(209 days)
Not Found
No
The summary describes a standard OCT imaging device and its performance in a clinical study comparing image quality to a predicate device. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image analysis, interpretation, or other functions.
No.
The device is used for imaging and visualization of ocular structures, not for treating conditions.
Yes
The device is described as an "aid in the visualization of anterior segment findings" and is used to image ocular structures. The performance studies also compare its ability to visualize pathology in cataract and glaucoma patients, which indicates its use in identifying and assessing disease, thus serving a diagnostic purpose.
No
The device description explicitly lists several hardware components including a main unit, AC input power source, touch panel LCD monitor, external hard drive, mouse, and keyboard. It also describes the device as a "non-contact, high resolution tomographic and biomicrosopic device" that obtains images using swept-source OCT, which is a hardware-based imaging modality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states "in vivo imaging of ocular structures" and "aid in the visualization of anterior segment findings." This describes a device used to image structures within the living body, not to perform tests on samples taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a non-contact imaging device that uses light to create images of ocular structures. This aligns with in vivo imaging, not in vitro testing.
- No mention of analyzing biological samples: The entire description focuses on imaging the eye itself, not on analyzing blood, tissue, or other biological samples.
Therefore, the Tomey Corneal Anterior Segment OCT CASIA2 is an in vivo imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OBO
Device Description
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 [detected 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
- AS Global scan
- AS H+V Scan
- AS Single
- Lens
- Lens scan
- Lens Raster
- Lens Global scan
- Lens H+V Scan
- Lens Single
- Iridocorneal Angle
- Angle HD N (nasal)
- Angle HD T (temporal)
- Angle HD S (superior)
- Angle HD I (inferior)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Swept Source OCT
Anatomical Site
ocular structures in the anterior segment, cornea, angle, lens, iris, iridocorneal angle
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
The prospective comparative clinical performance study enrolled 134 subjects (45 normal, 46 cataract, 43 glaucoma). Image Quality was compared to predicate Optovue RTVue Avanti XR OCT, as evaluated by 3 masked graders. Outcomes were pooled for all subjects as well as evaluated separately for normal, cataract, and glaucoma groups, in subjects with a range of cataract severity/types and a range from narrow to open angles.
Images from CASIA2 and Avanti devices for 7 different scan types were assessed for Image Quality based on visibility of anatomic structures (cornea, angle, lens, and iris) and ocular pathology. The image grading procedure was pre-specified in the study protocol and images were assessed by 3 graders masked to subject, disease population, device, and result from other graders.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Performance Data: Bench testing has been performed to comply with applicable standards to demonstrate that the CASIA2 performs as intended and is substantially equivalent to the predicate device, RTVue XR OCT (K153080) with Cam attachment, with respect to imaging of ocular structures. Software documentation was provided, and software verification was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Documentation regarding cybersecurity was submitted as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" and an overall risk assessment regarding security and safety of the device was conducted following ISO 14971:2019-12. The CASIA 2 device complies with recognized consensus standards regarding electrical safety, optical safety and biocompatibility. The system level testing with software version 4.3 was conducted with passing results. The performance testing demonstrated that the device satisfies the performance requirements specified for its intended use and is equivalent to the relevant performance characteristics of the predicate device.
Clinical Performance Data: The prospective comparative clinical performance study enrolled 134 subjects (45 normal, 46 cataract, 43 glaucoma). Image Quality was compared to predicate Optovue RTVue Avanti XR OCT, as evaluated by 3 masked graders. Outcomes were pooled for all subjects as well as evaluated separately for normal, cataract, and glaucoma groups, in subjects with a range of cataract severity/types and a range from narrow to open angles. Images from CASIA2 and Avanti devices for 7 different scan types were assessed for Image Quality based on visibility of anatomic structures (cornea, angle, lens, and iris) and ocular pathology. The image grading procedure was pre-specified in the study protocol and images were assessed by 3 graders masked to subject, disease population, device, and result from other graders. CASIA2 provided better overall image quality in comparison to Avanti in the pooled population for the grader average score as well as in the majority of the individual grader comparisons. The individual populations, normal, cataract, and glaucoma groups, had similar results as the pooled population. For the assessment of the presence of pathology, the CASIA2 images allowed for the observance of pathology more often than Avanti images for all scan types compared. Visibility of angle and lens were observed more often with CASIA2 in comparison to Avanti. Cornea was observed as often with CASIA2 as with Avanti and visibility of iris was observed either as often as or more often with CASIA2 in comparison to Avanti depending on the scan types. The 5 additional scans available for CASIA2 only, with no Avanti comparison, were also assessed for image quality, scores varied from average to good.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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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
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
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. | The Avanti is an optical coherence
tomography system intended for the in
vivo imaging, cross-sectional, and three
dimensional imaging and measurement of
anterior and posterior ocular structures,
including retina, retinal nerve fiber layer,
ganglion cell complex (GCC), optic disc,
cornea, corneal epithelia, corneal stroma,
pachymetry, corneal power, and anterior
chamber of the eye. With the integrated
normative database, Avanti is also a
quantitative tool for the comparison of
retina, retinal nerve fiber layer, and optic
disc measurements in the human eye to a
database of a known normal subjects. It is
indicated for use as a diagnostic device to
aid in the detection and management of
ocular diseases.
The Avanti with the AngioVue software
feature is indicated as an aid in the
visualization of vascular structures of the
retina and choroid in normal subjects, and
in subjects with glaucoma and retinal
diseases. The AngioAnalytics software
feature of AngioVue is indicated for the
measurement of vascular density, the
foveal avascular zone, the thickness of
retinal layers, and nerve fiber layer, and
measurement of optic disc parameters in
normal subjects, and in subjects with
glaucoma and retinal diseases. |
| Feature | Tomey CASIA2 | Optovue RTVue XR OCT Avanti with
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 |