(167 days)
No
The device description and performance studies focus on a manually operated mechanical device and clinical outcomes, with no mention of AI or ML components.
Yes
The device is indicated for canaloplasty and trabeculotomy to reduce intraocular pressure in adult patients with primary open-angle glaucoma, which is a therapeutic purpose.
No
This device is designed for surgical procedures (canaloplasty and trabeculotomy) to reduce intraocular pressure, not for diagnosing a condition. Its function involves physical intervention within the eye rather than collecting and analyzing data for diagnosis.
No
The device description clearly states it is a handheld, manually operated device with physical components like a stainless-steel cannula, polymeric microcatheter, and advancement wheels. It is a physical surgical instrument, not software.
Based on the provided information, the OMNI® Surgical System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to perform a surgical procedure (canaloplasty and trabeculotomy) to reduce intraocular pressure in patients with glaucoma. This is a therapeutic intervention performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is a surgical tool used to physically manipulate tissues within the eye. It is not designed to analyze biological samples or provide diagnostic information.
- Performance Studies: The performance studies described involve simulated use in cadaver eyes and a clinical study on live patients. These studies evaluate the device's ability to perform the surgical procedure and its clinical effectiveness in reducing IOP, not its ability to diagnose a condition or analyze a sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The OMNI® Surgical System does not fit this description. It is a surgical device used for treatment.
N/A
Intended Use / Indications for Use
The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
Product codes
MRH, HMZ
Device Description
The Sight Sciences OMNI Surgical System (with modified indication) is a handheld, manually operated device used by ophthalmologists to access, microcatheterize, and viscodilate Schlemm's canal ("canaloplasty") and to re-access Schlemm's canal and cut trabecular meshwork tissue ("trabeculotomy"). The OMNI Surgical System is provided sterile and disposed after single-patient use. The device is fabricated from biocompatible materials standard to the medical device industry. Each OMNI Surgical System device dispenses fluid on the principle of exchanging volumes much like a syringe and is designed to function with commercially available cohesive viscoelastic fluids (also known as ophthalmic viscosurgical device, or "OVD").
The OMNI Surgical System device includes a stainless-steel cannula, polymeric microcatheter, removable priming lock, internal reservoir and plunger tube, a Luer fitting for direct connection with an OVD cartridge to prime the internal reservoir, and two advancement wheels. A single advancement wheel is located on each side of the handle. This allows the OMNI Surgical System device to be used in either eye (OD or OS) and in either hand of the surgeon (left or right), by turning the device 180 degrees along its vertical axis. These wheels are used to advance and retract the microcatheter.
The stainless-steel cannula has a curved shape with a beveled tip for entry through the trabecular meshwork into Schlemm's canal. To perform the combined and sequential canaloplasty/trabeculotomy procedures, the canaloplasty is performed first, followed by trabeculotomy as explained in further detail below.
Performing Canaloplasty First: the microcatheter is advanced into Schlemm's canal up to 180 degrees (one hemisphere) by rotating the advancement wheel forward until the wheel stops (about 20mm). When the device is being used to deliver viscoelastic fluid, retraction of the microcatheter causes the plunger tube to advance into the viscoelastic fluid reservoir thereby automatically dispensing viscoelastic fluid along the length of Schlemm's canal and collector channels. The microcatheter can be advanced/retracted up to 20 mm per cycle by manually rotating the advancement wheel. The microcatheter can be fully advanced/retracted multiple times, however, viscoelastic fluid can only be dispensed during the first two advancement/retraction cycles in order to dispense viscoelastic fluid along each hemisphere of Schlemm's canal. Thus, the OMNI Surgical System device is designed to be used twice within Schlemm's canal to deliver a controlled volume of viscoelastic fluid along the first 180 degrees of the canal, followed by a second delivery of viscoelastic fluid along the other 180 degrees. The OMNI Surgical System delivers a total viscoelastic fluid volume of 11 microliters throughout Schlemm's canal (approximately 5.5 microliters for each of the first two advancement/retraction cycles).
Performing Trabeculotomy Second: the beveled tip of the curved stainless-steel cannula is repositioned into the same Schlemm's canal location after finishing canaloplasty. The polymeric microcatheter is re-advanced into Schlemm's canal up to 180 degrees (one hemisphere) by rotating the advancement wheel forward until the wheel stops (about 20 mm). With the microcatheter resting in the canal, the cannula is removed from the corneal incision and out of the eye causing the microcatheter to cut through the trabecular meshwork. This process can be repeated in the second Schlemm's hemisphere.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Schlemm's Canal and Trabecular Meshwork
Indicated Patient Age Range
adult patients
Intended User / Care Setting
ophthalmologists
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
Bench Testing:
Study Type: Simulated Use - Cadaver Eye Testing
Sample Size: 8 OMNI Surgical System devices in 4 human cadaver eyes
Key Results: The study demonstrated the OMNI Surgical System's ability to perform its indicated use, including viscodilation of Schlemm's canal followed by trabeculotomy. The surgeon was able to consistently access, microcatheterize, and viscodilate Schlemm's canal and re-access, microcatheterize, and cut trabecular meshwork in human cadaveric tissue. The device functioned as intended and met defined specifications.
