(209 days)
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.
The Tomey Cornea/Anterior Segment OCT CASIA2 (CASIA2) is a non-contact, high resolution tomographic and biomicrocopic 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. 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.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The provided text doesn't explicitly list "acceptance criteria" in a table format with numerical targets. Instead, it describes a comparative clinical study where the Tomey Cornea/Anterior Segment OCT CASIA2 was compared against a predicate device (Optovue RTVue XR OCT Avanti) for image quality and visualization of anatomical structures and pathologies. The "acceptance criteria" are implicitly demonstrated by showing that the CASIA2 performs at least as well as and in many cases better than the predicate device for its intended use of visualizing anterior segment findings.
The following table summarizes the reported device performance and the implicitly met acceptance criteria of being comparable or superior to the predicate device.
| Performance Metric (Implicit Acceptance Criteria: Comparable or Superior to Predicate) | Reported Device Performance (Tomey CASIA2) |
|---|---|
| Overall Image Quality (compared to Avanti) | Better overall image quality in comparison to Avanti in the pooled population for the grader average score, and in the majority of individual grader comparisons. Similar results were found across normal, cataract, and glaucoma groups. |
| Visibility of Pathology (compared to Avanti) | Allowed for the observance of pathology more often than Avanti images for all scan types compared. |
| Visibility of Angle (compared to Avanti) | Observed more often with CASIA2 in comparison to Avanti. |
| Visibility of Lens (compared to Avanti) | Observed more often with CASIA2 in comparison to Avanti. |
| Visibility of Cornea (compared to Avanti) | Observed as often with CASIA2 as with Avanti. |
| Visibility of Iris (compared to Avanti) | Observed either as often as or more often with CASIA2 in comparison to Avanti, depending on the scan types. |
| Image Quality of CASIA2-only Scans | The 5 additional scans available only for CASIA2 (with no Avanti comparison) were also assessed for image quality, and scores varied from average to good. This implicitly demonstrates sufficient performance for these unique features. |
| Safety and Effectiveness | The differences between the proposed device and the predicate device are not significant and do not raise new issues of safety or effectiveness. The Tomey CASIA2 is deemed as safe and effective as the predicate device. This is a direct statement of meeting the "substantial equivalence" criteria. |
Study Proving Device Meets Acceptance Criteria
2. Sample Size and Data Provenance:
- Test Set Sample Size: 134 subjects.
- 45 Normal subjects
- 46 Cataract subjects
- 43 Glaucoma subjects
- Data Provenance: The text states it was a "prospective comparative clinical performance study." While the specific country of origin isn't stated for the clinical data, Tomey Corporation is based in Japan (as per the submitter information), and the consultant ORA, Inc. is in the USA. Clinical studies for FDA submissions typically involve diverse populations or are clearly described if conducted solely in one region. However, the text only specifies "subjects."
3. Number of Experts and Qualifications:
- Number of Experts: 3 masked graders.
- Qualifications of Experts: Not explicitly stated beyond "masked graders." It is highly probable, given the nature of the study, that these graders were ophthalmologists or optometrists with expertise in interpreting OCT images of the anterior segment. The term "masked graders" implies they were blinded to key study parameters (subject, disease population, device, and results from other graders).
4. Adjudication Method for the Test Set:
- The image grading procedure was "pre-specified in the study protocol."
- Images were assessed by 3 masked graders.
- The results report "grader average score" and "individual grader comparisons." This indicates that the individual scores of the three graders were analyzed, and a pooled average was used for comparison. There is no explicit mention of an "adjudication" process in the sense of a definitive consensus or tie-breaking mechanism if graders disagreed. The reporting suggests independent grading followed by aggregation or direct comparison of individual scores.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? Yes, a multi-reader, multi-case comparative study was conducted, as 3 masked graders evaluated images from 134 subjects across different disease states and scan types.
- Effect Size (Human Readers Improvement with AI vs. No AI): This study does not involve AI assistance for human readers. It is a comparison of two different OCT devices (Tomey CASIA2 vs. Optovue Avanti) for image quality as assessed by human readers. Therefore, there is no effect size related to human reader improvement with AI assistance. The study implicitly shows that the CASIA2 enables human readers to observe pathology and anatomical structures better or as often as the predicate device due to its image quality.
