(291 days)
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Not Found
No
The summary describes a neurostimulation device with no mention of AI or ML in its description, intended use, or performance studies.
Yes
The device is intended to provide a temporary increase in tear production using neurostimulation, which directly impacts a physiological function for a therapeutic benefit.
No
The device is described as providing "a temporary increase in tear production during neurostimulation." Its purpose is to stimulate tear production, not to diagnose a condition.
No
The device description explicitly states it consists of four distinct non-sterile subassemblies: Disposable Tips, a reusable Base, a reusable Charging Station, and a reusable Cover. These are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The Intranasal Tear Neurostimulator directly stimulates the nasal cavities to increase tear production. It does not examine specimens from the human body.
- Intended Use: The intended use is to provide a temporary increase in tear production through neurostimulation, not to diagnose or provide information about a physiological state or disease by analyzing a specimen.
The device is a therapeutic device that directly interacts with the patient's body to achieve a physiological effect.
N/A
Intended Use / Indications for Use
The Intranasal Tear Neurostimulator provides a temporary increase in tear production during neurostimulation in adult patients.
Product codes
POJ
Device Description
The Intranasal Tear Neurostimulator is a non-surgical, non-implantable device intended for the application of low level electrical stimulation to sensory neurons of the nasal cavities to acutely increase tear production in adult patients. The device consists of four distinct non-sterile subassemblies:
- Disposable Tips that insert up to 28mm into the nasal cavity and stimulate the target tissue of the intranasal skin and mucosa.
- A reusable Base which produces the electrical stimulation waveform.
- A reusable Charging Station which recharges the sealed battery inside the Base.
- A reusable Cover to protect the Disposable Tips.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Nasal cavities
Indicated Patient Age Range
adult patients, >22 years of age
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
OCUN-009
- Study Type: Pivotal clinical trial, randomized, controlled, double-masked
- Sample Size: 48 subjects (>22 years of age)
- Standalone Performance: Not applicable
- Key Results:
- Effectiveness: Primary effectiveness endpoint was the difference between unstimulated and stimulated tear production quantified by Schirmer scores. Average Schirmer score was 25.3 mm ± 10.7 during active electrostimulation, compared with 9.2 mm ± 7.3 for Sham control (p
§ 886.5300 Tear electrostimulation device.
(a)
Identification. A tear electrostimulation device is a non-implantable, electrostimulation device intended to increase tear production.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(2) Patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Physician and patient labeling must include:
(i) Summaries of electrical stimulation parameters;
(ii) Instructions on how to correctly use and maintain the device;
(iii) Instructions and explanations of all user-interface components;
(iv) Information related to electromagnetic compatibility classification; and
(v) Instructions on how to clean the device.
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DE NOVO CLASSIFICATION REQUEST FOR INTRANASAL TEAR NEUROSTIMULATOR
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Tear Electrostimulation Device. A tear electrostimulation device is a nonimplantable device intended to increase tear production.
NEW REGULATION NUMBER: 21 CFR 886.5300
CLASSIFICATION: Class II
PRODUCT CODE: POJ
BACKGROUND
DEVICE NAME: Intranasal Tear Neurostimulator
SUBMISSION NUMBER: DEN160030
DATE OF DE NOVO: July 5, 2016
CONTACT: Oculeve, Inc. 395 Oyster Point Blvd, Suite 501 South San Francisco, CA 94080
INDICATIONS FOR USE
The Intranasal Tear Neurostimulator provides a temporary increase in tear production during neurostimulation in adult patients.
LIMITATIONS
The sale, distribution, and use of the Intranasal Tear Neurostimulator are restricted to prescription use in accordance with 21 CFR 801.109.
The safety and effectiveness of the Intranasal Tear Neurostimulator for the treatment of aqueous deficient dry eye disease has not been established.
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.
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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
The Intranasal Tear Neurostimulator is a non-surgical, non-implantable device intended for the application of low level electrical stimulation to sensory neurons of the nasal cavities to acutely increase tear production in adult patients.