Clinical Evidence:
Study Type: Retrospective, observational, multi-center, single-arm, consecutive case series study ("ROMEO")
Sample Size: 129 patients with a single qualifying eye
Data Source: Conducted at 11 sites throughout the U.S.
Key Results:
Effectiveness:
- Mean IOP reduction:
- +Cataract Group (baseline IOP >= 16 mmHg): From 19.5 ± 3.8 mmHg at baseline to 15.2 ± 3.0 mmHg at 12 months.
- Standalone Group (baseline IOP >= 16 mmHg): From 20.0 ± 3.6 mmHg at baseline to 15.3 ± 2.7 mmHg at 12 months.
- Number of Medications Required: Reduced from 1.8 ± 1.3 at baseline to 1.1 ± 1.2 at 12 months (all patients).
- Responder Analysis (>= 20% reduction in IOP at Month 12, no increase in medication, no secondary surgery):
- Standalone (Pre-op IOP > 18 mmHg): 58.3% (14/24)
- Standalone (All meeting Lewis criteria, Pre-Op IOP >=16 mmHg): 45.7% (16/35)
- +Cataract (BL > 18 mmHg): 62.5% (15/24)
- +Cataract (All meeting Lewis criteria, BL >=16 mmHg): 43.5% (20/46)
Safety:
- Adverse events were generally infrequent, mild, non-serious, transient in nature, resolved with or without treatment, and consistent with expectations.
- Most common adverse events: posterior capsular opacity, mild anterior chamber inflammation, cystoid macular edema, corneal edema, IOP increase >= 10 mmHg above baseline >30 days postoperative, and hyphema > 1 mm.
- No serious adverse events or serious device-related adverse events reported.
Secondary Surgical Interventions: 7.0% (9/129 eyes) required secondary surgical intervention to reduce IOP. This included SLT, glaucoma drainage device, trabeculectomy, and paracentesis.
Key Metrics
Effectiveness Results (Mean IOP ± SD):
- +Cataract (Baseline IOP >= 16 mmHg):
- Baseline: 19.5 ± 3.8 mmHg
- 1 month: 15.7 ± 4.0 mmHg
- 6 month: 15.1 ± 2.9 mmHg
- 12 month: 15.2 ± 3.0 mmHg
- Standalone (Baseline IOP >= 16 mmHg):
- Baseline: 20.0 ± 3.6 mmHg
- 1 month: 15.3 ± 4.4 mmHg
- 6 month: 15.6 ± 3.0 mmHg
- 12 month: 15.3 ± 2.7 mmHg
Number of Medications Required Over Time (ROMEO – All patients):
- Baseline: 1.8 ± 1.3
- 1 month: 1.3 ± 1.3
- 6 month: 1.1 ± 1.2
- 12 month: 1.1 ± 1.2
Proportion of Standalone Subjects with >= 20% Reduction in IOP at Month 12, no increase in medication, no secondary surgery:
- Pre-op IOP > 18 mmHg: 58.3% (14/24)
- Pre-op IOP =16 mmHg): 45.7%* (16/35)
Proportion of +Cataract Subjects with >= 20% Reduction in IOP at Month 12, no increase in medication, no secondary surgery:
- BL > 18 mmHg: 62.5% (15/24)
- BL =16 mmHg): 43.5%* (20/46)
Safety Results (Adverse Events %):
- Posterior capsule opacity: 14.7% (19/129)
- Mild anterior chamber inflammation: 10.9% (14/129)
- Cystoid macular edema: 5.4% (7/129)
- Corneal edema: 4.7% (6/129)
- IOP increase >= 10 mmHg above baseline >30 days postoperative: 4.7% (6/129)
- Hyphema > 1 mm: 3.9% (5/129)
- Worsening of visual field mean deviation >= 2 dB: 3.1% (4/129)
- BCVA loss of >= 2 lines Snellen at or after 3 months post-op: 2.3% (3/129)
- Cataract surgery complication: 1.6% (2/129)
- Choroidal effusion: 0.8% (1/129)
- Macular degeneration (dry): 0.8% (1/129)
- Epiretinal membrane peel: 0.8% (1/129)
- Ocular allergic reaction: 0.8% (1/129)
- Posterior vitreous detachment: 0.8% (1/129)
- Vitreous hemorrhage: 0.8% (1/129)
- Cyclodialysis: 0.8% (1/129)
- Lid edema: 0.8% (1/129)
- Late hypotony: 0.8% (1/129)
- Loss of light perception: 0%
- Chronic anterior iritis as defined in the FDA MIGS guidance: 0%
Secondary Surgical Interventions for IOP: 7.0% (9/129 eyes)
- +Cataract group: 4.9% (4/81)
- Standalone group: 10.4% (5/48)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
March 1, 2021
Sight Sciences, Inc. Edward Sinclair Vice President, Regulatory Affairs 4040 Campbell Ave, Suite 100 Menlo Park, California 94025
Re: K202678
Trade/Device Name: OMNI® Surgical System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRH, HMZ Dated: January 18, 2021 Received: January 21, 2021
Dear Edward Sinclair:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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,
LT Charles Chiang Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202678
Device Name OMNI® Surgical System
Indications for Use (Describe)
The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
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) |
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3
510(k) SUMMARY
Submitter Information
| 510(k) Owner: | Sight Sciences, Inc.
