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. The Icare HOME tonometer technology is based on the previously cleared Icare tonometer model TA011 (K063873), which has been commercially distributed in the United States, Europe and many other countries worldwide. The measurement method, the measurement algorithm and technology of the two models are identical and both models use the same disposable probe tip. The Icare HOME tonometer utilizes the rebound method to measure intraocular pressure. A small (1.8 mm diameter), light (26.5 mg), sterile, single-use probe tip makes brief and gentle contact with the eye. The device 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 for both measurement modes. The probe moves to the cornea and returns to the neutral position during each of the six measurements. After the six measurements the tonometer calculates the final IOP and stores it with other information in the tonometer's memory, including date, time, eye identification (right or left) and measurement quality i.e., the standard deviation of the six individual measurements. The Icare HOME Tonometer can record over one thousand measurement results. The physician can transfer this recorded measurement information to a computer through a USB cable.

AI/ML Overview

Here's an analysis of the provided text, extracting information related to acceptance criteria and the study proving the device meets them:

Device: Icare HOME Tonometer (K163343/S001)
Intended Use: Prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in a tabulated format with pass/fail. Instead, it describes various tests and their "acceptable" outcomes. I've extrapolated these into a table based on the success statements. Note that some criteria are qualitative (e.g., "acceptable", "meets standards"), reflecting the regulatory language.

Aspect Tested	Acceptance Criteria (Implicitly Stated)	Reported Device Performance
Bench Performance - Accuracy (vs. Manometer)	Differences between Icare HOME tonometer and manometer values at each pressure should be less than +/- 3 mmHg.	Differences were less than +/- 3 mmHg across the range.
Bench Performance - Precision (Standard Deviation)	Standard deviations and coefficients of variation should be consistently low.	Standard deviations and coefficients of variation for each Icare Home tonometer were consistently low (0-8%) across the measurement range, specifically <0.52 mmHg and <5.5% CV for 10-30 mmHg.
Bench Performance - Accuracy (10, 20, 30 mmHg)	Within-level measurement differences maximal 1 mmHg, at least 50% of measurements same (IQR=0). Within-unit mean, overall mean, and average of means close to actual pressure.	Within-level measurement differences were at most 1 mmHg; at least 50% of within-level measurements were the same (IQR = 0); means were close to actual pressure.
Bench Performance - Accuracy (40, 50 mmHg)	Within-level measurement differences within 3 mmHg; at least 50% of measurements within 1-2 mmHg.	Within-level measurement differences within 3 mmHg; at least 50% within 1 mmHg (40 mmHg) and 2 mmHg (50 mmHg).
Bench Performance - Bias/Imprecision at Extremes	Expected to be within acceptable limits for intended use.	Slightly more bias and imprecision at extremes (2 mmHg at 5 mmHg, 2-3 mmHg at 40 and 50 mmHg). CV of 8.1% at 5 mmHg vs 0.0-5.5% for 10-50 mmHg. Still deemed "suitable for home-use."
Bench Performance - Operator/Instrument Variability	Little variation due to operator or between instruments.	Very little difference attributed to either inter-operator or inter-instrument variability.
Clinical Performance - Agreement with GAT (Overall)	Limits of agreement meeting ANSI Z80.10-2009 performance goals (less than 5% outside ± 5 mmHg, less than 1% outside ± 7.5 mmHg).	Mean difference (HOME - GAT) = -0.53 mmHg; SD = 2.43 mmHg. 3.2% outside ± 5 mmHg, 0.3% outside ± 7.5 mmHg. All ANSI performance goals met.
Clinical Performance - Agreement with GAT (by IOP Group)	Less than 5% outside ± 5 mmHg and less than 1% outside ± 7.5 mmHg for each group (≤16 mmHg, >16 to <23 mmHg, ≥23 mmHg).	2.8%, 4.2%, 1.5% outside ± 5 mmHg; 0.7%, 0.0%, 0.0% outside ± 7.5 mmHg respectively. All ANSI performance goals met.
Clinical Performance - Repeatability (Overall)	Repeatability to be comparable or acceptable for a home-use device.	Overall Repeatability CV% = 9.76%.
Clinical Performance - Safety (Adverse Events)	No adverse events reported.	No adverse events (including corneal abrasions) were reported in the clinical study.
Clinical Performance - Safety (Corneal Staining)	Minimal increase in staining, no clinically significant increase (typically ≥ 2 grades).	5% experienced increased staining after certification, 11.3% after all HOME measurements. Only 1.3% experienced a clinically significant increase (≥2 grades). No subject experienced ≥3 grades increase.
Clinical Performance - Safety (Discomfort - VAS)	Minimal change in discomfort.	Median change from baseline was zero, max increase 23 units on 100-point VAS scale.
Human Factors - Safety Critical Observations	No safety critical observations, use errors, or close calls associated with critical severity outcomes.	All 17 participants successfully completed all scenarios without committing any use errors, close calls, or operational difficulties associated with critical severity outcomes.
Human Factors - Moderator Assistance	No assistance required for critical tasks.	No participants required moderator assistance for critical tasks.
Human Factors - Practicality of Use (Home Use Period)	Patients able to acquire measurements as intended (3-6 times/day).	1.8% of subject-days logged <3 measurements; most subjects used 3 times/day; 10.3% logged 6 measurements.
Human Factors - Attempts per Measurement	Similar to simulated conditions.	Mean attempts per successful measurement (1.5) similar to simulated testing (1.4). Proportion of 1-attempt measurements (75.9%) same as simulated testing.

