(352 days)
Not Found (De Novo Classification Request)
Not Found
No
The device description focuses on electromechanical components and a control circuit with firmware for locking the device after a set number of uses. There is no mention of AI, ML, or any learning or adaptive capabilities.
Yes
The device is indicated for temporary use to increase acute tear production, which addresses a medical condition (insufficient tear production) and aims to improve a physiological function.
No
The device is a neurostimulator intended to increase tear production. It does not analyze patient data or provide a diagnosis.
No
The device description explicitly details hardware components such as a motor, cantilever beam, control circuit, battery, and housing. It is an electromechanical device, not software-only.
Based on the provided information, the iTEAR100 Neurostimulator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- iTEAR100 Function: The iTEAR100 Neurostimulator is an electromechanical device that directly stimulates a nerve (external nasal nerve) to induce a physiological response (increased tear production). It does not analyze samples taken from the body.
- Intended Use: The intended use is to "increase acute tear production during vibratory stimulation of the external nasal nerve," which is a direct intervention on the body, not a diagnostic test performed on a sample.
- Device Description: The description details a physical device with a motor, vibrating tip, and control circuit, all designed for external application and stimulation.
- Clinical Studies: The clinical studies described measure the effect of the device's stimulation on tear production (using the Schirmer Index), which is a measure of a physiological response to the device, not a diagnostic test on a sample.
Therefore, the iTEAR100 Neurostimulator falls under the category of a therapeutic or interventional medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iTEAR100 Neurostimulator is an electromechanical nerve stimulator device, indicated for temporary use (up to 30 days) to increase acute tear production during vibratory stimulation of the external nasal nerve in adults, under prescription of an eye care provider.
Product codes
QKV
Device Description
iTEAR100 Neurostimulator is a hand-held, portable electromechanical actuator intended to acutely increase tear production through vibratory stimulation of the external nasal nerve in patients. The device is battery-operated with a single vibratory tip. As the effective tip is pushed against the tissue, the beam deflects inward until it is deflected fully into the device. The device is comprised of a direct current vibration motor, vibrating beam(cantilever), a control circuit with micro SD card, tactile switch.
The motor is attached to a cantilever beam made from acrylonitrile butadiene styrene (ABS), a control circuit to charge the battery and deliver power to the motor, and a housing also made from ABS. The motor and cantilever beam move together to produce a linear vibration at the tip of the cantilever (oscillating tip). A lithium-ion rechargeable battery is supplied inside the device, and is not removable or replaceable. A micro USB port on the device allows for charging. The device is locked by firmware from use after a predetermined number of stimulation days has been triggered.
The frequency of operation without any force applied is approximately 270 Hz. The amplitude of movement is approximately 0.5 mm without force applied. In the optimal force range, the cantilever tip is depressed approximately 1 mm and the frequency is approximately 250 Hz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
external nasal nerve, nasal cartilage, nasal bone, nose, eye
Indicated Patient Age Range
Adults. Specifically, inclusion criteria for CLP-OO2 was "Twenty-one (21) years of age or older" and for CLP-007 was "18 years of age or older".
Intended User / Care Setting
Under prescription of an eye care provider. Patient training is required on the proper use of the device before home use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two clinical studies: CLP-OO2 and CLP-OO7.
CLP-OO2 Study:
- Study Type: A prospective, open-label, single-arm, multi-center (8 US sites), 2-stage study.
- Sample Size: Enrolled 108 subjects, 101 completed 30 days, 58 reached 180-day endpoint in extended follow-up.
- Key Results:
- The primary endpoint was statistically significant improvement from baseline to Day 30 on the Schirmer Index (SI).
- The stimulated Schirmer's test score was greater than the unstimulated test score at each visit during the 30-day follow-up period.
- An increase in the pre-stimulation Schirmer score during the course of the study was also noted.
