(267 days)
Yes
The device description mentions "The device automatically locates the treatment location" and "the eye tracker compensates for any eye movement." While not explicitly stating AI/ML, these functionalities strongly suggest the use of image processing and potentially AI/ML algorithms for automated localization and tracking.
Yes
The device performs selective laser trabeculoplasty (SLT), which is a medical procedure used to treat glaucoma by lowering intraocular pressure. This therapeutic intervention directly affects the patient's physiological condition.
No
The Eagle device is described as a laser device for performing selective laser trabeculoplasty (a treatment), and its intended use is therapy, not diagnosis. It automatically locates the treatment location and applies laser treatment, indicating a therapeutic function.
No
The device description clearly states that the Eagle device is a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser, which is a hardware component. It also describes the physical characteristics of the laser spots and how they are delivered.
No, 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 and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
- Eagle Device Function: The Eagle device is a laser used to perform a surgical procedure (selective laser trabeculoplasty) directly on the patient's eye. It is a therapeutic device, not a diagnostic one. It does not examine specimens from the body to provide diagnostic information.
The description clearly indicates the device is used for treatment, not for in vitro diagnostic testing.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The Eagle device is a prescription device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam. The Eagle device has the same intended use as the predicate device. The Eagle device has the following Indications for Use (IFU) statement:
The Eagle device is indicated for use in selective laser trabeculoplasty (SLT).
Product codes
HOF
Device Description
The Eagle device is a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser that is intended for use in performing selective laser trabeculoplasty. The laser spots produced by the Eagle device have a 400 um spot size, a 3 ns pulse duration, and a 50-Hz pulse repetition rate. The sequence of laser spots consists of 120 spots in a predefined circumferential elliptical pattern delivered at a pre-defined pulse energy level. The spots are delivered through the limbus to the trabecular meshwork in a non-contact fashion, without the need for the use of a contact gonioscopy lens. The device automatically locates the treatment location. The treatment location may be adjusted slightly by the operator. Once confirmed by the operator, the device then automatically applies the laser treatment sequence to the limbal region of the eye, while the eye tracker compensates for any eye movement. The default energy setting is 1.8 mJ/pulse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eye, orbit, or surrounding skin; Trabecular meshwork
Indicated Patient Age Range
40 years or older
Intended User / Care Setting
Not Found
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
A prospective, multi-center, randomized, controlled trial was conducted to evaluate the safety and effectiveness of laser trabeculoplasty using the Eagle device to compared to conventional selective laser trabeculoplasty (SLT). 276 participants age 40 years or older with primary openangle glaucoma, pseudoexfoliation glaucoma, pigmentary glaucoma, or ocular hypertension on three or fewer IOP-lowering medications at baseline were enrolled across 14 sites. Prior incisional or laser-based glaucoma procedures, severe glaucoma in either eye, dense pigmentation or hemorrhage in the perilimbal conjunctival area or anterior sclera were exclusionary. Eligible participants underwent baseline IOP-lowering medication washout and those with post-washout IOP between 22 – 35 mmHg were randomized 1:1 to 360° treatment with either the Eagle device or with a conventional SLT device. Participants were followed for 12 months post-treatment. The primary effectiveness endpoint was the between-group difference in the mean change in unmedicated IOP at 6 months compared to baseline. The primary safety outcome was the rate of ocular adverse events (AEs) in each treatment group at or prior to 12 months.
A total of 196 participants were enrolled and randomized, 99 to Eagle and 97 to conventional SLT. Of these, 187 participants, 96 Eagle and 91 conventional SLT, underwent the assigned laser procedure. The mean age of participants was 65.6 ± 9.4 years (range 40 – 88 years) and 39.0% were women. 98% of participants were white, 1% were Black, 0.5% were Asian and 0.5% were mixed race. 87% of participants had glaucoma. 73% had primary open angle glaucoma, 11% had pseudoexfoliative glaucoma and 3% had pigmentary glaucoma. The remaining 13% of participants had ocular hypertension. Mean screening IOP was 21.5 ± 5.4 mmHg for the Eagle group and 20.5 ± 4.5 mmHg for the conventional SLT group. At the time of enrollment, 32.2% of participants were not taking any hypotensive medications. The average number of ocular hypotensive medications at screening was 1.2 ± 1.0 for the Eagle group compared to 1.1 ± 1.0 for the SLT group. Post-washout baseline IOP was 26.5 ± 3.6 mmHg in the Eagle group and 25.8 ± 3.6 mmHg in the SLT group.
The Eagle procedure provided a mean (±SE per the least-square estimation) reduction of unmedicated IOP at 6 months of 5.5 ± 0.5 mmHg (95% Cl -6.5 to -4.5), compared with 6.3 ± 0.5 mmHg (95% Cl -7.3 to -5.2) in the conventional SLT group (Table 1). The difference in mean reduction in IOP between the two groups (SLT-Eagle) was -0.80 mmHg (95% Cl -2.28 to 0.68 mmHg).
No ocular serious adverse events (SAEs) were reported in the first six months. One ocular SAE of subluxation of a pre-existing intraocular lens (IOL) was reported in one participant in the conventional SLT group on post-procedure day 1, which was corrected with surgical repositioning. One ocular SAE was reported in an Eagle group participant who experienced a decline in visual field due to non-glaucomatous acute optic neuropathy at the 12-month followup visit.
The most commonly reported non-serious AE was punctate subconjunctival hemorrhage (21% in the Eagle group vs 1% in the conventional SLT group). These events resolved without clinical sequelae. Elevated IOP was reported in two participants in the Eagle group and two participants in the conventional SLT group. The proportion of participants with a worsening of visual field mean deviation by ≥2.5 dB was 6.6% and 9.9% in the Eagle group vs. 12.6% and 15.7% in the conventional SLT group at 6 and 12 months, respectively. In the first six months, progression of cataracts was reported in three Eagle participants and one conventional SLT participant. Between 6 and 12 months, three Eagle and four conventional SLT participants had progression of cataracts and one conventional SLT participant developed a new cataract.
Secondary surgical interventions (SSIs) were reported in four Eagle participants (trabeculectomy [N=1], cataract surgery [N=2], and laser retinopexy [N=1] to repair a retinal tear) and three conventional SLT participants (cataract surgeries [N=2], IOL repositioning [N=1]).
