(307 days)
Not Found
Not Found
No
The device description details a mechanical pump system controlled by a PID loop based on pressure sensor feedback. There is no mention of AI or ML in the device description, intended use, or performance studies. The physician's app is for programming and reviewing data, not for AI/ML analysis.
Yes.
The device is indicated for the reduction of Intraocular Pressure (IOP) in adult patients with open-angle glaucoma and is designed to treat a medical condition.
No
Explanation: The device is indicated for the reduction of Intraocular Pressure (IOP) and applies negative pressure, which are therapeutic actions, not diagnostic ones. While it monitors NP inside the goggle with pressure sensors, this is for controlling the treatment's delivery rather than diagnosing a patient's condition.
No
The device description clearly outlines hardware components including a programmable pump, goggles with tubing, pressure sensors, relief valves, and a touch-screen interface. While there is a "Physicians App," it is described as an integral component of a system that includes significant hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The FSYX™ Ocular Pressure Adjusting Pump System is a physical device that applies negative pressure to the eyes to reduce intraocular pressure. It directly interacts with the patient's body and does not analyze biological specimens.
- Intended Use: The intended use is to reduce intraocular pressure during sleep in patients with open-angle glaucoma. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The device is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FSYXTM Ocular Pressure Adjusting Pump is indicated for the reduction of Intraocular Pressure (IOP) during sleep in adult patients with open-angle glaucoma and IOP ≤ 21 mmHg who are currently using or have undergone another IOP-lowering treatment.
Product codes
QQJ
Device Description
The FSYX™ Ocular Pressure Adjusting Pump System is comprised of two distinct elements, the programmable pump and the goggles with tubing. The FSYX™ Ocular Pressure Adjusting Pump System is designed to allow the application and monitoring of bilateral negative pressure (NP) in the microenvironment in front of a patient's eyes.
The FSYX™ Ocular Pressure Adjusting Pump System goggles are designed to fit and seal around the eyes of patients, creating an air-tight chamber in which NP can be created and maintained. A headstrap is included with the goggles to facilitate reliable positioning on the patient's face during sleep. The goggles can be connected and disconnected from the FSYXM Ocular Pressure Adjusting Pump to allow for daily cleaning. FSYX™ Ocular Pressure Adjusting Pump System goggles should be replaced every 30 days.
The FSYX™ Ocular Pressure Adjusting Pump houses 2 miniature diaphragm pumps that produce programmable NP pressure levels independently for each eye. The pumps are connected to a manifold that pneumatically interfaces the connector integral to the tubing system of the goggles. The manifold also mechanically and pneumatically connects a plurality of pressure sensors and relief valves. To create NP for each goggle lens, a pump extracts air from the cavity created by the goggle and the patient's face. The pump is pneumatically connected to the goggle through a negative pressure line comprised of a tube, a portion of the connector, and a portion of the manifold. The air extracted from the goggle is evacuated from the FSYX™ Ocular Pressure Adjusting Pump through a pneumatic path integral to the manifold. For each individual gogle. there is a separate pump and NP line, which allows independent NP application treatments for each eye.
The NP inside each goggle is monitored by a pressure sensor that is pneumatically connected to the respective goggle through a sense line. The NP and sense lines for each goggle are pneumatically connected proximal to the goggle cavity; this ensures that creation and monitoring of the NP level in each goggle can occur independently. The signal from each sensor is used in a separate Proportional-Integral-Derivative (PID) control loop for each pump so that the applied NP matches the value entered by the treating physician. If leaks exist at the interface between the seal and the patient's skin. NP is reduced and the PID controller increases rotational speed of the pump to counterbalance the leak and reestablish the prescribed NP level.
An additional differential pressure sensor is connected to each of the two independent sense lines to ensure that the differential signal matches the arithmetic difference between the NP levels set for the treatment of each eye and the actual NP levels sensed in each eye. An alarm is generated if the measured difference substantially departs from the arithmetic one.
For each independent NP line, a relief valve is also provided to mechanically limit the maximum allowable applied NP to a level
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR FSYXTM OCULAR PRESSURE ADJUSTING PUMP SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
External ocular negative pressure system. An external ocular negative pressure system uses hardware and software to create negative pressure in front of the eye to temporarily lower intraocular pressure in glaucoma patients.
NEW REGULATION NUMBER: 21 CFR 886.5000
CLASSIFICATION: II
PRODUCT CODE: QQJ
BACKGROUND
DEVICE NAME: FSYX™ Ocular Pressure Adjusting Pump System
SUBMISSION NUMBER: DEN230055
DATE DE NOVO RECEIVED: August 25, 2023
SPONSOR INFORMATION:
Balance Ophthalmics 3101 W 57th Street Sioux Falls, SD 51708 USA
INDICATIONS FOR USE
The FSYX Ocular Pressure Adjusting Pump System is indicated as follows:
The FSYXTM Ocular Pressure Adjusting Pump is indicated for the reduction of Intraocular Pressure (IOP) during sleep in adult patients with open-angle glaucoma and IOP ≤ 21 mmHg who are currently using or have undergone another IOP-lowering treatment.
LIMITATIONS
The sale, distribution, and use of FSYX™ Ocular Pressure Adjusting Pump System are restricted to prescription use in accordance with 21 CFR 801.109.
