(267 days)
The iCare HOME2 tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.
The iCare HOME2 tonometer (model TA023) is a hand-held, battery operated device which measures intraocular pressure (IOP) without the need for topical anaesthesia by rebound tonometry. The tonometer is to be used by the patients themselves. 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 method, the IOP measurement algorithm and rebound technology (including disposable probe) are identical with the predicate device. iCare HOME2 tonometer is a further developed version of iCare HOME tonometer. It features enhancements such as possibility to measure IOP in any angle between 0° and 90° (horizontal to supine patient position) and possibility for wireless measurement result transfer to mobile device or to PC. External design and user interface have been modified for better usability and ergonomics. The measurement data can be uploaded to iCare CLINIC for further analysis using either iCare EXPORT (desktop application) or iCare PATIENT2 (mobile application). iCare PATIENT2 is a mobile app intended for transferring eye pressure measurement data from the iCare tonometer to the iCare CLINIC cloud service or an external system. The app displays the eye pressure measurement results and helps in glaucoma management. It is indicated for use by healthcare professionals and patients. Measurement results can be transferred to iCare CLINIC with either through a Bluetooth connection or by connecting the USB C type connector to the device and mobile phone, depending on the user's mobile phone operating system.
The iCare HOME2 tonometer is intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance document for iCare HOME2 (K211355) does not explicitly list "acceptance criteria" in a bulleted or numbered format with specific thresholds. However, based on the provided "Performance and Safety Data" and "Clinical Performance Testing" sections, we can infer the implied acceptance criteria were related to accuracy, repeatability, and reproducibility compared to existing tonometers, as well as safety.
The key performance metric presented is the agreement between the iCare HOME2 and a reference tonometer (iCare IC200).
| Acceptance Criteria (Inferred from study design) | Reported Device Performance (iCare HOME2 vs. iCare IC200) |
|---|---|
| Accuracy and Agreement with Reference Tonometer (iCare IC200) | Overall (N=47 patients):- Mean paired difference (iCare HOME2 - iCare IC200): 0.55 mmHg- Standard deviation of the difference: 2.69 mmHg- 95% CI for Mean Difference: -0.86, -0.23 mmHg (Note: This range seems incorrectly transcribed in the original document as it does not align with the mean paired difference, it may be a typo. Usually, it would encompass the mean diff. Assuming the mean diff is correct.)- 95% Limits of Agreement (LOA) for Mean Difference: -5.82, 4.72 mmHg (This indicates that 95% of the differences between the two devices fall within this range). |
| Repeatability (Variability of repeat measurements) | For each patient, variability (difference of repeat measurements) for all IOP ranges was ~7.9%. |
| Reproducibility (Agreement regardless of device, operator, or measurement angle) | Demonstrated high agreement with manometric pressure regardless of the device, operator, or the measurement angle (from bench testing). |
| Safety | No adverse events (including corneal abrasions) were recorded in the study population. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 47 patients.
- Data Provenance: Prospective clinical study performed at East West Eye Institute, CA 90013, USA. The patients were either diagnosed glaucoma patients or 'glaucoma suspects'.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth. The ground truth was established by comparison to a "reference tonometer (iCare IC200)," which is a cleared medical device. While healthcare professionals (likely ophthalmologists or technicians) would have operated both devices during the clinical study, their role in establishing a "ground truth" (beyond operating the reference device) for each patient's IOP is not detailed. The iCare IC200 itself is considered a "reference" for comparison.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It appears a direct comparison between the iCare HOME2 measurements and the iCare IC200 measurements was performed. A "random eye was selected as the study eye for each patient."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The study described is not a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers with and without AI assistance.** This device is a tonometer, a measurement device, not an AI-powered diagnostic imaging tool that assists human readers.** Therefore, this question is not applicable to the submitted document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The iCare HOME2 is a physical tonometer device that performs measurements. It has an "IOP measurement algorithm" that calculates IOP from probe deceleration and rebound time. The clinical study evaluated the performance of this device (which includes its internal algorithm) when used by patients (self-measurement) compared to a reference tonometer (likely operated by a healthcare professional). Therefore, in a sense, the measurement output itself is "standalone" from direct human interpretation of raw data, but it's a device measurement, not an AI algorithm assisting human interpretation.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established by comparison to a legally marketed reference medical device: the iCare IC200 tonometer (cleared in K190316). In addition, bench testing used "manometrically controlled artificial cornea" for accuracy and reproducibility assessment, implying manometric pressure served as a higher-level ground truth in those tests. For the clinical study, the IC200 served as the comparative standard.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" in the context of machine learning or AI. The iCare HOME2 tonometer uses a "rebound method" and an "IOP measurement algorithm," which are stated to be "identical with the predicate device." This suggests the core measurement algorithm was likely developed and validated prior to this submission (possibly with data from the predicate device iCare HOME), and this submission focuses on the safety and effectiveness of the new device iteration. No specific training set for a machine learning model is mentioned.
9. How the Ground Truth for the Training Set was Established
As no specific training set for an AI/machine learning model is mentioned for iCare HOME2, information on how its ground truth was established is not available in the provided document. The device's measurement principles are inherited from the predicate device.
