(371 days)
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No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
This device is for biometric determination and aids in IOL calculation, but it does not directly treat or alleviate a medical condition.
Yes
The device is described as performing "biometric determination of the following ocular measures: axial length, corneal radius, corneal cylinder axis, anterior chamber depth, white-to-white (WTW) and pupil diameter of the human eye" and also "measures corneal topography." These measurements provide information that can be used to diagnose or manage conditions, and it specifically mentions aiding "in the calculation of the appropriate IOL power and type to be implanted" for IOL candidates, which is a key part of surgical planning and treatment. Therefore, the device provides information crucial for diagnosis and treatment planning.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. Without this information, it's impossible to definitively classify the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The intended use of ALADDIN is to measure physical characteristics of the human eye (axial length, corneal radius, etc.) and aid in IOL calculations. This is a direct measurement of the organ itself, not an analysis of a biological sample taken from the body.
Therefore, ALADDIN falls under the category of an ophthalmic device used for diagnostic and surgical planning purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ALADDIN is intended for biometric determination of the following ocular measures: axial length, corneal radius, corneal cylinder axis, anterior chamber depth, white-to-white (WTW) and pupil diameter of the human eye. ALADDIN also measures corneal topography. For patients who are candidates for intraocular lens (IOL) implantation, ALADDIN also aids in the calculation of the appropriate IOL power and type to be implanted.
Product codes
HJO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human eye
Indicated Patient Age Range
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Intended User / Care Setting
physicians and eye-care professionals and may only be used under the supervision of a physician.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a symbol often associated with healthcare.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MD 20993-002
June 5, 2014
Visia Imaging S.r.l. c/o Ms. Marisa Testa Regulatory Affairs Consultant Thema USA 110 East Granada Blvd., Suite 209 Ormond Beach, FL 32176
Re: K131567
Trade/Device Name: ALADDIN Regulation Number: 21 CFR 886.1850 Regulation Name: Biomicroscope, Slit-lamp, AC-powered Regulatory Class: Class II Product Code: HJO Dated: May 1, 2014 Received: May 6, 2014
Dear Ms. Testa:
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.
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Page 2 - Ms. Marisa Testa
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CDRHOffices/ucm 1 15809.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Deborah L. Falls -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): K131567
Device Name: ALADDIN
Indications for Use:
ALADDIN is intended for biometric determination of the following ocular measures: axial length, corneal radius, corneal cylinder axis, anterior chamber depth, white-to-white (WTW) and pupil diameter of the human eye. ALADDIN also measures corneal topography. For patients who are candidates for intraocular lens (IOL) implantation, ALADDIN also aids in
the calculation of the appropriate IOL power and type to be implanted.
ALADDIN is intended for use by physicians and eye-care professionals and may only be used under the supervision of a physician.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence, Center for Devices and Radiological Health, Office of Device Evaluation
Jan C. Callaway -S 2014.05.30 11:45:33 -04'00'
Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation
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