The Icare ic100 (TA011) tonometer is a hand-held, battery operated device which measures intraocular pressure (IOP) without the need for topical anesthesia. The Icare ic100 (TA011) tonometer is fundamentally the same as the predicate Icare tonometer model TA01i (cleared by FDA under K063873). The measurement method, the IOP measurement algorithm and rebound technology (including disposable probe) are identical for both models. The Icare ic100 (TA011) tonometer utilizes the rebound method to measure intraocular pressure. A small (1.8 mm diameter), light (26.5 mg), sterile, single-use probe makes brief and gentle contact with the eye. The tonometer measures the deceleration of the magnetized probe and the rebound time during contact with the eye and calculates the IOP from these parameters. Deceleration of the probe is slower at low IOP compared to high IOP.

A single measurement sequence includes six measurements. After the six measurements are completed, the tonometer calculates the final IOP and the result is provided on the display.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Icare ic100 tonometer based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with specific numerical targets. Instead, it focuses on demonstrating that the Icare ic100 performs comparably to its predicate device, the Icare TA01i. The core of the performance demonstration is that the operational principle, measurement algorithm, and rebound technology are identical.

Therefore, the "acceptance criteria" are implied to be substantially equivalent performance to the predicate device, particularly with regard to IOP measurement accuracy.

Performance Aspect	Acceptance Criteria (Implied)	Reported Device Performance (Icare ic100)
Measurement Method	Identical to predicate device	Identical to predicate device (IOP measurement algorithm unchanged, rebound technology identical)
IOP Measurement Algorithm	Identical to predicate device	Identical to predicate device (K063873)
Rebound Technology	Identical to predicate device	Identical to predicate device
Range of Measurement	Same as predicate (7-50 mmHg)	Same as predicate (7-50 mmHg)
Accuracy / Equivalence to Predicate	Performance comparable to Icare TA01i, validated according to ANSI Z80.10-2014 & IEC standards.	Verification tests carried out in accordance with ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers confirmed that performance and safety aspects are comparable.
Electrical Safety	Compliance with IEC 60601-1	In compliance with IEC 60601-1
Electromagnetic Compatibility	Compliance with IEC 60601-1-2	In compliance with IEC 60601-1-2
Software Life Cycle Processes	Compliance with IEC 62304	Verified against the requirements of IEC 62304

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on a specific "test set" and its sample size for evaluating the Icare ic100's primary measurement performance (IOP accuracy). The submission primarily relies on the equivalency of the measurement method, algorithm, and rebound technology to the predicate device.

It states that "Verification tests, where applicable, have been carried out in accordance with ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers to confirm that the performance and safety aspects of the modified tonometer are comparable with the Icare TA01i." However, specific sample sizes (e.g., number of subjects, number of measurements) for these verification tests are not provided in this document.

Therefore, we cannot determine the sample size or data provenance (country, retrospective/prospective) from the provided text for a specific performance test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. Since the submission focuses on substantial equivalence to a predicate device with an identical measurement algorithm, it's possible that direct clinical studies establishing a new ground truth were not deemed necessary or details were not included in this summary. The ground truth for the predicate's calibration was stated to be "Goldmann reference tonometer data."

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with AI vs Without AI Assistance

This device (Icare ic100 tonometer) is a standalone medical device for measuring intraocular pressure. It is not an AI-assisted diagnostic device, nor does it involve human readers interpreting images or data alongside AI. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The entire device operates as a standalone algorithm without continuous human-in-the-loop intervention during the measurement process itself. The "algorithm only" performance is the device's performance. The document states:

"The Icare ic100 (TA011) uses the same operating principle found in the predicate device and in all rebound type tonometers."
"The IOP measurement algorithm is unchanged from the FDA cleared Icare tonometer model TA01i (K063873). Parameters from the signals produced by the probe momentarily contacting the eye (rebound parameters) are used to calculate an IOP-index. An embedded calibration table which was derived using Goldmann reference tonometer data is used to calculate an IOP value (in mmHg) based on the IOP-index."