4040 Campbell Ave., Suite 100
Menlo Park, CA 94025
Tel: (877) 266-1144 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Edward J. Sinclair
Vice President, Regulatory Affairs
4040 Campbell Ave., Suite 100
Menlo Park, CA 94025
Tel: 650-218-9149 |
| Date Prepared: | March 1, 2021 |
Device Name and Classification
| Trade Name: | OMNI® Surgical System |
|---|---|
| Common Name: | Ophthalmic Infusion Pump |
| Classification Name: | Infusion Pump |
| Regulation Number: | 21 CFR 880.5725 |
| Device Classification: | Class II |
| Primary Product Code: | MRH |
| Secondary Product Code: | HMZ |
Primary Predicate Device
| Device Name: | OMNI® Surgical System |
|---|---|
| 510(k) Holder: | Sight Sciences, Inc. |
| 510(k) Number: | K173332 |
| Clearance Date: | December 21, 2017 |
Reference Device
| Device Name: | iScience Interventional Canaloplasty Microcatheter (iTrack™ Surgical System) | |
|---|---|---|
| 510(k) Holder: | Ellex iScience, Inc. | |
| 510(k) Number: | K080067 | |
| Clearance Date: | July 18, 2008 |
Intended Use
4
The OMNI® Surgical System is an ophthalmic surgical tool for the delivery of controlled amounts of viscoelastic fluid into the anterior segment and the cutting of trabecular meshwork when a trabeculotomy is indicated.
Indications for Use
The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
Device Description
The Sight Sciences OMNI Surgical System (with modified indication) is a handheld, manually operated device used by ophthalmologists to access, microcatheterize, and viscodilate Schlemm's canal ("canaloplasty") and to re-access Schlemm's canal and cut trabecular meshwork tissue ("trabeculotomy"). The OMNI Surgical System is provided sterile and disposed after single-patient use. The device is fabricated from biocompatible materials standard to the medical device industry. Each OMNI Surgical System device dispenses fluid on the principle of exchanging volumes much like a syringe and is designed to function with commercially available cohesive viscoelastic fluids (also known as ophthalmic viscosurgical device, or "OVD").
The OMNI Surgical System device includes a stainless-steel cannula, polymeric microcatheter, removable priming lock, internal reservoir and plunger tube, a Luer fitting for direct connection with an OVD cartridge to prime the internal reservoir, and two advancement wheels. A single advancement wheel is located on each side of the handle. This allows the OMNI Surgical System device to be used in either eye (OD or OS) and in either hand of the surgeon (left or right), by turning the device 180 degrees along its vertical axis. These wheels are used to advance and retract the microcatheter.
The stainless-steel cannula has a curved shape with a beveled tip for entry through the trabecular meshwork into Schlemm's canal. To perform the combined and sequential canaloplasty/trabeculotomy procedures, the canaloplasty is performed first, followed by trabeculotomy as explained in further detail below.
Performing Canaloplasty First: the microcatheter is advanced into Schlemm's canal up to 180 degrees (one hemisphere) by rotating the advancement wheel forward until the wheel stops (about 20mm). When the device is being used to deliver viscoelastic fluid, retraction of the microcatheter causes the plunger tube to advance into the viscoelastic fluid reservoir thereby automatically dispensing viscoelastic fluid along the length of Schlemm's canal and collector channels. The microcatheter can be advanced/retracted up to 20 mm per cycle by manually rotating the advancement wheel. The microcatheter can be fully advanced/retracted multiple times, however, viscoelastic fluid can only be dispensed during the first two advancement/retraction cycles in order to dispense viscoelastic fluid along each hemisphere of
5
Schlemm's canal. Thus, the OMNI Surgical System device is designed to be used twice within Schlemm's canal to deliver a controlled volume of viscoelastic fluid along the first 180 degrees of the canal, followed by a second delivery of viscoelastic fluid along the other 180 degrees. The OMNI Surgical System delivers a total viscoelastic fluid volume of 11 microliters throughout Schlemm's canal (approximately 5.5 microliters for each of the first two advancement/retraction cycles).
Performing Trabeculotomy Second: the beveled tip of the curved stainless-steel cannula is repositioned into the same Schlemm's canal location after finishing canaloplasty. The polymeric microcatheter is re-advanced into Schlemm's canal up to 180 degrees (one hemisphere) by rotating the advancement wheel forward until the wheel stops (about 20 mm). With the microcatheter resting in the canal, the cannula is removed from the corneal incision and out of the eye causing the microcatheter to cut through the trabecular meshwork. This process can be repeated in the second Schlemm's hemisphere.