1
The following contraindications, warnings, and precautions apply to the FSYX™ Ocular Pressure Adjusting Pump System:
- Not for use in patients with allergy to silicone; 1
- ्र Patients using the FSYX™ Ocular Pressure Adjusting Pump System should not modify or discontinue any of their other glaucoma treatments without consultation with their health care provider;
- ﻳ Not recommended for use in patients with a history of retinal detachment or patients with narrow anterior chamber angle anatomy;
- . The safety and effectiveness of the FSYX™ Ocular Pressure Adjusting Pump System has not been established in patients with the following conditions: penetrating keratoplasty, prior sub-conjunctival glaucoma surgery such as trabeculectomy and tube shunt;
- . There is insufficient safety and effectiveness data for treatment durations > 6 hours and for negative pressure (NP) settings ≥ -17 mm Hg. Treatment durations between 6 and 8 hours and/or treatment at NP levels > - 17 mm Hg should be undertaken with caution. Treatment duration greater than 8 hours/session is not recommended.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS. PRECAUTIONS AND CONTRAINDICATIONS.
The device lowers IOP only while negative pressure is being properly applied. The effectiveness of the temporary IOP-lowering effect of the device to slow or halt glaucoma progression and to serve as a sole IOP-lowering treatment for glaucoma patients has not been established.
DEVICE DESCRIPTION
The FSYX™ Ocular Pressure Adjusting Pump System is comprised of two distinct elements, the programmable pump and the goggles with tubing. The FSYX™ Ocular Pressure Adjusting Pump System is designed to allow the application and monitoring of bilateral negative pressure (NP) in the microenvironment in front of a patient's eves.
Image /page/1/Picture/10 description: The image contains two separate images. The first image is of a black device with a screen that says "EQUINOX" in blue letters. The second image is of a pair of clear goggles with a black strap and a black connector attached to the goggles with clear tubes.
Figure IA: FSYX Ocular Pressure Adjusting Punp; Figure IB: FSYX Ocular Pressure Adjusting Punp System Goggles
2
The FSYX™ Ocular Pressure Adjusting Pump System goggles are designed to fit and seal around the eyes of patients, creating an air-tight chamber in which NP can be created and maintained. A headstrap is included with the goggles to facilitate reliable positioning on the patient's face during sleep. The goggles can be connected and disconnected from the FSYXM Ocular Pressure Adjusting Pump to allow for daily cleaning. FSYX™ Ocular Pressure Adjusting Pump System goggles should be replaced every 30 days.
The FSYX™ Ocular Pressure Adjusting Pump houses 2 miniature diaphragm pumps that produce programmable NP pressure levels independently for each eye. The pumps are connected to a manifold that pneumatically interfaces the connector integral to the tubing system of the goggles. The manifold also mechanically and pneumatically connects a plurality of pressure sensors and relief valves. To create NP for each goggle lens, a pump extracts air from the cavity created by the goggle and the patient's face. The pump is pneumatically connected to the goggle through a negative pressure line comprised of a tube, a portion of the connector, and a portion of the manifold. The air extracted from the goggle is evacuated from the FSYX™ Ocular Pressure Adjusting Pump through a pneumatic path integral to the manifold. For each individual gogle. there is a separate pump and NP line, which allows independent NP application treatments for each eye.
The NP inside each goggle is monitored by a pressure sensor that is pneumatically connected to the respective goggle through a sense line. The NP and sense lines for each goggle are pneumatically connected proximal to the goggle cavity; this ensures that creation and monitoring of the NP level in each goggle can occur independently. The signal from each sensor is used in a separate Proportional-Integral-Derivative (PID) control loop for each pump so that the applied NP matches the value entered by the treating physician. If leaks exist at the interface between the seal and the patient's skin. NP is reduced and the PID controller increases rotational speed of the pump to counterbalance the leak and reestablish the prescribed NP level.
An additional differential pressure sensor is connected to each of the two independent sense lines to ensure that the differential signal matches the arithmetic difference between the NP levels set for the treatment of each eye and the actual NP levels sensed in each eye. An alarm is generated if the measured difference substantially departs from the arithmetic one.
For each independent NP line, a relief valve is also provided to mechanically limit the maximum allowable applied NP to a level 21 mm Hg in either eye. Key exclusion criteria included those with allergies to silicone or latex, history of prior penetrating glaucoma surgery (e.g., trabeculectomy or aqueous shunt implantation), narrow anterior chamber anatomy, eyelid edema, festoons or excessive skin laxity, conjunctival chemosis, orbital anatomy precluding a prober goggles seal around both eyes, anticipated need for any ocular surgery, and/or ocular condition that would interfere with the interpretation of study outcomes or preclude safe participation in the study. During a 14-day "run-in" period prior to randomization, participants were instructed to begin at-home device use with gradual increase in device wear time. After completion of the "run-in" period, one eye per eligible participant was randomized to receive negative pressure (NP) application with the device while the fellow eye served as a control (zero NP). After randomization, participants were recommended to use the device for approximately six hours per night, five nights per week. An overnight, sleep lab visit was conducted within three weeks of randomization to assess supine IOPs prior to device use and during device use. Additional inclinic follow-up visits were scheduled at Weeks 6, 12, 26, and 38. Final overnight sleep-lab and in-clinic visits were conducted around Week 52. Various scheduled 10P assessments for key effectiveness endpoints were planned to be performed with Goldmann applanation tonometry (GAT) at the slit-lamp biomicroscope and with pneumotonometry through modified "excursion goggles." Participants were allowed to remain on IOP-lowering medications during the study. NP programming was based on achieving a "reference" floor IOP of 6 mm Hg; however, investigators were given discretion over adjusting the study-eye NP level as needed based on data from device home use, participant comfort, and adverse events (AEs).