This indicates that the standalone algorithm's performance is fundamental to the device's function, which is considered substantially equivalent to the predicate.

7. The Type of Ground Truth Used

For the calibration table embedded in the algorithm (which is identical to the predicate), the ground truth used was Goldmann reference tonometer data. This is explicitly stated: "An embedded calibration table which was derived using Goldmann reference tonometer data is used to calculate an IOP value (in mmHg) based on the IOP-index."

8. The Sample Size for the Training Set

The document states that the "IOP measurement algorithm is unchanged from the FDA cleared Icare tonometer model TA01i (K063873)" and that its calibration table was "derived using Goldmann reference tonometer data." However, the sample size for this derivation (training set for the calibration table) is not provided in this document.

9. How the Ground Truth for the Training Set was Established

The ground truth for the training set (from which the calibration table was derived for the predicate device's algorithm) was established using Goldmann reference tonometer data. The Goldmann applanation tonometer is considered the clinical gold standard for IOP measurement. This implies that measurements from the rebound tonometer were compared against concurrently measured Goldmann values to create the calibration.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 19, 2016

Icare Finland Oy Mr. Matti Tulikoura Regulatory Manager Ayritie 22 FI-01510 Vantaa, Finland

Re: K153694

Trade/Device Name: Icare Ic100 Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKX, HKY Dated: February 11, 2016 Received: February 12, 2016

Dear Mr. Tulikoura:

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. 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 (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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name ic100

Indications for Use (Describe)

The Icare ic100 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

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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FORM FDA 3881 (8/14)

Page 1 of 1

ICARE FINLAND OY

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8.1 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS

8.2 SUBMITTER NAME AND ADDRESS

Icare Finland Oy Äyritie 22 Vantaa Finland FI-01510

Contact:	Matti Tulikoura (Regulatory Manager)
Phone:	358 9 8775 1150
Fax:	358 9 728 6670
Email:	matti.tulikoura@icarefinland.com

Date Prepared: 12 April 2016

8.2 DEVICE NAME

Trade Name:	Icare ic100
Common/Usual Name:	Tonometer
Classification Name:	Tonometer and Accessories
Regulation No:	886.1930
Device Regulatory Class:	II
Review Panel:	Ophthalmic
Product Code:	HKYHKX
Premarket Notification (510(k)) Number:	N/A

8.3 PROPOSED MODIFICATION

The proposed modification described in this Traditional 510(k) covers the dimensional and graphical user interface (GUI) changes to the current Icare TA01i to allow for improved ergonomics and a larger OLED Display.

The Icare ic100 (TA011) uses the same operating principle found in the predicate device and in all rebound type tonometers.

The intended use of the Icare ic100 (TA011) as well as the method used by the clinician to obtain a reading remains unchanged by this modification.

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8.4 DEVICE DESCRIPTION

A single measurement sequence includes six measurements. After the six measurements are completed, the tonometer calculates the final IOP and the result is provided on the display.

METHOD OF OPERATION

Measurement Method

The IOP measurement algorithm is unchanged from the FDA cleared Icare tonometer model TA01i (K063873). Parameters from the signals produced by the probe momentarily contacting the eye (rebound parameters) are used to calculate an IOP-index. An embedded calibration table which was derived using Goldmann reference tonometer data is used to calculate an IOP value (in mmHg) based on the IOP-index. After the sixth measurement, the highest and lowest of the six IOP measurements are excluded and the remaining four are averaged to obtain the final IOP result which is displayed to the user.

Signal Processing

Identical to the predicate device, the Icare ic100 (TA011) tonometer records the speed of the probe upon initiation of a measurement sequence. The speed information is obtained from a coil, in which electrical signal is induced when the magnetized probe moves inside the coil.

The electrical signal is directly proportional to the speed of the probe. The analog signal obtained from the coil is amplified and digitized. Digitization is done using a microcontroller with embedded analog to digital converter. The digitized signal is stored and processed by a microcontroller. Intraocular pressure is calculated from the digitized speed data.

