(49 days)
Not Found
No
The summary describes a digital imaging camera and its performance in a clinical study, but there is no mention of AI or ML being used for image analysis, diagnosis, or any other function. The performance metrics relate to the device's ability to capture images and the agreement between human observers interpreting those images.
No.
The device is used for photo documentation and imaging of ocular diseases, not for treating them.
Yes
The device is used for "photo documentation of ocular diseases" and clinical studies were performed to evaluate its sensitivity and specificity for "detecting any stage ROP". This indicates its role in identifying and documenting disease, which is a diagnostic function.
No
The device description explicitly states it has a hand-held probe unit, a control box, and a foot-pedal control unit, which are hardware components.
Based on the provided information, the 3nethra neo is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- 3nethra neo Function: The 3nethra neo is a digital imaging camera that captures images of the retina in infant eyes. It is used for photo documentation of ocular diseases. This is an in vivo (within the living body) imaging process, not an in vitro (outside the living body) test.
- No Sample Analysis: The device does not analyze biological samples. It captures visual information directly from the patient's eye.
Therefore, the 3nethra neo falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
3nethra neo is used as a wide field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
The 3nethra neo is a compact, portable and easy to use, mydriatic, digital wide field imaging camera used for the photo documentation of ocular diseases that manifest in infant eyes. 3nethra neo needs to be connected to a computer for running the application software, to store, view, retrieve, and export the digital ophthalmic images. The 3nethra neo has a hand-held probe unit, a control box and a foot-pedal control unit. Warm white LED with intensity control via foot-pedal is used to provide illumination to the eye in order to capture images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
wide field retinal imaging digital camera
Anatomical Site
ocular diseases that manifest in infants.
Indicated Patient Age Range
infants
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Method: 128 premature Asian Indian Infants from 35 neonatal centers were A screened using the RetCam and the "3nethra neo" alternately with either device first. A minimum of seven images from each eye including the dilated anterior segment was obtained from each device. Images from the "3nethra neo" were cropped to resemble those of the RetCam. Two RO specialists masked to the origin of the randomly presented images were provided with birth weights (BW), gestational age (GA) and post menstrual ages (PMA) at imaging. They reported the presence of retinal immaturity, maturity or on the stage of Retinopathy of Prematurity (ROP) and zone of involvement, for each eye, in each session and reached a 'decision' on whether to treat, follow-up or discharge the baby based on the findings in both eyes.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance Data:
Method: 128 premature Asian Indian Infants from 35 neonatal centers were A screened using the RetCam and the "3nethra neo" alternately with either device first. A minimum of seven images from each eye including the dilated anterior segment was obtained from each device. Images from the "3nethra neo" were cropped to resemble those of the RetCam. Two RO specialists masked to the origin of the randomly presented images were provided with birth weights (BW), gestational age (GA) and post menstrual ages (PMA) at imaging. They reported the presence of retinal immaturity, maturity or on the stage of Retinopathy of Prematurity (ROP) and zone of involvement, for each eye, in each session and reached a 'decision' on whether to treat, follow-up or discharge the baby based on the findings in both eyes.
Result: 144 sessions of 128 infants (73 male: 55 female) were analyzed. The mean for BW was 1485 grams, GA was 31.1 and PMA was 40.2 weeks respectively. The '3nethra neo' had a sensitivity of 97.4 and 99.3 and a specificity of 81.1 and 75.6 for detecting any stage ROP for the two observers respectively. The kappa for clinical decision and agreement were 0.60 and 79% and 0.90 and 95% for the two observers respectively. Inter rater agreeability for staging was 0.8 and 73.4% agreement. Both observers correctly identified all (n=27) zone 3 diseases on the '3nethra neo' images.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The '3nethra neo' had a sensitivity of 97.4 and 99.3 and a specificity of 81.1 and 75.6 for detecting any stage ROP for the two observers respectively. The kappa for clinical decision and agreement were 0.60 and 79% and 0.90 and 95% for the two observers respectively. Inter rater agreeability for staging was 0.8 and 73.4% agreement.