Key Metrics
Effectiveness:
Difference in mean reduction of unmedicated IOP between SLT-Eagle at 6 months: -0.80 mmHg (95% Cl -2.28 to 0.68 mmHg).
Safety:
No ocular serious adverse events (SAEs) reported in first six months for the Eagle group.
One ocular SAE (acute optic neuropathy) reported in one Eagle group participant at 12-month follow-up.
Most common non-serious AE: punctate subconjunctival hemorrhage (20.8% in Eagle group vs 1.1% in conventional SLT group).
Elevated IOP: 2.1% in Eagle group vs 2.2% in conventional SLT group.
Worsening of visual field mean deviation by ≥2.5 dB: 6.6% (6 months) and 9.9% (12 months) in Eagle group vs 12.6% (6 months) and 15.7% (12 months) in conventional SLT group.
Cataract progression: 3 (3.1%) Eagle participants vs 1 (1.1%) conventional SLT participant in first 6 months.
Secondary surgical interventions (SSIs): 4 Eagle participants vs 3 conventional SLT participants.
Increase of Anterior Chamber Cells by +0.5 or more: Eagle 31.3% (Post Procedure), 18.9% (1D), 3.2% (7D), 0.0% (1M, 3M), 1.1% (6M, 12M). SLT 20.9% (Post Procedure), 12.1% (1D), 3.3% (7D), 2.2% (1M), 1.1% (3M), 1.2% (6M), 2.4% (12M).
Increase of Anterior Chamber Flare by +0.5 or more: Eagle 20.8% (Post Procedure), 11.6% (1D), 2.1% (7D), 0.0% (1M, 3M), 1.1% (6M, 12M). SLT 16.5% (Post Procedure), 7.7% (1D), 1.1% (7D, 1M, 3M, 6M, 12M).
Predicate Device(s)
Lumenis Selecta Duet LED (K220877)
Reference Device(s)
Topcon PSLT for PASCAL Streamline (K171488), OD-OS Navilas Laser System 577s (K162191)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 8, 2023
BELKIN Vision Ltd. % Anne-Marie Riplev Clinical & Regulatory Consultant Regulatory Pathways Group, Inc. 440 N. Barranca Ave., #2471 Covina. California 91723
Re: K230722
Trade/Device Name: Eagle Device Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HOF Dated: November 2, 2023 Received: November 2, 2023
Dear Anne-Marie Ripley:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Claudine H. Krawczyk -S
Claudine Krawczyk Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230722
Device Name Eagle device
Indications for Use (Describe) The Eagle device is indicated for use in selective laser trabeculoplasty (SLT).
Type of Use (Select one or both, as applicable) | |
---|---|
☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) SUMMARY K230722
l. Submitter Information
- 510(k) Owner: BELKIN Vision Ltd. 13 Gan Rave Blvd. Yavne, Israel, 8122214 +972-8-857-1619
- Contact Person: Anne-Marie Ripley Regulatory Pathways Group, Inc. 440 N. Barranca Ave., #2471 Covina, CA 91723 aripley@regulatorypathways.com
- Date Prepared: December 8, 2023
II. Device Name and Classification
- Device Trade Name: Eagle device
- Common Name: Ophthalmic laser
- Classification Name: Ophthalmic laser
- Regulation Number: 21 CFR 886.4390
- Device Classification: Class 2
- Product Code: HQF
III. Predicate Device and Reference Devices
Predicate Device
- Lumenis Selecta Duet LED (K220877) .
Reference Devices
5
Topcon PSLT for PASCAL Streamline (K171488) supports automated delivery of laser spots in a pre-defined pattern for SLT indications and high pulse repetition rate laser spots.
OD-OS Navilas Laser System 577s (K162191), which allows for laser treatment to the retina using an automated delivery system with eye tracking, supports algorithms for eye tracking to ensure that the laser beam position is maintained at the desired treatment location throughout the laser treatment.
IV. Device Description
The Eagle device is a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser that is intended for use in performing selective laser trabeculoplasty. The laser spots produced by the Eagle device have a 400 um spot size, a 3 ns pulse duration, and a 50-Hz pulse repetition rate. The sequence of laser spots consists of 120 spots in a predefined circumferential elliptical pattern delivered at a pre-defined pulse energy level. The spots are delivered through the limbus to the trabecular meshwork in a non-contact fashion, without the need for the use of a contact gonioscopy lens. The device automatically locates the treatment location. The treatment location may be adjusted slightly by the operator. Once confirmed by the operator, the device then automatically applies the laser treatment sequence to the limbal region of the eye, while the eye tracker compensates for any eye movement. The default energy setting is 1.8 mJ/pulse.
V. Intended Use and Indications for Use
The Eagle device is a prescription device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam. The Eagle device has the same intended use as the predicate device. The Eagle device has the following Indications for Use (IFU) statement:
The Eagle device is indicated for use in selective laser trabeculoplasty (SLT).
The IFU statement of the Eagle device is not substantially different from that of the predicate device. The non-substantial difference in the IFU statement for the Eagle versus the predicate
6
device is that the IFU statement for the Eagle device is narrower; it does not include posterior capsulotomy, pupillary membranectomy in aphakic and pseudophakic patients, and iridotomy.
Comparison of Technological Characteristics with the Predicate Device VI.
Although the Eagle device and the predicate do not share identical technological characteristics, these differences do not raise different types of questions of safety and effectiveness.
| Characteristic | Subject Device
BELKIN Vision
Eagle device | Predicate Device
Lumenis Be Inc.