- Safety: 2 events definitely related to the device (headache, sneezing, ticking sensation; intermittent nose soreness). 7 events possibly related to the device. Headache and dizziness were the most common related events. Most related events were transient and resolved within approx. 1 week. One serious unanticipated adverse event (continuous nausea, dizziness, lightheaded, headache for 30 days) possibly related to the device. Four subjects experienced a loss of 2 lines or more in visual acuity, which returned to baseline.
CLP-007 Study:
- Study Type: Multi-center, nonsignificant-risk, prospective, double-masked, randomized, sham controlled, single visit clinical trial. All subjects received cross-over treatment with the active device at the conclusion of the study procedures.
- Sample Size: Enrolled 60 subjects (28 in Active group, 32 in Sham group).
- Key Results:
- The primary endpoint was the mean within-subject change in the Schirmer's test score post vs. pre neurostimulation in the active treatment vs. sham groups in the primary analysis population (subjects with baseline Schirmer's test score
§ 886.5305 Electromechanical tear stimulator.
(a)
Identification. An electromechanical tear stimulator is a non-implantable device intended to increase tear production via mechanical stimulation.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing under anticipated conditions of use must evaluate tear production and all adverse events, including tissue damage, pain, headache, and discomfort.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted:
(i) An assessment of mechanical output specifications, including vibration amplitude and frequency, pressure and force, and acoustic (noise level) properties;
(ii) Mechanical safety testing to validate safeguards related to the pressure aspects of the device; and
(iii) Use life testing.
(3) Performance data must demonstrate the electrical safety, thermal safety, and electromagnetic compatibility (EMC) of all electrical components of the device.
(4) All patient-contacting components of the device must be demonstrated to be biocompatible.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Physician and patient labeling must include:
(i) A detailed summary of the device's technical parameters;
(ii) Instructions for use, including an explanation of all user-interface components and information regarding proper device placement;
(iii) Information related to electromagnetic compatibility classification;
(iv) Instructions on how to clean and maintain the device;
(v) A summary of the clinical performance testing conducted with the device;
(vi) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device; and
(vii) Information on how the device operates and the typical sensations experienced during treatment.
0
DE NOVO CLASSIFICATION REQUEST FOR ITEAR100 NEUROSTIMULATOR
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Electromechanical tear stimulator. An electromechanical tear stimulator is a nonimplantable device intended to increase tear production via mechanical stimulation.
NEW REGULATION NUMBER: 21 CFR 886.5305
CLASSIFICATION: Class II
PRODUCT CODE: QKV
BACKGROUND
DEVICE NAME: iTEAR100 Neurostimulator
SUBMISSION NUMBER: DEN190026
DATE DE NOVO RECEIVED: May 15, 2019
Olympic Ophthalmics, Inc. CONTACT: 400 NW Gilman Blvd #1370 Issaquah, WA 98027
INDICATIONS FOR USE
The iTEAR100 Neurostimulator is an electromechanical nerve stimulator device, indicated for temporary use (up to 30 days) to increase acute tear production during vibratory stimulation of the external nasal nerve in adults, under prescription of an eye care provider.
LIMITATIONS
The sale, distribution, and use of the iTEAR100 Neurostimulator is restricted to prescription use in accordance with 21 CFR 801.109.
Patient training is required on the proper use of the device before home use.
The safety and effectiveness of the iTEAR100 Neurostimulator for the treatment of dry eye disease or for the improvement in dry eye symptoms have not been established.
1
The device increases tear production during neurostimulation, i.e., tearing was assessed only during stimulation.
The clinical study was not designed to evaluate any changes in nerve sensitivity.
Clinical study results demonstrate a trend of decreased effectiveness (tear production) over time. The mechanism for this decrease has not been identified and was not analyzed as part of the study.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
iTEAR100 Neurostimulator is a hand-held, portable electromechanical actuator intended to acutely increase tear production through vibratory stimulation of the external nasal nerve in patients. The device is battery-operated with a single vibratory tip. As the effective tip is pushed against the tissue, the beam deflects inward until it is deflected fully into the device. The device is comprised of a direct current vibration motor, vibrating beam(cantilever), a control circuit with micro SD card, tactile switch.
