K Number
K211868
Device Name
MYAH
Date Cleared
2022-03-01

(258 days)

Product Code
Regulation Number
886.1850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MY AH is intended for measuring the axial length of the eye in a population age 5 and above and is intended for use under the care of an eye care professional. MYAH is not intended to be used in patients with cataracts.
Device Description
Not Found
More Information

Not Found

Not Found

No
The provided 510(k) summary does not contain any mention of AI, ML, deep learning, or related concepts, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.

No
The device is intended for measuring the axial length of the eye, which is a diagnostic or monitoring function, not a therapeutic one. It does not treat or alleviate a medical condition.

Yes
The device is intended for "measuring the axial length of the eye", which is a diagnostic measurement used by eye care professionals to assess eye conditions.

Unknown

The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.

Based on the provided information, 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 intended use of MYAH is to measure the axial length of the eye. This is a physical measurement of a part of the body, not a test performed on a biological sample.
  • Lack of IVD Indicators: The description does not mention any analysis of biological samples, chemical reactions, or detection of substances within a sample, which are characteristic of IVDs.

Therefore, MYAH falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

MY AH is intended for measuring the axial length of the eye in a population age 5 and above and is intended for use under the care of an eye care professional.

MYAH is not intended to be used in patients with cataracts.

Product codes

MXK

Device Description

Not Found

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

eye

Indicated Patient Age Range

age 5 and above

Intended User / Care Setting

eye care professional

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)

Not Found

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.

Not Found

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.

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March 11, 2022

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

VISIA imaging S.R.L. Marisa Testa CEO & QA/RA Consultant Thema S.R.L. Via Saragat 5 Imola, BO 40026 Italy

Re: K211868

Trade/Device Name: Myah Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: MXK

Dear Marisa Testa:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 1, 2022. Specifically, FDA is updating this SE Letter to correct typographical errors in the IFU, as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Elvin Ng, Office of Ophthalmic, Anesthesia, Respiratory, ENT & Dental Devices (OHT1), 240-402-4662, elvin.ng@fda.hhs.gov.

Sincerely,

Elvin Y. Ng -S

Elvin Ng Assistant Director Retina and Diagnostic Devices Team (THT1A3) Division of Ophthalmic Devices (DHT1A) Office of Ophthalmic, Anesthesia, Respiratory, ENT & Dental Devices (OHT1) Office of Product Evaluation and Quality (OPEQ) Center for Devices and Radiological Health

1

March 1, 2022

Image /page/1/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

VISIA imaging S.R.L. Marisa Testa CEO & QA/RA Consultant Thema S.R.L. Via Saragat 5 Imola, BO 40026 Italy

Re: K211868

Trade/Device Name: Myah Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: MXK Dated: January 19, 2022 Received: January 24, 2022

Dear Marisa 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies.combination product submissions. 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

2

requirements, including, but not limited to: registration and listing (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elvin Y. I

Elvin Ng Retina and Diagnostic Devices Team (THT1A3) Division of Ophthalmic Devices (DHT1A) Office of Ophthalmic, Anesthesia, Respiratory, ENT & Dental Devices (OHT1) Office of Product Evaluation and Quality (OPEQ) Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211868

Device Name MYAH

Indications for Use (Describe)

MY AH is intended for measuring the axial length of the eye in a population age 5 and above and is intended for use under the care of an eye care professional.

MYAH is not intended to be used in patients with cataracts.

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)
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