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.
Retcam3 Ophthalmic Imaging System (K102859), Phoenix Clinical ICON (K170527)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
December 21, 2018
Forus Health Pvt. Ltd. Shruti Kashinath Lead, Quality and Regulatory #86/2, Ground Floor, Dvg Smaraka Bhavana, Bull Temple Road 5th Main Nr Colony Bengalura, 560019 In
Re: K183059
Trade/Device Name: 3nethra neo Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI. Dated: October 29, 2018 Received: November 2, 2018
Dear Shruti Kashinath:
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/cfpmp/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
1
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 (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
Bradley S. Cunningham -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183059
Device Name 3nethra neo
Indications for Use (Describe)
3nethra neo is used as a wide field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for Forus Health. The word "Forus" is in a large, bold, light blue font. To the right of "Forus" is the word "Health" in a smaller, gray font. The logo is simple and modern.
Original Premarket 510(k) Notification 510(k) Summary
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
1. General Information
| Applicant | Forus Health Pvt. Ltd |
|---|---|
| Applicant's Address | #86/2, Ground Floor, Dvg Smaraka |
| Bhavana, Bull Temple Road, 5th Main Nr | |
| Colony | |
| Bengaluru, | |
| Karnataka, INDIA 560019 | |
| Phone Contact | +91 80 4162 4041 4162 4042 |
| FAX | +91 80 4206 5393 |
| Contact Person & Email | Shruti Kashinath |
| shruti@forushealth.com | |
| Date Prepared | Oct-10-2018 |
| Common Name | Ophthalmic Camera |
| Trade Name and Model | 3nethra neo |
| Device Classification | 2 |
| Product Code | HKI |
| Classification Name | Camera, Ophthalmic, Ac-powered |
| Regulation Number | 886.1120 |
| Classification Panel | Ophthalmic |
| Predicate Devices | Retcam3 Ophthalmic Imaging System |
| (K102859) | |
| Phoenix Clinical ICON (K170527) |
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2. 3nethra neo Device Description
The 3nethra neo is a compact, portable and easy to use, mydriatic, digital wide field imaging camera used for the photo documentation of ocular diseases that manifest in infant eyes. 3nethra neo needs to be connected to a computer for running the application software, to store, view, retrieve, and export the digital ophthalmic images. The 3nethra neo has a hand-held probe unit, a control box and a foot-pedal control unit. Warm white LED with intensity control via foot-pedal is used to provide illumination to the eye in order to capture images.
3. Indications for Use
3nethra neo is used as a wide field retinal imaging digital camera for photo documentation of ocular diseases that manifest in infants.
4. Substantial Equivalence Summary and Predicate Device
The design of 3nethra neo is substantially equivalent to the design of the predicate device. The methods of action and use are identical and the user functions are all identical in functionality between the 3nethra neo and the predicate.
> Primary Predicate:
Device Name: RetCam 3 Ophthalmic Imaging System (K102859) Device Class: Class II Product Code: HKI Applicant: Clarity Medical Systems
> Secondary Predicate:
Device Name: Phoenix Clinical Icon (K170527) Device Class: Class II Product Code: HKI Applicant: Phoenix Technology Group
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Original Premarket 510(k) Notification 510(k) Summary
》 Technological Similarities
| Technological
Characteristic
s | 3nethra neo | Retcam 3 Ophthalmic
Imaging System
(K102859) | Phoenix Clinical
ICON
(K170527) |
|--------------------------------------|----------------------------------------------------|----------------------------------------------------|---------------------------------------|
| Design | | | |
| Feature | White light module | White light module | White Light Module |
| Camera | | | |
| Field of view | 120 degrees | 30 to 130 degrees | 100 degrees |
| Frame rate | >=20 fps | 30 fps | 30 fps |
| Light Source | | | |
| Light source type | White light LED | White light LED | White light LED |
| Light intensity control | Zero to maximum | Zero to maximum | Zero to maximum |
| Maximum light source output power | 6.04mW/cm^2 | 21 mW/cm^2 | 6.1 mW/cm^2 |
| External fixation light (if any) | None | None | None |
| Electrical | | | |
| Power Supply | AC 100-240 V,
50/60 Hz | AC 100-240 V, 50/60
Hz | AC 100-240 V, 50/60
Hz |
| Operating Conditions | | | |
| Insert filter | No insert filter
needed | No insert filter needed | No insert filter needed |
| Imaging Format | .PNG/.jpeg (after
export)/.DCM(after
export) | .TIF/.JPEG/.AVI/.BMP | .TIF/.JPEG/.AVI |
| Safety | | | |
| Safety
Compliance | IEC 60601-1,
IEC 60601-1-2 | IEC 60601-1,
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 |
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Technological Differences A
| Technological
Characteristics | 3nethra neo | Retcam 3
Ophthalmic
Imaging System
(K102859) | Phoenix Clinical
ICON
(K170527) |
|----------------------------------|------------------------------------------|-------------------------------------------------------|---------------------------------------|
| Design | | | |
| Feature | No Fluorescence
Angiography
module | Fluorescence
Angiography
module | Fluorescence
Angiography
module |
These technological differences do not alter the intended use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate.