The motor is attached to a cantilever beam made from acrylonitrile butadiene styrene (ABS), a control circuit to charge the battery and deliver power to the motor, and a housing also made from ABS. The motor and cantilever beam move together to produce a linear vibration at the tip of the cantilever (oscillating tip). A lithium-ion rechargeable battery is supplied inside the device, and is not removable or replaceable. A micro USB port on the device allows for charging. The device is locked by firmware from use after a predetermined number of stimulation days has been triggered.
The frequency of operation without any force applied is approximately 270 Hz. The amplitude of movement is approximately 0.5 mm without force applied. In the optimal force range, the cantilever tip is depressed approximately 1 mm and the frequency is approximately 250 Hz. Below is a list of stimulation parameters for the device:
| Parameter | Control - In air | With Force |
|---|---|---|
| Frequency | 270 Hz | 250 Hz |
| Amplitude | 0.6 mm | Not tested |
| Acceleration (g) | 50 | 5 |
| Tip Retraction (maximum force) (100%) | 70 | 24 |
| Ethnicity | Hispanic/Latino | 5 |
| Not | ||
| Hispanic/Latino | 101 | |
| NA | 2 | |
| Race | White | 87 |
| Black | 2 | |
| Other | 3 | |
| NA | 16 | |
| All | 108 |
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Table 2 - Subject Accountability
| | Main Study | | | | Optional Extended
Follow-up:
At Day 30, 80
subjects chose to
enroll in the
extended follow-up | |
|--------------------------------------|------------|-----------------|--------|--------|--------------------------------------------------------------------------------------------------------------|---------|
| | Baseline | Day 3
(call) | Day 14 | Day 30 | Day 90 | Day 180 |
| Theoretical | 108 | 108 | 108 | 108 | 80 | 80 |
| Death | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrawal
(cumulative) | 0 | 0 | 4 | 6 | 6 | 9 |
| Lost to
Follow Up
(cumulative) | 0 | 0 | 1 | 1 | 7 | 13 |
| Missing | 0 | 1 | 2 | 0 | 0 | 0 |
| Expected | 108 | 108 | 104 | 102 | 74 | 71 |
| ActualA | 108 | 103 | 97 | 88 | 51 | 40 |
| ActualB | 108 | 107 | 101 | 101 | 67 | 58 |
| % Follow Up
ActualA | 100% | 95.4% | 89.8% | 81.5% | 63.8% | 50.0% |
| % Follow Up
ActualB | 100% | 99.1% | 93.5% | 93.5% | 83.8% | 72.5% |
Expected is equal to Theoretical minus Deaths minus Withdrawals
Actual is all subjects with data available for primary endpoint and within window
is all subjects with data available for primary endpoint
Follow-up Actual is equal to ActualA divided by Theoref
Follow-up Actual® is equal to Actual® divided by Theoretical
The stimulated Schirmer's test score was greater than the unstimulated test score at each visit during the 30-day follow-up period (Table 3). There was also an increase in the pre-stimulation Schirmer score during the course of the study.
8
Image /page/8/Figure/0 description: The image is a bar graph that shows pre-stimulation and post-stimulation values at baseline, day 14, and day 30. The graph also shows the difference between pre- and post-stimulation. At baseline, the pre-stimulation value is around 6, and the post-stimulation value is around 28. At day 30, the pre-stimulation value is around 9, and the post-stimulation value is around 19.
Table 3 - Change in tear production (Schirmer score)
Safety information for the entire 180-day follow-up period is provided below.
