(292 days)
Not Found
No
The summary describes a digital camera for capturing images and videos of the eye and surrounding areas. It details the hardware, image capture process, storage, and transfer methods. There is no mention of any image analysis, processing, or interpretation features that would typically involve AI/ML. The performance studies listed are related to safety, compatibility, and basic functionality, not algorithmic performance.
No
The device is described as a camera for capturing images and videos of the eye and surrounding areas for documentation purposes. It is not designed to treat, prevent, or mitigate any disease or condition.
No.
The device is described as a medical digital camera used to capture images and videos for documentation, not for making a diagnosis.
No
The device description explicitly mentions hardware components such as a camera, smartphone, dock station, lens protector, allen wrench, eyecaps, cleaning cloth, and slit lamp adapter. It also describes physical functions like capturing images and videos using light sources and fixation targets. The performance studies include electrical safety, EMC, optical safety, optical performance, environmental, biocompatibility, and usability testing, all of which are relevant to a physical device.
Based on the provided information, the Eyer® Retinal Camera model NM-STD is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Eyer® Retinal Camera directly captures images and videos of the human eye and surrounding areas. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for capturing images and videos for documentation. While these images might be used by a medical professional to aid in diagnosis, the device itself is not performing a diagnostic test on a biological sample.
- The device description focuses on imaging technology and capturing visual information. There is no mention of analyzing biological markers or performing tests on specimens.
The Eyer® Retinal Camera is a medical imaging device used for visualization and documentation, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Eyer® Retinal Camera model NM-STD is a medical non-mydriatic digital camera with a Samsung Galaxy S10 smartphone to capture digital images and videos of the funan eye, surface of the human eye and surrounding areas
Product codes
HKI
Device Description
The Eyer Retinal Camera NM-STD retinography is accompanied by accessories: dock station (1pc), lens protector (1 pc), allen wrench (1pc), eyecap (2 pcs) cleaning cloth (1 pc) and slit lamp adapter (1pc).
Eyer Retinal Camera NM-STD is designed for use in a medical environment. Captured images and video are used for documentation. The images and videos are stored in an internal database of the smartphone application, in a security way.
For the retinal function, Eyer Retinal Camera NM-STD is designed for non-mydriatic fundus imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the fundus 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. Eyer Retinal Camera NM-STD has eleven fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-center image. It is possible to fix the center by selecting the appropriate point.
For the anterior function, Eyer Retinal Camera NM-STD has a white light source for imaging eye surface and surrounding areas, in this configuration the device does not make contact with the patient.
The transfer of images to a PC is carried out via FTP, DICOM or CFIS communication, with the client responsible for the connection and subsequent storage.
The Eyer Retinal Camera NM-STD, energy comes from the smartphone that has a rechargeable Li-lon battery and is charged when the device is docked on charge station, which is connected to the mains by power supply cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fundus of the human eye, surface of the human eye and surrounding areas
Indicated Patient Age Range
Not Found
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)
- Electrical safety (ES) and electromagnetic compatibility (EMC): Eyer Retinal Camera NM-STD was tested according to all suitable clauses of IEC 60601-1:2005+A1:2012+A2:2020 (edition 3.2) (safety) and #19-8 - IEC 60601-1-2:2014 (edition 4.0).
- Optical Safety: Eyer Retinal Camera NM-STD were tested according to the standard # 10-123 - ISO 15004-1 e #10-102 - ANSI Z80.36.
- Optical Performance: Eyer Retinal Camera NM-STD fulfills the requirements of standard #10-74 - ISO 10940:2009 -Ophthalmic instruments - Fundus cameras.
- Software Verification and Validation: Software verification and validation were conducted to ensure the fulfillment of the system requirements and functionality. Eyer Retinal Camera NM-STD complies with the standard #13-79 - IEC 62304:2015. with Class A.
- Environmental testing: Eyer Retinal Camera NM-STD was tested according to # 10-123 - ISO 15004-1:2020 and IEC 60601-1 standards to verify the mechanical stress and ambient conditions for use and storage as prescribed for the device. The devices fulfill the requirements of the standard.
