(224 days)
No
The document describes a standard slit lamp with imaging capabilities and mentions image manipulation software, but there is no mention of AI, ML, deep learning, or any related concepts in the provided text.
No
The device is used for examination and diagnosis, not for treating or curing a disease.
Yes
The intended use statement explicitly states it is "used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment."
No
The device description explicitly states it consists of a "main unit and the illumination power supply unit," which are hardware components. While it includes software for data collection and image manipulation, it is not solely software.
Based on the provided information, the Righton Zoom Slit Lamp NS-2D with photo option is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is used for "eye examination of the anterior eye segment" and "ophthalmic observation and microphotography." This involves direct examination of the patient's eye, not the analysis of specimens taken from the body.
- Intended Use: The intended use is to "aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment." This is a clinical diagnostic tool used for direct patient examination.
While the device uses image processing and is compared to software systems, its primary function is to capture images of the eye for visual examination by a healthcare professional, not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Righton Zoom Slit Lamp NS-2D with photo option is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
Product codes
HJO, HJQ
Device Description
The NS-2D zoom slit lamps are designed for ophthalmic observation and microphotography. These slit lamps feature zoom stereoscopic converging microscopes that can be used for ophthalmic observation. Each instrument consists primarily of the main unit and the illumination power supply unit.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior eye segment, from the cornea epithelium to the posterior capsule
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on non-clinical testing results, the Righton Zoom Slit Lamp NS-2D with option and the data collection and image manipulation software have demonstrated that they are equivalent to the predicate devices with respect to intended uses, technological characteristics and safety and effectiveness.
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
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, 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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AUG 3 0 2011
.
510(k) Summary
The information contained in this premarket notification 510(k) summary is submitted as required by 21 CFR 807.92(c):
| Submitter: | RIGHTMEDICAL Products LLC.
5325 Cleveland Street,
Virginia Beach, VA. USA
23462 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mélanie Deslauriers
Regulatory Affairs Coordinator
Phone: 416-615-0185
Fax: 416-631-8272
regaffairs@rightmedical.com |
| Date Prepared: | August 2011 |
| Trade Name: | Righton Zoom Slit Lamp NS-2D with option |
| Common Name: | AC-Powered Slit lamp Biomicroscope |
| Product Code: | HJO |
| Class: | Class II |
| Regulation: | 21 CFR 886.1850 |
| Predicate Device: | Substantial Equivalence of the Slit Lamp is claimed based
on the Appasamy A1A-11 Zoom Slit Lamp (K082031).
Substantial Equivalence of the data collection and image
manipulation software is claimed based on the EyeCap
Imaging System (K000368) and on the Nidek Navis Software
(K013694). |
| Device Description: | The NS-2D zoom slit lamps are designed for ophthalmic
observation and microphotography. These slit lamps feature
zoom stereoscopic converging microscopes that can be
used for ophthalmic observation. Each instrument consists
primarily of the main unit and the illumination power supply
unit. |
:
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1
Substantial Equivalence Tables:
| | Righton NS-2D Zoom | Appasamy A1A 11 Zoom
(K082031) |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used in examination of the anterior
eye segment, from the cornea
epithelium to the posterior capsule.
It is used to aid in the diagnosis of
diseases or trauma which affect the
structural properties of the anterior
eye segment. | Used in examination of the anterior
eye segment, from the cornea
epithelium to the posterior capsule.
It is used to aid in the diagnosis of
diseases or trauma which affect the
structural properties of the anterior
eye segment. |
| Method of operation | Converging-type Zoom Microscope
(12.5°)
(Greenough Type) | Converging-type Zoom Microscope
(Galilean Type) |
| Exposure parameters | Magnification Change: Continuous
by manual zoom
Eyepiece: 12.5x and 15.0x
PD Range: 52mm to 75mm
Slit Width: 0mm to 16mm
continuously variable
Slit Apertures: ø0.2, 1, 2, 5, 10, 14,
16 mm, 0 to 12 mm continuously
variable
Slit Inclination: 0°, 5°, 10°, 15° and
20°
Slit Rotation: 90° to right and left
Diopter adjustment: -8D to +8D for
the 12.5x eyepiece and
-6D to +6D for the 15x eyepiece
Working Distance: 100mm | Magnification Change: Continuous
by manual zoom
Eyepiece: 12.5x
PD Range: 55mm to 75mm
Slit Width: 0mm to 14mm
Slit Apertures: 0mm to 14mm,
ø0.2, 1, 3, 4, 6, 10, 14mm
Slit Inclination: 0°, 5°, 10°, 15° and
20°
Slit Angles: 0° to 180°
Diopter adjustment: -6D to +6D
Working Distance: 100mm |
| Total Magnification | 5.9x to 32.5x for 12.5x eyepiece
7.1x to 39x for 15.0x eyepiece | 5.5x to 35.0x |
| Filters | Transparent
Heat Absorption
ND (28%)
Green
Cobalt Blue | Transparent
Heat Absorption
Green
Cobalt Blue |
| Fixation Light | LED (Class 1) | LED |
| Data collection and/or
display system | Yes | NAV |
| Flammability of
materials | This instrument is not suitable for
use in a flammable atmosphere.
Do not use this instrument if any
flammable gases are present. | This instrument is not suitable for
use in a flammable atmosphere.
Do not use this instrument if any
flammable gases are present. |
| Max. temperature of
parts of the device held
by the operator or
accessible to the patient | No parts of device with
patient/operator contact is
energized and remains at ambient
temperature | No parts of device with
patient/operator contact is
energized and remains at ambient
temperature |
| Brightness Control | 12V 30W halogen bulb | 12V 30W halogen bulb |
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Conclusion:
Based on non-clinical testing results, the Righton Zoom Slit Lamp NS-2D with option and the data collection and image manipulation software have demonstrated that they are equivalent to the predicate devices with respect to intended uses, technological characteristics and safety and effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the border of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Right Medical Products LLC c/o Ms. Mélanie Deslauriers, B.Sc., MBA Regulatory Affairs Manager 5325 Cleveland Street, Suite 303 Virginia Beach, VA 23462
AUG 3 0 2011
Re: K110129
Trade/Device Name: Righton Zoom Slit Lamp with Photo Option, Model NS-2D Regulation Number: 21 CFR 886.1850 Regulation Name:, AC-Powered Slit-Lamp Biomicroscope Regulatory Class: Class II Product Code: HJQ Dated: August 5, 2011 Received: August 10, 2011
Dear Ms. Deslauriers:
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, Trug 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. 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.
4
Page 2 - Ms. Mélanie Deslauriers, B.Sc., MBA
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 thream 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the eltectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm far the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Pact 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K110129
Device Name: Righton Zoom Slit Lamp NS-2D with photo option
Indications for Use:
The Righton Zoom Slit Lamp NS-2D with photo option is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110129
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