The device consists of four distinct non-sterile subassemblies, as listed below:
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Disposable Tips that insert up to 28mm into the nasal cavity and stimulate the target tissue of the intranasal skin and mucosa.
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A reusable Base which produces the electrical stimulation waveform.
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A reusable Charging Station which recharges the sealed battery inside the Base.
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A reusable Cover to protect the Disposable Tips.
Figure 1 provides a photograph of the device assembly; additional details for each component are discussed below.
Image /page/1/Picture/10 description: The image shows two different views of a device. On the left, the device is egg-shaped and blue, sitting on a white base next to a white box. The device has a white button with a plus and minus sign on it. On the right, there are two of the same devices, but they are hanging and have a different top.
FIGURE 1. THE OCULEVE INTRANASAL TEAR NEUROSTIMULATOR COMPONENTS
The device (Base) automatically turns off after one minute of stimulation. Alternatively, the device may also be turned off by holding down the "-" button for 2 seconds. The device will vibrate and the LEDs will turn off to indicate that the power has been switched off.
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Additionally, the device (Base) has a "Daily device usage limit" of thirty (30) minutes. If an orange LED flashes 2 times, the daily use limit (30 minutes) has been reached, and the device will no longer deliver stimulation.
Figure 2 is a schematic showing correct use of the device.
Image /page/2/Picture/2 description: In the image, there are two side-by-side images of a woman using a nasal rinse. The woman is older with fair skin and light hair. She is holding a blue and white nasal rinse bottle to her nose. The background is a solid blue color.
FIGURE 2. USE OF THE INTRANASAL TEAR NEUROSTIMULATOR. (L) STARTING POSITION AND (R) CORRECT TREATMENT POSITION
DISPOSABLE TIPS
The Disposable Tips connect to the Base and incorporates a silicone hydrogel that touches the inside of the nose, at a depth of up to 28 mm from the nasal columella (the skin separating the two nostrils), to provide stimulation. The Disposable Tips are removed and replaced daily; a separate Cover can be used to protect the Disposable Tips between uses.
BASE
The hand-held, battery-powered Base is the portion of the device which produces the required electrical output for stimulation. The Base produces a train of charge-balanced pulses that is patterned by modulating pulse amplitude, pulse width and pulse shape. The intensity of the stimulation is adjustable by using the (+) or (-) control buttons, which cycle the Base through six different levels (including zero, a non-stimulation level). The Base is held in the palm of the hand, allowing the patient to press one of two buttons to increase or decrease the intensity of stimulation. A series of LEDs on the Base illuminate to indicate powering the device on/off, the intensity level during use, and the charging of the Base's battery when connected to the Charging Station.
CHARGING STATION
The Charging Station provides a dock for recharging the battery located inside the Base. With the Disposable Tips removed, the Base can be inverted and placed onto the Charging Station.
COVER
The Cover is made of polycarbonate material and fits over the tips. The Cover can be used to protect the Disposable Tips between uses.
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SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The Disposable Tips of the Intranasal Tear Neurostimulator were tested for cytotoxicity. sensitization, irritation, acute systemic toxicity per ISO 10993-1 "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process." All results demonstrated acceptable performance.
SHELF LIFE/STERILITY
The Intranasal Tear Neurostimulator is non-sterile. The Disposable Tips are disposable and are meant to be replaced daily. The Cover is reusable. Cleaning and maintenance instructions of the stimulator components of the device are included in the labeling.
ELECTRICAL SAFETY
The Intranasal Tear Neurostimulator was tested per the requirements of AAMI/ANSI ES60601-1:2012 and IEC 60601-1:2006 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance." The Base and Charging Station are compliant to these standards.
The device was also tested per the requirements of IEC 60601-1-11:2015 "Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment." The device is in conformance with this standard.