6. Standalone (Algorithm Only) Performance:
- The text describes the device as providing "imaging of ocular structures" and being "an aid in the visualization of anterior segment findings." The performance evaluation focuses on the quality of these images as assessed by human graders. There is no mention of an embedded algorithm providing automated diagnoses or measurements that would require a standalone performance study. The device itself is the imaging system, not an AI diagnostic algorithm.
7. Type of Ground Truth Used:
- The ground truth for the assessment of image quality, visibility of structures, and pathology was expert perception/consensus through grading by 3 masked experts. The study directly compared the ability of the new device's images versus the predicate device's images to allow observation by these experts. Patients were categorized by clinical diagnosis (normal, cataract, glaucoma), implying these clinical diagnoses served as the underlying "truth" for evaluating the device's utility in those populations, though the primary outcome was image quality.
8. Sample Size for the Training Set:
- The document does not provide information regarding a training set sample size. This is expected as the Tomey CASIA2 is an imaging device, not an AI algorithm that requires a dedicated training set to learn patterns. The study focuses on the performance of the device's output (images) rather than the performance of a learned model.
9. How Ground Truth for Training Set was Established:
- Since there's no mention of an AI algorithm requiring a training set, this information is not applicable and not provided in the document.
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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
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April 27, 2022
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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
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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
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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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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.
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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 withAngioVue Software (K180660) |
|---|---|---|
| Manufacturer | Tomey | Optovue, Inc. |
| Classification | 886.157 | 886.157 |
| Product Code | OBO | HLI, OBO |
| Indications for use | The Tomey Cornea/Anterior SegmentOCT CASIA2 is a non-contact, highresolution tomographic andbiomicroscopic device indicated for thein vivo imaging of ocular structures inthe anterior segment. The TomeyCornea/Anterior Segment OCT CASIA2is indicated as an aid in the visualizationof anterior segment findings. | The Avanti is an optical coherencetomography system intended for the invivo imaging, cross-sectional, and threedimensional imaging and measurement ofanterior 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 anteriorchamber of the eye. With the integratednormative database, Avanti is also aquantitative tool for the comparison ofretina, retinal nerve fiber layer, and opticdisc measurements in the human eye to adatabase of a known normal subjects. It isindicated for use as a diagnostic device toaid in the detection and management ofocular diseases.The Avanti with the AngioVue softwarefeature is indicated as an aid in thevisualization of vascular structures of theretina and choroid in normal subjects, andin subjects with glaucoma and retinaldiseases. The AngioAnalytics softwarefeature of AngioVue is indicated for themeasurement of vascular density, thefoveal avascular zone, the thickness ofretinal layers, and nerve fiber layer, andmeasurement of optic disc parameters innormal subjects, and in subjects withglaucoma and retinal diseases. |
| Feature | Tomey CASIA2 | Optovue RTVue XR OCT Avanti withAngioVue 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:Radial scan: 16 mmRaster scan: 12mm x 12mmScan depth: 13 mm | Corneal image: 12 mm x 8 mmCAM-L: 13 mm |
| Optical Resolution | Axial: 10µm or less (in tissue)Transverse: 30µm or less (in air) | 15µm (in the X and Y directions), 5 µm(in the Z direction) |
| Exposure Power atPupil | 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 | ||
| Wavelength | 520 nm (LED) | Unknown |
| Power output | 2.32 mW | Unknown |
| Continuous/Pulsed | Pulsed | Unknown |
| Pulse Durations | 1/30 sec | Unknown |
| Technological Characteristics: Others | ||
| Feature | Tomey CASIA2 | Optovue RTVue XR OCT Avanti withAngioVue Software (K180660) |
| Minimum PupilDiameter | φ 3.0 mm | φ 2.5 mm |
| Focus Range | - 18 D to +15 D | - 15 D to +12 D |
| Image Display | ||
| AS Global Scan | AS Global Scan | 3D Cornea |
