(20 days)
Not Found
No
The document describes a digital camera for capturing images of the eye and mentions transferring images to an "AI Optics Server," but it does not describe any AI/ML functionality within the device itself or how the server processes the images using AI/ML. The focus is on the camera's imaging capabilities and substantial equivalence to a predicate device.
No
The device is described as a camera intended to capture digital images, which are used for documentation and consultation, not for treatment.
No
The device is described as a camera intended to capture digital images for documentation and consultation. There is no mention of it analyzing images or providing a diagnosis.
No
The device description explicitly details hardware components such as a camera, charging base, eye cup, power cable, internal memory, and a rechargeable battery. It is a physical medical device that captures images.
Based on the provided information, the Sentinel Camera is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Sentinel Camera's Function: The Sentinel Camera directly captures images of the human eye in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use is to "capture digital images of the human eye" for "documentation and consultation." This is a direct imaging function, not an in vitro diagnostic test.
Therefore, the Sentinel Camera falls under the category of medical imaging devices, not IVD devices.
N/A
Intended Use / Indications for Use
Sentinel Camera is a non-mydriatic medical digital camera that is intended to capture digital images of the human eye.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
The Sentinel Camera is accompanied by the following accessories: a charging base, eye cup, and power cable.
The Sentinel Camera is designed for use in a medical environment. Captured images are used for documentation and consultation. Sentinel Camera has internal memory where captured images are stored.
The Sentinel Camera is designed for non-mydriatic retinal imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the retina and white light is flashed when an image is taken. The pupil does not respond to the infrared light, so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. The Sentinel Camera has three internal fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-centered image. The left and right fixation targets provide disc-centered images.
The transfer of images to the AI Optics Server is carried out via Wi-Fi communication.
The Sentinel Camera has a rechargeable Li-ion battery that is charged when the camera is placed on charging base, which is connected to the mains by the power cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital images of the human eye
Anatomical Site
human eye
Indicated Patient Age Range
System is not patient population specific.
Intended User / Care Setting
medical environment
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data for the Sentinel Camera, including extensive testing against recognized standards, supports the substantial equivalence of the Sentinel Camera to the predicate device. Both devices underwent similar testing to external standards. The testing demonstrates that the Sentinel Camera meets the necessary safety and performance criteria, with no new questions of safety or effectiveness raised by the differences in technological characteristics, therefore supporting the conclusion of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
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Image /page/0/Picture/0 description: The image contains 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.
December 17, 2024
AI Optics % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K243664
Trade/Device Name: Sentinel Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: November 27, 2024 Received: November 27, 2024
Dear Prithul Bom:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (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-regulatory
2
assistance/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. 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
Enclosure
3
Indications for Use
510(k) Number (if known) K243664
Device Name Sentinel Camera
Indications for Use (Describe)
Sentinel Camera is a non-mydriatic medical digital camera that is intended to capture digital images of the human eye.
| 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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Image /page/4/Picture/0 description: The image contains the logo for AI Optics. The logo consists of a circular icon to the left of the text "AI Optics". The icon is a partial circle with lines radiating outward from the open side of the circle. The text "AI Optics" is in a sans-serif font and is aligned horizontally with the icon.
Page 1 of 5
Sentinel Camera 510(k) Summary (K243664)
| 510(k) Submitter: | AI Optics |
|---|---|
| Address: | 145 Lexington Ave |
| Floor 10 | |
| New York, New York 10016 | |
| Company Phone: | 914-874-3256 |
| Contact Person: | Andrew DiGiore |
| Date: | December 16, 2024 |
| Subject Device: | |
| Trade Name: | Sentinel Camera |
| 510(k) Number: | K243664 |
| Common Name: | Ophthalmic Camera |
| Classification Name: | Camera, Ophthalmic, AC-Powered |
| (21 CFR 886.1120) | |
| Regulatory Class: | II |
| Product Code: | HKI |
| Predicate Device: | |
| Trade Name: | Optomed Aurora Camera |
| Optomed Aurora Retinal Module | |
| Optomed Aurora Anterior Module | |
| 510(k) Number: | K180378 |
| Regulatory Class: | II |
| Product Code: | HKI |
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Image /page/5/Picture/0 description: The image shows the logo for AI Optics. The logo consists of a blue circle that is partially filled with blue lines radiating from the center. To the right of the circle are the words "AI Optics" in blue sans-serif font.
Description of the Device
The Sentinel Camera is accompanied by the following accessories: a charging base, eye cup, and power cable.
The Sentinel Camera is designed for use in a medical environment. Captured images are used for documentation and consultation. Sentinel Camera has internal memory where captured images are stored.
The Sentinel Camera is designed for non-mydriatic retinal imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the retina and white light is flashed when an image is taken. The pupil does not respond to the infrared light, so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. The Sentinel Camera has three internal fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-centered image. The left and right fixation targets provide disc-centered images.
The transfer of images to the AI Optics Server is carried out via Wi-Fi communication.
The Sentinel Camera has a rechargeable Li-ion battery that is charged when the camera is placed on charging base, which is connected to the mains by the power cable.
Indications for Use
Sentinel Camera is a non-mydriatic medical digital camera that is intended to capture digital images of the human eye.
Comparison of Technological Characteristics
The technological characteristics of the Sentinel Camera closely match those of the Optomed Aurora Camera Optomed Aurora Retinal Module Optomed Aurora Anterior Module (K180378). Both devices utilize similar imaging technology, including a high-resolution camera and light sources for illumination. The slight variations in specifications does not raise new questions of safety and effectiveness.
Table 1 below includes a summary of the technical information used in the substantial equivalence discussion.
