The Icare HOME tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.

Device Description

The Icare HOME tonometer is a home-use handheld, battery operated device that measures the intraocular pressure (IOP) without the need for topical anaesthesia. It is for prescription use only and to be used under the supervision of a healthcare professional. The device is intended to be used by patients at home.

The tonometer uses the rebound method. A small and light, sterile, single-use probe makes brief contact with the eye. The device measures the deceleration of the probe and the rebound time and calculates the IOP from these parameters. Deceleration of the probe is slower at low IOP compared to high IOP.

The measurement sequence includes six measurements. The probe moves to the cornea and back during every measurement. The tonometer stores information on every complete measurement sequence of six measurements. The stored information includes the calculated final IOP, time and date of the measurement, identification of the eye (right or left) and the quality level of the measurement (i.e. the standard deviation of the six individual measurements).

The measurement data can be uploaded to Icare CLINIC for further analysis using either Icare EXPORT (desktop application) or Icare PATIENT (mobile application). Icare CLINIC is a browser-based software designed for managing patient information and the IOP measurement data.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria related to a performance study for the Icare HOME tonometer, nor does it describe a study that explicitly proves the device meets such criteria in terms of clinical accuracy or diagnostic performance. Instead, this document is a 510(k) summary for a premarket notification, focusing on demonstrating substantial equivalence to a predicate device.

The document highlights:

Changes: The modifications are primarily related to software (Icare LINK replaced with Icare CLINIC, Icare EXPORT, and Icare PATIENT) and connectivity (added Android support). There are also minor changes to user interface sounds and product appearance.
Performance and Safety Data: The document states that the device has been tested according to relevant FDA recognized consensus standards for electrical safety, ophthalmic instruments, usability, software lifecycle processes, and photobiological safety.
No Clinical Studies: Crucially, it explicitly states: "No clinical studies were performed to test this device modification." This means there is no new clinical data presented here to establish performance metrics (like accuracy, sensitivity, specificity, etc.) against a ground truth in a clinical setting for this specific modification. The substantial equivalence is based on the argument that the technological changes do not raise new issues of safety or effectiveness, and therefore, the performance is assumed to be equivalent to the predicate device.

Given this, I cannot extract the detailed information requested in the prompt (acceptance criteria, reported device performance, sample size for test set, expert qualifications, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, how training set ground truth was established) as this information is not present in the provided document for this specific 510(k) submission. The document focuses on demonstrating that the modified device is substantially equivalent to the predicate device without requiring new clinical performance data.

However, based on the general context of medical device regulatory submissions and the information provided, here's what can be inferred or stated regarding the lack of such information:

Information Requested	Details from the Document
1. Table of acceptance criteria and reported device performance	Not provided in this document. The document focuses on demonstrating substantial equivalence based on technical changes and compliance with general safety standards, not on new clinical performance metrics. The measurement range of the device is stated as 5-50 mmHg, but this is a characteristic, not a performance criterion against a ground truth.
2. Sample size for the test set and data provenance	Not applicable/Not provided. No new clinical test set data is presented for this 510(k) submission, as it explicitly states, "No clinical studies were performed to test this device modification." The evaluation relies on the safety and effectiveness of the previously cleared predicate device and the assessment that the changes do not introduce new risks.
3. Number of experts used to establish ground truth & qualifications	Not applicable/Not provided. As no new clinical studies were performed for this specific modification, there's no mention of experts establishing ground truth for a test set in this document.
4. Adjudication method for the test set	Not applicable/Not provided. No new clinical studies were performed for this specific modification.
5. MRMC comparative effectiveness study and effect size	Not applicable/Not provided. The document does not describe any MRMC studies or human-in-the-loop performance evaluations specifically for this device modification. The device is a tonometer, which directly measures IOP, and thus, comparative effectiveness with human readers (in the sense of image interpretation for AI) isn't directly relevant in the same way it would be for an AI-powered diagnostic imaging device. Its accuracy would typically be compared to a gold standard IOP measurement method.
6. Standalone (algorithm only without human-in-the-loop) performance	Not explicitly detailed as a new study. While the tonometer itself operates standalone to measure IOP, the document does not present new standalone performance data (e.g., accuracy against a gold standard) for this modified device. The assertion of substantial equivalence implies that its standalone performance is considered equivalent to the predicate device, for which such data would have been provided in its original 510(k).
7. Type of ground truth used	Not applicable/Not provided in this document for new studies. For IOP measurement devices, the ground truth for performance studies would typically be established by a well-calibrated reference tonometer (e.g., Goldmann Applanation Tonometer) or other validated methods, but this is referring to the original predicate device's clearance.
8. Sample size for the training set	Not applicable. This device is hardware-based for IOP measurement and the modifications pertain to software for data management/connectivity and minor hardware appearance changes. There is no indication of a machine learning-based component that would require a "training set" in the traditional sense of AI algorithm development for classification or prediction from data within the scope of this 510(k) submission. Therefore, a training set is not pertinent to the changes described.
9. How the ground truth for the training set was established	Not applicable. As there is no training set for a machine learning algorithm described in this 510(k) modification, this question is not relevant to the provided text. The device performs a direct physical measurement. The software changes concern data handling and connectivity, not interpretive AI.

