(121 days)
Not Found
No
The summary describes a standard slit lamp biomicroscope and does not mention any AI or ML capabilities, image processing, or related performance metrics.
No
The device is used for examination and aiding in diagnosis, not for treating or preventing diseases.
Yes
Explanation: 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 segment."
No
The device description explicitly states it is an "AC-power slit lamp biomicroscope," which is a physical hardware device used for eye examination.
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 Atlantis Slit Lamp is a biomicroscope used for direct visual examination of the anterior segment of the eye. 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 segment." This is a direct examination of the living tissue, not an analysis of a sample.
Therefore, based on the provided information, the Atlantis Slit Lamp is a medical device used for direct examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Atlantis 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 segment.
Product codes
HJO
Device Description
The Atlantis Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination There are 2 models 2000 and 2000 Plus. These models differ only in the supplied accessories (beam-splitter, camera mount and observation tube). 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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The USOphthalmic, LLC Atlantis 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, LLC Atlantis 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, LLC Atlantis 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
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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510 (k) SUMMARY
Summary of Safety and Effectiveness for the Atlantis Slit Lamp
submitted by USOphthalmic, LLC 9990 NW 14th Street Unit # 105 Doral, Florida 33172 Phone: (305) 969-4545
JAN 2 8 2010
Gustavo Lancewicki Contact Person: Atlantis Slit Lamp Device Trade Name: Common Name: Slit Lamp Biomicroscope, Slit-lamp, AC-powered per 21 CFR § 886.1850 Classification Name:
Identification of a Legally Marketed Predicate Device
The USOphthalmic, LLC Atlantis 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 Atlantis Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination There are 2 models 2000 and 2000 Plus. These models differ only in the supplied accessories (beam-splitter, camera mount and observation tube). All models have the same operating characteristics and intended use.
Intended Use
The Atlantis 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 eve segment.
Summary of Technological Characteristics
An 8-point comparison of technological characteristics of the USOphthalmic, LLC Atlantis Slit Lamp and the predicate devices was performed. The devices were found to be substantially equivalent.
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Summary of Performance Data
The USOphthalmic, LLC Atlantis 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 Require-. ments for Safety
The USOphthalmic, LLC Atlantis 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, LLC Atlantis 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.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle with its wings spread, facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 2 8 2010
US Ophthalmic LLC c/o Mr. Al Weisenborn Al Weisenborn Medical Device Consulting 19526 East Lake Dr. Miami, Florida 33015-2218 United States
Re: K093021
Trade/Device Name: Atlantis Slit Lamp, models 2000 and 2000 Plus Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: December 23, 2009 Received: December 24, 2009
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. 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 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
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Page 2 - Mr. Al Weisenborn
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 electronic 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 for 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" (21CFR 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 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.
Kesia Alexander Jr.
Malvina B. Evdelman, 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): K093021
Device Name: Atlantis Slit Lamp
Indications for Use:
The Atlantis 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 segment.
Prescription Use X (Per 21 CFR 801 Subpart D)
ﻪ ﺍﻟﻤﺴﺎ
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Aesa.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K093021