(286 days)
Not Found
No
The summary describes standard image processing functions (measurement, comparison, montage) and hardware components, but does not mention any AI/ML terms or capabilities.
No.
The device is intended to capture, display, and process images for diagnosis and evaluation, not for providing therapy or treatment.
Yes
The Intended Use section explicitly states that the device is "intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health."
No
The device description explicitly details multiple hardware components including an optical module, mobile platform module, power supply module, control module, and chin rest module, all of which are integral to the device's function of capturing and processing images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Fundus Camera RetiCam 3100 captures digital images of the posterior and external structures of the eye. It does not perform tests on biological samples.
- Intended Use: The intended use is to aid clinicians in the evaluation, diagnosis, and documentation of ocular health by providing images. This is an in-vivo imaging function, not an in-vitro diagnostic test.
Therefore, the device falls under the category of an ophthalmic imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Fundus Camera RetiCam 3100 is intended to capture digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.
Product codes
HKI
Device Description
The RetiCam 3100 fundus camera is capable to capture, display, story, manage, process digital images of the posterior and external structures of the eye continuously, in real time.
The RetiCam 3100 fundus camera displays color fundus images continuously, in real time. The fundus digital image acquisition and image processing system is capable to perform measurement of the length (digital caliper), and perform area measurements, image comparison and image montage.
The RetiCam 3100 fundus camera function module includes: optical module, mobile platform module, power supply module, control module, chin rest module.
Optical Module
The optical module is responsible for providing background light illumination, flash shooting, fixing lamp control, lens focal length adjustment and pupil monitoring of patients when the fundus camera works. The optical module mainly consists of two parts: the light source module and the lens light path module.
-
- The light source component is the source of the light source when the product works, including background light, fixation light and flash when shooting.
-
- The lens light path is responsible for reflecting the patient's fundus image to the digital camera. The functions of lens focusing, pupil size switching and double camera pupil monitoring are used to ensure that the patient's fundus image can be presented clearly and reliably.
Mobile Platform Module
This module is mainly responsible for control of the position of optical module (i.e. up, down, left, right, back and forth movement of the optical module). This includes X, Y, Z axes, which are designed with servo motor and bearing, which are controlled by PCB board in the control module.
Power Supply Module
Power supply to each module through medical switching power supply.
Control Module
To enable operators to control the product, understand the working status of the product, observe the patient's condition, and carry out the corresponding inspection work normally.
There is a computer system integrated in the product, the input and output function are realized by touch screen display.
Chin Rest Module
To place the patient's head and keep the patient's eyes stable and easy to observe.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior and external structures of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as designed Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- AAMI/ANSI/ES 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General ● requirements for basic safety and essential performance
- IEC 60601-1-2:2014. Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety . and Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And ISO 15004-1:2006 Ophthalmic instruments - Fundamental requirements and test methods -Part 1: General requirements applicable to all ophthalmic instruments
- ISO 15004-2:2007 Ophthalmic instruments -- Fundamental requirements and test methods --Part 2: Light hazard protection
- ISO 10940:2009 Ophthalmic instruments Fundus cameras ●
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
- . ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
- . ANSI Z80.36-2016 American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
Summary of the results of performance testing and the device requirements based on ISO 10940:
- Resolving Power (Field of view > 30° ): Centre 2: 60lp/mm, Middle (r/2) 2: 40lp/mm, Periphery (r) 2: 25lp/mm. Test results: 60 lp/mm, 40 lp/mm, 25 lp/mm.
- Tolerance of angular field of view: 50° ±5%. Test results: 48.0°.
- Tolerance of pixel pitch: 6.45 um ±7%. Test results: 6.59.
- Range of Focus: -15D to +15D. Test results: Meet the specification.
No clinical study is included in this submission.
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.
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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Chongqing Bio NewVision Medical Equipment Ltd. % Ray Wang Beijing Believe-Med Technology Service Co., Ltd. R912, B#15, XiYueHui, No.5, YiHe North Rd., Fangshan District Beijing, 102401 CHINA
Re: K190954
Trade/Device Name: Fundus Camera RetiCam 3100 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: December 13, 2019 Received: December 16, 2019
Dear Ray Wang:
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,
for Tieuvi Nguyen, Ph.D. 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): K190954
Device Name Fundus Camera RetiCam 3100
Indications for Use (Describe)
The Fundus Camera RetiCam 3100 is intended to capture digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.
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)
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510(K) SUMMARY
This 510(k) Summary information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
APPLICANT INFORMATION
Date of Preparation: 01/20/2020
Sponsor Identification
Chongqing Bio NewVision Medical Equipment Ltd.