Comparison of Technological Characteristics with the Predicate
The primary predicate in this 510(k) submission is the OMNI Surgical System described in K173332 and K201953, based on substantial equivalence to the Ellex iScience Interventional Canaloplasty Microcatheter ("iTrack Surgical System") cleared in K080067. The same iTrack Surgical System device (K080067) is also used as a reference device in this 510(k) submission.
The Sight Sciences OMNI Surgical System subject device complies with the same product design requirements and applicable standards as the predicate OMNI Surgical System and shares the identical principle of operation, intended use, and key technological characteristics.
Additionally, the technical features of the subject OMNI Surgical System are similar, but not identical to the commercially available Ellex iTrack Surgical System reference device. The different technological characteristics do not raise different questions of safety and effectiveness. The subject OMNI Surgical System with modified indications and the Ellex iTrack device are both manually operated devices that utilize a microcatheter to access Schlemm's canal and deliver viscoelastic fluid. Fluid is dispensed from each system on the principle of exchanging volumes much like a syringe. The iTrack device serves as a reference device to support the scientific methods to assess the safety and effectiveness of the device to lower IOP in glaucoma patients. The iTrack device is used in the same anatomical location as the OMNI device and is intended for use to perform canaloplasty to lower IOP in glaucoma patients, which is similar to the intended use proposed for the OMNI device.
A comparison of the attributes of the subject OMNI Surgical System with the predicate OMNI Surgical System and the Ellex iTrack Surgical System (iScience Interventional Canaloplasty Microcatheter) reference device are listed in Table 1 below.
Table 1. Technological Characteristics Comparison
6
| Characteristic | OMNI Surgical System | OMNI Surgical System
(K173332) | Ellex iTrack Surgical System
(iScience Interventional
Canaloplasty Microcatheter
K080067)
REFERENCE DEVICE |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | SUBJECT DEVICE
Ophthalmic surgical tool for
delivery of controlled amounts
of viscoelastic fluid into the
anterior segment and used to
cut trabecular meshwork
when a trabeculotomy is
indicated | PRIMARY PREDICATE DEVICE
Ophthalmic surgical tool for
delivery of controlled amounts
of viscoelastic fluid into the
anterior segment and used to
cut trabecular meshwork
when a trabeculotomy is
indicated | Delivery of controlled amounts
of viscoelastic fluid during
ophthalmic surgery |
| Indications for
Use | The OMNI® Surgical System is
indicated for canaloplasty
(micro-catheterization and
transluminal viscodilation of
Schlemm's canal) followed by
trabeculotomy (cutting of
trabecular meshwork) to
reduce intraocular pressure in
adult patients with open-angle
glaucoma | The OMNI® Surgical System is
a manually operated device
for delivery of small amounts
of viscoelastic fluid, for
example Healon® or Healon
GV® from Abbott Medical
Optics, Amvisc® from Bausch
& Lomb, or PROVISC® from
Alcon, during ophthalmic
surgery. It is also indicated to
cut trabecular meshwork
tissue during trabeculotomy
procedures | The iScience Interventional
Canaloplasty Microcatheter is
indicated for fluid infusion and
aspiration during surgery. The
iScience Interventional
Canaloplasty Microcatheter is
indicated for catheterization
and viscodilation of Schlemm's
canal to reduce intraocular
pressure in adult patients with
open angle glaucoma |
| Regulation | 880.5725 (Infusion Pump) | 880.5725 (Infusion Pump) | 886.4350 (Manual ophthalmic
surgical instrument)
876.1500 (Endoscope and
accessories) |
| Device Class | Class II | Class II | Class II |
| Product Code | Primary: MRH (Ophthalmic
Infusion Pump)
Secondary: HMZ
(Trabeculotome) | Primary: MRH (Ophthalmic
Infusion Pump)
Secondary: HMZ
(Trabeculotome) | Primary: MPA (Endoscope)
Secondary: HMX (Manual
Ophthalmic Surgical
Instrument) |
| Prescription
Status | Prescription use only | Prescription use only | Prescription use only |
| Target
Anatomy | Schlemm's Canal and
Trabecular Meshwork | Schlemm's Canal and
Trabecular Meshwork | Schlemm's Canal and
Trabecular Meshwork |
| Operating
Principle | Manual | Manual | • Manual (microcatheter)
• Powered (endoilluminator) |
| Design/
Mechanism of
Action | • Stainless-steel cannula has
sharp tip that can be used to
pierce the trabecular
meshwork and provide access
into Schlemm's canal. Minor
dimensional changes to
cannula tip height and radius
• Flexible microcatheter with
rounded, atraumatic tip for
dispensing of viscoelastic
• Microcatheter is blue color to
facilitate its visibility in
Schlemm's canal as it is
advanced/retracted through
the cannula
• Microcatheter allows access
to 360° of Schlemm's canal in
two 180° segments
• Proximal handle changed to
ovoid shape with elastomeric
material for added grip
• Proximal handle allows
ambidextrous use in either
patient eye
• Internal viscoelastic reservoir
and plunger tube with
dimensional changes to allow
dispensing of viscoelastic
• Ovoid handle shape allows
advancement wheels (finger
wheels) to be reduced to two
for advancing and retracting
microcatheter up to 20mm
using a rack and pinion
mechanism