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Image /page/6/Picture/0 description: The image contains the logo for AI Optics. The logo consists of a circular graphic on the left and the text "AI Optics" on the right. The circular graphic is a partial circle made up of several lines, and the text is in a sans-serif font.
Sentinel Camera Traditional 510(k) Premarket Submission Page 3 of 5
Table 1: Substantial Equivalence
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Device Name | Sentinel Camera | Optomed Aurora Camera |
| Optomed Aurora Retinal Module | ||
| Optomed Aurora Anterior Module | ||
| 510(k) Number | K243664 | K180378 |
| Classification | HKI | HKI |
| Device Class | Class II | Class II |
| CFR Section | 21 CFR 886.1120 | 21 CFR 886.1120 |
| Common Name | Ophthalmic camera | Ophthalmic camera |
| Indication for Use | Sentinel Camera is a medical digital | |
| camera that is intended to capture | ||
| images of the eye. | Optomed Aurora Camera is a medical | |
| digital camera that is used with | ||
| dedicated optics modules intended to | ||
| capture images and videos of fundus of | ||
| the eye and surface of the eye. | ||
| Optomed Aurora Camera with Optomed | ||
| Aurora Retinal Module is intended to | ||
| capture digital images and videos of the | ||
| human eye. | ||
| Optomed Aurora Camera with Optomed | ||
| Aurora Anterior Module is intended to | ||
| capture digital images and video of the | ||
| surface of the human eye and | ||
| surrounding areas. | ||
| Usage | Prescription Use | Prescription Use |
| Use Condition | Intended to be used without mydriasis | |
| but can be used also with mydriatic | ||
| drops. | Intended to be used without mydriasis | |
| but can be used also with mydriatic | ||
| drops. | ||
| Patient Population | System is not patient population | |
| specific. | System is not patient population | |
| specific. | ||
| Illumination Source | • White: OSRAM Oslon Compact PL | |
| • IR: Roithner Lasertechnik SMB1N | ||
| • Target LEDs: Kingbright | Aurora Retinal Module: | |
| • White: OSRAM Oslon LUWH9GP | ||
| • NIR: OSRAM Oslon SFH-4716 | ||
| • Target LEDs: Vishay VLMS1500-GS08 |
Aurora Anterior Module:
• White: OSRAM Advanced Power Topled LW G6SP-EAFS-JKQL-1
• Blue: OSRAM Advanced Power Topled LB G6SP-V2BB-35-1 |
| Display System | 4.0", TFT-LCD, 720x720 pixels | 4.0", TFT-LCD, 800x480 pixels |
| Camera Sensor | Color CMOS camera maximum resolution 5 MP | Color CMOS camera maximum resolution 5 MP |
| Diopter
Compensation | From -20 D to +15 D | From -20 D to +20 D |
| Field of View | 50 x 40 degrees | 50 x 40 degrees |
| Storage Media | Internal storage | MicroSDHC memory card |
| Image Data Format | PNG | JPEG, MPEG-4 |
| Weight | 900 g | Aurora Camera: 514g
Aurora Retinal Module: 310g
Aurora Anterior Module: 105g |
| Battery | Rechargeable Li-Ion battery, 3.65 V, 5200 mAh | Rechargeable Li-Ion battery, 5000065, 3.63 V, 2600 mAh |
| Data Transfer | Data transfer via Wi-Fi | Data transfer via USB (1.1) |
| Standards | • IEC 60601-1:2005+A2:2020 (Edition 3.2)
• IEC 60601-1-2: 2014 +A1: 2020 (Edition 4.1)
• ISO 15004-1:2020
• ANSI Z80.36:2016
• ISO 10940:2009
• NEMA PS3.1-30.20: 2021
• IEC 62304:2015
• ISO 10993-1:2018
• NEMA PS 3.1 - 3.20 2022 | • IEC 60601- 1:2005+A1:2012 (Edition 3.1)
• IEC 60601-1-2:2014 (Edition 4.0)
• IEC 60601-1- 6:2010+A1:2013 (Edition 3.1)
• IEC 62471:2006
• ISO 15004-1:2006
• ISO 15004-2:2007
• ISO 10940:2009
• IEC 62304:2006 +A1:2015 |
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Image /page/7/Picture/0 description: The image contains the logo for AI Optics. The logo consists of a circular icon on the left and the text "AI Optics" on the right. The circular icon is a stylized representation of a lens or aperture, with a series of lines radiating outward from the center. The text "AI Optics" is written in a sans-serif font, with the letters "AI" slightly larger than the word "Optics". The logo is a simple and modern design, and the use of the color blue gives it a professional and trustworthy feel.
Page 4 of 5
Performance Data
Performance data for the Sentinel Camera, including extensive testing against recognized standards, supports the substantial equivalence of the Sentinel Camera to the predicate device. Both devices underwent similar testing to external standards. The testing demonstrates that the Sentinel Camera meets
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Image /page/8/Picture/0 description: The image shows the logo for AI Optics. The logo consists of a circular icon on the left and the text "AI Optics" on the right. The circular icon is a partial circle with lines radiating outward from the center, resembling a stylized lens or aperture. The text "AI Optics" is written in a sans-serif font and is aligned horizontally with the circular icon.
Page 5 of 5
the necessary safety and performance criteria, with no new questions of safety or effectiveness raised by the differences in technological characteristics, therefore supporting the conclusion of substantial equivalence.
Conclusion
Based on the provided performance data and the comparison, Sentinel Camera is as safe, as effective, and performs as well as or better than the predicate device. Sentinel Camera is substantially equivalent to the predicate device.