Because applanation-based IOP measurement cannot be performed while a patient is wearing the FSYX Ocular Pressure Adjusting Pump System goggles, study participants wore "Excursion goggles," a modified version of the FSYX Ocular Pressure Adjusting Pump System goggles intended for home use, during the application of NP at the in-clinic visits at the investigational
9
sites. The Excursion goggles were designed with an "access port" to allow for IOP measurements with a Reichert Model 30 pneumotonometer during NP application (refer to Figure 2 below).
Image /page/9/Picture/1 description: The image shows a pair of goggles with two access ports labeled. The goggles are gray and black and have a strap attached to them. The access ports are located on the sides of the goggles and are connected to tubes.
Figure 2: Excursion Goggles
The primary effectiveness endpoint was the proportion of eves with IOP reduction of 20% or greater at 52 weeks (Visit 8) as measured via pneumotonometry with Excursion goggles worn from "before" to "during" application of negative pressure during in-clinic visit. The prespecified hypothesis for the primary effectiveness endpoint is the proportion of eyes with IOP reduction of 20% or greater at 52 week (Visit 8) in-clinic visit is higher in the treatment group compared to the control group at a one-sided alpha level of 0.025. The corresponding statistical hypotheses are as follows:
Null Hypothesis: nT1 - nF1 0
The TT 1 and TF 1 are the proportion of eyes at the Week 52 in-clinic visit with IOP reduction ≥ 20% compared to baseline for the treated and control eves, respectively. The secondary endpoint was the proportion of eyes in the mITT population with Week-52 sleep lab IOP (measured supine during NP application, via excursion tonometry, at 11:00 pm, 2:00 am, and 5:00 am, all within ± 60 minutes of the specified time point) reduction of 20% or greater compared to baseline IOP (measured prior to NP application). The pre-specified hypothesis for the secondary effectiveness endpoint is the proportion of eyes with IOP reduction of 20% or greater at 52 week (Visit 8) in sleep lab is higher in the treatment group compared to the control group at a onesided alpha level of 0.025. The corresponding statistical hypotheses are as follows:
10
Null Hypothesis: nT2 - nF2 0
The TT2 and TF2 are the proportion of eyes at the Week 52 in sleep lab visit with IOP reduction > 20% compared to baseline for the treated (study) and control eves, respectively.
Safety outcomes of interest included ocular, periocular, and non-ocular AEs, changes in best corrected distance visual acuity (BCDVA), slit-lamp biomicroscopy and ophthalmoscopy findings, changes in GAT IOP after completion of NP application, changes in visual field (VF), and changes in optical coherence tomography (OCT) imaging.
"Artemis" Study Results:
165 participants were enrolled. 55 were found ineligible or otherwise withdrew consent by the baseline or medication washout visit. 110 participants entered the "run-in" period and returned for the mid-run-in period visit (Day -7). During the "run-in" period, eight participants discontinued: four withdrew consent at Day -7 and four discontinued due to concerns with sleeplab availability. 106 returned for the randomization visit (Day 0). Another eight participants were discontinued due to ineligibility or withdrawal of consent. 94 participants were randomized at Day 0. One randomized participant exited the study before receiving any study treatment; therefore, the modified intent-to-treat (mITT) population is comprised of 93 participants. 31 randomized participants (33%) failed to complete both the final sleep lab and the Week 52 inoffice visit and two were reported with major protocol deviations; thus, a total of 62 participants (64.5%) completed the trial.
For the mITT population (N=93), the mean age was 62,4±10.7 vears. 67,7% were women. The majority (68.8%: 64/93) were white, 13 (14.0%) were Black/African American, and 15 (16.1%) were Asian. Most participants (80.6%; 75/93) reported Ethnicity of not Hispanic/not Latino. The mean study-eye baseline IOP by GAT was 14.7±2.0 mm Hg (range 12-20 mm Hg) and the mean study-eye baseline visual field (VF) mean deviation (MD) was -4.03±4.86 dB (range -22.59 to +2.38 dB). Most participants were on either no (44.1%; 41/93) or only one (37.6%; 35/93) IOP-lowering medication at the time of screening. A small proportion of study and control eyes (5%; 5/93) had prior "minimally invasive glaucoma surgery" (MIGS). 15% of study eyes and 19% of control eyes had a prior glaucoma laser procedure. The median study-eye vertical cup-to-disc (C/D) ratio was 0.7 (range 0.3 to 0.95). The mean study-eye central corneal thickness (CCT) was 536.2+38.2 um (range 413-640 um).
11
| mITT (N = 93) | PP (N = 60) | |
|---|---|---|
| Age at Consent | (Years) | (Years) |
| N | 93 | 60 |
| Mean ± SD | 62.4 ± 10.7 | 61.4 ± 10.6 |
| 1st Quartile | 54 | 53.8 |
| Median | 61 | 61 |
| 3rd Quartile | 70 | 69.3 |
| Min, Max | 40, 85 | 40, 81 |
| n (%) | n (%) | |
| Gender | ||
| Male | 30 (32.3%) | 21 (35.0%) |
| Female | 63 (67.7%) | 39 (65.0%) |
| Race | ||
| White | 64 (68.8%) | 44 (73.3%) |
| Black/African American | 13 (14.0%) | 9 (15.0%) |
| American Indian/Alaskan Native | 0 (0.0%) | 0 (0.0%) |
| Asian | 15 (16.1%) | 7 (11.7%) |
| Native Hawaiian/Pacific Islander | 0 (0.0%) | 0 (0.0%) |
| Other - Mestizo | 1 (1.1%) | 0 (0.0%) |
| Ethnicity | ||
| Hispanic or Latino | 18 (19.4%) | 13 (21.7%) |
| Not Hispanic and not Latino | 75 (80.6%) | 47 (78.3%) |
| Study Eye | ||
| OD | 46 (49.5%) | 32 (53.3%) |
| OS | 47 (50.5%) | 28 (46.7%) |
Table1: Demographics (mITT and PP Populations)
The mean programmed NP level over the scheduled study visits ranged between -10.0 mmHg to -12.1 mmHg. Mean daily device wear time across study intervals ranged from 5.44 to 5.63 hours. Participants used the device on approximately 78% or more of the days between each in-clinic visit. At the initial sleep-lab visit, mean pre-NP IOP was 3.2 ± 2.8 mm Hg higher than the Day 0 in-clinic visit for the study eye and 1.7 ± 2.9 mmHg higher in the control eve. 41.25% (66/160) of eyes had >20% increase in supine, pre-NP IOP compared to the preceding in-clinic pre-NP IOP. At the Week-52 sleep-lab visit, mean pre-NP IOP was 2.4 ± 3.7 mmHg higher than the Week 52 in-clinic visit for the study eye and 1.9 ± 2.9 mmHg higher in the control eye. 34.4% (42/122) of eyes had >20% increase in supine, pre-NP IOP compared to the preceding in-clinic pre-NP IOP.