• Tactile and audible clicks
indicate precise advancement
• Viscoelastic dispensed during
retraction of first two cycles
after priming with viscoelastic
fluid
• Flexible microcatheter
introduced into Schlemm's
canal and pulled through to
cut trabecular meshwork
• Priming Lock moved to
accommodate new Luer
fitting and prevents accidental
dispensing during viscoelastic
priming
• Changes were made to the | • Stainless-steel cannula has
sharp tip that can be used to
pierce the trabecular
meshwork and provide access
into Schlemm's canal
• Flexible microcatheter with
rounded, atraumatic tip for
dispensing of viscoelastic
• Microcatheter is blue color to
facilitate its visibility in
Schlemm's canal as it is
advanced/retracted through
the cannula
• Microcatheter allows access
to 360° of Schlemm's canal in
two 180° segments
• Proximal handle has
rectangular shape
• Proximal handle allows
ambidextrous use in either
patient eye
• Internal viscoelastic reservoir
and plunger tube to allow
dispensing of viscoelastic
• Four advancement wheels
(finger wheels) for advancing
and retracting microcatheter
up to 20mm using a rack and
pinion mechanism
• Tactile and audible clicks
indicate precise advancement
• Viscoelastic dispensed during
retraction of first two cycles
after priming with viscoelastic
fluid
• Flexible microcatheter
introduced into Schlemm's
canal and pulled through to
cut trabecular meshwork
• Priming Lock Pin prevents
accidental dispensing during
viscoelastic priming | • Flexible microcatheter for
dispensation of viscoelastic
fluid
• Microcatheter has a round,
bolus, atraumatic tip
• Microcatheter allows access
to 360° of Schlemm's canal in
one pass
• Microcatheter has internal
catheter support wire
• Tactile and audible clicks
indicate precise advancement
• Viscoelastic manually
dispensed during retraction
microcatheter
• No cannula – a 27 ga needle
(not included) is used to
pierce the trabecular
meshwork
• Centrally located hub
• Microcatheter attaches at
proximal end to Ellex
ViscoInjector
• Viscoelastic cartridge placed
into ViscoInjector
• Microcatheter manually
advanced/retracted by
surgeon using microsurgical
forceps (not included)
• Knob on ViscoInjector turned
to dispense viscoelastic
during microcatheter
retraction
• Microcatheter is clear and
transparent but incorporates
a red light at its tip to
facilitate visibility in
Schlemm's canal |
| Characteristic | OMNI Surgical System
SUBJECT DEVICE | OMNI Surgical System
(K173332)
PRIMARY PREDICATE DEVICE | Ellex iTrack Surgical System
(iScience Interventional
Canaloplasty Microcatheter
K080067)
REFERENCE DEVICE |
| | reservoir, Luer fitting and a
new bonding adhesive was
used | | |
| Dispensing
Control | After priming, viscoelastic
dispensing control occurs
through manual rotation of
either advancement wheel at
the distal end of the device.
Synchronization of the two
wheels was reversed for ease
of use | After priming, viscoelastic
dispensing control occurs
through manual rotation of
either of the advancement
wheels at the distal end of the
device | Rotational action via a knob on
the ViscoInjector to dispense
viscoelastic fluid |
| Dispensing
Mechanism | Internal reservoir with plunger
tube (syringe-like volume
exchange). Three internal
component dimensions
modified to reduce air bubble
formation during priming | Internal reservoir with plunger
tube (syringe-like volume
exchange). | OVD cartridge attaches to the
device inside the Ellex
ViscoInjector (syringe-like
volume exchange) |
| Viscoelastic
Fluid (OVD)
and Priming
Method | Cohesive viscoelastic fluid
(OVD or ophthalmic
viscosurgical device) is supplied
separately. Viscoelastic loaded
into device (primed) prior to
use by attaching OVD cartridge
directly to a Luer fitting that
replaces the cap on proximal
end of OMNI device handle for
ease of priming | Cohesive viscoelastic fluid
(OVD or ophthalmic
viscosurgical device) is supplied
separately. Viscoelastic loaded
into device (primed) prior to
use by attaching OVD cartridge
to a supplied Nozzle that is
inserted into a on proximal end
of OMNI device handle | Cohesive viscoelastic fluid
(OVD or ophthalmic
viscosurgical device) is supplied
separately. OVD cartridge
attaches to the device inside
the Ellex ViscoInjector |
| OVD Volume
Dispensed | 11 μL | 9 μL | Not stated |
| Materials | Medical grade materials,
including ABS, polycarbonate,
stainless steel, silicone,
parylene coating,
cyanoacrylate, acrylated
urethane, polyimide | Medical grade materials,
including ABS, polycarbonate,
stainless steel, silicone,
parylene coating,
cyanoacrylate, acrylated
urethane, polyimide | Microcatheter - polyimide
tubing and an outer sheath of
polyethylene terephthalate
(PET) shrink tubing, with a
lubricious coating |
| User Interface | Handheld | Handheld | Handheld |
| Microcatheter
Shaft Outer
Diameter | 200 microns | 200 microns | 200 microns |
| Microcatheter
Tip Outer
Diameter Range | 0.0090 to 0.0110 inches | 0.0095 to 0.0110 inches | 0.0098 inches |
| Sterile and
Single Use | Provided sterile. Single patient
use | Provided sterile. Single patient
use | Provided sterile. Single
patient use |
| Characteristic | OMNI Surgical System | OMNI Surgical System
(K173332) | Ellex iTrack Surgical System
(iScience Interventional
Canaloplasty Microcatheter
K080067) |
| | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE |
| Sterilization