Table 4 - Ophthalmic Adverse Events
| Event
Description | Day
to
AE | Duration
(days) | Severity | Impact
of
Device | Action Taken |
|-----------------------------------------------|-----------------|--------------------|----------|------------------------|--------------------------------|
| Inflammation due to Schirmer strip | 13 | 14 | Mild | No change | Drug Rx |
| Blurred vision | 1 | 232* | Mild | No Change | New Contact Lenses |
| Eye Floater | 92 | 1 | Mild | No Change | None |
| Corneal Medicamentosa | 91 | 60 | Mild | No change | Decrease artificial tear usage |
| Corneal Neovascularization | 180 | 21 | Moderate | No change | None |
| Dry Eye Pain | 2 | 19 | Mild | No change | Artificial Tears |
| Eyelid irritation due to Schirmer strip | 0 | 1 | Mild | No change | None |
| Stye on lower lid OD | 1 | | Mild | No change | Drug Rx |
| Vitreous Hemorrhage OS | 64 | 16 | Mild | Discontinued | None |
| Severe itching and sensitive eyes papillae OU | 5 | 8 | Moderate | Discontinued | Drug Rx |
| Eye infection OU | 55 | 7 | Mild | No change | None |
| Eye infection OU | 74 | 8 | Mild | No change | None |
| Eye infection OU | 95 | 0 | Mild | No change | None |
| Corneal Abrasion due to Schirmer strip | | 23 | Moderate | No change | Drug Rx |
| Sjogren's syndrome | 30 | Ongoing | Mild | No change | Referred to rheumatologist |
*The cause of the blurry vision was poor contact lens fit and the days to resolution represents the time of the phone call inquiry that was made outside the study follow-up period, since the subject could not recall the exact date of the new lens fitting.
9
There were 2 events that were definitely related to the device: one event described as headache, sneezing, and ticking sensation (onset at 1 day from study enrollment); the other was described as intermittent nose soreness (onset at 85 days from study enrollment). There were 7 events that were possibly related to the device (Table 5).
| Event
Description | Day
to
AE | Duration
(days) | Severity | Impact
of
Device | Action Taken |
|--------------------------------------------------------|-----------------|--------------------|----------|------------------------|-----------------------------------------|
| Inflammation due
to Schirmer strip | 13 | 14 | Mild | No change | Drug Rx |
| Blurred vision | 1 | 232* | Mild | No Change | New
Contact
Lenses |
| Eye Floater | 92 | 1 | Mild | No Change | None |
| Corneal
Medicamentosa | 91 | 60 | Mild | No change | Decrease
artificial
tear
usage |
| Corneal
Neovascularization | 180 | 21 | Moderate | No change | None |
| Dry Eye Pain | 2 | 19 | Mild | No change | Artificial Tears |
| Eyelid irritation
due to Schirmer
strip | 0 | 1 | Mild | No change | None |
| Stye on lower lid
OD | 1 | | Mild | No change | Drug Rx |
| Vitreous
Hemorrhage OS | 64 | 16 | Mild | Discontinued | None |
| Severe itching and
sensitive
eyes
papillae OU | 5 | 8 | Moderate | Discontinued | Drug Rx |
| Eye infection OU | 55 | 7 | Mild | No change | None |
| Eye infection OU | 74 | 8 | Mild | No change | None |
| Eye infection OU | 95 | 0 | Mild | No change | None |
| Corneal Abrasion
due to Schirmer
strip | | 23 | Moderate | No change | Drug Rx |
| Sjogren's
syndrome | 30 | Ongoing | Mild | No change | Referred
to
rheumatologist |
Table 5 - Adverse Events Possibly Related to Device
*The cause of the blurry vision was poor contact lens fit and the days to resolution represents the time of the phone call inquiry that was made outside the study follow-up period, since the subject could not recall the exact date of the new lens fitting.