2. Sample Sizes and Data Provenance

Test Set (Clinical Performance Testing):
- Sample Size: 460 participants enrolled across 5 US sites. 385 eyes of 385 participants found eligible. Data from 376 eyes included in effectiveness analyses.
- Data Provenance: Prospective, observational, multi-center clinical trial conducted in the U.S.
Human Factors Testing:
- Sample Size: 18 patients (17 completed all scenarios successfully, 1 did not pass certification in Phase 1 and was excluded).
- Data Provenance: Actual-Use HFE Validation Test conducted in the U.S.
Bench Testing: No specific sample size of "data points" is given, but it involved three Icare HOME tonometer units and two operators.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Clinical Performance Testing:
- The ground truth for IOP was established using Goldmann Applanation Tonometry (GAT) measurements, which are considered the clinical standard. These were performed by an "eye care professional" (implied subject matter expert).
- Qualifications: "eye care professional" is stated, specifics like years of experience or board certification are not provided in this document.
- Other Ground Truth: Corneal epithelial defects were assessed using the Oxford Scheme grading, and discomfort via Visual Analog Scale (VAS) questionnaire.
Human Factors Testing:
- Training and re-certification were conducted by a "qualified HCP trainer (ophthalmologist, optometric technician)."
- The certification process for the device (determining proficiency) involved "Icare Home tonometer readings did not sufficiently agree with the GAT measurement" for one participant. This suggests GAT was part of their certification ground truth.

4. Adjudication Method for the Test Set

Clinical Performance Testing (GAT ground truth): An eye care professional took two GAT measurements, with a third if the first two were not within 2 mmHg of each other. This is a form of internal consistency/adjudication for the GAT reading itself, but not for discrepancies between the device and the GAT.
Human Factors Testing (Device Proficiency): Certification involved comparison of Icare HOME readings with GAT measurements. No explicit multi-reader adjudication process for the outcomes is described for either the clinical or human factors studies.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, a traditional MRMC comparative effectiveness study where multiple human readers interpret cases with and without AI assistance to measure improvement in human performance was not described.
The study design was to compare the Icare HOME device's performance (self-measured IOP) against established clinical methods (GAT and Icare TA01i, both performed by healthcare professionals), and to assess human factors for home use. It was not designed to show how human readers improve their interpretation with AI assistance, as the device itself is a measurement tool, not an interpretative AI.

6. Standalone (Algorithm Only) Performance

Was standalone performance done? Yes, the "Bench Performance Testing" section describes the device's accuracy and precision measured against a manometer-controlled model, which is an assessment of the device's inherent measurement capability independent of human operation.
The entire "Clinical Performance Testing" section also evaluates the device's measurements (Icare Home device measurements) compared to gold standard measurements (GAT, TA01i measurements) in a clinical setting, though it emphasizes self-measurement by patients. This can be considered assessing the device's standalone accuracy in the hand of a lay user versus clinical ground truth.

7. Type of Ground Truth Used

The ground truth used for performance evaluation was primarily:

Manometer-controlled model values: For bench testing of accuracy.
Goldmann Applanation Tonometry (GAT): Considered the clinical gold standard for IOP measurement in the clinical performance study.
Icare TA01i tonometer measurements: Also used as a reference point in the clinical study, as it's the predicate device with the same measurement technology.
Expert assessment/observation: For human factors testing, observing user interactions and their ability to follow instructions.
Clinical outcomes/observations: For safety, including adverse events, corneal staining, and patient-reported discomfort (VAS).

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" for the device's algorithm. The device (Icare HOME tonometer) uses a "rebound method to measure intraocular pressure" and its "measurement method, the measurement algorithm and technology... are identical" to the predicate Icare TA01i tonometer. This suggests the core algorithm for IOP calculation was already established and validated with the predicate device, or developed using other data not detailed as part of the submission. The current submission focuses on validating the new device (Icare HOME) for its specific use case (home use by patients) against predicate devices and clinical standards.

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

As a training set for the device's algorithm is not explicitly mentioned (due to the device using an established algorithm from a predicate), how such ground truth was established is not detailed within this submission document. The focus is on the performance testing of the device for its intended use.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

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

March 21, 2017

Icare Finland Oy % Mr. Mark DuVal President and CEO DuVal & Associates, P.A. 1820 Medical Arts Building. 825 Nicollet Mall Minneapolis, MN 55402

Re: K163343/S001

Trade/Device Name: Icare Home tonometer Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and accessories Regulatory Class: Class II Product Code: HKX Dated: February 6, 2017 Received: February 7, 2017

Dear Mr. DuVal:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

Denise L. Hampton -S

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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Indications for Use

510(k) Number (if known)

K163343

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.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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5.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

SUMMARY PREPARED: March 8th, 2017

5.1 SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED

Icare Finland Oy APPLICANT: Äyritie 22 01510 Vantaa, Finland
Contact Person: Mr. Matti Tulikoura Tel .: +358 400 609507 Email: matti.tulikoura@icarefinland.com

5.2 NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME TRADE NAME: Icare HOME tonometer

COMMON NAME:	same
CLASSIFICATIONNAME:	Tonometer, Ac-Powered
DEVICECLASSIFICATION:	Class II under 886.1930
PRODUCT CODE:	HKX
PREDICATE DEVICE:	Primary Predicate Device Icare TA01i Tonometer (K063873) Secondary Predicate Device Goldmann-type Applanation Tonometer, Haag-Streit AT900 (K981432)

5.3 BRIEF DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

The Icare HOME tonometer utilizes the rebound method to measure intraocular pressure. A small (1.8 mm diameter), light (26.5 mg), sterile, single-use probe tip makes brief and

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gentle contact with the eye. The device 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 for both measurement modes. The probe moves to the cornea and returns to the neutral position during each of the six measurements. After the six measurements the tonometer calculates the final IOP and stores it with other information in the tonometer's memory, including date, time, eye identification (right or left) and measurement quality i.e., the standard deviation of the six individual measurements.