Selecta Duet LED | Comparison of Subject Device to
Predicate Device |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K230722 | K220877 | |
| Device Class | 2 | 2 | Same |
| Classification
Product Code | HQF | HQF | Same |
| Regulation Number | 886.4390 | 886.4390 | Same |
| Intended Use | Selective Laser
Trabeculoplasty (SLT) | Selective Laser
Trabeculoplasty | Same |
| Indications for use | Selective laser
trabeculoplasty (SLT). | In SLT mode:
Selective laser
trabeculoplasty (SLT)
In YAG mode:
Photodisruption of
ocular tissue using light
energy emitted by a
Nd:YAG laser, including
discission of the
posterior capsule of the
eye (posterior
capsulotomy), and
discission of pupillary
membranes (pupillary
membranectomy) in
aphakic and
pseudophakic patients,
and
iridotomy/iridectomy | Different, but the differences do
not raise different types of
questions of safety and
effectiveness. Both devices are
indicated for SLT. |
| Laser Parameters | | | |
| Laser type | Q-switched, frequency-
doubled Nd:YAG | Q-switched, frequency-
doubled Nd:YAG | Same |
| Wavelength | 532 nm | 532 nm | Same |
| Laser pulse duration | 3 ns | 3 ns | Same |
| Characteristic | Subject Device | Predicate Device | Comparison of Subject Device to Predicate Device |
| | BELKIN Vision
Eagle device
K230722 | Lumenis Be Inc.
Selecta Duet LED
K220877 | |
| Pulse energy range | 1.1 – 1.9 mJ | 0.3 – 2.6 mJ | Different, but the difference does not raise different types of questions of safety and effectiveness. The pulse energy range of Subject Device is within the energy range of the Predicate Device. The energy level of the subject device is fixed for the entire set of 120 spots while the energy level of the predicate device may be changed as laser spots are applied to the trabecular meshwork (TM).
The safety and effectiveness of the Eagle device's pulse energy range were supported by non-clinical and clinical performance data. |
| Pulse repetition rate | 50 Hz | Up to 3 Hz | Different, but the difference does not raise different types of questions of safety and effectiveness.
The safety and effectiveness of the Eagle device's 50-Hz pulse repetition rate were supported by non-clinical and clinical performance data. |
| Laser Beam Delivery | | | |
| Method of laser delivery (pattern) | Automated delivery of laser spots in a pre-defined pattern (360° ellipse) through the limbus without the use of a contact gonioscopy lens; the trabecular meshwork (TM) is not directly visualized as laser spots are applied. | Manual delivery of laser spots through a contact gonioscopy lens to directly visualize the TM. Spots are applied for usually 180° or 360° of the TM. | Same pattern (i.e. 360° ellipse)
Method of delivery is different, but the difference does not raise different types of questions of safety and effectiveness.
The safety and effectiveness of the Eagle device's automated delivery were supported by non-clinical and clinical performance data. |
| Target tissue | Trabecular meshwork | Trabecular meshwork | Same |
| Characteristic | Subject Device | Predicate Device | Comparison of Subject Device to
Predicate Device |
| | BELKIN Vision
Eagle device | Lumenis Be Inc.
Selecta Duet LED | |
| | K230722 | K220877 | |
| Method of
maintaining laser
beam targeting | Anatomical detection
algorithm and eye
tracking to compensate
for eye movements
during the procedure. | Direct visualization of
aiming beam and target
tissue through slit lamp
microscope and handheld
gonioscope contact lens. | Different, but the difference does
not raise different types of
questions of safety and
effectiveness.
Reference Device 2 supports the
bench testing methods used to
demonstrate the safety and
effectiveness of this technological
feature. |
| Spot diameter | 400 μm | 400 μm | Same |
| Auxiliary optical characteristics | | | |
| Aiming laser | Diode laser | Diode laser | Same |
| Aiming wavelength | 635 nm | 635 nm | Same |
| Method of
maintaining the
focal position of
treatment beam | Manually set using a
joystick to adjust the
axial position by
visualizing the overlap of
two ranging (650 nm)
diode laser beams. | Manually set using a
joystick to adjust the axial
position using aiming
beam and microscope
image as a guide. | Similar |
| Illumination | LED illumination ring,
visible white light | LED illumination source,
both visible white light
and filtered light | Similar |
| Physical dimensions | | | |
| System weight | 30 kg / 66 lbs | 31 kg / 68 lbs | Similar |
| System dimensions
(H x W X D) | 52 x 53 x 63 cm
20.5 x 21.8 x 25 inches | 57 x 75 x 44 cm,
23 x 30 x 18 inches | Similar |
7
8
Summary of Non-Clinical Testing VII.
Based on the risk assessment and design control requirements, the following verification and validation testing was performed:
- Device performance testing ●
- Validation of laser fluence delivery to the target tissue
- . Environmental and transportation testing were conducted per elements of:
- o ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
9
- ASTM D6653-13 Standard Test Methods for Determining the Effects of High o Altitude on Packaging Systems by Vacuum Method
- o ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems (Assurance Level II)
- ASTM D5276-19 Standard Test Method for Drop Test of Loaded Containers by O Free Fall
- ASTM D4728-17 Standard Test Method for Random Vibration Testing of о Shipping Containers
- Laser and optical radiation hazard evaluation and safety testing was conducted per: ●
- IEC 60601-2-22: 2007 (3rd Ed.) Medical electrical equipment Part 2: Particular o requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1:2014 Safety of laser products Part 1: Equipment classification and o requirements
- Product reliability testing was conducted per Telcordia SR-332.
- Biocompatibility testing: The biocompatibility profile of the tissue contacting components of the device were assessed for cytotoxicity, sensitization (Guinea pig maximization) and intracutaneous reactivity testing as recommended by FDA's 2020 Biocompatibility Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'" and relevant parts of International Standard Organization (ISO) 10993 Biological evaluation of medical devices standard series.
- . Software verification and validation testing: BELKIN developed and verified the software in accordance with a major level of concern described in the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and also per the IEC 62304:2006 and A1:2015 Medical Device Software - Software Life Cycle Processes standard.
- . Electromagnetic compatibility (EMC) was conducted per IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests.
- Electrical safety testing was conducted per IEC 60601-1:2005 + CORR1:2006 + . CORR2:2007 + AMD1:2012 Medical electrical equipment – Part 1: General requirements for safety 1: collateral standard: Safety Requirements for Medical Electrical Systems.