Headache and dizziness were the most common related events reported in the study. Seven (7) of the 9 related adverse events were considered mild, 1 was considered moderate, and 1 was considered severe. Most related events were transient and resolved within approximately 1 week. After a single device treatment, one subject experienced continuous nausea, dizziness,
10
lightheaded and headache for 30-day duration. The subject was instructed to seek neurological evaluation, stop device use, and discontinue from the study. This adverse event was considered to be a serious unanticipated adverse event, possibly related to the device. Four subjects experienced a loss of 2 lines or more in visual acuity during treatment. For 3 of the 4 subjects, loss of visual acuity was attributed to fluctuations in the disease, and/or the fact that subjects were asked not to use artificial tears or other treatments when follow-up visits were scheduled. Pinhole correction and manifest refraction was not attempted or used for any of these subjects. The subjects' vision returned to baseline or 20/20 as fast as 2 weeks for 1 subject and within 180 days for the other 2 subjects. The last subject experienced a loss of visual acuity when the 30 day follow-up visit was performed without correction, but demonstrated no change in visual acuity when the exam was performed with correction, at 180 days. Therefore, this subject's change in visual acuity was attributed to a lack of correction at the 30 day visit. All 4 subjects' vision returned to baseline during the follow-up period. The investigators believed that the alterations in vision were due to temporary worsening of dry eye disease, however, causality could not be definitively determined due to limitations in the study design.
CLP-007 Study
CLP-007 was a multi-center, nonsignificant-risk, prospective, double-masked, randomized, sham controlled, single visit clinical trial that enrolled 60 subjects. The sham group received an iTEAR100 Neurostimulator device which looked identical to and made noise similar to a fully functional device but had a tip that did not vibrate. All subjects received cross-over treatment with the active device at the conclusion of the study procedures. Regardless of whether they were using the sham or active device, subjects were instructed to apply the device tip against the skin of the nose at the junction of the nasal cartilage and the nasal bone. The application duration was 30 seconds or less for each side of the nose.
The inclusion and exclusion criteria are provided below:
Inclusion Criteria
-
- 18 years of age or older;
-
- Willing and able to provide an English language written informed consent;
-
- Able to safely use the study device and be free of any condition that, in the opinion of the investigator, could impair study participation.
Exclusion Criteria
-
- Presence of clinically significant nasal/facial skin conditions (e.g., infection, ulceration, wound):
-
- Under arrest or was otherwise in custody;
-
- Presence of any other condition, which in the judgment of the principal investigator would prevent a potential subject from safely completing the study or tolerating device use, such as mental illness, dementia, severe agitation, etc.).
No study-mandated tests were required for enrollment. The schedule of assessments and procedures for the study is shown in the table below.
11
Table 6 - Clinical Assessments
| Schedule | |
|---|---|
| Assessment | Screening/Day |
| 0a | |
| Eligibility screening & IC | X |
| OSDI questionnaire | X |
| Demographic information | X |
| Focused DES history | X |
| Baseline nasal skin exam & facial neurological exam | X |
| Baseline visual acuity (OS) | X |
| Baseline slit lamp examination (SLE) with emphasis on comeal edema (OS) | X |
| Baseline blood pressure (BP), heart rate (HR), pulse oximetry | X |
| Baseline Schirmer's test (OD) | X |
| Baseline meibomian gland expression score (OS) | X |
| Randomization & experimental device training/treatmentb | X |
| Repeat Schirmer's test (OD) with new Schirmer strip during device treatmentb,c | X |
| Repeat BP, HR, pulse oximetry during Schirmer's test (at 2.5 & 5 min)b | X |
| Repeat nasal skin exam & facial neurological exam | X |
| Repeat visual acuity (OS) | X |
| Repeat SLE with emphasis on corneal edema (OS) | X |
| Repeat meibomian gland expression score (OS) | X |
| Cross-over treatment with fully active iTEAR device & qualitative assessment of | |
| response | X |
| PI usability survey | X |
| Subject usability survey | X |
| Record adverse events | X |
a Screening and Day 0 were the same
b Second investigator to perform; initial investigator was out of the room.