The Icare HOME Tonometer can record over one thousand measurement results. The physician can transfer this recorded measurement information to a computer through a USB cable.

INDICATION FOR USE 5.4

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

ર્સ રાજ્યના સાથે જિલ્લાના એક ગામનાં મુખ્યત્વે આવેલું એક ગામનાં મુખ્યત્વે ખાતે ખાતે ખાતે ખેતી કરવામાં આવેલું એક ગામનાં મુખ્યત્વે ખેત-ઉત PREDICATE DEVICE COMPARISON TABLE

	ICARE HOME	ICARE TA01i(K063873)	GOLDMANN-TYPEAPPLANATIONTONOMETER, HAAG-STREIT AT900(K981432)
Intended Use	IOP measurement	IOP measurement	IOP measurement
Intended Users	Patients at home	Health careprofessionals in aclinical environment	Health careprofessionals in aclinical environment
Indicationsfor UseStatement	The Icare HOMETonometer is aprescription deviceintended as an adjunct tothe routine clinicalmonitoring ofintraocular pressure(IOP) of adult patients.	The Icare TA01iTonometer is intendedto be used for themeasurement ofintraocular pressure ofthe human eye.	The Goldman manualtonometer is anappliance that serves tomeasure intraocularpressure, according tothe Goldman method.The measuring of thepressure requires tomaintain a uniformapplanation of thesurface of the cornea. Itis specially indicated inglaucoma disease.
	ICARE HOME	ICARE TA01i(K063873)	GOLDMANN-TYPEAPPLANATIONTONOMETER,HAAG- STREITAT900(K981432)
Design	Handheldmicroprocessorbased	Handheldmicroprocessorbased	Slit lamp mounted,purely mechanical,manual dial
Measurement range	5-50 mmHg	7-50 mmHg	0-80 mmHg
Contact interface	Sterilized, single useplastic probe, cornea	Sterilized, single useplastic probe, cornea	multiuseplastic prism,
MeasurementMethod	Rebound	Rebound	Applanation
MeasurementAlgorithm	Mean of four central ofsix total measurementsand standard deviationof six measurements	Mean of four central ofsix total measurementsand standard deviationof six measurements	N/A
Contact Tip	Light weight,disposable, single use,plastic probe with tipradius of 0.9 mm	Light weight,disposable, single use,plastic probe with tipradius of 0.9 mm	Prism as applanationsurface
Anesthesia required	No	No	Yes
Contact tipsterilization	Sterilized,disposable, singleuse	Sterilized,disposable, singleuse	Prisms need to bedisinfected after eachpatient
Power supply	2 x CR123 batteries	4 x AA batteries	Non-electrical,manually adjustedspring
Calibration	No calibrationrequired	No calibrationrequired	Maintenancecalibration requiredonce a month
Weight	5.29 oz (150 g)	5.47 oz withoutbatteries (155 g)	1.1 lb (0.5 kg)
Dimensions	4.22" x 3.15" x1.18″ (110 mm x 80mm x 30 mm)	1.26" x 3.15" ×9.06″ (32 mm × 80mm x 230 mm)	9.8" x 4.5" x 3.5"(250 mm × 115 mm× 89 mm)

TABLE 1, ICARE HOME TONOMETER COMPARED TO PREDICATE DEVICES.

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BRIEF SUMMARY OF NONCLINICAL AND CLINICAL TESTS AND RESULTS 5.6

The following performance data are provided in support of the substantial equivalence determination:

. Risk management: The hardware and software hazards associated with the HOME system were identified and recorded in the Risk Analysis document according to ISO14971. All risks have been reduced to safe levels.

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Safety testing demonstrate the conformance to the standards and the substantial equivalence of the Icare Home Tonometer to the predicate device for electrical safety (IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007), electromagnetic compatibility (IEC 60601-1-2: 2014 Ed. 4.0) and light safety (IEC 60825-1:2001, IEC 62471:2006, EN 15004-2:2007). Additionally, testing demonstrated that the Icare Home Tonometer meets the U.S. requirements for electrical safety specified in ANSI/AAMI ES60601-1:2005.
. The Level of Concern for the Icare HOME unit is considered "moderate" based on FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software verification and validation testing was provided commensurate with this level of concern.
. Biocompatibility testing of the Icare HOME Probe was performed in conformance with the applicable elements of ISO 10993 standard. Testing criteria were established for the Icare HOME Probe as an ocular surface contact device with transient contact duration (< 24 hours). The finished product, Icare Tonometer Probe (TP02), was evaluated to meet the particular requirements for cytotoxicity, ocular irritation, and sensitization. This testing was conducted by a qualified contract laboratory in accordance with the provisions of 21 CFR 58. Good Laboratory Practice for Nonclinical Laboratory Studies.

The forehead and cheek support were tested for biocompatibility in accordance with ISO 10993 for the TA02 Icare ONE Tonometer. The construction of the forehead and cheek support for that product is identical to that utilized for the TA022 Icare HOME Tonometer and the results are applicable. Primary skin irritation, sensitization by guinea pig maximization, and cytotoxicity were performed by Ethox International in accordance with the applicable ISO standards and in compliance with the provisions of 21 CRF 58, Good Laboratory Practices for Nonclinical Laboratory Studies.

