(224 days)
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.
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.
The provided 510(k) summary for the Righton Zoom Slit Lamp NS-2D with option does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
This submission focuses on establishing substantial equivalence to predicate devices. Substantial equivalence is determined by comparing the new device's intended use, technological characteristics, and safety and effectiveness to legally marketed predicate devices, rather than establishing new performance criteria through a specific study with defined acceptance criteria.
Therefore, many of your requested points cannot be answered from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance:
- Cannot be answered. The submission does not define specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) for the device itself or its imaging software. Instead, it compares the device's technical specifications to those of its predicate devices.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Cannot be answered. No test set or associated data is mentioned. The submission is based on non-clinical testing and comparison to predicate devices, not a clinical study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Cannot be answered. No ground truth establishment is described as there is no clinical test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be answered. No adjudication method is mentioned as there is no clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be answered. This is not an AI-assisted device, and no MRMC study is mentioned. The device is a slit lamp for ophthalmic observation and microphotogrpahy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be answered. Not applicable, as this is not an algorithm-only device. The device is a diagnostic instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be answered. No ground truth is described.
8. The sample size for the training set:
- Cannot be answered. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established:
- Cannot be answered. No training set or ground truth establishment is mentioned.
Summary of available information:
The submission focuses entirely on demonstrating substantial equivalence to existing legally marketed predicate devices by comparing their intended use and technological characteristics.
Table of Comparison (substituting "Acceptance Criteria" with "Predicate Device Specifications" as no specific acceptance criteria were provided):
| Feature/Characteristic | Predicate Device (Appasamy A1A-11 Zoom K082031 / EyeCap Imaging System K000368 / Nidek Navis Software K013694) | Righton NS-2D Zoom (Reported Device Performance) |
|---|---|---|
| Intended Use | Examination of the anterior eye segment to aid in diagnosis of diseases or trauma affecting its structural properties. | Examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. 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 (Galilean Type) | Converging-type Zoom Microscope (12.5°) (Greenough Type) |
| Magnification Change | Continuous by manual zoom | Continuous by manual zoom |
| Eyepiece | 12.5x | 12.5x and 15.0x |
| PD Range | 55mm to 75mm | 52mm to 75mm |
| Slit Width | 0mm to 14mm | 0mm to 16mm continuously variable |
| Slit Apertures | 0mm to 14mm, ø0.2, 1, 3, 4, 6, 10, 14mm | ø0.2, 1, 2, 5, 10, 14, 16 mm, 0 to 12 mm continuously variable |
| Slit Inclination | 0°, 5°, 10°, 15° and 20° | 0°, 5°, 10°, 15° and 20° |
| Slit Rotation | 0° to 180° (Slit Angles) | 90° to right and left |
| Diopter Adjustment | -6D to +6D | -8D to +8D for the 12.5x eyepiece and -6D to +6D for the 15x eyepiece |
| Working Distance | 100mm | 100mm |
| Total Magnification | 5.5x to 35.0x | 5.9x to 32.5x for 12.5x eyepiece, 7.1x to 39x for 15.0x eyepiece |
| Filters | Transparent, Heat Absorption, Green, Cobalt Blue | Transparent, Heat Absorption, ND (28%), Green, Cobalt Blue |
| Fixation Light | LED | LED (Class 1) |
| Data collection and/or display system | NAV (Not available on predicate device) | Yes (claimed equivalent to EyeCap Imaging System K000368 and Nidek Navis Software K013694) |
| Flammability of materials | Not suitable for use in flammable atmosphere. Do not use if flammable gases are present. | Not suitable for use in a flammable atmosphere. Do not use this instrument if any flammable gases are present. |
| Max. temperature of parts | No parts with patient/operator contact are energized and remain 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 |
Study to Prove Acceptance Criteria:
The "study" cited is a non-clinical testing results and a comparison to predicate devices, which concluded that the Righton Zoom Slit Lamp NS-2D with option and its data collection/image manipulation software are substantially equivalent to the predicate devices. This means that the device is considered safe and effective because it is similar enough to devices already legally on the market. It does not involve a specific study to meet pre-defined performance acceptance criteria as would be the case for a novel device or an AI algorithm requiring validation of diagnostic performance.
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AUG 3 0 2011
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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. USA23462 |
|---|---|
| Contact Person: | Mélanie DeslauriersRegulatory Affairs CoordinatorPhone: 416-615-0185Fax: 416-631-8272regaffairs@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 basedon the Appasamy A1A-11 Zoom Slit Lamp (K082031).Substantial Equivalence of the data collection and imagemanipulation software is claimed based on the EyeCapImaging System (K000368) and on the Nidek Navis Software(K013694). |
| Device Description: | The NS-2D zoom slit lamps are designed for ophthalmicobservation and microphotography. These slit lamps featurezoom stereoscopic converging microscopes that can beused for ophthalmic observation. Each instrument consistsprimarily of the main unit and the illumination power supplyunit. |
:
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Substantial Equivalence Tables:
| Righton NS-2D Zoom | Appasamy A1A 11 Zoom(K082031) | |
|---|---|---|
| Intended Use | Used in examination of the anterioreye segment, from the corneaepithelium to the posterior capsule.It is used to aid in the diagnosis ofdiseases or trauma which affect thestructural properties of the anterioreye segment. | Used in examination of the anterioreye segment, from the corneaepithelium to the posterior capsule.It is used to aid in the diagnosis ofdiseases or trauma which affect thestructural properties of the anterioreye segment. |
| Method of operation | Converging-type Zoom Microscope(12.5°)(Greenough Type) | Converging-type Zoom Microscope(Galilean Type) |
| Exposure parameters | Magnification Change: Continuousby manual zoomEyepiece: 12.5x and 15.0xPD Range: 52mm to 75mmSlit Width: 0mm to 16mmcontinuously variableSlit Apertures: ø0.2, 1, 2, 5, 10, 14,16 mm, 0 to 12 mm continuouslyvariableSlit Inclination: 0°, 5°, 10°, 15° and20°Slit Rotation: 90° to right and leftDiopter adjustment: -8D to +8D forthe 12.5x eyepiece and-6D to +6D for the 15x eyepieceWorking Distance: 100mm | Magnification Change: Continuousby manual zoomEyepiece: 12.5xPD Range: 55mm to 75mmSlit Width: 0mm to 14mmSlit Apertures: 0mm to 14mm,ø0.2, 1, 3, 4, 6, 10, 14mmSlit Inclination: 0°, 5°, 10°, 15° and20°Slit Angles: 0° to 180°Diopter adjustment: -6D to +6DWorking Distance: 100mm |
| Total Magnification | 5.9x to 32.5x for 12.5x eyepiece7.1x to 39x for 15.0x eyepiece | 5.5x to 35.0x |
| Filters | TransparentHeat AbsorptionND (28%)GreenCobalt Blue | TransparentHeat AbsorptionGreenCobalt Blue |
| Fixation Light | LED (Class 1) | LED |
| Data collection and/ordisplay system | Yes | NAV |
| Flammability ofmaterials | This instrument is not suitable foruse in a flammable atmosphere.Do not use this instrument if anyflammable gases are present. | This instrument is not suitable foruse in a flammable atmosphere.Do not use this instrument if anyflammable gases are present. |
| Max. temperature ofparts of the device heldby the operator oraccessible to the patient | No parts of device withpatient/operator contact isenergized and remains at ambienttemperature | No parts of device withpatient/operator contact isenergized and remains at ambienttemperature |
| 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.
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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.
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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
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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
iii
§ 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.