(112 days)
No
The description focuses on the physical measurement method (rebound tonometry) and a calculation based on deceleration and rebound time. There is no mention of AI, ML, image processing, or complex algorithms that would typically indicate the use of such technologies. The "measurement algorithm" is described as identical to a previously cleared device from 2006, which predates widespread medical device AI/ML applications.
No
The device is described as an "adjunct to the routine clinical monitoring of intraocular pressure (IOP)". Monitoring IOP is a diagnostic or prognostic function, not a therapeutic one. The device measures a physiological parameter (IOP) but does not treat, alleviate, cure, or prevent any disease, nor does it affect the structure or function of the body.
Yes.
The device measures intraocular pressure (IOP), which is a key parameter used in the diagnosis and monitoring of glaucoma and other eye conditions. The "Intended Use" states it is an "adjunct to the routine clinical monitoring of intraocular pressure (IOP)". Measuring and monitoring IOP is a diagnostic function, as it provides information used to identify or track a disease state.
No
The device description explicitly states it is a "handheld, battery operated device" and describes its physical components and measurement method involving a probe tip making contact with the eye. This indicates it is a hardware device, not software-only.
Based on the provided information, the Icare HOME tonometer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to measure intraocular pressure (IOP) in adult patients as an adjunct to routine clinical monitoring. This is a measurement taken directly from the patient's body (in vivo), not from a sample of bodily fluid or tissue (in vitro).
- Device Description: The device measures the deceleration and rebound time of a probe making contact with the eye. This is a physical measurement of a physiological parameter, not a test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention analyzing any biological samples (blood, urine, tissue, etc.) or performing any tests on such samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Icare HOME tonometer directly measures a physical property of the eye.
N/A
Intended Use / Indications for 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.
Product codes
HKX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraocular (eye/cornea)
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Home-use by patients, with transfer of information to a physician.
Description of the training set, sample size, data source, and annotation protocol
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.
Inclusion criteria:
- Glaucoma patients that have confirmed optic nerve damage with visual field loss consistent with glaucomatous optic neuropathy, OR
- Glaucoma-suspect patients being followed for elevated IOP, for risk factors for developing glaucoma, or for possible optic nerve damage.
Exclusion criteria:
- Age 3D in both eyes 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 that might limit self-handling of the HOME tonometer
- Lack of comprehension or willingness to use the HOME tonometer as instructed
- Corneal scarring in both eyes
- History of prior incisional glaucoma surgery or corneal surgery, including corneal laser surgery in both eyes
- Microphthalmos in both eyes
- Buphthalmos in both eyes
- Contact lens use in both eyes
- Symptoms of Dry Eye Syndrome and signs of dry eye on examination of cornea in both eyes
- Known history of difficulty in obtaining GAT IOP measurements or any factors that might contribute to inaccurate GAT IOP measurements (e.g. lid squeezing or tremor)
- Nystagmus
- Keratoconus in both eyes
- 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
- Cataract Extraction within the last two months in both eyes
- Experience using or interacting with the HOME tonometer during a previous usability or clinical trial
- Any affiliation with Icare and its employees
- 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:
- Phase 1 - Training/Certification and Initial Testing: Each participant took part in a 30-minute device training/certification session delivered by a qualified HCP trainer (ophthalmologist, optometric technician). 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 journal 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:
- 6 glaucoma patients and 12 glaucoma-suspect patients
- Gender: 8 females and 10 males
- Age: 40-49 years of age: 10 participants; 50-59 years of age: 5 participants; 60-69 years of age: 1 participants; 70-80 years of age: 2 participants
- Education level: Completed high school or a portion thereof: 11 participants; College Degree: 6 participants; Advanced Degree: 1 participant
Description of the test set, sample size, data source, and annotation protocol
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 eyes of 385 participants found to be eligible. Data from 376 eyes 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 eye 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 eye(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 neuropathy.
Exclusion criteria were as follows:
- Age 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 surgery in the study eye
- 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 eye
- 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%).