#1-10, Floor 9th of building #4, Group 2N of 2nd Project, Fulicheng Zhihuiguoji, Shapingba District, 401331 Chongqing, PEOPLE'S REPUBLIC OF CHINA
Contact Person: Wang Hao, Quality Manager Tel: 86-13657617625 Fax: 86-23-65456482 Email: wh(@fortune-newvision.com
Designated Submission Correspondent: Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District BeiJing, China 102401Tel: +86-18910677558 Fax: +86-10- 56335780 Email: ray.wang@believe-med.com
IDENTIFICATION OF SUBJECT DEVICE
Trade Name: Fundus Camera RetiCam 3100 Regulation Number:21 CFR 886.1120 Regulation Name: camera, ophthalmic, ac-powered Classification: II Product Code: HKI
INDICATIONS FOR USE
The Fundus Camera RetiCam 3100 is intended to capture digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.
DEVICE DESCRIPTION
The RetiCam 3100 fundus camera is capable to capture, display, story, manage, process digital images of the posterior and external structures of the eye continuously, in real time.
The RetiCam 3100 fundus camera displays color fundus images continuously, in real time. The fundus
4
digital image acquisition and image processing system is capable to perform measurement of the length (digital caliper), and perform area measurements, image comparison and image montage.
The RetiCam 3100 fundus camera function module includes: optical module, mobile platform module, power supply module, control module, chin rest module.
Optical Module
The optical module is responsible for providing background light illumination, flash shooting, fixing lamp control, lens focal length adjustment and pupil monitoring of patients when the fundus camera works. The optical module mainly consists of two parts: the light source module and the lens light path module.
-
- The light source component is the source of the light source when the product works, including background light, fixation light and flash when shooting.
-
- The lens light path is responsible for reflecting the patient's fundus image to the digital camera. The functions of lens focusing, pupil size switching and double camera pupil monitoring are used to ensure that the patient's fundus image can be presented clearly and reliably.
Mobile Platform Module
This module is mainly responsible for control of the position of optical module (i.e. up, down, left, right, back and forth movement of the optical module). This includes X, Y, Z axes, which are designed with servo motor and bearing, which are controlled by PCB board in the control module.
Power Supply Module
Power supply to each module through medical switching power supply.
Control Module
To enable operators to control the product, understand the working status of the product, observe the patient's condition, and carry out the corresponding inspection work normally.
There is a computer system integrated in the product, the input and output function are realized by touch screen display.
Chin Rest Module
To place the patient's head and keep the patient's eyes stable and easy to observe.
IDENTIFICATION OF PREDICATE DEVICE(S)
Primary Predicate Device 510(k) Number: K122572 Product Name: iCam Fundus Camera Manufacturer: Optovue, Inc.
Secondary Predicate Device 510(k) Number: K101935 Product Name: Digital Retinography System (DRS) Manufacturer: CENTERVUE SPA
5
NON-CLINICAL TESTING
Non clinical tests were conducted to verify that the proposed device met all design specifications as designed Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- AAMI/ANSI/ES 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General ● requirements for basic safety and essential performance
- IEC 60601-1-2:2014. Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety . and Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And ISO 15004-1:2006 Ophthalmic instruments - Fundamental requirements and test methods -Part 1: General requirements applicable to all ophthalmic instruments
- ISO 15004-2:2007 Ophthalmic instruments -- Fundamental requirements and test methods --Part 2: Light hazard protection
- ISO 10940:2009 Ophthalmic instruments Fundus cameras ●
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
- . ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
- . ANSI Z80.36-2016 American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
| Specification | Test Results | Testing Basis | |
|---|---|---|---|
| Resolving Power (Field | |||
| of view > 30° ) | Centre 2: 60lp/mm | ||
| Middle (r/2) 2: 40lp/mm | |||
| Periphery (r) 2: 25lp/mm | 60 lp/mm | ||
| 40 lp/mm | |||
| 25 lp/mm | 4.2 of ISO 10940 | ||
| Tolerance of angular | |||
| field of view | 50° ±5% | 48.0° | |
| Tolerance of pixel pitch | 6.45 um ±7% | 6.59 | |
| Range of Focus | -15D to +15D | Meet the | |
| specification |
Summary of the results of performance testing and the device requirements based on ISO 10940
CLINICAL TEST CONCLUSION
No clinical study is included in this submission.