The Intranasal Tear Neurostimulator was tested specifically per the requirements of IEC 60601-2-10, Edition 2.0 Issue: 2012/06 "Medical Electrical Equipment Part 2-10: Particular Requirements for the Safety of Nerve and Muscle Stimulators - Includes Amendment A1: 2001." The device is in conformance with this standard.
ELECTROMAGNETIC COMPATIBILITY
The Intranasal Tear Neurostimulator was tested according to the IEC 60601-1-2. Issue: 2007/03/01 Ed:3.0 (Equivalent to AAMI/ANSI/IEC 60601-1-2:2007/(R)2012) "Medical Electrical Equipment - Part 1-2:General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests." Results demonstrated that the Base and Charging Station are compliant to this standard.
SOFTWARE
The following device functions of the Intranasal Tear Neurostimulator are controlled by the software:
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- · The allowance of multiple stimulation sessions of various intensity levels.
- · The control of stimulation intensity levels.
- · The notification to the user when the charging is complete.
- The connection to mobile applications to download or clear historical stimulation data.
The software will mitigate safety risks as follows:
- · The software limits the output current to a maximum of 5 mA.
- · The software disables stimulation if the tip expiration time is exceeded. if the stimulation mode exceeds the maximum usage time, or exceeds the maximum usage time within the rolling usage time window.
A failure or latent flaw in the software for the Intranasal Tear Neurostimulator could indirectly result in patient injury: therefore, the software of this device is considered to have a "Moderate" level of concern. The submission contained all of the elements of software documentation corresponding to the "Moderate" level of concern, as outlined in the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Adequate documentation describing the software/firmware, software specifications, architecture design, software development environment, traceability, revision level history, unresolved anomalies provide the foundation that the software will operate in a manner as described in the specifications. Hazard analysis was performed to characterize software risks including device malfunction and measurement related errors. The submission included verification and validation (V&V) testing to address the potential hazards with satisfactory results.
SUMMARY OF CLINICAL INFORMATION
The applicant conducted two pivotal clinical trials, OCUN-009 and OCUN-010, and a human factors usability study, OCUN-012, described below, which demonstrated that patients can use the Intranasal Tear Neurostimulator properly. The safety and effectiveness of the device was evaluated based upon the outcomes of studies OCUN-009 and OCUN-010. The two pivotal studies were found to be appropriate to support the action of the device effect (increased tear production during neurostimulation); however, therapeutic benefit, e.g., symptomatic relief from dry eye, was not assessed in the clinical studies.
OCUN-009
Pivotal clinical trial OCUN-009 was conducted to evaluate the safety and acute tear production during neurostimulation. The results of this trial provide reasonable assurance of safety and effectiveness of the device to increase tear production during stimulation. This two-day trial was a randomized, controlled, double-masked, study conducted at 2 sites in the United States. Fortyeight subjects (>22 years of age) received one active and two control treatments. On Day 1, participant eligibility was assessed. On Day 2, each study participant was subjected to three applications (1 active and 2 control) of the device in random order. Active treatment was performed using the Intranasal Tear Neurostimulator as intended. One control treatment used an active device that was "off-target" (i.e., extra-nasal). The other control treatment used a sham device. Tear production was assessed using the Schirmer test. which uses a paper strip that is
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inserted into the eye for several minutes to provide a direct measurement of tear production in subjects due to the naso-lacrimal reflex. Schirmer scores and assessment of oxygen saturation (SpO2), heart rate (HR) and blood pressure (BP) were performed simultaneously during each application. Following completion of the 3 applications, subjects were assessed for visual acuity changes and underwent slit lamp and nasal examinations.
The primary effectiveness endpoint was the difference between unstimulated and stimulated tear production quantified by Schirmer scores. Based on measurements using the Schirmer test, there was an increase in tear production during electrostimulation. The average Schirmer score was reported for the active and two control applications. An average Schirmer score of 25.3 mm ± 10.7 was observed during active electrostimulation, compared with 9.2 mm ± 7.3 for the Sham control application (p