| AS H+V Scan | AS H+V Scan | Cornea Cross Line |
| Angle HD | Angle HD_N (nasal)Angle HD_T (temporal)Angle HD_S (superior)Angle HD_I (inferior) | Angle_NasalAngle_TemporalAngle_SuperiorAngle_Inferior |
| AS single | AS single | Cornea line |
| Lens Scan | Lens Scan | No comparative scan |
| Lens Raster | Vitreous Raster | No comparative scan |
| Lens Global Scan | Lens Global Scan | No comparative scan |
| Lens H+V Scan | Lens H+V Scan | No comparative scan |
| Lens Single | Lens Single | No comparative scan |
| Recommended Networking Specifications | ||
| Operating System | Windows® 8.1 or 10 64 bit | Windows 7, 8 and 10; 64-bit OScompatible |
| Processor Speed | Intel® Core™i5 Processor or higher | 3.3 GHz; six-core |
| Network Bandwidth | 1 Gbps or higher | |
| Computer RAM | 8GB or more | 16 GB or higher |
| Monitor Resolution | 1920 x 1080 at 32-bit color |
Table 1: Comparison Table of Technological Characteristics
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Substantial Equivalence Discussion for the CASIA2 per the 510(k) Decision-Making Flowchart
- Is the predicate device legally marketed?
Yes, the predicate device is the Optovue RTVue XR OCT Avanti with AngioVue Software cleared in K180660.
- Do the devices have the same intended use?
Yes, both devices have the same intended use for the examination of the anterior segment of the eye when comparing the Optovue RTVue XR OCT Avanti with the CAM (cornea anterior module) attachment.
- Do the devices have the same technological characteristics?
Both the Tomey CASIA2 and the RTVue XR OCT Avanti are OCT devices. The principle of operation is identical in that both devices employ a non-invasive, non-contact low-coherence interferometry technique [specifically, spectral domain optical coherence tomography (SD-OCT)] to generate highresolution cross-sectional images of internal ocular tissue microstructures by measuring optical reflections from tissue. Both provide cross sectional images of the anterior structures of the eye (i.e., cornea and iris).
There are some identified differences in technological characteristics between the CASIA2 and the RTVue XR OCT Avanti as listed below.
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There are minor differences in technological characteristics between the Tomey CASIA2 and the predicate device including scan rate, wavelength, size of field of view, optical resolution, and exposure power at pupil.
There are also minor differences in technological characteristics between the Tomey CASIA2 and the predicate device as related to pupil diameter and focus range.
- Do the difference technological characteristics of the devices raise different questions of safety and effectiveness?
No, the different technological characteristics do not raise different questions of safety or effectiveness. Both devices use SD-OCT technology to perform in vivo viewing, and imaging ocular structures in the anterior segment of the eye.
5.a. Are the methods acceptable?
Yes, the testing methods used are per applicable recognized consensus standards as well as well understood bench and clinical testing protocols.
5.b. Do the data demonstrate substantial equivalence?
Yes, the data demonstrate substantial equivalence. This is discussed further in the Clinical Performance section below.
5.1 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 CASIA 2 OCT testing conformed to the following standards:
- . ISO 15004-1. Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
- IEC 60601-1. Medical electrical equipment Part 1: General requirements for basic safety and o essential performance
- o ANSI Z80.36: 2016 American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
- IEC 60601-1-6 Edition 3.1 2013-10 Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance
- ISO 10993-1 Fifth Edition 2018-08 Biological evaluation of medical devices Part 1: Evaluation ● and testing within a risk management process
- IEC 62304: 2006 Medical devices software - Software life cycle processes
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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.
5.2 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.
5.3 Conclusion
Therefore, based on the same intended use and similar technological characteristics with substantial equivalence to the predicate device confirmed with performance testing, the Tomey CASIA2 is technologically and functionally equivalent to the predicate device, RTVue XR OCT (K153080) for anterior segment imaging. The differences between the proposed device, CASIA2, and the predicate device are not significant and do not raise new issues of safety or effectiveness of the device. The Tomey CASIA2 is as safe and effective as the predicate device, and thus, may be considered substantially equivalent.
§ 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.