Icare HOME Tonometer

K200966 · Icare Finland OY · HKY · May 7, 2020 · Ophthalmic

Device Facts

• Record ID: K200966
• Device Name: Icare HOME Tonometer
• Applicant: Icare Finland OY
• Product Code: HKY · Ophthalmic
• Decision Date: May 7, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

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.

Device Story

Handheld, battery-operated rebound tonometer for home use; measures intraocular pressure (IOP) without topical anesthesia. Device uses sterile, single-use probe making brief corneal contact; measures probe deceleration and rebound time to calculate IOP. Sequence consists of six measurements; device stores final IOP, timestamp, eye identification, and measurement quality (standard deviation). Data uploaded to Icare CLINIC via Icare EXPORT (desktop) or Icare PATIENT (mobile) applications. Used by patients at home under healthcare professional supervision. Healthcare providers access data via browser-based Icare CLINIC for clinical monitoring and decision-making. Benefits include convenient, non-invasive IOP tracking outside clinical settings.

Clinical Evidence

No clinical studies were performed to test this device modification. Evidence consists of bench testing and compliance with recognized consensus standards including ANSI AAMI ES60601-1, ISO 15004-1, IEC 60601-1-6, IEC 62304, IEC 62366-1, IEC 60601-1-11, and IEC 62471.

Technological Characteristics

Handheld, battery-powered (2x CR123) rebound tonometer. Dimensions ~110mm x 80mm x 30mm; weight ~150g. Uses lightweight, disposable, gamma-sterilized plastic probes. Connectivity via USB (including Android support). Software lifecycle per IEC 62304 (Class B). No maintenance calibration required. Measurement range 5-50 mmHg.

Indications for Use

Indicated for adult patients requiring adjunct routine clinical monitoring of intraocular pressure (IOP).

Regulatory Classification

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.

Predicate Devices

• Icare HOME tonometer (type TA022) (K163343)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

### 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# ical

# 510(k) Summary

### 1.1 Submitter Name and Address

Icare Finland Oy Äyritie 22 Vantaa, Finland FI-01510

Contact: Hannes Hyvönen Phone: [phone] Fax: [phone] 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.

{4}------------------------------------------------

## 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

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.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "icare" in a bold, sans-serif font. The word is black, and there is a thin blue line underneath it. The letters are closely spaced, and the overall appearance is clean and modern.

### 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<br>"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 dimensions<br>and weight | Same | Dimensions:<br>~110mm x 80mm x 30mm<br>Weight: ~150g |
| 13. | Device Software<br>Accessories | Difference, Icare LINK replaced<br>with Icare CLINIC, Icare<br>EXPORT and Icare PATIENT<br>software | Icare LINK software |
| 14. | Connectivity<br>interface | Equivalent, added support for<br>Android smartphone or tablet<br>with USB OTG micro B male –<br>micro B male cable and USB<br>micro B to C adapter | USB |
| 15. | User interface<br>sounds | Equivalent, improved indication<br>sounds (errors in 3kHz, all other<br>indications remain the same<br>4kHz) | All indication sounds 4 kHz. |
| 16. | Product<br>appearance | Equivalent, narrow collar<br>changes device appearance<br>slightly<br>Image: icare device TO with red circle around collar | Image: icare device FROM with red circle around collar |

{6}------------------------------------------------

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)

{7}------------------------------------------------

### 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.

{8}------------------------------------------------

### 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.