Method | Gamma radiation | Gamma radiation | Gamma radiation |
| | Sterility
Assurance Level | 10-6 | 10-6 |
| Packaging | | Thermoformed plastic tray
with heat-sealed Tyvek lid | Tyvek pouch with a polymer
tray card |
| | Shelf Life | 13 Months | 6 Months |
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Risk Analysis
The risk management process at Sight Sciences complies with EN ISO 14971:2012 "Medical devices -- Application of risk management to medical devices." As required by this standard, risk analyses are conducted according to defined procedures, using experienced, qualified personnel from multiple functions throughout the organization with prior experience in risk assessment.
Risk analysis activities were first documented in a Risk Management Plan. This plan specified the risk management activities to be conducted based on labeling changes to the cleared OMNI Surgical System. The following activities were completed:
- The Clinical Hazards for the OMNI Surgical System were assessed by qualified personnel with respect to the proposed changes in indications for use. The result of this analysis indicated that no new hazards were identified.
- . In accordance with the Plan, all Failure Modes Effect Analyses (FMEA) were assessed by the qualified team of personnel. This included a review of the design FMEA, process FMEA and Use FMEA. In order to evaluate the hazards related to the proposed changes to indications for use, it was determined that design control activities, including bench performance testing and clinical performance testing, were required to verify that potential harm and effects resulting from the previously identified hazards did not result in any new failure modes, causes or effects and did not change the severity and occurrence rankings.
- Design control verification activities resulting from assessment of the FMEA's included nonclinical bench performance testing according to a written protocol with appropriate sample sizes and pre-determined acceptance criteria. Clinical performance testing was performed according to a written protocol.
Based on the risk management documentation and supported by successful non-clinical bench performance testing and clinical performance testing, all identified clinical hazards remained mitigated to an acceptable level of residual risk. The review of the design, process and use FMEA's determined that no changes to the risk management file were required in order to
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implement the changes to the indications for use. Taking into account the modified indications of the OMNI Surgical System, the potential benefits to patients outweigh the low residual risk.
Performance Data
A. Bench Testing
Design verification was already established and did not need to be repeated. Based on the risk analysis, bench simulated use testing and clinical performance testing were determined to be needed. Simulated use testing in human cadaver eyes was performed using the OMNI Surgical System. The results of this nonclinical testing demonstrate that the OMNI Surgical System meets the defined specifications and functioned as intended.
Simulated Use - Cadaver Eye Testing
The changes to the indications for use were supported by simulated use testing in human cadaver eyes. Cadaver eyes were used to validate the OMNI Surgical System's ability to perform its indicated use, including viscodilation of Schlemm's canal followed by trabeculotomy. The study was performed by an ophthalmologist along with a physician assistant. A total of eight OMNI Surgical System devices were tested in four cadaver eyes. Following the Instructions For Use (with the modified indications) the surgeon was able to consistently access, microcatheterize, and viscodilate Schlemm's canal ("canaloplasty") and re-access, microcatheterize, and cut trabecular meshwork ("trabeculotomy") in human cadaveric tissue.
Conclusions of Bench Performance Testing
The human eye performance testing results demonstrate the ability of the surgeon's assistant to prepare the OMNI Surgical System device, and the ophthalmic surgeon to (a) access Schlemm's canal, (b) navigate Schlemm's canal with the microcatheter, (c) deliver viscoelastic fluid into Schlemm's canal upon retraction of the microcatheter from the canal, and (d) regain access to Schlemm's canal and perform a trabeculotomy.
B. Clinical Evidence Supporting Substantial Equivalence
A retrospective, observational, multi-center, single-arm, consecutive case series study ("ROMEO") was conducted at 11 sites throughout the U.S. where surgeons used the OMNI Surgical System for the microcatheterization and viscodilation of Schlemm's canal ("canaloplasty") followed by trabeculotomy as a standalone procedure or in combination with cataract extraction. Results from this study were compared with a literature control.1 In this study, a prior iteration of the OMNI device was used. Minor system technological differences between the device used in this study (the predicate device K173332) and the
4 Lewis RA, von Wolff K, Tetz M, Kearney JR, Shingleton B, Samuelson TW. Canaloplasty: circumferential viscodilation and tensioning of Schlemm's canal using a flexible microcatheter for the treatment of open-angle glaucoma in adults: interim clinical study analysis. J Cataract Refract Surg. 2007 Jul;33(7):1217-26.
