(243 days)
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Not Found
No
The provided text does not contain any mention of AI, ML, deep learning, or related terms, nor does it describe functionalities that inherently require such technologies for basic biometric measurements and IOL calculations.
No.
The device is used for measurement and calculation (e.g., IOL power and type) but does not directly treat or prevent a disease or condition.
Yes.
Explanation: The device is intended for "biometric determination of the following ocular measures: axial length, corneal radius, corneal cylinder axis, anterior chamber depth (ACD), central corneal thickness (LT), white-to-white (WTW) and pupil diameter of the human eye" and also "measures corneal topography", which are all diagnostic measurements. Additionally, it "aids in the calculation of the appropriate IOL power and type to be implanted" for IOL candidates, further indicating a diagnostic role in patient assessment and treatment planning.
Unknown
The provided text describes the intended use and indications for use of a device named "ALADDIN HW3.0". The name "HW3.0" strongly suggests a hardware component ("HW" likely stands for hardware, and "3.0" indicates a version). Without a "Device Description" section, it's impossible to definitively determine if the device is solely software or includes hardware.
Based on the provided information, the ALADDIN HW3.0 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- ALADDIN HW3.0 Function: The intended use of ALADDIN HW3.0 is to directly measure various physical characteristics of the human eye in vivo (within the living body). It measures things like axial length, corneal radius, ACD, etc., and performs corneal topography. It also aids in IOL power calculation based on these measurements.
The device interacts directly with the patient's eye to obtain measurements, rather than analyzing a sample taken from the patient. Therefore, it falls under the category of a medical device used for diagnosis and treatment planning, but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ALADDIN HW3.0 is intended for biometric determination of the following ocular measures: axial length, corneal radius, corneal cylinder axis, anterior chamber depth (ACD), central corneal thickness (L T), white-to-white (WTW) and pupil diameter of the human eye. ALADDIN HW3.0 also measures corneal topography.
For patients who are candidates for intraocular lens (IOL) implantation, ALADDIN HW3.0 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
ALADDIN HW3.0 is intended for use by 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): 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.
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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.
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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)
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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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing, ribbon-like element connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 5, 2016
VISIA Imaging S.r.l. % Ms. Marisa Testa CEO/Regulatory Affairs Manager Thema S.r.l. Via Saragat 5 40026 Impola (BO)-Italy
Re: K160327
Trade/Device Name: ALADDIN HW3.0 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: August 22, 2016 Received: August 24, 2016
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.
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.
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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 and Part 809 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 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 801and Part 809 please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Kesia Alexander
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name ALADDIN HW3.0
Indications for Use (Describe)
ALADDIN HW3.0 is intended for biometric determination of the following ocular measures: axial length, corneal radius, corneal cylinder axis, anterior chamber depth (ACD), central corneal thickness (LT), white-to-white (WTW) and pupil diameter of the human eye. ALADDIN HW3.0 also measures corneal topography.
For patients who are candidates for intraocular lens (IOL) implantation, ALADDIN HW3.0 also aids in the calculation of the appropriate IOL power and type to be implanted.
ALADDIN HW3.0 is intended for use by physicians and eye-care professionals and may only be used under the supervision of a physician.
Type of Use (Select one or both, as applicable)
× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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