- Human factors testing was conducted per
- FDA guidance, "Applying Human Factors and Usability Engineering to Medical o Devices"
- ANSI/AAMI IEC 62366-1 Medical devices Part 1: Application of usability o engineering to medical devices, and
- IEC 60601-1-6 Medical electrical equipment Part 1-6: General requirements for o basic safety and essential performance – Collateral standard: Usability
- Animal testing was conducted per 21 CFR Part 58 (Good Laboratory Practices) in rabbit to evaluate the acute and subacute safety of the device compared to the standard
10
selective laser trabeculoplasty (SLT). Macroscopic treatment-related changes were comparable in eyes undergoing SLT with the Eagle device and the SLT comparator device. Mild changes were limited in acute phase and resolved by day 29. The study provides evidence to support the substantial equivalence of the Eagle device to the predicate device in post-treatment tissue reactions.
Results of the non-clinical testing support a substantial equivalence determination. The Eagle device is substantially equivalent to its predicate device for the indications for use.
VIII. Clinical Performance Testing
A prospective, multi-center, randomized, controlled trial was conducted to evaluate the safety and effectiveness of laser trabeculoplasty using the Eagle device to compared to conventional selective laser trabeculoplasty (SLT). 276 participants age 40 years or older with primary openangle glaucoma, pseudoexfoliation glaucoma, pigmentary glaucoma, or ocular hypertension on three or fewer IOP-lowering medications at baseline were enrolled across 14 sites. Prior incisional or laser-based glaucoma procedures, severe glaucoma in either eye, dense pigmentation or hemorrhage in the perilimbal conjunctival area or anterior sclera were exclusionary. Eligible participants underwent baseline IOP-lowering medication washout and those with post-washout IOP between 22 – 35 mmHg were randomized 1:1 to 360° treatment with either the Eagle device or with a conventional SLT device. Participants were followed for 12 months post-treatment. The primary effectiveness endpoint was the between-group difference in the mean change in unmedicated IOP at 6 months compared to baseline. The primary safety outcome was the rate of ocular adverse events (AEs) in each treatment group at or prior to 12 months.
A total of 196 participants were enrolled and randomized, 99 to Eagle and 97 to conventional SLT. Of these, 187 participants, 96 Eagle and 91 conventional SLT, underwent the assigned laser procedure. The mean age of participants was 65.6 ± 9.4 years (range 40 – 88 years) and 39.0% were women. 98% of participants were white, 1% were Black, 0.5% were Asian and 0.5% were mixed race. 87% of participants had glaucoma. 73% had primary open angle glaucoma, 11% had pseudoexfoliative glaucoma and 3% had pigmentary glaucoma. The remaining 13% of participants had ocular hypertension. Mean screening IOP was 21.5 ± 5.4 mmHg for the Eagle group and 20.5 ± 4.5 mmHg for the conventional SLT group. At the time of enrollment, 32.2% of participants were not taking any hypotensive medications. The average number of ocular hypotensive medications at screening was 1.2 ± 1.0 for the Eagle group compared to 1.1 ± 1.0 for the SLT group. Post-washout baseline IOP was 26.5 ± 3.6 mmHg in the Eagle group and 25.8 ± 3.6 mmHg in the SLT group.
Effectiveness
The Eagle procedure provided a mean (±SE per the least-square estimation) reduction of unmedicated IOP at 6 months of 5.5 ± 0.5 mmHg (95% Cl -6.5 to -4.5), compared with 6.3 ± 0.5 mmHg (95% Cl -7.3 to -5.2) in the conventional SLT group (Table 1). The difference in mean
11
reduction in IOP between the two groups (SLT-Eagle) was -0.80 mmHg (95% Cl -2.28 to 0.68 mmHg). Table 2 presents the primary effectiveness endpoint analysis for the Eagle group, stratified by the energy level used.
| Method | Eagle
N
Mean ± SE3
(95% CI) | SLT
N
Mean ± SE3
(95% CI) | ANCOVA p-value2
p-value
H0: Δ ≤ -1.95 mmHg
Ha: Δ > -1.95 mmHg
Δ = Difference in Mean
(SLT - Eagle) |
|----------------------------------------------|--------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| ITT Population4 (N= 196) | | | |
| Primary Analysis | 99
-4.63 ± 0.49
(-5.60, -3.67) | 97
-5.70 ± 0.50
(-6.69, -4.71) | 0.209 |
| Difference in mean = SLT – Eagle
(95% CI) | | -1.07 (-2.45, 0.32) | |
| mPP Population5 (N= 152) | | | |
| Primary Analysis | 77
-5.48 ± 0.52
(-6.52, -4.45) | 75
-6.29 ± 0.53
(-7.34, -5.23) | 0.127 |
| Difference in mean = SLT - Eagle
(95% CI) | | -0.80 (-2.28, 0.68) | |
Table 1: Primary Effectiveness Endpoint 6 Month Unmedicated IOP Change from Baseline Primary Analysis1 per Least Squares Estimation of ANCOVA Model2
Baseline value was used to impute 6-month for participants with SSI or unsafe to washout at 6 months. The SSIs were defined as 1 surgical procedures that might affect the level of IOP (such as iridotomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, cataract surgery that might affect IOP).
2 ANCOVA Model: Yij = μ + ti + ß*(Xij – average of Xij) + rj + eij, Yij is the change-from-baseline IOP (the 6-month IOP value was subtracted from baseline IOP for each eye) for treatment i and study eve i, Xij is the corresponding baseline IOP measurement, μ is the overall mean, ti is the treatment indicator, ß is the effect of baseline IOP, rj is an indicator of beta-blocker use in the fellow eye, and eij is the error term.
3 Standard Error (i.e., standard deviation of mean)
4 The ITT Population is defined as all randomized participants.
5 The Modified Per Protocol (mPP) population included participants who met the Per Protocol (PP) definition. In addition, participants who met any of the following criteria during the first 6 months were included in the mPP population as failures: Had a secondary surgical intervention (SSI) in the study eye that could affect IOP; had an ocular SAE in the study eye; or participant for whom 6-month washout was considered unsafe. For these participants, 6-month IOP was imputed with their baseline IOP measurement for the primary endpoint analysis. Participants who were missing their reasons were not included in the mPP population.
Per protocol (PP) was defined as all enrolled and randomized participants who were treated and for whom data concerning the primary effectiveness endpoint measure was available and who had no major protocol deviations (e.g. inclusion and/or exclusion criteria violations, treatment not according to randomization, IOP measured in an unmasked fashion). Participants with major protocol deviations were excluded from the PP population.