- Biocompatibility: Eyer Retinal Camera NM-STD have an eyecap that contacts skin around the eye during normal usage of the device. A piece made of elastomeric material that touches the patient's skin during the exam, used to give firmness to the manipulation and create an environment isolated from external light. The chosen material was SILPURAN 2420 from manufacturer WACKER and is a non-toxic silicone that has a certificate of conformity with ISO 10993 standard and USP Class IV Biological Tests.
- Usability (Human Factors): Eyer Retinal Camera NM-STD was designed and evaluated by following the principles depicted in the usability engineering process. The usage of Eyer Retinal Camera NM-STD was evaluated to be suitable for its intended use and the device complies with the standards IEC 60601-1-6:2013.
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
§ 886.1120 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.
0
February 22, 2023
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Phelcom Technologies Bruno Milhoci Regulatory Affairs Coordinator Passarini Regulatory Affairs of America LLC 555 Thirteenth Street. NW Washington, District of Columbia 20004
Re: K221329
Trade/Device Name: Eyer Retinal Camera NM-STD Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: January 10, 2023 Received: January 23, 2023
Dear Bruno Milhoci:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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/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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (OS) 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 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-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. 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
2
Indications for Use
510(k) Number (if known) K221329
Device Name Eyer Retinal Camera model NM-STD
Indications for Use (Describe)
Eyer® Retinal Camera model NM-STD is a medical non-mydriatic digital camera with a Samsung Galaxy S10 smartphone to capture digital images and videos of the funan eye, surface of the human eye and surrounding areas
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
PHELCOM TECHNOLOGIES Traditional 510(k) Premarket Submission Eyer Retinal Camera NM-STD
Image /page/3/Picture/1 description: The image shows the logo for Phelcom. The logo consists of a circular icon with a stylized "P" inside, followed by the text "PHELCOM" in a sans-serif font. Above and to the right of the text is the identifier "K221329".
510(k) Summary
| 510(k) submitter: | Phelcom Technologies | |
|---|---|---|
| Address: | Rua José Missali, 820 - Parque | |
| Santa Felícia Jardim - São Carlos - | ||
| SP - CEP: 13562-405 - Brazil. | ||
| Company phone: | +55 (16) 3421 8488 | |
| Contact person: | Bruno Milhoci de Souza | |
| Date: | February, 22, 2023 | |
| Subject device: | Trade name: | Eyer Retinal Camera NM-STD |
| 510(k) number: | K221329 | |
| Common/ usual 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 |
4
Image /page/4/Picture/1 description: The image shows the logo for Phelcom. The logo consists of a stylized letter P on the left and the word "PHELCOM" on the right. Above the word "PHELCOM" is the text "K221329".
Description of the device
The Eyer Retinal Camera NM-STD retinography is accompanied by accessories: dock station (1pc), lens protector (1 pc), allen wrench (1pc), eyecap (2 pcs) cleaning cloth (1 pc) and slit lamp adapter (1pc).
Eyer Retinal Camera NM-STD is designed for use in a medical environment. Captured images and video are used for documentation. The images and videos are stored in an internal database of the smartphone application, in a security way.
For the retinal function, Eyer Retinal Camera NM-STD is designed for non-mydriatic fundus imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the fundus 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. Eyer Retinal Camera NM-STD has eleven fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-center image. It is possible to fix the center by selecting the appropriate point.
For the anterior function, Eyer Retinal Camera NM-STD has a white light source for imaging eye surface and surrounding areas, in this configuration the device does not make contact with the patient.
The transfer of images to a PC is carried out via FTP, DICOM or CFIS communication, with the client responsible for the connection and subsequent storage.
The Eyer Retinal Camera NM-STD, energy comes from the smartphone that has a rechargeable Li-lon battery and is charged when the device is docked on charge station, which is connected to the mains by power supply cable.
Indications for Use
Eyer® Retinal Camera model NM-STD is a medical non-mydriatic digital camera with a Samsung Galaxy S10 smartphone to capture digital images and videos of the human eye, surface of the human eye and surrounding areas
Contraindications:
There are no known contraindications.