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subject device are described in Table 1. Each site had collected data on intraocular pressure (IOP), the use of ocular hypotensive medications, and safety outcomes in adult patients with open angle glaucoma. Endpoint stratification was performed by type of procedure; combined with cataract extraction, or stand-alone. A total of 129 patients with a single qualifying eye were treated with the OMNI Surgical System and followed post-operatively at months 1, 6 and 12. There were 81 (63%) procedures combined with cataract surgery, and 48 (37%) standalone procedures.
Effectiveness Results
Descriptive statistics were assessed over time for the subgroup of patients who met the entry criteria of the literature control (i.e. a baseline IOP ≥ 16 mmHg).
| Table 2. OMNI +Cataract and Standalone Results (Subgroup using the Lewis 2007
| eligibility, baseline IOP ≥ 16 mmHg) | ||||||
|---|---|---|---|---|---|---|
| +Cataract | Standalone | |||||
| Visit | Mean IOP ± SD | Range | n | Mean IOP ± SD | Range | n |
| Baseline | 19.5 ± 3.8 | 16.0-33.0 | 45 | 20.0 ± 3.6 | 16.0-31.0 | 38 |
| 1 month | 15.7 ± 4.0 | 6.7-25.0 | 44 | 15.3 ± 4.4 | 8.0-27.0 | 36 |
| 6 month | 15.1 ± 2.9 | 10.0-22.0 | 40 | 15.6 ± 3.0 | 9.0-20.0 | 37 |
| 12 month | 15.2 ± 3.0 | 10.0-22.0 | 42 | 15.3 ± 2.7 | 7.0-19.5 | 36 |
| Table 3. Number of Medications Required Over Time (ROMEO – All patients) | |||||
|---|---|---|---|---|---|
| Visit | Mean ± SD | Range | n | ||
| Baseline | 1.8 ± 1.3 | 0-4 | 129 | ||
| 1 month | 1.3 ± 1.3 | 0-5 | 125 | ||
| 6 month | 1.1 ± 1.2 | 0-5 | 115 | ||
| 12 month | 1.1 ± 1.2 | 0-5 | 120 |
A post-hoc responder analysis was also performed to assess the proportion of patients who experienced a ≥ 20% reduction in IOP at Month 12, no increase in medication, no secondary surgery. Refer to Table 4 for results in patients who had OMNI performed as a Standalone procedure and Table 5 for results in patients who had OMNI performed in conjunction with cataract surgery.
| Table 4. Proportion of Standalone Subjects with ≥ 20% Reduction in IOP at Month 12, no
| increase in medication, no secondary surgery | ||||
|---|---|---|---|---|
| Group | Proportion |
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| Pre-op IOP > 18 mmHg | 14/24 | 58.3% |
|---|---|---|
| Pre-op IOP ≤ 18 mmHg | 4/24 | 16.7%* |
| All Standalone | 18/48 | 37.5%* |
| All meeting Lewis criteria (Pre-Op IOP ≥16 mmHg) | 16/35 | 45.7%* |
- 20% responder analysis is not appropriate for patients with baseline IOP ≤ 18 mmHg because baseline IOP was controlled.
Table 5. Proportion of +Cataract Subjects with ≥ 20% Reduction in IOP at Month 12, no increase in medication, no secondary surgery
| Group | n | Proportion |
|---|---|---|
| BL > 18 mmHg | 15/24 | 62.5% |
| BL ≤ 18 mmHg | 10/57 | 17.5%* |
| All Combined with cataract | 25/81 | 30.9%* |
| All meeting Lewis criteria (BL ≥16 mmHg) | 20/46 | 43.5%* |
- 20% responder analysis is not appropriate for patients with baseline IOP ≤ 18 mmHg because baseline IOP was controlled.
Safety Results
All 129 patients treated with the OMNI Surgical system were included in the safety analyses. Adverse events were generally infrequent, mild, non-serious, transient in nature, resolved with or without treatment and were consistent with those expected in the target population. The most common adverse events reported prior to and including the 12month visit were: posterior capsular opacity, mild anterior chamber inflammation, secondary surgical intervention for IOP control, cystoid macular edema, IOP spike, and hyphema, as listed in Table 6. There were no serious adverse events or serious device-related adverse events reported in the study.
