(174 days)
Not Found
No
The summary describes a standard slit lamp biomicroscope and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No.
The device is used for examination and diagnosis, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segments." This indicates its role in assisting diagnosis, which is the primary function of a diagnostic device.
No
The device description explicitly states it is an "AC-power slit lamp biomicroscope," which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Function: The GILRAS Slit Lamp is a biomicroscope used for direct visual examination of the anterior eye segment. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "eye examination of the anterior eye segment" and "to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segments." This is a clinical examination, not an in vitro test.
Therefore, based on the provided information, the GILRAS Slit Lamp is a medical device used for clinical examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GILRAS Slit Lamp is an AC-power slit lamp biomicroscope 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 segments.
Product codes (comma separated list FDA assigned to the subject device)
HJO
Device Description
The GILRAS Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination. There are 3 models GR-SL36, GR-SL54, and GR-SL72. These models differ only in the supplied accessories. All models have the same operating characteristics and intended use.
Mentions image processing
Not Found
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)
The USOphthalmic GILRAS Slit Lamp complies with the requirements of listed FDA Recognized Consensus Standards.
- ISO 10939:2007, Ophthalmic instruments -- Slit-lamp microscopes .
- IEC 60601-1, Medical Electrical Equipment Part 1: General . Requirements for Safety
The USOphthalmic GILRAS Slit Lamp is substantially equivalent to the 66 Vision-Tech YZ Slit Lamp that is legally marketed and distributed by Suzhou 66 Vision-Tech Co., LTD. This has been demonstrated through a 8-point technological comparison of features.
Because the USOphthalmic GILRAS Slit Lamp meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 886.1850 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.
0
K080776
Summary of Safety and Effectiveness for the GILRAS Slit Lamp
submitted by Al Weisenborn 19526 East Lake Drive Miami, Florida 33015 Phone: (305) 829-3437
SEP - 9 2008
on behalf of
USOphthalmic 7255 NW 68th Street Unit # 9 Miami, FL 33166 Phone: (305) 969-4545
Contact Person: Ezequiel D. Lukin Device Trade Name: GILRAS Slit Lamp Common Name: Slit Lamp Classification Name: Biomicroscope, Slit-lamp, AC-powered per 21 CFR § 886.1850
Identification of a Legally Marketed Predicate Device
The USOphthalmic GILRAS Slit Lamp is substantially equivalent to 66 Vision-Tech YZ Slit Lamp that is legally marketed and distributed by Suzhou 66 Vision-Tech Co., LTD pursuant to premarket notification K033190.
Device Description
The GILRAS Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination. There are 3 models GR-SL36, GR-SL54, and GR-SL72. These models differ only in the supplied accessories. All models have the same operating characteristics and intended use.
Intended Use
The GILRAS Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eve 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 segments.
1
Summary of Technological Characteristics
An 23-point comparison of the technological characteristics of the USOphthalmic GILRAS Slit Lamp and the predicate devices was performed. The devices were found to be substantially equivalent as shown in the table below.