· Device treatment begins immediately after placement of Schirmer's test strip
The primary endpoint of this study was the mean within-subject change in the Schirmer's test. score post vs. pre neurostimulation in the active treatment vs. sham groups in the primary analysis population (i.e., subjects with baseline Schirmer's test score ≤10mm). The replacement Schirmer technique was used for this study, under which a Schirmer strip is applied to the subject's eye to assess pre-stimulation tear production, and then a second strip is inserted to assess post-stimulation tear production.
12
The safety of the device was evaluated by the incidence of device-related adverse events and serious adverse events, as well as changes in the following measures:
- Best corrected Snellen distance visual acuity (VA); .
- . Ophthalmic exam with emphasis to determine the presence of corneal edema;
- . Nasal skin examination and facial neurologic examination;
- . Hemodynamic parameters (blood pressure, heart rate, pulse oximetry).
Below are the study demographics:
Table 8 - Baseline Demographics
| Summaryª | Randomized Treatment | ||
|---|---|---|---|
| Active (N=28) | Sham (N=32) | All Subjects (N=60) | |
| Sex, n (%) | 16 (57.1%) | 24 (75.0%) | 40 (66.7%) |
| Female | 16 (57.1%) | 24 (75.0%) | 40 (66.7%) |
| Male | 12 (42.9%) | 8 (25.0%) | 20 (33.3%) |
| Age (Years) | |||
| Mean (SD) | 49.7 (15.99) | 50.0 (16.25) | 49.9 (16.00) |
| Median | 51 | 50 | 51 |
| Min, Max | 24, 79 | 21, 77 | 21, 79 |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 3 (10.7%) | 7 (21.9%) | 10 (16.7%) |
| Not Hispanic or Latino | 25 (89.3%) | 25 (78.1%) | 50 (83.3%) |
| Race, n (%) | |||
| Asian | 5 (17.9%) | 7 (21.9%) | 12 (20.0%) |
| Black | 2 (7.1%) | 1 (3.1%) | 3 (5.0%) |
| Caucasian | 18 (64.3%) | 21 (65.6%) | 39 (65.0%) |
| Other | 3 (10.7%) | 3 (9.4%) | 6 (10.0%) |
| Subjects using Eye | |||
| Treatment, n (%) | 21 (75.0%) | 25 (78.1%) | 46 (76.7%) |
Each randomized subject underwent all study assessments, thus subject accountability was 100%. In the primary analysis population, there was a statistically significant increase in Schirmer's test scores in the active group (mean within-subject change pre- to post-stimulation = 21.7mm) compared to sham (mean within-subject change pre- to post-stimulation = - 0.5mm) with a between group difference of 22.2mm (SD 2.61) favoring the active device, as shown in in the figure below. The bars included in the figure show the standard deviation for the mean change reported, which indicates the degree of variability for the with-in subject change scores.
13
Image /page/13/Figure/0 description: The image is a bar graph titled "Mean Change in Schirmer From Baseline". The y-axis is labeled "Schirmer Change Post-stimulation (mm)" and ranges from -10 to 35. There are two bars, one labeled "Active, 21.7" which has a value of approximately 21.7, and the other labeled "Sham, -0.5" which has a value of approximately -0.5.
Figure 9 - Schirmer's Test Score Change in Active Compared to Sham Groups
There were no device-related adverse events or serious adverse events reported in this study. One unrelated adverse event involved a near-syncopal episode that occurred following the administration of topical proparacaine anesthetic to the subject's right eye prior to placement of the baseline Schirmer's test strip. The subject was randomized but had not received treatment with either a sham or an active study device. She was terminated from any further study participation and was monitored by the investigator at the site until her symptoms had resolved. Additionally, there were no observed significant changes in post vs. pre-test visual acuity, corneal edema, facial neurologic examinations, or hemodynamic parameters.
Pediatric Extrapolation
In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.