Sterilization is performed by gamma irradiation and has been validated to a sterility assurance level in accordance with ISO 11137-1 and ISO 11137-2.
Transportation tests in accordance with industry standards and packaging validation in accordance with ISO 11607-1 have been performed to ensure the package remains intact and is protective of the product throughout the 3-year shelf-life of the product.
For determination of the 3-year shelf life, aging was performed in real-time, on finished ● Icare tonometer probes packaged and sterilized under routine production conditions, and aged under typical office or home storage conditions. Testing was performed at the end of the three-year aging period to ensure packaging and product integrity.

Bench Performance Testing

Bench testing was performed to characterize the bias and precision of the intraocular pressure (IOP) measurements from the test tonometer (Icare HOME) device and the bias and precision of the IOP measurements from a predicate tonometer (the FDA cleared Icare TA01 i tonometer) over a wide range of IOP values in a manometer-controlled model. Data was collected according to ANSI Z80.10-2009 "Ophthalmic Instruments – Tonometers" (in accordance with FDA's extent of recognition) with the following results:

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1. The differences between the Icare HOME tonometer (three units) and manometer values at each pressure were less than +/- 3 mmHg. This level of accuracy is acceptable for the intended use of the HOME tonometer.
1. The standard deviations and coefficients of variation for each Icare Home tonometer are consistently low (0-8%) across the measurement range, demonstrating good precision of the Icare Home Tonometer for the measurement of pressure.
1. For the actual pressure levels of 10, 20, and 30 mmHg, the within-level measurement differences were at most 1 mmHg (= maximum - minimum), and at least 50% of the withinlevel measurements are the same (i.e. IQR = 0). For these pressure levels, the within-unit mean, overall mean, and average of means are close to the actual pressure level, which demonstrates excellent accuracy of the HOME measurement to the actual pressure level. For the actual levels of 40 and 50 mmHg, some of the HOME measurement differences were more than 1 mmHg compared to the actual pressure level, but these differences are relatively small compared to the actual pressure level. The within-level measurement differences at the higher-pressure levels are all within 3 mmHg, and at least 50% of measurement differences are within 1 mmHg for the level of 40 mmHg and within 2 mmHg for the level of 50 mmHg.
1. The within-unit SD, the overall SD, and the "average" SD of HOME measurements are all <0.52 mmHg; the corresponding CV values are all <5.5%. These SD and CV values show that the HOME tonometer provides IOP measurements with very high precision when the actual pressure levels are within 10 to 30 mmHg.
1. There was slightly more bias and imprecision at the very extremes of the measuring range; Differences between Icare HOME and actual pressure were observed to be within 1 mmHg in the pressure range 10-30 mmHg. At the very extremes of the measuring range, the differences were observed to be slightly larger (i.e. 2 mmHg at the 5 mmHg level and 2-3 mmHg at the 40 and 50 mmHg levels). Similarly, the precision of the device was observed to be better within the pressure range 10-50 mmHg (i.e. CV of 0.0% - 5.5%) as compared to the 5 mmHg pressure level (i.e. CV of 8.1%).
1. The performance of the HOME device was consistent across the three units and there was little variation in measurements due to operator.

In summary, the accuracy was found suitable for the home-use tonometer. Additionally, repeatability in both single and series modes of operation was established using three HOME tonometers and two operators. There was very little difference attributed to either inter-operator or inter-instrument variability.

Human factors testing

Human factors engineering (HFE) work on the design and product labeling included a series of HFE analyses, design refinement activities, formative usability tests, and culminated in simulated and actual-use validation (i.e., summative) usability tests. The Actual-Use HFE Validation Test described below demonstrated the Icare HOME tonometer is reasonably safe and effective from a human factors standpoint for use by the intended user population in the intended use

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environments.

Actual-Use HFE Validation Test: An actual-use HFE validation test was conducted in the U.S. with 18 patients to supplement the findings of the simulated-use study. The procedures involved participant training/certification. scenario based testing. a 1-week home use training decay. followed by re-testing and recertification. The inclusion criteria were as follows:

Inclusion criteria

Glaucoma patients that have confirmed optic nerve damage with visual field loss o consistent with glaucomatous optic neuropathy, OR
Glaucoma-suspect patients being followed for elevated IOP, for risk factors for o developing glaucoma, or for possible optic nerve damage.

Exclusion criteria

o Age < 40 years
0 Uncorrected Near Visual Acuity (UCNVA) of 20/200 or worse (binocular) in both eves
0 Only one functional eye
0 Poor or eccentric fixation in one or both eyes
0 High corneal astigmatism >3D in both eyes based on their current refractive prescription if available. Those without a prescription will undergo auto-refraction to obtain Keratometry readings.
0 Disabling arthritis or limited motor coordination that might limit self-handling of the HOME tonometer
o Lack of comprehension or willingness to use the HOME tonometer as instructed
Corneal scarring in both eyes o
History of prior incisional glaucoma surgery or corneal surgery, including corneal laser о surgery in both eyes
Microphthalmos in both eyes o
Buphthalmos in both eyes о
Contact lens use in both eyes о
Symptoms of Dry Eye Syndrome and signs of dry eye on examination of cornea in both O eves
Known history of difficulty in obtaining GAT IOP measurements or any factors that о might contribute to inaccurate GAT IOP measurements (e.g. lid squeezing or tremor)
0 Nystagmus
Keratoconus in both eves o
0 Any other corneal or conjunctival pathology or infection in both eyes
Central corneal thickness greater than 0.60 mm or less than 0.50 mm in both eyes o
Cataract Extraction within the last two months in both eyes O
0 Experience using or interacting with the HOME tonometer during a previous usability or clinical trial
0 Any affiliation with Icare and its employees
0 Any occupation as a healthcare professional or research and development employee at a medical device manufacturer