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January 25, 2022
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Icare Finland Oy Hannes Hyvönen Regulatory Affairs Manager Ayritie 22 Vantaa, 01510 Finland
Re: K211355
Trade/Device Name: iCare HOME2 Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer And Accessories Regulatory Class: Class II Product Code: HKY Dated: December 17, 2021 Received: December 22, 2021
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 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
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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 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 Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211355
Device Name iCare HOME2
Indications for Use (Describe)
The iCare HOME2 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) | |
|---|---|
| Remediation Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart G) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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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 Email: regulatory@icare-world.com Date prepared: January 18th, 2022
1.2 Device Name
| Trade Name: | iCare HOME2 |
|---|---|
| Type/model: | TA023 |
| 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: K211355 This premarket notification type is Traditional 510(k).
1.3 Predicate and Reference Device
Primary predicate: iCare HOME tonometer (type TA022), K200966
Reference device: iCare IC200 tonometer (type TA031), K190316.
The predicate device and the reference device have not been subject to a design-related recall.
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1.4 Indications for Use / Intended Use
"The iCare HOME2 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 HOME2 tonometer is the same as the predicate device.
1.5 Device Description
The iCare HOME2 tonometer (model TA023) is a hand-held, battery operated device which measures intraocular pressure (IOP) without the need for topical anaesthesia by rebound tonometry. The tonometer is to be used by the patients themselves.
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 method, the IOP measurement algorithm and rebound technology (including disposable probe) are identical with the predicate device.
iCare HOME2 tonometer is a further developed version of iCare HOME tonometer. It features enhancements such as possibility to measure IOP in any angle between 0° and 90° (horizontal to supine patient position) and possibility for wireless measurement result transfer to mobile device or to PC. External design and user interface have been modified for better usability and ergonomics.
The measurement data can be uploaded to iCare CLINIC for further analysis using either iCare EXPORT (desktop application) or iCare PATIENT2 (mobile application). iCare PATIENT2 is a mobile app intended for transferring eye pressure measurement data from the iCare tonometer to the iCare CLINIC cloud service or an external system. The app displays the eye pressure measurement results and helps in glaucoma management. It is
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indicated for use by healthcare professionals and patients. Measurement results can be transferred to iCare CLINIC with either through a Bluetooth connection or by connecting the USB C type connector to the device and mobile phone, depending on the user's mobile phone operating system.
1.6 Comparison of Technological Characteristics with the Predicate Device
Comparison of the subject device (iCare HOME2) to the predicate device (iCare HOME) and reference device (iCare IC200) is presented in the table below:
| Characteristic | Subject device | Primary Predicate Device(K200966) | Reference Device(K190316) |
|---|---|---|---|
| ProductAppearance | Image: iCare HOME2 tonometer | Image: iCare HOME tonometer | Image: iCare IC200 Tonometer |
| Product/DeviceIdentification | iCare HOME2 tonometer(Type: TA023) | iCare HOME tonometer(Type: TA022) | iCare IC200 Tonometer(Type: TA031) |
| Intended Use /Indications forUse Statement | Same as iCare HOME(K200966) | IOP Measurement"The Icare HOME tonometeris a prescription deviceintended as an adjunct to theroutine clinical monitoring ofintraocular pressure (IOP) ofadult patients." | IOP Measurement"The Icare ic200tonometer is intended to beused for the measurementof intraocular pressure ofthe human eye." |
| Intended users | Same as iCare HOME(K200966) | Patients at home | Healthcare professionals |
| Measurementmethod | Same as iCare HOME(K200966) and iCare IC200(K190316) | Rebound tonometry | Rebound tonometry |
| Measurementrange | 7-50 mmHg, substantiallyequivalent to iCare HOME(K200966)Same as iCare IC200 (K190316) | 5-50 mmHg | 7-50 mmHg |
| Versatility ofMeasurementposition | Tonometer can be used in anyangle between 0° (sitting,standing) and 90° (patient insupine position)Substantially equivalent as iCareHOME K200966, added supineposition (similar to iCare IC200K190316). | Tonometer must be orientedhorizontally (0°, patient insitting or standing position) | Tonometer can be used inany angle between 0°(sitting, standing) and 90°(patient in supine position) |
| Device Display | 1.50" OLED display(same as to iCare IC200K190316) | No display | 1.50" OLED display |
| Automatic eyerecognitionsystem | Same as iCare HOME K200966 | Yes | No |
| Design | Same as iCare HOME(K200966) and iCare IC200(K190316) | Handheld microprocessorbased | Handheld microprocessorbased |
| Calibration | Same as iCare HOME(K200966) and iCare IC200(K190316) | No maintenance calibrationrequired | No maintenance calibrationrequired |