In summary, this 510(k) document is a "Special 510(k)" for a device modification, and the strategy is to demonstrate substantial equivalence to a predicate device without new clinical performance data, relying on the argument that the changes do not affect the fundamental safety and effectiveness of the IOP measurement.

Summary

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May 7, 2020

Icare Finland Oy Hannes Hyvönen Regulatory Affairs Manager Äyritie 22 Vantaa, 01510 Finland

Re: K200966

Trade/Device Name: Icare HOME Tonometer Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKY Dated: April 7, 2020 Received: April 10, 2020

Dear Hannes Hyvönen:

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/cfpmn/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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (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 (OS) 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 mediation-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/cdrh-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 Ng Acting Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200966

Device Name Icare HOME Tonometer

Indications for Use (Describe)

The Icare HOME tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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ical

510(k) Summary

1.1 Submitter Name and Address

Icare Finland Oy Äyritie 22 Vantaa, Finland FI-01510

Contact: Hannes Hyvönen Phone: 358 9 8875 1150 Fax: 358 9 728 6670 Email: regulatory(@icarefinland.com Date prepared: May 4, 2020

1.2 Device Name

Trade Name:	Icare HOME tonometer
Common/Usual Name:	Tonometer
Classification Name:	Tonometer and Accessories
Regulation No:	21 CFR 886.1930
Device Regulatory Class:	II
Review Panel:	Ophthalmic
Product Code:	HKY

Premarket Notification 510(k) Number: K200966 This premarket notification type is Special 510(k).

1.3 Predicate Device

Icare HOME tonometer (type TA022), K163343 This predicate has not been subject to a design-related recall.

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1.4 Indications for Use / Intended Use

"The Icare HOME tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients."

The intended use of the Icare HOME tonometer (type TA022) as well as the method used to obtain IOP measurement remain unchanged by this design modification.

1.5 Device Description

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1.6 Comparison of Technological Characteristics with the Predicate

Device

Comparison of the modified device to the cleared device is presented in the table below:

#	Characteristic	Modified device (subject of this 510k)	Cleared device (K163343)
1.	Product/Device Identification	Same	Icare HOME tonometer (type TA022)
2.	Intended Use / Indications for Use Statement	Same	IOP Measurement"The Icare HOME tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients."
3.	Intended Users	Same	Patients at home
4.	Design	Same	Handheld microprocessor based
5.	Calibration	Same	No maintenance calibration required
6.	Measurement range	Same	5-50 mmHg
7.	Measurement method	Same	Rebound tonometry
8.	Contact tip (probe)	Same	Lightweight, disposable, single use, plastic probe
9.	Contact tip sterilization	Same	Gamma-sterilized
10.	Anaesthesia required	Same	No
11.	Power supply	Same	2 x CR123 batteries
12.	Device dimensionsand weight	Same	Dimensions:~110mm x 80mm x 30mmWeight: ~150g
13.	Device SoftwareAccessories	Difference, Icare LINK replacedwith Icare CLINIC, IcareEXPORT and Icare PATIENTsoftware	Icare LINK software
14.	Connectivityinterface	Equivalent, added support forAndroid smartphone or tabletwith USB OTG micro B male –micro B male cable and USBmicro B to C adapter	USB
15.	User interfacesounds	Equivalent, improved indicationsounds (errors in 3kHz, all otherindications remain the same4kHz)	All indication sounds 4 kHz.
16.	Productappearance	Equivalent, narrow collarchanges device appearanceslightlyImage: icare device TO with red circle around collar	Image: icare device FROM with red circle around collar

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Image /page/6/Picture/1 description: The image shows the word "icare" in a bold, sans-serif font. The letters are black, and there is a thin blue line underneath the word. The background is white. The word appears to be a logo or brand name.

Icare HOME 510(k)

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1.7 Performance and Safety Data

The device has been tested according to relevant FDA recognized consensus standards. The following performance and safety data of the modified device are provided in support of the substantial equivalence:

. ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
. ISO 15004-1:2006 Ophthalmic instruments – Fundamental requirements and test methods - Part 1: General requirements
IEC 60601-1-6:2010 + A1:2013 Medical electrical equipment Part 1-6: General ● requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62304:2006 + A1:2015 Medical device software Software life-cycle . processes (Device firmware and software level of concern: Class B)
IEC 62366-1:2015 Medical devices Application of usability engineering to ● medical devices
. IEC 60601-1-11:2015 Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment
. IEC 62471:2006 Photobiological safety of lamps and lamp systems

There were no significant changes related to electromagnetic compatibility (EMC), sterilization or biocompatibility. Device and software risk analysis has been performed in accordance with ISO 14971 risk management standard. No clinical studies were performed to test this device modification.

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1.8 Substantial Equivalence

The modified Icare HOME is substantially equivalent to the predicate device. The technological differences between the Icare HOME and its predicate device raise no new issues of safety and effectiveness. Performance and safety data demonstrate that the Icare HOME is as safe and effective as the predicate device.

Regulation Number and Section

§ 886.1930 Tonometer and accessories.

(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.