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| Day 0 | Week 6 | Week 12 | Week 26 | Week 38 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Study | Control | Study | Control | Study | Control | Study | Control | Study | Control | |
| Programmed | ||||||||||
| NP, N | 93 | 93 | 81 | 81 | 74 | 74 | 68 | 68 | 65 | 65 |
| Mean | 10.0 | 0.0 | 12.0 | 0.0 | 12.1 | 0.0 | 11.7 | 0.0 | 11.9 | 0.0 |
| SD | 2.4 | 0.0 | 3.1 | 0.0 | 3.0 | 0.0 | 3.1 | 0.0 | 3.8 | 0.0 |
| 1st Quartile | 8.0 | 0.0 | 10.0 | 0.0 | 10.0 | 0.0 | 10.0 | 0.0 | 10.0 | 0.0 |
| Median | 10.0 | 0.0 | 12.0 | 0.0 | 12.0 | 0.0 | 12.0 | 0.0 | 11.0 | 0.0 |
| 3rd Quartile | 11.0 | 0.0 | 14.0 | 0.0 | 14.0 | 0.0 | 14.0 | 0.0 | 14.0 | 0.0 |
| Minimum | 5.0 | 0.0 | 6.0 | 0.0 | 6.0 | 0.0 | 5.0 | 0.0 | 5.0 | 0.0 |
| Maximum | 16.0 | 0.0 | 20.0 | 0.0 | 20.0 | 0.0 | 20.0 | 0.0 | 20.0 | 0.0 |
| Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Total | 93 | 93 | 81 | 81 | 74 | 74 | 68 | 68 | 65 | 65 |
| Programmed | ||||||||||
| NP Change | ||||||||||
| from Day 0, N | -- | -- | 81 | 81 | 74 | 74 | 68 | 68 | 65 | 65 |
| Mean | -- | -- | 2.0 | 0.0 | 2.0 | 0.0 | 1.6 | 0.0 | 1.8 | 0.0 |
| SD | -- | -- | 2.9 | 0.0 | 2.8 | 0.0 | 3.2 | 0.0 | 4.0 | 0.0 |
| 1st Quartile | -- | -- | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Median | -- | -- | 2.0 | 0.0 | 2.0 | 0.0 | 1.5 | 0.0 | 1.0 | 0.0 |
| 3rd Quartile | -- | -- | 4.0 | 0.0 | 4.0 | 0.0 | 4.0 | 0.0 | 4.0 | 0.0 |
| Minimum | -- | -- | -6.0 | 0.0 | -6.0 | 0.0 | -8.0 | 0.0 | -8.0 | 0.0 |
| Maximum | -- | -- | 9.0 | 0.0 | 9.0 | 0.0 | 9.0 | 0.0 | 12.0 | 0.0 |
| Not Reported | -- | -- | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Total | -- | -- | 81 | 81 | 74 | 74 | 68 | 68 | 65 | 65 |
Table 3: Negative Pressure Settings for Subsequent Home Use (mITT Population)
Table 4: Ocular Pressure Adjusting Pump Home Use (mITT Population)
| Visit Interval | Day 0 to
Week 6 | Week 6 to
Week 12 | Week 12 to
Week 26 | Week 26 to
Week 38 | Week 38 to
Week 52 |
|----------------------------------------------------------------------|--------------------|----------------------|-----------------------|-----------------------|-----------------------|
| Nominal visit interval
(days) | 42 | 42 | 98 | 84 | 98 |
| Days of OPAP use during the visit interval | | | | | |
| Average days between
visits | 37.73 | 43.76 | 87.10 | 84.95 | 101.61 |
| N | 81 | 74 | 68 | 65 | 62 |
| Mean | 32.95 | 37.49 | 71.59 | 66.43 | 79.79 |
| SD | 8.87 | 11.43 | 19.82 | 23.10 | 23.17 |
| Median | 31.00 | 38.50 | 72.00 | 68.00 | 79.00 |
| Minimum | 14.00 | 8.00 | 5.00 | 2.00 | 20.00 |
| Maximum | 56.00 | 63.00 | 112.00 | 132.00 | 126.00 |
| Average daily wear (in hours) of OPAP use during the visit interval" | | | | | |
| N | 81 | 74 | 68 | 65 | 62 |
| Mean | 5.52 | 5.44 | 5.52 | 5.52 | 5.63 |
| SD | 1.22 | 1.42 | 1.55 | 1.43 | 1.33 |
| Median | 5.83 | 5.77 | 5.91 | 5.93 | 5.85 |
| Minimum | 2.71 | 2.01 | 1.01 | 2.05 | 2.02 |
| Maximum¹ | 7.65 | 7.82 | 8.92 | 8.98 | 8.34 |
Days where treatment was dispensed for more than 20min.
