3nethra neo
Device Facts
| Record ID | K183059 |
|---|---|
| Device Name | 3nethra neo |
| Applicant | Forus Health Pvt.Ltd |
| Product Code | HKI · Ophthalmic |
| Decision Date | Dec 21, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1120 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
3nethra neo is a portable, mydriatic, digital wide-field retinal imaging camera for infants. System comprises hand-held probe, control box, and foot-pedal. Device connects to external computer for application software to store, view, retrieve, and export images. Warm white LED illumination intensity is controlled via foot-pedal. Clinicians use device to capture retinal images; images are then reviewed on a computer to document ocular diseases, assess retinal maturity, or stage Retinopathy of Prematurity (ROP). Output supports clinical decision-making regarding treatment, follow-up, or discharge. Benefits include non-invasive photo documentation of infant ocular health.
Clinical Evidence
Prospective study of 128 premature infants (144 sessions) comparing 3nethra neo to RetCam. Primary endpoints: detection of ROP stage/zone and clinical decision-making. Results: Sensitivity 97.4%-99.3%, specificity 75.6%-81.1% for ROP detection. Inter-rater agreement for staging was 0.8 (73.4% agreement). All 27 zone 3 diseases correctly identified. Bench testing confirmed compliance with IEC 60601-1, IEC 60601-1-2, ISO 15004-2, ANSI Z80.36, and ISO 10940 (resolving power >60 lp/mm). Biocompatibility confirmed per ISO 10993-5 and 10993-10.
Technological Characteristics
Portable digital camera; white light LED illumination (max 6.04mW/cm^2); 120-degree FOV; >=20 fps frame rate. Connects to external PC via AC power (100-240V). Complies with IEC 60601-1, IEC 60601-1-2, ISO 15004-2, ANSI Z80.36, ISO 10940, and ISO 10993. No fluorescence angiography module. Imaging formats: .PNG, .jpeg, .DCM.
Indications for Use
Indicated for wide field retinal imaging and photo documentation of ocular diseases in infants.
Regulatory Classification
Identification
An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Special Controls
*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.
Predicate Devices
Submission Summary (Full Text)
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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
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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
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#### 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<br>Bhavana, Bull Temple Road, 5th Main Nr<br>Colony<br>Bengaluru,<br>Karnataka, INDIA 560019 |
| Phone Contact | +91 80 4162 4041 4162 4042 |
| FAX | +91 80 4206 5393 |
| Contact Person & Email | Shruti Kashinath<br>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<br>(K102859)<br>Phoenix Clinical ICON (K170527) |
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Image /page/4/Picture/0 description: The image shows the logo for Forus Health. The word "Forus" is in a bright blue color, and the word "Health" is in a smaller, gray font. The logo is simple and modern.
## 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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Image /page/5/Picture/0 description: The image shows the logo for Forus Health. The word "Forus" is in a bright blue color, and the word "Health" is in a smaller, gray font. The logo is simple and modern.
#### Original Premarket 510(k) Notification 510(k) Summary
#### 》 Technological Similarities
| Technological<br>Characteristic<br>s | 3nethra neo | Retcam 3 Ophthalmic<br>Imaging System<br>(K102859) | Phoenix Clinical<br>ICON<br>(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,<br>50/60 Hz | AC 100-240 V, 50/60<br>Hz | AC 100-240 V, 50/60<br>Hz |
| Operating Conditions | | | |
| Insert filter | No insert filter<br>needed | No insert filter needed | No insert filter needed |
| Imaging Format | .PNG/.jpeg (after<br>export)/.DCM(after<br>export) | .TIF/.JPEG/.AVI/.BMP | .TIF/.JPEG/.AVI |
| Safety | | | |
| Safety<br>Compliance | IEC 60601-1,<br>IEC 60601-1-2 | IEC 60601-1,<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 |
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Image /page/6/Picture/0 description: The image shows the logo for Forus Health. The word "Forus" is written in a large, bold, light blue font. To the right of "Forus", the word "Health" is written in a smaller, gray font. The logo is simple and modern, and the colors are calming and professional.
#### Technological Differences A
| Technological<br>Characteristics | 3nethra neo | Retcam 3<br>Ophthalmic<br>Imaging System<br>(K102859) | Phoenix Clinical<br>ICON<br>(K170527) |
|----------------------------------|------------------------------------------|-------------------------------------------------------|---------------------------------------|
| Design | | | |
| Feature | No Fluorescence<br>Angiography<br>module | Fluorescence<br>Angiography<br>module | Fluorescence<br>Angiography<br>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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Image /page/7/Picture/0 description: The image shows the logo for Forus Health. The word "Forus" is in a bright blue color, and the word "Health" is in a gray color. The logo is simple and modern, and it is likely used to represent the company's brand.
#### > 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.