The use scenarios were administered over the course of three phases as follows:

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. Phase 1 - Training/Certification and Initial Testing: Each participant took part in a 30minute device training/certification session delivered by a qualified HCP trainer (ophthalmologist, optometrictechnician). After a two-hour training decay period, the participants were asked to perform IOP measurement scenarios in each eye.
Phase 2 – Independent Home-use Period: Each participant was directed to use the Icare HOME tonometer to measure his/ her IOP three to six times per day during the home-use period over the course of one week, and to complete a daily journal of their experiences.
. Phase 3 - Follow-up Testing and Certification: Each participant returned with the completed iournal for a second. 90-minute test session. First, participants performed the HFE use scenario (self- measure the IOP in both eyes using the Icare HOME tonometer independently). Next, an eye care professional administered re-certification which included self-measurement with the Icare HOME tonometer. Finally, a subjective assessment was administered to determine root causes(s) associated with any events and participant comments.

Demographics (glaucoma status, gender, age, education level): Eighteen patients with the following characteristics participated in this Actual-Use HFE Validation Test:

6 glaucoma patients and 12 glaucoma-suspect patients
. Gender: 8 females and 10 males
. Age:
- 40-49 years of age: 10 participants o
- 50-59 years of age: 5 participants O
- 60-69 years of age: 1 participants O
- 70-80 years of age: 2 participants o
Education level: ●
- Completed high school or a portion thereof: 11 participants o
- o College Degree: 6 participants
- o Advanced Degree: 1 participant

Findings of Phases 1 and 3: Overall, there were no safety critical observations and no adverse events reported throughout the test or during the home use period. More specifically, all 17 (100%) participants successfully completed all scenarios without committing any use errors, close calls or operational difficulties associated with critical severity outcomes. Further, none of these participants required moderator assistance to complete the scenarios.

A total of eight participants were observed performing nine non-safety critical behaviors. Of these nine instances, six occurred during Phase 1 while three occurred during Phase 3. This pattern of observations demonstrates that the one-week home-use period seemingly improved participant performance. These observations tended to occur more frequently during Scenario steps 4 (Turn knobs to adjust forehead and cheek support positioning) and 6 (Press Measure button to achieve of 6 measurements).

The non-safety critical observations along with the associated mitigation (where necessary) were as follows:

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. Touched probe with finger prior to use (n=1). Labeling was revised to include the customary recommendation provided by manufacturers of contact lenses to wash and dry their hands with soap and a clean towel prior to handling the probe.
Did not fully adjust forehead support (n=1) ●
Inadvertently measured right eye instead of the left eye (n=1). There is no hazard in this ● event, as the device automatically detects and logs which eye is being measured.
. Used a different forehead/cheek supports setting in response to errors (n=1)
Almost forgot to adjust forehead/cheek supports and recovered (n=2) .
Pattern of difficulty obtaining measurement (n=3) ●

Phase 1 Certification: At the conclusion of each training/certification session, the eye care professional assessed if the participant successfully completed the training and passed certification using the criteria specified in the protocol and device labeling (i.e. certification procedure is required for real world use of the Icare HOME Tonometer).

Out of 18 participants, one participant did not pass certification during Phase 1 and was excluded from the study due to not meeting the training/certification requirements. This is consistent with the findings of the clinical performance testing performed by Icare in which 10.7% of subjects were unable to demonstrate proficiency with the Icare Home tonometer after initial training and failed to meet these same certification criteria.

Phase 3 Certification: The HCP trainer followed the same certification criteria from Phase 1 to recertify each participant. One participant did not pass re-certification during Phase 3 because the Icare HOME tonometer readings did not sufficiently agree with the GAT measurement.

Phase 2 (home use period): The primary purpose of the home use period was to serve as a oneweek training decay.

The Icare HOME tonometer is intended for home use to monitor IOP multiple times per day (3-6 times per day specified in the product labeling). The data confirmed the practicality of patients being able to acquire a measurement a minimum of 3 times per day (only 1.8% of subject-days logged < 3 measurements) with most subjects choosing to use the device 3 times per day. 10.3% of subject-davs logged 6 measurements, which is the recommended maximum number of measurements per day. With no adverse events reported during the home use period, the safety of measurements acquired 6 times per day was confirmed.

The mean attempts per successful measurement during the home-use period (1.5 per measurement) was remarkably similar to the mean attempts per successful measurement during the clinical performance testing performed under simulated home-use conditions (1.4 per measurement).

The proportion of measurements for which only one attempt was required (75.9%) was the same as the proportion observed during the clinical performance testing performed by Icare under simulated home-use conditions (75.9%).

Home-use journal entries recorded during Phase 2 were discussed with the participants during the exit interview to determine if there were any unanticipated use problems. The journal

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entries did not reveal any unanticipated hazards or new use problems with only the following issues being noted by participants along with the associated mitigation (where necessary):

Multiple attempts required in response to Service Light error (7 participants) ●
Multiple attempts required due to probe not being centered (5 participants)
Multiple attempts required due to eye blinking during probe movement (3 participants) ●
Touching probe during troubleshooting due to participant's familiarity with handling ● contact lenses (participant reported that touching the probe with clean hands is not a concern to him) (1 participant)
- o Labeling was revised to include the customary recommendation provided by manufacturers of contact lenses to wash and dry their hands with soap and a clean towel prior to handling the probe.
. Eyes felt dry during device use (1 participant)
Used a different forehead/cheek support setting in response to errors (1 participant) .
Dropped probe due to small size properly discarded (1 participant) ●
Multiple successful measures due to lack of confidence (1 participant) ●