"Sum of the usage of ONLY the days above 20min (any usage less than 20min is considered ZERO, and its corresponding day is not considered a usage day), divided by "Days of MPO use during the visit interval", divided by 3600 seconds, then converted into hours
This statistic includes subjects who restarted treatment after an 8-hour treatment cycle was completed.
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| Negative Pressure Settings (mmHg) | |||||
|---|---|---|---|---|---|
| Avg | |||||
| Nightly | |||||
| Wear Time | 0-6 Week | ||||
| Interval | 6-12 Week | ||||
| Interval | 12-26 Week | ||||
| Interval | 26-38 Week | ||||
| Interval | 38-52 Week | ||||
| Interval | |||||
| 0-3 Hours | 14.0 ± 2.6 | ||||
| (4) | |||||
| [11.0, 17.0] | 13.7 ± 2.8 | ||||
| (6) | |||||
| [10.0, 17.0] | 12.7 ± 2.7 | ||||
| (6) | |||||
| [10.0, 17.0] | 13.3 ± 4.4 | ||||
| (4) | |||||
| [9.0, 18.0] | 12.3 ± 6.7 | ||||
| (3) | |||||
| [5.0, 18.0] | |||||
| >3-4 Hour | 12.9 ± 3.6 | ||||
| (7) | |||||
| [7.0, 19.0] | 13.6 ± 3.1 | ||||
| (7) | |||||
| [10.0, 19.0] | 11.7 ± 2.3 | ||||
| (7) | |||||
| [7.0, 14.0] | 12.6 ± 4.7 | ||||
| (7) | |||||
| [6.0, 19.0] | 11.3 ± 4.2 | ||||
| (3) | |||||
| [8.0, 16.0] | |||||
| >4-5 Hour | 13.4 ± 2.8 | ||||
| (15) | |||||
| [7.0, 17.0] | 10.3 ± 3.3 | ||||
| (12) | |||||
| [6.0, 14.0] | 11.8 ± 4.4 | ||||
| (8) | |||||
| [6.0, 19.0] | 11.9 ± 3.4 | ||||
| (10) | |||||
| [6.0, 19.0] | 11.1 ± 2.2 | ||||
| (10) | |||||
| [7.0, 14.0] | |||||
| >5-6 Hour | 12.5 ± 3.8 | ||||
| (21) | |||||
| [6.0, 20.0] | 12.3 ± 3.4 | ||||
| (18) | |||||
| [6.0, 20.0] | 12.1 ± 2.7 | ||||
| (16) | |||||
| [7.0, 18.0] | 11.6 ± 3.9 | ||||
| (12) | |||||
| [7.0, 20.0] | 11.6 ± 4.2 | ||||
| (20) | |||||
| [5.0, 20.0] | |||||
| >6-7 Hour | 12.7 ± 2.7 | ||||
| (29) | |||||
| [7.0, 18.0] | 12.4 ± 2.5 | ||||
| (22) | |||||
| [7.0, 17.0] | 11.9 ± 3.4 | ||||
| (22) | |||||
| [6.0, 20.0] | 13.2 ± 3.6 | ||||
| (25) | |||||
| [5.0, 20.0] | 12.9 ± 3.6 | ||||
| (18) | |||||
| [7.0, 20.0] | |||||
| >7-8 Hour | 12.2 ± 1.3 | ||||
| (5) | |||||
| [11.0, 14.0] | 12.1 ± 2.4 | ||||
| (8) | |||||
| [7.0, 14.0] | 12.9 ± 2.6 | ||||
| (8) | |||||
| [8.0, 16.0] | 13.0 ± 4.8 | ||||
| (6) | |||||
| [7.0, 20.0] | 13.2 ± 4.9 | ||||
| (6) | |||||
| [7.0, 20.0] | |||||
| >8 Hours | - | - | 11.0 ± NA | ||
| (1) | |||||
| [11.0, 11.0] | 11.0 ± NA | ||||
| (1) | |||||
| [11.0, 11.0] | 10.0 ± 1.4 | ||||
| (2) | |||||
| [9.0, 11.0] |
Table 5: Negative Pressure Settings and Wear Time at Each Study Interval (mITT Population)
The primary analyses for the primary and secondary effectiveness endpoints are based on the mITT population (all randomized participants who have at least one full application of NP; N=93). 33 of 93 are with missing primary effectiveness endpoint measurements, resulting in a 35.5% missing rate for the two study groups. With all missing values imputed as "nonresponders," 58.1% (54/93) of study eyes achieved ≥ 20% reduction in IOP during NP application, as compared to 1.1% (1/93) of control eyes; this difference is statistically significant (p 5-10% increase | 9/80 (11.3%) | 15/80 (18.8%) | 24/160 (15.0%) |
| | >10-15% increase | 7/80 (8.8%) | 8/80 (10.0%) | 15/160 (9.4%) |
| | >15-20% increase | 6/80 (7.5%) | 5/80 (6.3%) | 11/160 (6.9%) |
| | >20-25% increase | 9/80 (11.3%) | 8/80 (10.0%) | 17/160 (10.6%) |
| | >25-30% increase | 6/80 (7.5%) | 5/80 (6.3%) | 11/160 (6.9%) |
| | >30% increase | 26/80 (32.5%) | 12/80 (15.0%) | 38/160 (23.8%) |
| Final
(Week 52)
Sleep Lab | % IOP Difference** | 16.4 ± 23.4 (61)
13.5 (-26.9, 73.9) | 13.0 ± 17.8 (61)
11.9 (-25.0, 68.6) | 14.7 ± 20.8 (122)
12.8 (-26.9, 73.9) |
| | Decrease | 16/61 (26.2%) | 16/61 (26.2%) | 32/122 (26.2%) |
| | 0-5% increase | 3/61 (4.9%) | 3/61 (4.9%) | 6/122 (4.9%) |