Comparison of Technological Characteristics
Table 5-A bellow includes a summary of the technical information used in the substantial equivalence discussion.
5
Image /page/5/Picture/1 description: The image shows the logo for Phelcom. The logo consists of a stylized letter 'C' in blue and green, followed by the word 'PHELCOM' in blue, block letters. Above the word 'PHELCOM' is the text 'K221329'.
5-A - Comparison of Characteristics
| Characteristic | Predicate Device | Subject Device |
|---|---|---|
| Regulatory Information | ||
| Device Name | Optomed Aurora Camera | |
| Optomed Aurora Retinal Module | ||
| Optomed Aurora Anterior Module | Eyer Retinal Camera NM-STD | |
| Manufacturer | Optomed Oy | Phelcom Technologies |
| 510(k) Number | K180378 | K221329 |
| Product Code | HKI | HKI |
| Device Class | ||
| CFR Section | ||
| Common Name | Class II | |
| 21 CFR 886.1120 | ||
| Ophthalmic camera | Class II | |
| 21 CFR 886.1120 | ||
| Ophthalmic camera | ||
| Indications for Use | 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. | Eyer® Retinal Camera model NM- | |
| STD is a medical non-mydriatic | ||
| digital camera with a Samsung | ||
| Galaxy S10 smartphone to capture | ||
| digital images and videos of the | ||
| fundus of the human eye, surface | ||
| of the human eye and surrounding | ||
| areas | ||
| 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. | ||
| Target Population | Images/ system is not patient | |
| population specific. | Images/ system is not patient | |
| population specific. | ||
| Hardware Design Features | ||
| Illumination source | Aurora Retinal Module: | Eyer Retinal Camera: |
| White: OSRAM Oslon LUW-H9GP; | ||
| 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 | White: OSRAM Oslon Compact; | |
| NIR: OSRAM CHIPLED; | ||
| Target LEDs: Kingbright. | ||
| Display system | 4.0", TFT-LCD, 800x480 pixels, | |
| 16.7 M colors, anti-glare coating. | 5.8", 1400x2960 pixels, Gorilla | |
| Glass protection (smartphone) | ||
| Camera sensor specification | Color CMOS camera maximum | |
| resolution 5 Mp. | Color CMOS camera maximum | |
| resolution 12 Mp. | ||
| Diopter compensation | From -20 D to +20 D | From -20 D to +20 D |
| Field of view | 50x40 degrees | 45 degrees |
| Storage media | MicroSDHC memory card | Internal smartphone storage |
| Image data format | JPEG, MPEG-4 | JPEG, MPEG-4 |
| Weight | Aurora Camera: 514g | |
| Aurora Retinal Module: 310g | ||
| Aurora Anterior Module: 105g | Eyer Retinal Camera: 700g | |
| Battery | Rechargeable Li-Ion battery, | |
| 5000065, 3.63 V, 2600 mAH. | Rechargeable Li-Ion battery, 3.85 V , 3000 mAh (smartphone). | |
| Output terminals and data collection | USB(1.1) terminal (B-connector). | |
| Compatible with Windows® 7/8/10 | ||
| and macOS(three latest versions). | Media transfer via FTP, DICOM | |
| and CIFS communication. | ||
| Standard | • 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 | ||
| • IEC 62366-1:2015 | • IEC 60601-1:2005+A1:2012+A2:2020 (edition 3.2); | |
| • IEC 60601-1-2:2014 (edition 4.0); | ||
| • ISO 15004-1:2020 | ||
| • ANSI Z80.36:2016 | ||
| • ISO 10940:2009 | ||
| • NEMA PS3.1-30.20: 2021 | ||
| • IEC 62304:2015 | ||
| • ISO 10993-1:2018 | ||
| • ISO 10993-5:2009 | ||
| • ISO 10993-10:2010 |
6
PHELCOM TECHNOLOGIES Traditional 510(k) Premarket Submission
Image /page/6/Picture/1 description: The image shows the logo for Phelcom. The logo consists of a circular icon on the left, followed by the text "PHELCOM" in a sans-serif font. Above the text, there is a smaller text string "K221329".