Clinical Performance Testing

A prospective, observational, multi-center clinical trial was conducted to assess the safety of the Icare HOME tonometer and to determine the measurement between self-measured IOP with the Icare HOME tonometer and clinic-measured IOP by Goldmann applanation tonometry (GAT) and by the Icare TA01i tonometer, as well as repeatability (variability between measurements taken by the same operator and the same device) of the Icare HOME tonometer compared to that of the other two methods. Performance goals for agreement as found in ANSI Z80.10-2009 were used. 460 participants age 40 or older were enrolled across five US sites and 385 eves of 385 participants found to be eligible. Data from 376 eves were included in the effectiveness analyses. All participants must have had a pre-existing diagnosis of glaucoma or 'glaucoma suspect.' Participants were trained by study staff as part of the certification procedure on how to use the Icare HOME tonometer. After a 10-minute break, the participants were asked to make three self-measurements without any direct supervision or interaction. Study staff then acquired three measurements on the Icare TA01 i tonometer, then an eve care professional took two GAT measurements (a third if the first two were not within 2 mm Hg of each other). Other testing procedures included auto-refraction, auto-keratometry, discomfort assessment using the Visual Analog Scale (VAS) questionnaire, assessment of fluorescein staining of the cornea and Oxford scheme grading of any corneal epithelial defects, and corneal pachymetry.

Inclusion criteria were as follows:

Patients with pre-existing diagnosis of "glaucoma" or "glaucoma suspect" in the study eve(s):

. Glaucoma suspects will include patients being followed for elevated IOP, for risk factors for developing glaucoma, or for possible optic nerve damage.
. Glaucoma patients will have confirmed optic nerve damage with visual field loss consistent with glaucomatous optic neuropathv.

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Exclusion criteria were as follows:

Age < 40 years Uncorrected Near Visual Acuitv (UCNVA) of 20/200 (binocular) .
. Subjects with only one functional eye
Subjects having poor or eccentric fixation in the study eye .
. Hearing impaired to the extent that the individual cannot hear and converse with others without an assistive aid and/or sign language
. High corneal astigmatism >3D in the study eye(s) based on their current refractive prescription if available. Those without a prescription will undergo auto-refraction to obtain Keratometry readings.
. Disabling arthritis or limited motor coordination limiting self-handling of the Icare Home tonometer
. Lack of comprehension or willingness to use the tonometer as instructed
Corneal scarring
History of prior incisional glaucoma surgery or corneal surgery, including corneal laser • surgerv in the studv eve
. Microphthalmos
Buphthalmos •
Contact Lens Use
. Symptoms of Dry Eye Syndrome and signs of dry eye on examination of cornea
. Known history of difficulty in obtaining Goldmann IOP measurements or any factors that might contribute to inaccurate Goldmann IOP measurements (e.g. lid squeezing or tremor)
. Nystagmus
. Keratoconus
Any other corneal or conjunctival pathology or infection ●
Central corneal thickness greater than 0.60 mm or less than 0.50 mm in the study eve .
. Inability to demonstrate proficiency with Icare Home tonometer after training and failure to complete certification procedures described in the attachment to this protocol
Cataract Extraction within last 2 months in study eye

10.7% (49/460) of subjects failed to complete the certification procedures described in the protocol for the following reasons:

Three Home readings differed by > 7mmHg (0.7%)
The first Home reading and the GAT measurement differed by > 5mmHg (6.3%) .
. Subject requested to stop (0.7%)
. Subject unable to use the device (3.0%).

Table 2 provides demographics of the completed eligible subjects and distribution of intraocular pressures.

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T ABLE 2. DEMOGRAPHICS OF THE COMPLETED ELIGIBLE SUBJECTS AND DISTRIBUTION OF IOP

Demographics		Overall
Age	N	383
	Mean (SD)	66.1 (12.6)
	Min, Max	35, 95
Gender	Male	171 (44.6%)
	Female	212 (55.4%)
Race	Asian Indian	2 (0.5%)
	Black/African American	70 (18.3%)
	Black/AfricanAmerican,AmericanIndian or	1 (0.3%)
	Black/AfricanAmerican,	1 (0.3%)
	Chinese	15 (3.9%)
	Chinese, Korean	1 (0.3%)
	Filipino	8 (2.1%)
	Filipino, Japanese	1 (0.3%)
	Japanese	157 (41.0%)
	Korean	9 (2.3%)
	Native	1 (0.3%)
	Other Asian	5 (1.3%)
	Vietnamese	1 (0.3%)
	White	108 (28.2%)
	Refused	3 (0.8%)
Ethnicity	NotSpanish/Hispanic/ Latino	355 (92.7%)
	Mexican,Mexican Am.,Chicano	16 (4.2%)
	Puerto Rican	2 (0.5%)
	OtherSpanish/Hispanic/ Latino	10 (2.6%)
Handedness	Right	355 (92.7%)
	Left	23 (6.0%)
	Ambidextrous	5 (1.3%)
Study Eye	OD (Right)	206 (53.8%)
	OS (Left)	177 (46.2%)
IOP Group	≤ 16 mmHg	146 (38.1%)
	> 16 to <23mmHg	169 (44.1%)
	≥ 23 mmHg	68 (17.8%)

In Table 3, the descriptive statistics for the IOP measurements from the Icare Home, GAT, and TA01i are provided.