12
Table 2: Primary Effectiveness Endpoint, Stratified by Energy Level (Eagle Group Only) 6 Month Unmedicated IOP Change from Baseline Primary Analysis1 per Least Squares Estimation of ANCOVA Model4
Primary Effectiveness Endpoint | 1.1 mJ/shot | 1.2 mJ/shot | 1.3 mJ/shot | 1.4 mJ/shot | 1.5 mJ/shot | 1.6 mJ/shot | 1.7 mJ/shot | 1.8 mJ/shot | 1.9 mJ/shot |
---|---|---|---|---|---|---|---|---|---|
ITT Population2 | |||||||||
N | 4 | 2 | 1 | 4 | 7 | 9 | 39 | 26 | 4 |
Change in unmedicated IOP from baseline | -5.29 ± 2.51 | -7.66 ± 3.45 | -8.63 ± 4.95 | -6.10 ± 2.44 | -1.88 ± 1.85 | -7.23 ± 1.64 | -4.93 ± 0.78 | -3.40 ± 0.95 | -4.87 ± 2.48 |
to 6 months (mmHg) Mean (SE)3 | (-10.29, -0.29) | (-14.52, -0.79) | (-18.47, 1.20) | (-10.96, -1.24) | (-5.57, 1.80) | (-10.50, -3.96) | (-6.49, -3.38) | (-5.30, -1.51) | (-9.81, 0.07) |
mPP Population5 | |||||||||
N | 4 | 2 | 1 | 2 | 3 | 9 | 33 | 20 | 3 |
Change in unmedicated IOP from baseline | -4.83 ± 2.53 | -7.36 ± 3.46 | -8.52 ± 4.95 | -7.83 ± 3.45 | -5.32 ± 2.83 | -7.28 ± 1.64 | -5.50 ± 0.85 | -4.30 ± 1.10 | -7.30 ± 2.87 |
to 6 months (mmHg) Mean (SE)3 | (-9.88, 0.23) | (-14.27, -0.45) | (-18.40, 1.37) | (-14.72, -0.95) | (-10.96, 0.33) | (-10.56, -4.00) | (-7.19, -3.80) | (-6.50, -2.11) | (-13.03, -1.58) |
I - Baseline value was used to imports with SS or unsfe to washout at 6 months. The SS were edition as surgical rocess that might affect the level of CP (such as inidorin, in trabeculectory, glaucoma shunt implantation, argon laser trabeculoplasty, cataract surgery), or other surgery that might affect (O.
2 The ITT Population is defined as all randomized participants. The ITT analysis because they did not undergo the assered asser are asser as a care as a care a coredure.
3 Standard Error (i.e., standard deviation of mean)
4 ANCOVA Model: Yij = i + i + f + f + if + i + ij, tij it the change-from-baseline (0 V the E-month (0 P rach qe) for earth eye for energy level and study eye i, liji sthe corresponding baseline (OP neasurenent, ui s the energy level indicator, Sis the effect of backer use in the fellow eye, and eij is the erot term.
The Modiled Percocol (nP) population in the Per Protocol (P) definition. In addition, participants who net any of the fille for the first Gronths wee included in the nP population as fallures: Halo secondary ($$) in the study eye that could affect OP; had an coular SAE in the study ever on participant for whon F-nonth was considered wasi these participants, Frinth OP was inqueted to the primary endopint analyss. Participants who were missing their F-month data for other reasons were not included in the mP population.
Per protocol (PP) was defined and andomized participats who whom data concerning the primary effectiveness endopint measure was wailoble and who had no maip rotocol devations (e, inclusion and or exclusions, treatment on teaching to randomization, (0º measured in an unmasked fashion). Participants with napo probod devaitions were ecclud from the PP population.
13
Safety
No ocular serious adverse events (SAEs) were reported in the first six months. One ocular SAE of subluxation of a pre-existing intraocular lens (IOL) was reported in one participant in the conventional SLT group on post-procedure day 1, which was corrected with surgical repositioning. One ocular SAE was reported in an Eagle group participant who experienced a decline in visual field due to non-glaucomatous acute optic neuropathy at the 12-month followup visit.
The most commonly reported non-serious AE was punctate subconjunctival hemorrhage (21% in the Eagle group vs 1% in the conventional SLT group). These events resolved without clinical sequelae. Elevated IOP was reported in two participants in the Eagle group and two participants in the conventional SLT group. The proportion of participants with a worsening of visual field mean deviation by ≥2.5 dB was 6.6% and 9.9% in the Eagle group vs. 12.6% and 15.7% in the conventional SLT group at 6 and 12 months, respectively. In the first six months, progression of cataracts was reported in three Eagle participants and one conventional SLT participant. Between 6 and 12 months, three Eagle and four conventional SLT participants had progression of cataracts and one conventional SLT participant developed a new cataract.
Secondary surgical interventions (SSIs) were reported in four Eagle participants (trabeculectomy [N=1], cataract surgery [N=2], and laser retinopexy [N=1] to repair a retinal tear) and three conventional SLT participants (cataract surgeries [N=2], IOL repositioning [N=1]). Table 3 and Table 4 present study eye ocular AEs within the first 6 months and between 6-12 months, respectively. Ocular adverse events in the study eye are shown stratified by energy level in Tables 7 and 8.
Anterior chamber (AC) cells and flare findings at each study visit for change from screening in are shown in Tables 5 and 6. Mild corneal haze was reported in one Eagle participant at Month 12. No moderate or severe corneal haze was reported in either group. At the 12-month assessment of 5-minute delayed corneal staining, 17% of the Eagle participants and 20% of the conventional SLT participants had staining in one quadrant. 5% of the Eagle participants and 4% of the conventional SLT participants had staining in two quadrants. No participants in either group had staining in three or more quadrants. Conjunctival staining scores at Month 12 were 2.11±3.01 in the Eagle group and 1.83±2.22 in the conventional SLT group.