Eyer Retinal Camera NM-STD
7
Image /page/7/Picture/1 description: The image shows the logo for Phelcom. The logo consists of a blue and green icon on the left, followed by the word "PHELCOM" in blue letters. The number "K221329" is located in the upper right corner of the image.
Discussion of differences
The main difference between the Eyer Retinal Camera NM-STD and the Optomed Aurora is that in the Eyer the exam solutions are integrated into the equipment, while in Aurora solutions are modular.
The following items are differences between the devices:
Display O
For the display system, the difference between the subject device and the predicate device is that the Eyer Retinal Camera has higher number of pixels on the screen. However, this does not interfere with the safety and effectiveness in relation to the predicate because both have the same result, which is to capture images and videos from the fundus of the human eye, surface of the human eye and surrounding areas.
O Data storage
Eyer Retinal Camera NM-STD uses the internal memory of the smartphone whereas the predicate uses SD card.
Battery O
The battery of the predicate has 2600 mAh, and the subject has 3000 mAh, but this does not affect the effectiveness or safety of the device.
Data collection O
The main differences between the Eyer Retinal Camera NM-STD and Aurora Optomed are the type of transmission. The Eyer uses WiFi to transfer the data.
O Field of View
The field of view of the subject device and of the predicate devices are similar.
Camera O
About the camera sensor specification, the subject device uses a camera with the maximum resolution of 12Mp, and the predicate device uses a camera with maximum resolution of 5Mp, however it does not influence the indication for uses or affect the safety and effectiveness of the device.
O Storage Media
The storage media of the smartphone on the subject device is internal and the predicate device has storage that is carried out on a memory card. And this does not have an impact on the effectiveness and safety of the device.
Performance Data
The following performance data is provided in support of the substantial equivalence determination.
O Electrical safety (ES) and electromagnetic compatibility (EMC)
Eyer Retinal Camera NM-STD was tested according to all suitable clauses of IEC 60601-1:2005+A1:2012+A2:2020 (edition 3.2) (safety) and #19-8 - IEC 60601-1-2:2014 (edition 4.0).
O Optical Safety
8
Image /page/8/Picture/1 description: The image shows the logo for Phelcom. The logo consists of a circular icon with a stylized "P" inside, followed by the text "PHELCOM" in bold, sans-serif font. Above the text is the identifier "K221329".
Eyer Retinal Camera NM-STD were tested according to the standard # 10-123 - ISO 15004-1 e #10-102 - ANSI Z80.36.
Optical Performance O
Eyer Retinal Camera NM-STD fulfills the requirements of standard #10-74 - ISO 10940:2009 -Ophthalmic instruments - Fundus cameras.
Software Verification and Validation O
Software verification and validation were conducted to ensure the fulfillment of the system requirements and functionality. Eyer Retinal Camera NM-STD complies with the standard #13-79 - IEC 62304:2015. with Class A.
Environmental testing O
Eyer Retinal Camera NM-STD was tested according to # 10-123 - ISO 15004-1:2020 and IEC 60601-1 standards to verify the mechanical stress and ambient conditions for use and storage as prescribed for the device. The devices fulfill the requirements of the standard.
Biocompatibility O
Eyer Retinal Camera NM-STD have an eyecap that contacts skin around the eye during normal usage of the device. A piece made of elastomeric material that touches the patient's skin during the exam, used to give firmness to the manipulation and create an environment isolated from external light. The chosen material was SILPURAN 2420 from manufacturer WACKER and is a non-toxic silicone that has a certificate of conformity with ISO 10993 standard and USP Class IV Biological Tests.
Usability (Human Factors) O
Eyer Retinal Camera NM-STD was designed and evaluated by following the principles depicted in the usability engineering process. The usage of Eyer Retinal Camera NM-STD was evaluated to be suitable for its intended use and the device complies with the standards IEC 60601-1-6:2013.
Conclusion
In conclusion, Phelcom Technologies believes that we have established substantial equivalence of the subject Eyer Retinal Camera NM-STD to the predicate. No new issues of safety or effectiveness are introduced by using this device. The basis for our conclusion is reached through successful review of product design specifications and testing results compared to the predicate device.