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Device	Statistics	≤ 16 mmHg	> 16 to <23 mmHg	≥ 23 mmHg	Overall
Home	N	143	167	66	376
First	Mean	12.44	18.26	26.18	17.44
Measurement	SD	3.18	2.91	5.52	6.01
	Median	12.00	18.00	25.00	17.00
	IQR	5.00	4.00	5.00	6.50
	Minimum	3.00	11.00	20.00	3.00
	Maximum	20.00	27.00	51.00	51.00
GAT	N	143	167	66	376
Mean/Median	Mean	12.86	18.99	26.41	17.96
Measurement	SD	2.17	1.78	4.86	5.50
	Median	13.00	18.50	24.50	17.50
	IQR	3.00	3.00	3.00	7.00
	Minimum	5.00	16.50	23.00	5.00
	Maximum	16.00	22.50	53.00	53.00
GAT	N	143	167	66	376
First	Mean	13.29	18.31	24.71	17.53
Measurement	SD	2.60	2.84	5.10	5.18
	Median	13.00	18.00	23.00	17.00
	IQR	3.00	5.00	5.00	7.00
	Minimum	5.00	11.00	18.00	5.00
	Maximum	20.00	25.00	50.00	50.00
TA01i	N	143	167	66	376
Mean/Median	Mean	12.93	19.14	26.53	18.07
Measurement	SD	2.36	1.77	4.92	5.56
	Median	13.00	19.00	25.00	18.00
	IQR	4.00	3.00	3.00	7.00
	Minimum	6.00	16.00	22.00	6.00
	Maximum	20.00	23.00	53.00	53.00
TA01i	N	143	167	66	376
First	Mean	13.27	18.11	24.80	17.44
Measurement	SD	2.64	2.97	5.58	5.32
	Median	13.00	17.00	23.00	17.00
	IQR	3.00	4.00	5.00	7.00
	Minimum	6.00	12.00	17.00	6.00
	Maximum	20.00	25.00	53.00	53.00

TABLE 3. DESCRIPTIVE STATISTICS OF IOP MEASUREMENTS (EFFECTIVENESS ANALYSIS COHORT)

Mean/Median: the median was used if the eye had three measurements. Otherwise, the mean was used if the eye had two measurements.

Table 4 provides the limits of agreement between the HOME tonometer and the two reference tonometers. The mean difference and standard deviation (Icare HOME - GAT) were -0.53 mmHg and 2.43 mmHg, respectively. All ANSI performance goals were met as less than 5% of measurements fell outside ± 5 mmHg at each pressure range and less than 1% fell outside ± 7.5 mmHg at each pressure range.

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TABLE 4. LIMITS OF AGREEMENT BETWEEN HOME AND REFERENCE (EFFECTIVENESS ANALYSIS COHORT)

Group	N	HomeMean (SD)	ReferenceMean (SD)	DifferenceMean (SD)	95% CI forMeanDifference	95% LOA forMeanDifference	Outside± 5 mmHgn (%)	Outside± 7.5 mmHgn (%)
Reference: GAT (Mean/Median Measurement)
≤ 16 mmHg	143	12.44(3.18)	12.86(2.17)	-0.42(2.54)	-0.84, -0.00	-5.50, 4.65	4(2.8%)	1(0.7%)
> 16 to <23 mmHg	167	18.26(2.91)	18.99(1.78)	-0.73(2.36)	-1.09, -0.37	-5.45, 3.99	7(4.2%)	0(0.0%)
≥ 23 mmHg	66	26.18(5.52)	26.41(4.86)	-0.23(2.39)	-0.81, 0.36	-5.00, 4.55	1(1.5%)	0(0.0%)
Overall	376	17.44(6.01)	17.96(5.50)	-0.53(2.43)	-0.77, -0.28	-5.39, 4.34	12(3.2%)	1(0.3%)
Reference: GAT (First Measurement)
≤ 16 mmHg	143	12.44(3.18)	12.93(2.36)	-0.49(2.55)	-0.91, -0.07	-5.59, 4.61
> 16 to <23 mmHg	167	18.26(2.91)	19.14(1.77)	-0.87(2.46)	-1.25, -0.50	-5.80, 4.06
≥ 23 mmHg	66	26.18(5.52)	26.53(4.92)	-0.35(2.41)	-0.94, 0.25	-5.18, 4.48
Overall	376	17.44(6.01)	18.07(5.56)	-0.64(2.49)	-0.89, -0.38	-5.62, 4.35
Reference: TA01i (Mean/Median Measurement)
≤ 16 mmHg	143	12.44(3.18)	13.29(2.60)	-0.85(2.60)	-1.28, -0.42	-6.06, 4.35
> 16 to <23 mmHg	167	18.26(2.91)	18.31(2.84)	-0.05(2.56)	-0.44, 0.34	-5.16, 5.07
≥ 23 mmHg	66	26.18(5.52)	24.71(5.10)	1.47(3.07)	0.72, 2.22	-4.67, 7.61
Overall	376	17.44(6.01)	17.53(5.18)	-0.09(2.78)	-0.37, 0.19	-5.65, 5.48
Reference: TA01i (First Measurement)
≤ 16 mmHg	143	12.44(3.18)	13.27(2.64)	-0.83(2.64)	-1.26, -0.39	-6.10, 4.45
> 16 to <23 mmHg	167	18.26(2.91)	18.11(2.97)	0.16(2.65)	-0.25, 0.56	-5.14, 5.45
≥ 23 mmHg	66	26.18(5.52)	24.80(5.58)	1.38(3.30)	0.57, 2.19	-5.22, 7.98
Overall	376	17.44(6.01)	17.44(5.32)	-0.00(2.87)	-0.29, 0.29	-5.74, 5.73

N is the number of eyes with measurements from both devices.

Difference = HOME - Reference.

95% confidence interval (CI) for mean difference is based on t-

distribution. 95% limits of agreement (LOA) = mean difference ±

2 × difference SD.