14
Ocular Events | Eagle | SLT | |||
---|---|---|---|---|---|
N = 96 | N = 91 | ||||
# of Events | n (%) | # of Events | n (%) | ||
Serious Adverse Events | l | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 1 | 1 (1.1%) | |
Subluxation of intra-ocular lens | — | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 1 | 1 (1.1%) | |
Non-Serious Adverse Events | 44 | 34 (35.4%) | 26 | 20 (22.0%) | |
Subconjunctival hemorrhage, punctate | 20 | 20 (20.8%) | 1 | 1 (1.1%) | |
Foreign body sensation | 3 | 3 (3.1%) | 3 | 3 (3.3%) | |
Cataract progression | ર્ રે | 3 (3.1%) | 1 | 1 (1.1%) | |
Superficial punctate keratitis | 2 | 2 (2.1%) | 4 | 4 (4.4%) | |
Elevated IOP (IOP increase from baseline | 2 | 2 (2.1%) | 2 | 2 (2.2%) | |
> 10 mmHg) | |||||
Conjunctivitis | 2 | 2 (2.1%) | --- | - | |
Mild or moderate anterior chamber | 1 | 1 (1.0%) | 3 | 3 (3.3%) | |
inflammation | |||||
Transient blurred vision | ਹ | 1 (1.0%) | 2 | 2 (2.2%) | |
Corneal erosion | 1 | 1 (1.0%) | 1 | 1 (1.1%) | |
Eye discharge | 1 | 1 (1.0%) | 1 | 1 (1.1%) | |
Eye discomfort | 1 | 1 (1.0%) | 1 | 1 (1.1%) | |
Eye pain | 1 | 1 (1.0%) | 1 | 1 (1.1%) | |
Hordeolum externum | 1 | 1 (1.0%) | 1 | 1 (1.1%) | |
Blepharitis | 1 | 1 (1.0%) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -- | |
Eye itchiness | 1 | 1 (1.0%) | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
Periodical hyperlacrimation | । | 1 (1.0%) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
Retinal tear | 1 | 1 (1.0%) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
Subconjunctival hemorrhage, moderate | 1 | 1 (1.0%) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --- | |
Cystoid macular edema | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 1 | 1 (1.1%) | |
Elevated IOP (IOP increase from baseline | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --- | 1 | 1 (1.1%) | |
10 mmHg more than baseline. |
3 One Eagle participant was reported to have a cataract at the 6-month visit and subsequently underwent cataract surgery. However, this participant's cataract was pre-existing with severe opacity (3+) at the time of enrollment. A protocol deviation was reported for enrollment of this participant despite them having a pre-existing severe cataract.
15
Ocular Events | Eagle | SLT | ||||
---|---|---|---|---|---|---|
N = 96 | N = 91 | |||||
# of Events | n (%) | # of Events | n (%) | |||
Serious Adverse Events | 1 | 1 (1.0%) | -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
Acute optic neuropathy | 1 | 1 (1.0%) | -- | --- | ||
Non-Serious Adverse Events | 7 | 6 (6.3%) | 7 | 7 (7.7%) | ||
Cataract progression | 3 | 3 (3.1%) | 4 | 4 (4.4%) | ||
Conjunctivitis | । | 1 (1.0%) | -- | --- | ||
Diabetic retinopathy | ਹ | 1 (1.0%) | - | - | ||
Elevated IOP (IOP increase from baseline | 1 | 1 (1.0%) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |||
≥ 10 mmHg)2 | ||||||
Foreign body sensation | । | 1 (1.0%) | -- | - | ||
Cataract | -- | -- | 1 | 1 (1.1%) | ||
Cataract surgery | -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 1 | 1 (1.1%) | ||
Guttata | -- | -- | 1 | 1 (1.1%) | ||
Any adverse events | 8 | 7 (7.3%) | 7 | 7 (7.7%) |
Table 4: Study Eye Adverse Events from 6-12 Months (Safety Population)
The counts (n) are the number of participants reported with the corresponding events. % = n / N x 100%. Multiple events could be reported for the same participant.
¹ Miettinen-Nurminen method
2 Steroid-induced elevated IOP occurred in one Eagle participant and was due to use of nasal steroid. This participant had a similar event during the first 6 months.
16
| | Post
Procedure
n (%) | 1D
n (%) | 7D
n (%) | 1M
n (%) | 3M
n (%) | 6M
n (%) | 12M
n (%) |
|------------------------------------|---------------------------------|---------------------------------|-----------------------------|-----------------------------|-----------------------------|-----------------------------|-----------------------------|
| Eagle (96 Eyes) | | | | | | | |
| N | 96 | 95 | 94 | 94 | 92 | 91 | 88 |
| Increase by +3 | 3 (3.1%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Increase by +2 | 6 (6.3%) | 5 (5.3%) | 1 (1.1%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Increase by +1 | 16 (16.7%) | 3 (3.2%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Increase by +0.5 | 5 (5.2%) | 10 (10.5%) | 2 (2.1%) | 0 (0.0%) | 0 (0.0%) | 1 (1.1%) | 1 (1.1%) |
| No Change | 66 (68.8%) | 77 (81.1%) | 91 (95.8%) | 94 (100.0%) | 92 (100.0%) | 90 (97.8%) | 81 (92.0%) |
| Decrease by +0.5 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.1%) |
| Decrease by +1 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 5 (5.7%) |
| Decrease by +2 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Increase +0.5 or
more (95% CI)¹ | 30 (31.3%)
(22.2%,
41.5%) | 18 (18.9%)
(11.6%,
28.3%) | 3 (3.2%)
(0.7%,
9.0%) | 0 (0.0%)
(0.0%,
3.8%) | 0 (0.0%)
(0.0%,
3.9%) | 1 (1.1%)
(0.0%,
5.9%) | 1 (1.1%)
(0.0%,
6.2%) |