LABELING
The professional and patient labeling are adequate and meet the requirements of 21 CFR 801.109. The labels summarize the clinical trial results that characterized the probable benefit and the identified risks of the device. including tissue damage, pain. headache, and discomfort. Both guides contain requirements for use by prescription only and proper patient training, Indications for Use, contraindications, device description, technical parameters, warnings, precautions, potential complications, instructions for use (including an explanation of all userinterface components and information regarding proper device placement), recommended stimulation schedule, instructions for device maintenance/cleaning, summary of clinical trials, information related to electromagnetic compatibility, language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device, expected service life, disposal & replacement, environmental operating conditions, electrical specifications, and symbols & markings.
RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of an electromechanical tear stimulator and the measures necessary to mitigate these risks.
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| Identified Risks | Mitigation Measures |
|---|---|
| Tissue damage due to | |
| overstimulation/understimulation | |
| or mechanical injury, device | |
| breakage | Clinical performance testing |
| Non-clinical performance testing | |
| Software verification, validation, and hazard analysis | |
| Labeling | |
| Adverse tissue reaction | Biocompatibility evaluation |
| Labeling | |
| Electrical shock or burn | Electrical, thermal, and mechanical safety testing |
| Software verification, validation, and hazard analysis | |
| Labeling | |
| Interference with other devices | Electromagnetic compatibility (EMC) testing |
| Software verification, validation, and hazard analysis | |
| Labeling | |
| Pain, headache, or discomfort | Clinical performance testing |
| Non-clinical performance testing | |
| Insufficient tear production | Clinical performance testing |
Table 9 - Identified Risks to Health and Mitigation Measures
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the electromechanical tear stimulator is subject to the following special controls:
-
- Clinical performance testing under anticipated conditions of use must evaluate tear production and all adverse events, including tissue damage, pain, headache, and discomfort.
-
- Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted:
- a. An assessment of mechanical output specifications including vibration amplitude and frequency, pressure and force, and acoustic (noise level) properties;
- b. Mechanical safety testing to validate safeguards related to the pressure aspects of the device; and
- c. Use life testing.
-
- Performance data must demonstrate the electrical safety, thermal safety, and electromagnetic compatibility (EMC) of all electrical components of the device.
-
- All patient-contacting components of the device must be demonstrated to be biocompatible.
-
- Software verification, validation and hazard analysis must be performed.
-
- Physician and patient labeling must include:
- a. A detailed summary of the device's technical parameters;
15
- Instructions for use, including an explanation of all user-interface components and b. information regarding proper device placement;
- Information related to electromagnetic compatibility classification: C.
- d. Instructions on how to clean and maintain the device;
- A summary of the clinical performance testing conducted with the device; e.
- Language to direct end users to contact the device manufacturer and MedWatch if f. they experience any adverse events with this device; and
- g. Information on how the device operates and the typical sensations experienced during treatment.
BENEFIT-RISK DETERMINATION
The risks of the device are based on non-clinical laboratory data, as well as data collected in clinical trials described above. The device exhibited an acceptable safety profile for up to 30 day use in the clinical studies which were conducted. One device-related serious adverse event was observed; this event resolved without treatment. Non-serious device-related adverse events were few in number and all were self-limited.
The probable benefits of the device are also based on nonclinical laboratory data, as well as data collected in clinical trials. Compared to a sham control, the device was shown to provide a statistically significant increase in acute tear production during a single stimulation. Results from an additional clinical study suggest that a temporary increase in acute tear production may be seen in response to repeated device stimulation up to 30 days.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
Benefit/Risk Conclusion
In conclusion, given the available information above, the probable benefits outweigh the probable risks for the iTEAR100 Neurostimulator. The device provides benefits, and the risks can be mitigated by use of general controls and the identified special controls.
CONCLUSION
The De Novo request for the iTEAR100 Neurostimulator is granted and the device is classified as follows:
Product Code: OKV Device Type: Electromechanical tear stimulator Class: II Regulation Number: 21 CFR 886.5305