| Contact tip(probe) | Same as iCare HOME(K200966) and similar to iCareIC200 (K190316) | Lightweight, disposable,single use, plastic probe(TP022) | Lightweight, disposable,single use, plastic probe(TP01s) |
| Contact tipsterilization | Same as iCare HOME(K200966) and iCare IC200(K190316) | Gamma-sterilized | Gamma-sterilized |
| Anaesthesiarequired | Same as iCare HOME(K200966) and iCare IC200(K190316) | No | No |
| Power supply | Substantially equivalent to iCareHOME K200966 (same as iCare | 2 x 3V CR123 batteries | 4 x 1,5V AA Alkaline LR6batteries |
| Device dimensions and weight | Substantially equivalentDimensions:50 mm x 94 mm x 152 mmWeight: 205g (without batteries),300g (with batteries) | Dimensions:110mm x 80mm x 30mmWeight: 112g (without batteries), 150g (with batteries) | Dimensions:43mm x 104mm x 214mmWeight: 165g (without batteries), 267g (with batteries) |
| Device Software Accessories | Substantially equivalent as iCare HOME (K200966), added iCare PATIENT2 as new SW accessory | iCare CLINIC, iCare EXPORT, iCare PATIENT, (also compatible with iCare PATIENT2) | iCare CLINIC, iCare EXPORT |
| Connectivity interface | USB 2.0 (USB type C)Substantially equivalent as iCare HOME (K200966)Bluetooth (Microchip RN4678 Module)Same as in iCare IC200 (K190316) | USB 2.0 (USB micro B) | Bluetooth (Microchip RN4678 Module) |
| User interface | Audio indications:Substantially equivalent to iCare HOME (K200966) and iCare IC200 (K190316)Graphical User Interface:Substantially equivalent to iCare HOME (K200966) and same as iCare IC200 (K190316)Probe base light:Substantially equivalent to iCare HOME (K200966) and iCare IC200 (K190316).In addition, blue light indicates that the distance from the eye is too far. | Audio indications:Beeps for device too near or too far situation, and for other errors.Graphical User Interface:Indication lights panelProbe base light:Green: angle correct, device readinessRed: angle incorrectBlinking red: measurement error messages | Audio indications:Beeps for device too near or too far situation, and for other errors.Graphical User Interface:OLED displayProbe base light:Green: angle correct, device readinessRed: angle incorrectBlinking red: measurement error messages |
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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 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
- . IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests.
- 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
- ANSI Z80.36-2016 American National Standard for Ophthalmics Light Hazard . Protection for Ophthalmic Instruments
There were no changes related to sterilization or biocompatibility. Device and software risk analysis has been performed in accordance with ISO 14971 risk management standard.
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1.8 Bench Performance Testing
Accuracy of the iCare HOME2 tonometer was assessed in a bench test using a manometrically controlled artificial cornea. Manometric pressure was set by using reference tonometer iCare IC200, cleared in K190316.
Repeatability and accuracy testing completed with iCare HOME2 tonometer demonstrated high agreement with manometric pressure and reference tonometers (iCare IC200 and iCare HOME).
Reproducibility test completed with iCare HOME2 tonometer demonstrated high agreement with manometric pressure regardless of the device, operator, or the measurement angle.
Software Verification and Validation Testing
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered as a "moderate" level of concern since a failure or latent flaw in the software could directly result in minor injury to the patient or operator.
Clinical Performance Testing 1.9
A clinical study was conducted to analyse the variability of the intraocular pressure (IOP) self-measurements with the iCare HOME2 tonometer in comparison to the variability of the IOP measurements with the reference tonometer (iCare IC200) over a wide range of IOP measurement values.
The performance data was obtained from a clinical study. The study was performed at East West Eye Institute, CA 90013, USA, and included 47 patients were found to be eligible for analysis. All the patients were either diagnosed glaucoma patients or 'glaucoma-suspects'. A random eye was selected as the study eye for each patient.
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Safety: No adverse events (including corneal abrasions) were recorded in the study population.
Results: The mean paired difference and standard deviation (iCare HOME2 - iCare IC200) were 0.55 mmHg and 2.69 mmHg. The iCare HOME2's variability (difference of repeat measurements) for each patient was ~7.9% for all the IOP ranges.
| Group | N | Reference, IC200 | Difference | 95% CI for Mean Difference | 95% LOA for Mean Difference | |
|---|---|---|---|---|---|---|
| HOME2Mean (SD) | Mean (SD) | |||||
| ≤ 16mmHg | 24 | 15.78(2.86) | 14.86(2.9) | -0.93(2.75) | -1.38, -0.48 | -6.32, 4.46 |
| >16 to <23mmHg | 13 | 20.17(2.28) | 19.56(2.75) | -0.6(2.66) | -1.2, -0.00 | -5.81, 4.61 |
| ≥ 23mmHg | 10 | 23.88(2.34) | 24.33 (2.42) | 0.44(2.36) | -0.17, 1.05 | -4.19, 5.07 |
| Overall | 47 | 18.72(4.17) | 18.17 (4.67) | 0.55(2.69) | -0.86, -0.23 | -5.82, 4.72 |
1.10 Substantial Equivalence
The iCare HOME2 is substantially equivalent to the predicate device. The devices have the same or substantially equivalent technological characteristics and the iCare HOME2 raises no new issues of safety and effectiveness. Performance and safety data demonstrate that the iCare HOME2 is as safe and effective as the predicate device.
§ 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.