| | >5-10% increase | 6/61 (9.8%) | 10/61 (16.4%) | 16/122 (13.1%) |
| | >10-15% increase | 8/61 (13.1%) | 5/61 (8.2%) | 13/122 (10.7%) |
| | >15-20% increase | 5/61 (8.2%) | 8/61 (13.1%) | 13/122 (10.7%) |
| | >20-25% increase | 5/61 (8.2%) | 4/61 (6.6%) | 9/122 (7.4%) |
| | >25-30% increase | 1/61 (1.6%) | 4/61 (6.6%) | 5/122 (4.1%) |
| | >30% increase | 17/61 (27.9%) | 11/61 (18.0%) | 28/122 (23.0%) |
Table 7: Comparison of Percent Change in Mean Baseline Sleep Lab IOP and Corresponding In-Clinic Baseline IOP (mITT Population)
The relationship between the change in IOP between pre-NP and during-NP measurement and the programmed NP level was variable. At the final in-clinic visit, the mean "dose-response" (percent change in IOP between pre-NP and during-NP measurement divided by the programmed NP level) was 58.3% ± 23.8% (median 53.4%; range 7.1% to 116%; interquartile range 45.5% to 75%).
Image /page/14/Figure/3 description: The image is a scatter plot showing the relationship between NP Setting and IOP Reduction as a Percent of NP Application. The x-axis represents the NP Setting, ranging from -20 to -5. The y-axis represents the IOP Reduction as a Percent of NP Application, ranging from 10% to 120%. The data points are scattered across the plot, with a higher concentration of points between -12 and -9 NP Setting.
Figure 1: IOP Reduction as Percent of NP Application
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The mean study-eye, in-clinic IOPs by GAT prior to NP application were 14.4 mm Hg, 14.7 mm Hg. and 14.4 mm Hg at Day 0. Week 26. and Week 52. respectively. The mean study-eve, inclinic IOPs by GAT immediately after NP application were 13.9 mm Hg, 13.7 mm Hg, and 14.2 mm Hg at Day 0. Week 26. and Week 52. respectively. In study eves, the mean percent changes from pre-NP to post-NP IOP by GAT were -3% (range -36% to +23%), -6% (range -40% to +23%), and -1% (range -39% to +25%) at Day 0, Week 26, and Week 52, respectively.
39 and 17 ocular AEs were reported in 25 study eyes and 13 control eyes. respectively. 24 ocular AEs in 19 study eyes were determined to be device-related. The most frequently occurring AEs in study eves were lid edema (11 eves: 11.8%), mild signs and symptoms of dry eve (5 eves: 5.4%), mild to moderate conjunctival hyperemia (4 eyes: 4.3%), and mild to moderate eye pain (3 eyes; 3.2%). Transient eye pain related to NP application during device wear was reported in three study eves.
20 and seven periorbital AEs were reported for 17 study eves and seven control eyes. respectively. All study-eye periorbital AEs were device-related and were resolved by study completion or by cessation of device use. The most frequently reported periorbital AEs in study eyes were mild to moderate periorbital edema (12 eyes; 12.9%) and mild periorbital contact dermatitis (4 eyes: 4.3%). Of the 37 participants with ocular or periorbital AEs, 59.5% (22/37) had a programmed NP level higher than the protocol-recommended programming. No signs or symptoms of hypotony were reported.
Two participants experienced mild to moderate headaches during device use. One participant reported a rash in the upper left cheek area. In addition, periorbital edema, periorbital contact dermatitis, and mild device-associated headache were reported by seven participants during the "run-in" period. Eight participants used the device with NP setting of -17 to -20 mm Hg for at least 26 weeks of the study. Of these eight, three experienced AEs (mild periorbital edema and dry eye signs and symptoms). Two participants achieved average nightly wear >8 hours during at least one study period; of these two, one reported headache, lid erythema, and periorbital edema on Day 0 and several NP adjustments were made throughout the study.