% = n ÷ N × 100.

The first HOME IOP measurement of each study eye was used in the analysis.

Mean/Median: the median was used if the eye had three measurements. Otherwise, the mean was used if the eye had two measurements.

Table 5 below provide correlations between the IOP measurements and pachymetry measurements.

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TABLE 5. LIMITS OF AGREEMENT BETWEEN HOME AND GAT BY CENTRAL CORNEAL THICKNESS (CCT) EFFECTIVENESS ANALYSIS COHORT

CCTGroup	N	HomeMean (SD)	GATMean (SD)	DifferenceMean (SD)	95% CI for MeanDifference	95% LOA for MeanDifference	Outside± 5 mmHgn (%)	Outside± 7.5 mmHgn (%)
500-520	94	17.43(5.70)	18.01(5.28)	-0.59(2.46)	-1.09, -0.08	-5.50, 4.33	3(3.2%)	0(0.0%)
521-540	100	16.52(6.50)	16.87(5.99)	-0.35(2.03)	-0.75, 0.06	-4.40, 3.71	1(1.0%)	0(0.0%)
541-560	95	17.98(6.55)	18.28(5.93)	-0.30(2.59)	-0.83, 0.23	-5.47, 4.87	3(3.2%)	0(0.0%)
561-580	57	17.70(5.53)	18.61(4.72)	-0.91(2.86)	-1.67, -0.15	-6.64, 4.81	4(7.0%)	1(1.8%)
581-600	30	18.33(4.03)	19.25(3.87)	-0.92(2.22)	-1.75, -0.09	-5.36, 3.53	1(3.3%)	0(0.0%)
Overall	376	17.44(6.01)	17.96(5.50)	-0.53(2.43)	-0.77, -0.28	-5.39, 4.34	12(3.2%)	1(0.3%)

N is the number of eyes with measurements from both devices.

Difference = HOME - Reference.

95% confidence interval (CI) for mean difference is based on t-distribution.

95% limits of agreement (LOA) = mean difference ± 2 x difference SD.

% = n = N × 100.

The first HOME IOP measurement of each study eye was used in the analysis.

The Mean/Median of GAT was used in the median was used if the eye had three measurements. Otherwise, the mean was used if the eye had two measurements.

Table 6 provides the repeatability analyses for all measurements in the effectiveness analysis cohort. The HOME repeatability (CV%) was comparable for the low and medium IOP range (~10% for each bin) and smaller for the high IOP range (~7.5%).

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	Number of			Repeatability
Group	Subjects	Mean	SD	Limit	CV%
HOME
≤ 16 mmHg	143	12.7	1.6	3.6	10.07
> 16 to <23 mmHg	167	18.4	3.7	5.4	10.44
≥ 23 mmHg	66	26.7	4.1	5.7	7.61
Overall	376	17.7	3.0	4.8	9.76
GAT
≤ 16 mmHg	143	12.9	0.8	2.5	6.97
> 16 to <23 mmHg	167	19.0	0.7	2.4	4.46
≥ 23 mmHg	66	26.4	2.6	4.5	6.07
Overall	376	18.0	0.9	2.6	5.18
TA01i
≤ 16 mmHg	143	13.3	0.9	2.6	7.08
> 16 to <23 mmHg	167	18.3	1.4	3.3	6.37
≥ 23 mmHg	66	24.9	2.1	4.1	5.87
Overall	376	17.6	1.3	3.2	6.53

TABLE 6. REPEATABILITY ALL MEASUREMENTS OF EFFECTIVENESS ANALYSIS COHORT

All statistics are estimated from a random-effect model with study eve and error as the random effect.

Mean = Intercept of the ANOVA model

Repeatability SD = Square root of the residual variance.

Repeatability limit = 2.8 x Repeatability SD.

Repeatability CV% = (Repeatability SD)/Intercept x 100%.

Safety: No adverse events (including corneal abrasions) were recorded in this study population of 383 eyes. Anterior corneal epithelial grading was performed at baseline and after each attempt to measure IOP using the Oxford Scheme (a scale from 0-5) illustrated in the study protocol. It should be noted that these findings represent a "worst case scenario" as during the study visit subjects underwent more HOME measurements in a short period of time compared to what would be experienced by patients in real world use of the device. Nonetheless, under these study conditions, only 5% of eves experienced an increase in staining after certification compared to baseline and only one eve (0.3%) experienced an increase of two grades or more which is generally considered a clinically significant change due to variability in the slit lamp grading scales. After the series of three HOME measurements (bringing the total of HOME measurements to four plus the one GAT certification measurement), the number of eves experiencing an increased to 11.3%; however, only five (1.3%) eyes experienced a clinically significant increase in staining. Furthermore, it should be noted that GAT induced an increase of two grades or more in two study eyes which is not unexpected. After all HOME measurements had been taken, no subject experienced an increase of three grades or more in staining compared to baseline. Before certification, after certification, and after the series of HOME validation measurements, subjects were asked to rate eye discomfort by placing a vertical mark on the VAS horizontal line to indicate the level of eye discomfort. 0% corresponds to "no discomfort" and 100% corresponds to "maximal discomfort". There was essentially no change in discomfort following the certification procedures (which consisted of three HOME measurements and one GAT measurement) and the series of three HOME validation measurements. The median change from baseline was zero and the maximum increase was only 23 units on the 100 point VAS scale.

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The results of the study demonstrated that Icare HOME is safe and performed as intended when used according to its indications for use and in accordance with its labeling.

5.7 BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

As described in this 510(k) Summary, all testing deemed necessary was conducted on the Icare HOME tonometer to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.

5.8 CONCLUSIONS

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

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.