| Feature | GILRAS Slit Lamp | 66 Vision-Tech YZ Slit Lamp |
|---|---|---|
| Manufacturer | Manufacturer: Shanghai | |
| MediWorks Precision Instruments, | ||
| LTD | ||
| Relabeler: USOphthalmic | Suzhou 66 Vision-Tech Co., LTD | |
| Trade name | GILRAS Slit Lamp | 66 Vision-Tech YZ Slit Lamp |
| 510(k) Number | K080776 | K033190 |
| Intended use | The GILRAS Slit Lamp is an AC- | |
| power slit lamp biomicroscope | ||
| 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 segments. | The 66 Vision-Tech YZ Slit lamp is | |
| an AC-power slit lamp biomicroscope | ||
| 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 | ||
| affects the structural properties of the | ||
| anterior eye segment. | ||
| Method of Operation | AC-powered | AC-powered |
| Exposure Parameters | 50000 Lux Maximum | |
| Continuously adjustable from 0 to | ||
| 50000 Lux | 75000 Lux at position ¼ | |
| 150000 Lux at position ½ | ||
| 300000 Lux at position 1 | ||
| Data Collection and/or | ||
| Display Systems | None | None |
| Flammability of | ||
| Materials | Non-combustion supporting materials | Non-combustion supporting materials |
| Maximum temperature | ||
| of Parts of the Device | ||
| Held by the Operator or | ||
| Accessible to the | 30°C | 30°C |
| Eyepiece Power | 12.5X | 12.5X |
| Total Magnification | GR-SL36 - 10X, 16X, 25X | |
| GR-SL54 - 6X, 10X, 16X, 25X, 40X | ||
| GR-SL72 - 10X, 16X, 25X | 6X, 10X, 16X, 25X, 40X | |
| Stereo Angle | 13° | 13° |
| Diopter Adjustment | -6D to +6D | -5D to +3D |
| Pupillary Adjustment: | 55mm to 78.5mm | 55mm to 78.5mm |
| Slit Width | Continuous from 14mm to 0mm (at | |
| 14mm slit becomes a circle) | Continuous from 9mm to 0mm (at | |
| 14mm slit becomes a circle) | ||
| Feature | GILRAS Slit Lamp | 66 Vision-Tech YZ Slit Lamp |
| Slit Length | Continuous from 14mm to 0mm (at | |
| 14mm,slit becomes a circle) | Continuous from 9mm to 0mm (at | |
| 14mm, slit becomes a circle) | ||
| Slit Angle | 0 to 180 degree with horizontal | |
| scanning capability | 0 to 180 degree with horizontal scan- | |
| ning capability | ||
| Aperture Diameters | 14, 8, 5, 3, 0.5,and 0.2mm | 9mm, 8mm, 5mm, 3mm, 2mm, 1mm, |
| 0.2mm | ||
| Filters | Heat-absorbing, Neutral Density, | |
| Cobalt Blue, and Red-Free | Heat absorption, gray, red-free, and | |
| blue | ||
| Slit Inclination | 5°, 10°, 15°, and 20° | 5°, 10°, 15°, and 20° |
| Illumination Lamp | 6V, 20W halogen lamp | 12V, 30W halogen lamp |
| Hruby Lens | Not available | Optionally Available |
| Fixation Target | Green LED | Red LED |
| Brightness Controls | Continuously adjustable from 0 to | |
| 50000 Lux | 3-mode: low, medium and high | |
| Patient Contact | ||
| Materials | Chin-rest paper | Chin-rest paper |
| Forehead-rest - | ||
| Polytetrafluoroethylene | Forehead-rest - | |
| Polytetrafluoroethylene | ||
| Beam Splitter | GR-SL36 - No | |
| GR-SL54 - No | Optional | |
| GR-SL72 - Yes |
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2
Summary of Performance Data
The USOphthalmic GILRAS Slit Lamp complies with the requirements of listed FDA Recognized Consensus Standards.
- ISO 10939:2007, Ophthalmic instruments -- Slit-lamp microscopes .
- IEC 60601-1, Medical Electrical Equipment Part 1: General . Requirements for Safety
The USOphthalmic GILRAS Slit Lamp is substantially equivalent to the 66 Vision-Tech YZ Slit Lamp that is legally marketed and distributed by Suzhou 66 Vision-Tech Co., LTD. This has been demonstrated through a 8-point technological comparison of features.
Because the USOphthalmic GILRAS Slit Lamp meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2008
USOphthalmic, LLC c/o Al Weisenborn 7255 NW 68th Street, Unit #9 Miami, FL 33166
Re: K080776
Trade/Device Name: GILRAS Slit Lamp, Models GR-SL36, GR-SL54 and GR-SL72 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slit-lamp Biomicroscope Regulatory Class: II Product Code: HJO Dated: August 14, 2008 Received: August 15, 2008
Dear Mr. Weisenborn:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarlee, Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Malvina B. Eggersta, und
Malvina B. Eydelman, M.L Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
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510(k) Number (if known):
Device Name: GILRAS Slit Lamp
Indications for Use:
The GILRAS Slit Lamp is an AC-power slit lamp biomicroscope 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 segments .
Prescription Use X (Per 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 IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Danid L. Kaushn
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K080776
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