5. Bench Test Summary
> Electrical safety and electromagnetic compatibility:
Electrical safety and EMC testing was conducted on the 3nethra neo in accordance with established protocols. The device complies with IEC 60601-1 for electrical safety and IEC 60601-1-2 standard for EMI/EMC.
> Light safety testing:
The 3nethra neo was evaluated for compliance to:
- ISO 15004-2- Ophthalmic Instruments Fundamental requirements and test o methods, and
- o ANSI Z80.36-American National Standard for Ophthalmics Light Hazard Protection for Ophthalmic Instruments.
The evaluation demonstrates compliance with Group 1 instrument requirements provided by the standards.
> Performance Testing:
- o The methodologies prescribed by ISO 10940 were used to evaluate the fundus imaging performance of our device.
- o The central resolving power of 3nethra neo was verified and found to be greater than 60 lp/mm. Also, resolving power requirements for the full FOV region were verified using an artificial eye and clinical setups.
The measured results are supportive of substantial equivalence to the predicate devices.
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> Animal Testing:
Biocompatibility testing:
The biocompatibility evaluation for the 3nethra neo was done through animal studies. The studies demonstrated compliance with the following standards:
- o ISO 10993-10:2010 Skin Sensitization
- o ISO 10993-10:2010 Intracutaneous Reactivity
- o ISO 10993-5:2009 Cytotoxicity
6. Clinical Performance Data
- Method: 128 premature Asian Indian Infants from 35 neonatal centers were A screened using the RetCam and the "3nethra neo" alternately with either device first. A minimum of seven images from each eye including the dilated anterior segment was obtained from each device. Images from the "3nethra neo" were cropped to resemble those of the RetCam. Two RO specialists masked to the origin of the randomly presented images were provided with birth weights (BW), gestational age (GA) and post menstrual ages (PMA) at imaging. They reported the presence of retinal immaturity, maturity or on the stage of Retinopathy of Prematurity (ROP) and zone of involvement, for each eye, in each session and reached a 'decision' on whether to treat, follow-up or discharge the baby based on the findings in both eyes.
- A Result: 144 sessions of 128 infants (73 male: 55 female) were analyzed. The mean for BW was 1485 grams, GA was 31.1 and PMA was 40.2 weeks respectively. The '3nethra neo' had a sensitivity of 97.4 and 99.3 and a specificity of 81.1 and 75.6 for detecting any stage ROP for the two observers respectively. The kappa for clinical decision and agreement were 0.60 and 79% and 0.90 and 95% for the two observers respectively. Inter rater agreeability for staging was 0.8 and 73.4% agreement. Both observers correctly identified all (n=27) zone 3 diseases on the '3nethra neo' images.
7. Conclusion on Bench tests and Clinical Performance Data
The bench tests and clinical performance data supports our conclusion of substantial equivalence of 3nethra neo to the mentioned predicate devices.