Demographics of the completed eligible subjects:
- N: 383
- Age: Mean (SD) 66.1 (12.6), Min 35, Max 95
- Gender: Male 171 (44.6%), Female 212 (55.4%)
- Race: Asian Indian 2 (0.5%), Black/African American 70 (18.3%), Black/African American, American Indian or 1 (0.3%), Black/African American, 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: Not Spanish/Hispanic / Latino 355 (92.7%), Mexican, Mexican Am., Chicano 16 (4.2%), Puerto Rican 2 (0.5%), Other Spanish/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 16 to
§ 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.
0
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
1
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
2
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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3
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 |
|---|---|
| CLASSIFICATION | |
| NAME: | Tonometer, Ac-Powered |
| DEVICE | |
| CLASSIFICATION: | 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 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
4
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-TYPE
APPLANATION
TONOMETER, HAAG-
STREIT AT900
(K981432) |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | IOP measurement | IOP measurement | IOP measurement |
| Intended Users | Patients at home | Health care
professionals in a
clinical environment | Health care
professionals in a
clinical environment |
| Indications
for Use
Statement | 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 Icare TA01i
Tonometer is intended
to be used for the
measurement of
intraocular pressure of
the human eye. | The Goldman manual
tonometer is an
appliance that serves to
measure intraocular
pressure, according to
the Goldman method.
The measuring of the
pressure requires to
maintain a uniform
applanation of the
surface of the cornea. It
is specially indicated in
glaucoma disease. |
| | ICARE HOME | ICARE TA01i
(K063873) | GOLDMANN-TYPE
APPLANATION
TONOMETER,
HAAG- STREIT
AT900
(K981432) |
| Design | Handheld
microprocessor
based | Handheld
microprocessor
based | Slit lamp mounted,
purely mechanical,
manual dial |
| Measurement range | 5-50 mmHg | 7-50 mmHg | 0-80 mmHg |
| Contact interface | Sterilized, single use
plastic probe, cornea | Sterilized, single use
plastic probe, cornea | multiuse
plastic prism, |
| Measurement
Method | Rebound | Rebound | Applanation |
| Measurement
Algorithm | Mean of four central of
six total measurements
and standard deviation
of six measurements | Mean of four central of
six total measurements
and standard deviation
of six measurements | N/A |
| Contact Tip | Light weight,
disposable, single use,
plastic probe with tip
radius of 0.9 mm | Light weight,
disposable, single use,
plastic probe with tip
radius of 0.9 mm | Prism as applanation
surface |
| Anesthesia required | No | No | Yes |
| Contact tip
sterilization | Sterilized,
disposable, single
use | Sterilized,
disposable, single
use | Prisms need to be
disinfected after each
patient |
| Power supply | 2 x CR123 batteries | 4 x AA batteries | Non-electrical,
manually adjusted
spring |
| Calibration | No calibration
required | No calibration
required | Maintenance
calibration required
once a month |
| Weight | 5.29 oz (150 g) | 5.47 oz without
batteries (155 g) | 1.1 lb (0.5 kg) |
| Dimensions | 4.22" x 3.15" x
1.18″ (110 mm x 80
mm x 30 mm) | 1.26" x 3.15" ×
9.06″ (32 mm × 80
mm 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.
5
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.
6
- 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 (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:
9
- . 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:
10
- . 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 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/Africa | ||
| n American | 70 (18.3%) | |
| Black/African | ||
| American, | ||
| American | ||
| Indian or | 1 (0.3%) | |
| Black/African | ||
| American, | 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 | Not | |
| Spanish/Hispanic | ||
| / Latino | 355 (92.7%) | |
| Mexican, | ||
| Mexican Am., | ||
| Chicano | 16 (4.2%) | |
| Puerto Rican | 2 (0.5%) | |
| Other | ||
| Spanish/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 16 to 16 to 16 to 16 to 16 to 16 to 16 to 16 to |