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| | Study Eyes
(N=93) | | | Control Eyes
(N=93) | | |
|------------------------------------------|----------------------|--------------|--------------|------------------------|--------------|--------------|
| Ocular or Periorbital Adverse Event: | # of
Report
s | # of
Eyes | % of
Eyes | # of
Report
s | # of
Eyes | % of
Eyes |
| Any ocular AE | 39 | 25 | 26.9% | 17 | 13 | 14.0% |
| Anterior basement membrane dystrophy | 1 | 1 | 1.1% | 1 | 1 | 1.1% |
| Conjunctival chalasis | 0 | 0 | 0 | 1 | 1 | 1.1% |
| Conjunctival hyperemia | 4 | 4 | 4.3% | 2 | 2 | 2.2% |
| Epithelial defect | 1 | 1 | 1.1% | 0 | 0 | 0 |
| Eye pain | 4 | 3 | 3.2% | 0 | 0 | 0 |
| Eye pain secondary to ocular trauma | 0 | 0 | 0 | 1 | 1 | 1.1% |
| Floater | 1 | 1 | 1.1% | 0 | 0 | 0 |
| Iritis | 1 | 1 | 1.1% | 1 | 1 | 1.1% |
| Lid edema | 12 | 11 | 11.8% | 1 | 1 | 1.1% |
| Lid erythema | 2 | 2 | 2.2% | 1 | 1 | 1.1% |
| Loss of BCDVA ≥ 10 letters from baseline | 2 | 2 | 2.2% | 2 | 2 | 2.2% |
| Meibomian gland dysfunction | 1 | 1 | 1.1% | 1 | 1 | 1.1% |
| Nuclear sclerotic cataract | 1 | 1 | 1.1% | 1 | 1 | 1.1% |
| Posterior vitreous detachment | 2 | 2 | 2.2% | 0 | 0 | 0 |
| Symptoms and signs of dry eye | 6 | 5 | 5.4% | 5 | 5 | 5.4% |
| Visual disturbance | 1 | 1 | 1.1% | 0 | 0 | 0 |
| Any periorbital AE | 20 | 17 | 18.3% | 7 | 7 | 7.5% |
| Cherry hemangioma | 0 | 0 | 0 | 1 | 1 | 1.1% |
| Nasal abrasion | 1 | 1 | 1.1% | 0 | 0 | 0 |
| Periorbital contact dermatitis | 4 | 4 | 4.3% | 3 | 3 | 3.2% |
| Periorbital edema | 12 | 12 | 12.9% | 1 | 1 | 1.1% |
| Periorbital folds above eyebrows | 1 | 1 | 1.1% | 1 | 1 | 1.1% |
| Table 8: | Ocular and Periorbital Adverse Events Reported After Study Randomization
(Safety Population) |
|----------|-------------------------------------------------------------------------------------------------|
| | |
| Table 9: Device-Related Ocular and Periorbital Adverse Events (Safety Population) |
|---|
| | Study Eyes
N=93 | | | Control Eyes
N=93 | | |
|------------------------------------------------|--------------------|--------------|--------------|----------------------|--------------|--------------|
| Related Adverse Event: | # of
Reports | # of
Eyes | % of
Eyes | # of
Reports | # of
Eyes | % of
Eyes |
| Any device-related ocular or
periorbital AE | 44 | 32 | 34.4% | 11 | 10 | 10.8% |
| Any device-related ocular AE | 24 | 19 | 20.4% | 5 | 4 | 4.3% |
| Conjunctival hyperemia | 3 | 3 | 3.2% | 1 | 1 | 1.1% |
| Eye pain | 3 | 3 | 3.2% | 0 | 0 | 0.0% |
| Lid edema | 12 | 11 | 11.8% | 1 | 1 | 1.1% |
| Lid erythema | 2 | 2 | 2.2% | 1 | 1 | 1.1% |
| Symptoms and signs of dry eye | 3 | 3 | 3.2% | 2 | 2 | 2.2% |
| Visual disturbance | 1 | 1 | 1.1% | 0 | 0 | 0.0% |
| Any device-related periorbital AE | 20 | 17 | 18.3% | 6 | 6 | 6.5% |
| Nasal abrasion | 1 | 1 | 1.1% | 0 | 0 | 0.0% |
| Periorbital contact dermatitis | 4 | 4 | 4.3% | 3 | 3 | 3.2% |
| Periorbital edema | 12 | 12 | 12.9% | 1 | 1 | 1.1% |
| Periorbital folds above eyebrows | 1 | 1 | 1.1% | 1 | 1 | 1.1% |
| Periorbital pain | 2 | 2 | 2.2% | 1 | 1 | 1.1% |
Includes events that occurred on the cate of randomization or later. Multiple reported for an eye.
Device-related consists of events considered possibly, or definitely relate
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Worsening of VF MD bv >2.5 dB was reported in seven participants at Week 26 (four study eves and five control eyes) and in four participants at Week 52 (three study eyes and three control eyes). The VF data from four of the seven (57.1%) Week-26 participants and from two of the four Week-52 participants (50.0%) were determined to be insufficient for analysis. In the remaining three of the seven Week-26 participants, no glaucoma progression was determined for either eye. In the remaining two Week-52 participants, glaucoma progression was not detected in the study eyes. Of the 62 participants who completed the Week-52 visit, the study-eye mean retinal nerve fiber layer (RNFL) thickness on OCT imaging (77.9 ± 13.6 um) was unchanged between baseline and Week 52. RNFL thickness thinning of >5 um was reported in 8% of study eyes and 11% of control eyes; none of these eyes had reported VF loss.
POSTMARKET EVALUATION
A postmarket study will be conducted to determine the long-term safety of the device over a three-year period. Assessments will include visual field (VF), optical coherence tomography (OCT), and all ocular and periocular safety events. Additionally, data from a fit-for-purpose patient-reported outcome measure (PROM) to evaluate the impact of the use of the device on certain aspects of health-related quality of life (HRQOL) will be collected. The study will evaluate the performance of the device in the real-world population as defined by the indications for use and per the instructions for use.
LABELING
The labeling is sufficient and satisfies the requirements of 21 CFR 801.109 for prescription devices.
Device instructions for use are provided for patient and prescribing users of the device separately. The FSYX Ocular Pressure Adjusting Pump System Patient Instructions for Use includes steps on how to connect the goggles to the FSYX Ocular Pressure Adjusting Pump. wear the goggles, start and end treatment, and adjust and clean the goggles. To supplement the patient instructions for use, a FSYX Ocular Pressure Adjusting Pump System Ouick Start Guide and FSYX Ocular Pressure Adjusting Pump System Goggle Fitting Guide are also provided to the patient.