When the moving probe makes contact with the cornea, the probe decelerates at a rate which depends on the intraocular pressure. Deceleration of the probe at low IOP is slower compared to high IOP.

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Calibration Procedure

As is the case for the predicate device, the design and principle of operation of the Icare ic100 (TA011) tonometer is such that maintenance calibration is not required. The tonometer does not include any mechanical or electrical parts subject to wear, excluding the probe base, which would cause an out of tolerance condition. Maintenance of the probe base is described in user manual.

Software

The Icare ic100 (TA011) Tonometer has embedded software utilizing a microcontroller. The software performs the following functions:

Provides a user interface utilizing the user operable button and an OLED display to control the measurement cycle
o Provides control to LED Probe base light
o Controls the probe's movement
Calculates the intraocular pressure from the probe speed during impact
. Handles possible error conditions, such as recognizing if probe didn't make contact with cornea or if the speed of the probe is abnormal
. Calculates the standard deviation of the measurements during the measurement cycle and instructs user to repeat the measurement if the variability is unacceptable
Provides time setting to the internal clock
. Retrieves the serial number for identification of the device
Stores measurement history in an external flash memory IC.

8.5 LABELING AND INTENDED USE

Instructions for Use (IFU) for the tonometer have been updated to reflect the design modifications.

The intended use of the Icare ic100 (TA011) as well as the method used by the clinician to obtain a reading remains unchanged by this modification.

Indications for Use:

The Icare ic 100 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

MATERIALS BIOCOMPATIBILITY 8.6

There has been no change to the materials that contact the eye. Patient contact materials for the forehead rest have been evaluated based on ISO 10993-1 due to their transient contact with intact skin

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8.7 CLEANING AND DISINFECTION

Cleaning instructions for the tonometer body and the recommended method for disinfecting remains unchanged.

Instructions have been provided in the Instructions for Use.

8.8 COMPARISON OF THE DEVICE WITH THE PREDICATE

The comparison table below summarizes the similarities and differences between both systems.

		ICARE TA01i (K063873)	ICARE iC100 (TA011)
1.	Indication for Use	The Icare TA01i Tonometer isintended to be used for themeasurement of intraocular pressureof the human eye.	Same
2.	Design	Hand-held microprocessor based	Same
3.	Measurement technique	Rebound tonometry	Same
4.	Calibration	No maintenance calibration required	Same
5.	Contact tip	Lightweight, disposable, single use,plastic probe (26.5mg)	Same
6.	Contact tip sterilization	Sterilized, disposable, single use	Same
7.	Force applied to eyeduring reboundmeasurement	8-16 mN	Same
8.	Display	4 digit LCD(2 digit reading)	1.50" OLED Display 128x128Full color
9.	Range of measurement	7-50 mmHg (display range 1-99mmHg)	Same
10.	Versatility	Tonometer must be orientedhorizontally	Same
11.	Anesthesia required	No	Same
12.	Weight	5.47 oz. without batteries(155 g)	4.94 oz. without batteries (140g)
13.	Dimensions	1.26" x 3.15" x 9.06"(32mm x 80mm x 230 mm)	1.14" x 3.74" x 8.46"(29mm x 95mm x 215mm)
14.	Power source	4 x 1.5 Volt AA batteries	Same

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PERFORMANCE AND SAFETY 8.9

Verification tests, where applicable, have been carried out in accordance with ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers to confirm that the performance and safety aspects of the modified tonometer are comparable with the Icare TA01i cleared for marketing under 510(k) K063873.

The software used in the Icare ic100 (TA011) has been verified against the requirements IEC 62304 Medical device software - Software life cycle processes.

The Icare ic100 (TA011) has also been evaluated against the requirements of IEC 60601-1 for electrical safety and to IEC 60601-1-2 for electromagnetic compatibility. In all tests the modified device was in compliance with these FDA recognized standards.

8.10 SUBSTANTIAL EQUIVALENCE

The Icare ic100 (TA011) Tonometer is considered to be substantially equivalent to the Icare TA01i described in the original 510(k) submission (K063873).

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.