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SUBSTANTIALLY EQUIVALENT (SE) COMPARISON
Table 1 Comparison of Technology Characteristics
| Item | Proposed Device | Primary Predicate Device (K122572) | Secondary Predicate Device (K101935) | Remark |
|---|---|---|---|---|
| Device name | Fundus Camera | |||
| RetiCam 3100 | iCam Fundus Camera | Digital Retinography System (DRS) | / | |
| Classification Name | Ophthalmic Camera | Ophthalmic Camera | Ophthalmic Camera | SAME |
| Product Code | HKI | HKI | HKI | SAME |
| Regulation Number | 886.1120 | 886.1120 | 886.1120 | SAME |
| Comparison | ||||
| Statement | The proposed device has same classification information as the predicate device. | |||
| Intended Use | The Fundus Camera RetiCam 3100 is | |||
| intended to capture digital images of the | ||||
| posterior and external structures of the eye | ||||
| without the use of a mydriatic agent and is | ||||
| intended for use as an aid to clinicians in | ||||
| the evaluation, diagnosis and | ||||
| documentation of ocular health. | The iCam takes digital images of the | |||
| posterior and external structures of the eye | ||||
| without the use of a mydriatic agent and is | ||||
| intended for use as an aid to clinicians in the | ||||
| evaluation, diagnosis and documentation of | ||||
| ocular health. | The CenterVue Digital Retinography | |||
| System DRS is intended for taking | ||||
| digital images of a human retina | ||||
| without the use of a mydriatic agent. | SAME | |||
| Usage | Prescription Use | Prescription Use | Prescription Use | SAME |
| Comparison | ||||
| Statement | The proposed device has similar intended use as the predicate device. | |||
| Main Unit Technical Specifications | ||||
| Operation Principle | The optical design of fundus camera is based on the principle of monocular indirect ophthalmoscopy. |
- Fundus observation
A build in light ray from the infrared light LED source to illuminate the fundus. Alignment of the device is performed by build in eye
tracking indicator and working distance indicator to adjust system to best XYZ position automatically. | | | |
| | | | | |
| | 2. Image capture: | | | |
| | System use split-image technique to do image focus adjustment automatically to capture the best quality of image. White light from | | | |
| | LEDs Flash module irradiates the fundus. The light reflected from eye portions forms an image, and the image is captured by built-in | | | |
| | color CMOS camera module for fundus image capture. | | | |
| Light Source | Observation: Infrared LED | | | SAME |
| | | Image capture: White LED | | |
| Eye Fixation | Internal 9 points | Internal 6 points | Not Available | Analysis 1 |
| Alignment | Manual focus tracking | Manual focus tracking | Automatic | SAME |
| Image Resolution | 2304 x 1728 (4 MP) | 1.3 MP | 2592 x 1944 (5 MP) | Analysis 2 |
| Field of view | 50 degrees | 45 degrees | 45 degrees | Analysis 3 |
| Operation Range | From -15 D to +15D | From -15 D to +15D | From -15 D to +15D | SAME |
| Interface | USB2.0, VGA, Network Port | USB 2.0 | USB 2.0 | Analysis 4 |
| Minimum Pupil Size | 3.0 mm | 4.0 mm | 4.0 mm | Analysis 5 |
| Working Distance | 35 mm | 25 mm | 37 mm | Analysis 6 |
| Power Supplier | A.C. 100-240 V, 50/60 Hz, 220 VA | AC100V to 240V, 50/60Hz | 100-240 VAC, 50/60 Hz | SAME |
| Comparison Statement: | The proposed device has the similar main unit specifications with the predicate device. Please refer to the difference analysis below the table | | | |
| Applied Standards: | | | | |
| Biocompatibility | ISO10993-5&ISO10993-10 | ISO10993-5&ISO10993-10 | ISO10993-5&ISO10993-10 | SAME |
| Electrical Safety | IEC60601-1 | IEC60601-1 | IEC60601-1 | SAME |
| EMC | IEC60601-1-2 | IEC60601-1-2 | IEC60601-1-2 | SAME |
| Performance | ISO 15004-1
ISO 15004-2
ISO 10940
ANSI Z80.36-2016 | ISO 15004-1
ISO 15004-2
ISO 10940 | ISO 15004-2
ISO 10940 | SAME |
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8
Substantially Equivalent (SE) Conclusion
The subject device has differences with predicate device, the difference analysis shown as followings:
-
- The eye fixation points are more than predicate device, it provides more different angle of fundus images.
-
- The higher pixel provides high resolution image, it does not adversely affect safety and effectiveness.
- The larger field view provides bigger observation range, it does not adversely affect safety and 3. effectiveness.
- More options are available for data transfer interface, all interface used are international standard 4. interface, it does not adversely affect safety and effectiveness.
- న్. The smaller minimum pupil size could be applied to more wider patient population with same quality fundus images.
- The working distance is changed by the different framework of device, it does not adversely affect 6. safety and effectiveness.
Therefore, the above differences between the proposed device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. There is no new technology used in the subject device.
Conclusion: The proposed device is Substantially Equivalent (SE) in safety and effectiveness to the selected predicate devices