. Both the CASIA2 and the Avanti are indicated as an optical coherence tomography system intended for in vivo imaging of anterior ocular structures of the anterior chamber of the eye. The Tomey OCT CASIA2 does not include the posterior segment indications. | Feature | Tomey CASIA2 | Optovue RTVue XR OCT Avanti with<br>AngioVue Software (K180660) | |----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Tomey | Optovue, Inc. | | Classification | 886.157 | 886.157 | | Product Code | OBO | HLI, OBO | | Indications for use | The Tomey Cornea/Anterior Segment<br>OCT CASIA2 is a non-contact, high<br>resolution tomographic and<br>biomicroscopic device indicated for the<br>in vivo imaging of ocular structures in<br>the anterior segment. The Tomey<br>Cornea/Anterior Segment OCT CASIA2<br>is indicated as an aid in the visualization<br>of anterior segment findings. | The Avanti is an optical coherence<br>tomography system intended for the in<br>vivo imaging, cross-sectional, and three<br>dimensional imaging and measurement of<br>anterior and posterior ocular structures,<br>including retina, retinal nerve fiber layer,<br>ganglion cell complex (GCC), optic disc,<br>cornea, corneal epithelia, corneal stroma,<br>pachymetry, corneal power, and anterior<br>chamber of the eye. With the integrated<br>normative database, Avanti is also a<br>quantitative tool for the comparison of<br>retina, retinal nerve fiber layer, and optic<br>disc measurements in the human eye to a<br>database of a known normal subjects. It is<br>indicated for use as a diagnostic device to<br>aid in the detection and management of<br>ocular diseases.<br>The Avanti with the AngioVue software<br>feature is indicated as an aid in the<br>visualization of vascular structures of the<br>retina and choroid in normal subjects, and<br>in subjects with glaucoma and retinal<br>diseases. The AngioAnalytics software<br>feature of AngioVue is indicated for the<br>measurement of vascular density, the<br>foveal avascular zone, the thickness of<br>retinal layers, and nerve fiber layer, and<br>measurement of optic disc parameters in<br>normal subjects, and in subjects with<br>glaucoma and retinal diseases. | | Feature | Tomey CASIA2 | Optovue RTVue XR OCT Avanti with<br>AngioVue Software (K180660) | | Technological Characteristics: OCT | | | | Imaging | Swept Source OCT | Spectral Domain OCT | | Scan Rate | 50,000 A-Scan/s | 70,000 A-Scan/s | | Technological Characteristics: Swept Source Laser | | | | -Wave Length | 1310 nm (LD) | 840 nm (SLD) | | -Power Output | <6 mW | Unknown | | -Continuous/Pulsed | Pulsed | Unknown | | -Pulse Durations | 12.56µs | Unknown | | Field of View | Transverse:<br>Radial scan: 16 mm<br>Raster scan: 12mm x 12mm<br>Scan depth: 13 mm | Corneal image: 12 mm x 8 mm<br>CAM-L: 13 mm | | Optical Resolution | Axial: 10µm or less (in tissue)<br>Transverse: 30µm or less (in air) | 15µm (in the X and Y directions), 5 µm<br>(in the Z direction) | | Exposure Power at<br>Pupil | 893 μW | <750 μW | | Technological Characteristics: Internal Fixation Lamp Center | | | | -Wavelength | 605 nm (LED) | Unknown | | -Power Output | 30mW | Unknown | | -Continuous/Pulsed | Continuous | Unknown | | Technological Characteristics: Accommodation Target | | | | Wavelength | 605 nm (LED) | Unknown | | Power output | 30mW | Unknown | | Continuous/Pulsed | Continuous | Unknown | | Technological Characteristics: External Fixation Lamp | | | | Wavelength | 670 nm (LED) | Unknown | | Power output | 2.8mW | Unknown | | Continuous/Pulsed | Continuous | Unknown | | Technological Characteristics: Alignment Lamp | | | | Wavelength | 810 nm (LED) | Unknown | | Power output | 2.32 mW | Unknown | | Continuous/Pulsed | Continuous | Unknown | | Technological Characteristics: Front Illumination (red) Lamp | | | | Wavelength | 940 nm (LED) | Unknown | | Power output | 2.32 mW | Unknown | | Continuous/Pulsed | Continuous | Unknown | | Technological Characteristics: Front Illumination (green) Lamp | |…