The FSYX Ocular Pressure Adjusting Pump System Healthcare Professionals Instructions for Use includes steps for establishing patient treatment settings (e.g., recommended duration and negative pressure programming), and patient training. A FSYX Ocular Pressure Adjusting Pump System Physicians Application Quick Start Guide is also provided to prescribers of the device.
Several product warnings are included in the labeling that carefully specify that treatment durations between 6 and 8 hours and/or treatments at NP levels of ≥ -17 mm Hg should be proceeded with caution.
The labeling also includes a summary of the clinical study procedures, patient population, and results.
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RISKS TO HEALTH
The table below identifies the risks to health that may be associated with the use of an external ocular negative pressure system and the measures necessary to mitigate these risks.
| Risks to Health | Mitigation Measures |
|---|---|
| Adverse tissue reaction | Biocompatibility evaluation |
| Excessive or insufficient negative pressure | |
| application and treatment duration leading to | |
| insufficient treatment of glaucoma and ocular | |
| and periorbital adverse events | Clinical performance testing |
| Postmarket surveillance | |
| Non-clinical performance testing | |
| Labeling | |
| Failure of software or system components | |
| resulting in insufficient treatment of glaucoma | Non-clinical performance testing |
| Shelf-life testing | |
| Software verification, validation, and hazard | |
| analysis | |
| User error leading to ocular and/or periorbital | |
| adverse events or insufficient treatment of | |
| glaucoma | Human factors validation testing |
| Labeling | |
| Inaccurate dosing due to lack of goggle seal | |
| resulting in insufficient treatment of glaucoma | Non-clinical performance testing |
| Equipment malfunction leading to user injury | |
| (e.g., shock, burn, interference) | Electromagnetic compatibility (EMC) testing |
| Electrical safety testing | |
| Labeling |
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act. the external ocular negative pressure system is subject to the following special controls:
- (1) Data obtained from premarket clinical performance validation testing and postmarket surveillance acquired under anticipated conditions of use must demonstrate that the device performs as intended when used in the intended patient population, and must evaluate the following, unless FDA determines based on the totality of the information provided for premarket review that data from postmarket surveillance is not required:
- Adverse events, including all ocular and periorbital events, worsening of visual (i) field and assessment of ocular tissue damage; and
- (ii) Reduction in intraocular pressure while the device is in use.
- (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include:
- Verification and validation of critical system components, such as pressure (i) generator, pressure delivery system, and power source; and
- Evaluation of the fail-safe pressure release mechanism. (ii)
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- (3) Performance testing must demonstrate the electromagnetic compatibility (EMC) and electrical, thermal, and mechanical safety of the device in the intended use environment.
- (4) Software verification, validation and hazard analysis must be performed. Validation testing must verify and validate programmable treatment parameters. Software documentation must include the following:
- (i) A description of programmable treatment limits such as negative pressure range and duration: and
- (ii) Mitigation measures to manage failure of any software/firmware or subsystem components and operator failures relating to negative pressure output.
- (5) The patient-contacting components of the device must be demonstrated to be biocompatible.
- (6) Human factors testing must demonstrate that the intended users can correctly use the device, based solely on the device labeling.
- (7) Labeling must include:
- (i) Warnings regarding negative pressure and treatment duration limitations; and
- A summary of the clinical performance testing conducted with the device, (ii) including a description of the study population, results, ocular and non-ocular adverse events.
BENEFIT-RISK DETERMINATION
The risks of the device are based on data collected in the Artemis study as summarized above. Thev include ocular and non-ocular adverse events (AEs) such as evelid edema, periorbital edema, conjunctival hyperemia, and eye pain. These AEs resolved with discontinuation of device use.
The probable benefits of the device are also based on data collected in the Artemis study. They include temporary lowering of intraocular pressure (IOP) while the device is in use and a nonpharmacologic and non-surgical option to lower IOP. IOP is a surrogate endpoint for the treatment of glaucoma (a chronic optic neuropathy that can lead to irreversible vision loss). because it is the only known modifiable risk factor for glaucoma. It has not been demonstrated whether these benefits will result in halting or slowing of the progression of glaucoma. This is a source of uncertainty. Other sources of uncertainty include missing data for the key effectiveness endpoints, the wide variability in nightly wear time among participants, and the lack of information on harmful impacts on quality of life and sleep and on long-term ocular effects from chronic application of negative pressure.
Additional factors considered in determining probable risks and benefits for the FYSX Ocular Pressure Adjusting Pump System device included uncertainty, risk mitigation, the novelty of the technology, and deliberations during the meeting of the Ophthalmic Devices Panel of the
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Medical Devices Advisory Committee held on March 21, 2024. The panel recommended a postmarket study to address some of the sources of uncertainty noted above.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device. The postmarket surveillance plan will include the collection of data to evaluate the impact of the use of the device on certain aspects of health-related quality of life (HRQOL).
Benefit/Risk Conclusion
In conclusion, given the available information, for the following Indications for Use statement:
The FSYXTM Ocular Pressure Adjusting Pump is indicated for the reduction of Intraocular Pressure (IOP) during sleep in adult patients with open-angle glaucoma and IOP ≤ 21 mmHg who are currently using or have undergone another IOP-lowering treatment.
The probable benefits outweigh the probable risks for the FSYX Ocular Pressure Adjusting Pump System. The device provides benefits and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
The De Novo request for the FSYX Ocular Pressure Adjusting Pump System is granted and the device is classified as follows:
Product Code: QQJ Device Type: External ocular negative pressure system Regulation Number: 21 CFR 886.5000 Class: II