| Not Reported | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Total | 96 | 95 | 95 | 94 | 92 | 92 | 88 |
| SLT (91 Eyes) | | | | | | | |
| N | 89 | 90 | 91 | 89 | 87 | 86 | 81 |
| Increase by +3 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Increase by +2 | 1 (1.1%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Increase by +1 | 9 (9.9%) | 3 (3.3%) | 2 (2.2%) | 1 (1.1%) | 1 (1.1%) | 1 (1.2%) | 1 (1.2%) |
| Increase by +0.5 | 9 (9.9%) | 8 (8.8%) | 1 (1.1%) | 1 (1.1%) | 0 (0.0%) | 0 (0.0%) | 1 (1.2%) |
| No Change | 70 (76.9%) | 79 (86.8%) | 88 (96.7%) | 87 (97.8%) | 86 (98.9%) | 85 (98.8%) | 75 (91.5%) |
| Decrease by +0.5 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (2.4%) |
| Decrease by +1 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (2.4%) |
| Decrease by +2 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Increase +0.5 or
more (95% CI)¹ | 19 (20.9%)
(13.1%,
30.7%) | 11 (12.1%)
(6.2%,
20.6%) | 3 (3.3%)
(0.7%,
9.3%) | 2 (2.2%)
(0.3%,
7.9%) | 1 (1.1%)
(0.0%,
6.2%) | 1 (1.2%)
(0.0%,
6.3%) | 2 (2.4%)
(0.3%,
8.5%) |
| Not Reported | 2 | 1 | 0 | 0 | 0 | 0 | 1 |
| Total | 91 | 91 | 91 | 89 | 87 | 86 | 82 |
Table 5: Slit Lamp Examination – Change in Anterior Chamber Cells from Screening by Visit (Safety Population)
1 Binomial distribution
17
| | Post
Procedure
n (%) | 1D
n (%) | 7D
n (%) | 1M
n (%) | 3M
n (%) | 6M
n (%) | 12M
n (%) |
|------------------------------------|---------------------------------|--------------------------------|-----------------------------|-----------------------------|-----------------------------|-----------------------------|-----------------------------|
| Eagle (96 Eyes) | | | | | | | |
| N | 96 | 95 | 94 | 94 | 92 | 91 | 88 |
| Increase by +3 | 1 (1.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Increase by +2 | 2 (2.1%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Increase by +1 | 9 (9.4%) | 11 (11.6%) | 2 (2.1%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Increase by +0.5 | 8 (8.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.1%) | 1 (1.1%) |
| No Change | 76 (79.2%) | 84 (88.4%) | 92 (96.8%) | 94 (100.0%) | 92 (100.0%) | 90 (97.8%) | 82 (93.2%) |
| Decrease by +0.5 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (2.3%) |
| Decrease by +1 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 3 (3.4%) |
| Decrease by +2 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Increase +0.5 or
more (95% CI)¹ | 20 (20.8%)
(13.2%,
30.3%) | 11 (11.6%)
(5.9%,
19.8%) | 2 (2.1%)
(0.3%,
7.4%) | 0 (0.0%)
(0.0%,
3.8%) | 0 (0.0%)
(0.0%,
3.9%) | 1 (1.1%)
(0.0%,
5.9%) | 1 (1.1%)
(0.0%,
6.2%) |
| Not Reported | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Total | 96 | 95 | 95 | 94 | 92 | 92 | 88 |
| SLT (91 Eyes) | | | | | | | |
| N | 89 | 90 | 91 | 89 | 87 | 86 | 81 |
| Increase by +3 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Increase by +2 | 1 (1.1%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Increase by +1 | 8 (8.8%) | 2 (2.2%) | 1 (1.1%) | 1 (1.1%) | 1 (1.1%) | 1 (1.2%) | 1 (1.2%) |
| Increase by +0.5 | 6 (6.6%) | 5 (5.5%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| No Change | 74 (81.3%) | 82 (90.1%) | 89 (97.8%) | 87 (97.8%) | 85 (97.7%) | 84 (97.7%) | 75 (91.5%) |
| Decrease by +0.5 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.2%) |
| Decrease by +1 | 0 (0.0%) | 1 (1.1%) | 1 (1.1%) | 1 (1.1%) | 1 (1.1%) | 1 (1.2%) | 4 (4.9%) |
| Decrease by +2 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Increase +0.5 or
more (95% CI)¹ | 15 (16.5%)
(9.5%,
25.7%) | 7 (7.7%)
(3.1%,
15.2%) | 1 (1.1%)
(0.0%,
6.0%) | 1 (1.1%)
(0.0%,
6.1%) | 1 (1.1%)
(0.0%,
6.2%) | 1 (1.2%)
(0.0%,
6.3%) | 1 (1.2%)
(0.0%,
6.6%) |
| Not Reported | 2 | 1 | 0 | 0 | 0 | 0 | 1 |
| Total | 91 | 91 | 91 | 89 | 87 | 86 | 82 |
Table 6: Slit Lamp Examination – Change in Anterior Chamber Flare from Screening by Visit (Safety Population)
1 Binomial distribution
18
| Ocular Events | 1.1 mJ/shot
N = 4
n (%) | 1.2 mJ/shot
N = 2
n (%) | 1.3 mJ/shot
N = 1
n (%) | 1.4 mJ/shot
N = 4
n (%) | 1.5 mJ/shot
N = 7
n (%) | 1.6 mJ/shot
N = 9
n (%) | 1.7 mJ/shot
N = 39
n (%) | 1.8 mJ/shot
N = 26
n (%) | 1.9 mJ/shot
N = 4
n (%) | Total
N = 96
n (%) |
|---------------------------------------------------|-------------------------------|-------------------------------|-------------------------------|-------------------------------|-------------------------------|-------------------------------|--------------------------------|--------------------------------|-------------------------------|--------------------------|
| Non-Serious Adverse Events | — | — | 1 (100.0%) | 1 (25.0%) | 2 (28.6%) | 4 (44.4%) | 10 (25.6%) | 15 (57.7%) | 1 (25.0%) | 34 (35.4%) |
| Blepharitis | — | — | — | — | — | — | — | 1 (3.8%) | — | 1 (1.0%) |
| Cataract progression | — | — | — | — | — | 1 (11.1%) | — | 2 (7.7%) | — | 3 (3.1%) |
| Conjunctivitis | — | — | — | — | — | 1 (11.1%) | 1 (2.6%) | — | — | 2 (2.1%) |
| Corneal erosion | — | — | — | — | — | — | 1 (2.6%) | — | — | 1 (1.0%) |
| Elevated IOP | — | — | — | — | 1 (14.3%) | — | — | 1 (3.8%) | — | 2 (2.1%) |
| Eye discharge | — | — | — | — | — | — | 1 (2.6%) | — | — | 1 (1.0%) |
| Eye discomfort | — | — | — | — | — | — | — | 1 (3.8%) | — | 1 (1.0%) |
| Eye itchiness | — | — | — | — | — | — | — | 1 (3.8%) | — | 1 (1.0%) |
| Eye pain | — | — | — | — | — | — | — | 1 (3.8%) | — | 1 (1.0%) |
| Foreign body sensation | — | — | — | 1 (25.0%) | — | — | 1 (2.6%) | 1 (3.8%) | — | 3 (3.1%) |
| Hordeolum externum | — | — | — | — | — | — | — | — | 1 (25.0%) | 1 (1.0%) |
| Mild or moderate anterior chamber
inflammation | — | — | — | — | — | — | — | 1 (3.8%) | — | 1 (1.0%) |
| Periodical hyperlacrimation | — | — | — | — | — | — | 1 (2.6%) | — | — | 1 (1.0%) |
| Retinal tear | — | — | — | — | — | — | — | 1 (3.8%) | — | 1 (1.0%) |
| Subconjunctival hemorrhage,
moderate | — | — | — | — | — | 1 (11.1%) | — | — | — | 1 (1.0%) |
| Subconjunctival hemorrhage,
punctate | — | — | 1 (100.0%) | — | 2 (28.6%) | 1 (11.1%) | 7 (17.9%) | 9 (34.6%) | — | 20 (20.8%) |
| Superficial punctate keratitis | — | — | — | — | — | — | — | 2 (7.7%) | — | 2 (2.1%) |
| Transient blurred vision | — | — | — | 1 (25.0%) | — | — | — | — | — | 1 (1.0%) |
| Any adverse events | 0 Reports
from | 0 Reports
from | 1 Reports
from | 2 Reports
from | 3 Reports
from | 4 Reports
from | 12 Reports
from | 21 Reports
from | 1 Reports
from | 44 Reports
from |
| | 0 participants
0.0% | 0 participants
0.0% | 1 participant
100.0% | 1 participant
25.0% | 2 participants
28.6% | 4 participants
44.4% | 10 participants
25.6% | 15 participants
57.7% | 1 participant
25.0% | 34 participants
35.4% |
Table 7: Study Eye Adverse Events at ≤6 Months, Stratified by Energy Level (Eagle Group Only) (Safety Population)
The counts (n) are the number of participants reported with the corresponding events. % = n / N x 100%. Multiple events could be reported for the same participant.
19
Table 8: Study Eye Adverse Events at >6 Months, Stratified by Energy Level (Eagle Group Only) (Safety Population)
Ocular Events | 1.1 mJ/shot | 1.2 mJ/shot | 1.3 mJ/shot | 1.4 mJ/shot | 1.5 mJ/shot | 1.6 mJ/shot | 1.7 mJ/shot | 1.8 mJ/shot | 1.9 mJ/shot | Total |
---|---|---|---|---|---|---|---|---|---|---|
N = 4 | ||||||||||
n (%) | N = 2 | |||||||||
n (%) | N = 1 | |||||||||
n (%) | N = 4 | |||||||||
n (%) | N = 7 | |||||||||
n (%) | N = 9 | |||||||||
n (%) | N = 39 | |||||||||
n (%) | N = 26 | |||||||||
n (%) | N = 4 | |||||||||
n (%) | N = 96 | |||||||||
n (%) | ||||||||||
Serious Adverse Events | – | – | – | – | – | – | – | 1 (3.8%) | – | 1 (1.0%) |
Acute optic neuropathy | – | – | – | – | – | – | – | 1 (3.8%) | – | 1 (1.0%) |
Non-Serious Adverse Events | 1 (25.0%) | – | – | 1 (25.0%) | 1 (14.3%) | 1 (11.1%) | – | 1 (3.8%) | 1 (25.0%) | 6 (6.3%) |
Cataract progression | 1 (25.0%) | – | – | – | – | 1 (11.1%) | – | 1 (3.8%) | – | 3 (3.1%) |
Conjunctivitis | – | – | – | 1 (25.0%) | – | – | – | – | – | 1 (1.0%) |
Diabetic retinopathy | – | – | – | – | – | – | – | – | 1 (25.0%) | 1 (1.0%) |
Elevated IOP | – | – | – | – | 1 (14.3%) | – | – | – | – | 1 (1.0%) |
Foreign body sensation | – | – | – | 1 (25.0%) | – | – | – | – | – | 1 (1.0%) |
Any adverse events | 1 Reports | |||||||||
from | ||||||||||
1 participant | ||||||||||
25.0% | 0 Reports | |||||||||
from | ||||||||||
0 participants | ||||||||||
0.0% | 0 Reports | |||||||||
from | ||||||||||
0 participants | ||||||||||
0.0% | 2 Reports | |||||||||
from | ||||||||||
1 participant | ||||||||||
25.0% | 1 Reports | |||||||||
from | ||||||||||
1 participant | ||||||||||
14.3% | 1 Reports | |||||||||
from | ||||||||||
1 participant | ||||||||||
11.1% | 0 Reports | |||||||||
from | ||||||||||
0 participants | ||||||||||
0.0% | 2 Reports | |||||||||
from | ||||||||||
2 participants | ||||||||||
7.7% | 1 Reports | |||||||||
from | ||||||||||
1 participant | ||||||||||
25.0% | 8 Reports | |||||||||
from | ||||||||||
7 participants | ||||||||||
7.3% |
The counts (n) are the number of participants reported with the corresponding events. % = n / N x 100%.
Multiple events could be reported for the same participant.
20
IX. Conclusions
The Eagle device has the same intended use as the legally marketed predicate device identified in this premarket notification. The IFU statement differs from that of the predicate, but the differences do not change the intended use of the device. The technological characteristics of the Eagle device differ from those of the predicate device, but the differences do not raise new or different types of questions of safety or effectiveness. The results of the non-clinical performance testing demonstrate that the Eagle device functions as intended. The results of the clinical performance testing support an acceptable safety and effectiveness profile that supports a determination of substantial equivalence. The non-clinical and clinical performance testing demonstrate that the Eagle device is substantially equivalent to the predicate device.