| Adverse Event | Standalone
(n=48)
n (%) | +Cataract (n=81)
n (%) | ALL Adverse
Events (n=129)
n (%) |
|-----------------------------------------------------------------|-------------------------------|---------------------------|----------------------------------------|
| Posterior capsule opacity | 5 (10.4) | 14 (17.3) | 19 (14.7) |
| Mild anterior chamber inflammation | 6 (12.5) | 8 (9.9) | 14 (10.9) |
| Cystoid macular edema | 3 (6.3) | 4 (4.9) | 7 (5.4) |
| Corneal edema | 2 (4.2)1 | 4 (4.9)2 | 6 (4.7) |
| IOP increase ≥ 10 mmHg above baseline
30 days postoperative | 3 (6.3) | 3 (3.7) | 6 (4.7) |
| Hyphema > 1 mm | 2 (4.2) | 3 (3.7) | 5 (3.9) |
Table 6. Adverse Events, by Procedure Sub-Group
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| Adverse Event | Standalone
(n=48)
n (%) | +Cataract (n=81)
n (%) | ALL Adverse
Events (n=129)
n (%) |
|----------------------------------------------------------------|-------------------------------|---------------------------|----------------------------------------|
| Worsening of visual field mean deviation
≥ 2 dB | 3 (6.3) | 1 (1.2) | 4 (3.1) |
| BCVA loss of ≥ 2 lines Snellen at or after 3
months post-op | 2 (4.2) | 1 (1.2) | 3 (2.3) |
| Cataract surgery complication | 1 (2.1)3 | 1 (1.2)4 | 2 (1.6) |
| Choroidal effusion | 0 | 1 (1.2) | 1 (0.8) |
| Macular degeneration (dry) | 1 (2.1) | 0 | 1 (0.8) |
| Epiretinal membrane peel | 1 (2.1) | 0 | 1 (0.8) |
| Ocular allergic reaction | 0 | 1 (1.2) | 1 (0.8) |
| Posterior vitreous detachment | 0 | 1 (1.2) | 1 (0.8) |
| Vitreous hemorrhage | 1 (2.1)5 | 0 | 1 (0.8) |
| Cyclodialysis | 0 | 1 (1.2) | 1 (0.8) |
| Lid edema | 1 (2.1) | 0 | 1 (0.8) |
| Late hypotony | 0 | 1 (1.2)6 | 1 (0.8) |
| Loss of light perception | 0 | 0 | 0 |
| Chronic anterior iritis as defined in the
FDA MIGS guidance | 0 | 0 | 0 |
| TOTAL | 31 | 43 | 74 |
1 One subject developed corneal edema at 4-6 months post-procedure which was noted to have resolved one year later.
- 2 Pre-existing Fuch's dystrophy in one subject which worsened required a DSAEK.
- 3 AE was an IOL dislocation from prior cataract surgery.
- 4 AE was lens fragment.
- 5 Vitreous hemorrhage verbatim description was "peripheral retinal hemorrhage" and resolved without treatment in 32 days by the Investigator.
- 6 One subject underwent post-surgical anterior chamber reformation with Healon viscoelastic fluid for a shallow chamber with failed laser cycloplexy for a related cyclodialysis cleft; multiple paracentesis was performed to remove viscoelastic causing an IOP spike and subsequent surgical cycloplexy to repair the cleft. Small choroidal effusions resolved with closure of the cleft.
Secondary Surgical Interventions
There were 9/129 eyes (7.0%) required a secondary surgical intervention to reduce IOP in the medical judgment of the Investigator. There were 4/81 secondary surgical interventions in the +cataract group (4.9%) and 5/48 in the standalone group (10.4%). The reinterventions were SLT (n=3/9, 33%), glaucoma drainage device (tube or valve) (n=3/9, 33%), trabeculectomy including Express device (n=2/9, 22%), and paracentesis (n=1/9, 11%).
In addition to secondary surgical intervention for IOP, two subjects underwent additional interventions in the follow-up period, one in the standalone OMNI group (n=1/48, 2.1%)
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and one in combined Omni with cataract extraction group (n=1/81, 1.2%). The subject in the standalone OMNI group had pre-existing Fuch's dystrophy and experienced a worsening requiring a Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) procedure which resolved the corneal edema. The second subject who underwent a combined cataract extraction and OMNI procedure was noted to have a shallow, but not a flat chamber. Small choroidal effusions were noted as well as a cyclodialysis cleft which was not notable on exam due to the shallow chamber. Chamber reformation using Healon was performed , partially for therapeutic reasons but mostly to facilitate view of the angle. This allowed gonioscopic visualization of the angle which revealed the location of the cleft and laser cycloplexy was attempted to close the cleft. An IOP spike ≥ 10 mmHg above baseline was secondary to the Healon injection and paracentesis were performed to remove viscoelastic material from the eye. When laser cycloplexy failed to close the cleft, the surgeon performed a surgical cycloplexy. Small choroidal effusions resolved with closure of the cleft.
Clinical Study Conclusions
The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is substantially equivalent to the legally marketed OMNI Surgical System.
The clinical performance data collected in the ROMEO study for the OMNI Surgical System suggest clinically significant IOP reduction in both the cataract and standalone arms for up to 12 months for the intended population of adult patients with primary open-angle glaucoma.
Conclusions
The Sight Sciences OMNI Surgical System subject device complies with the same product design requirements and applicable standards as the predicate OMNI Surgical System and shares the identical principle of operation, intended use, and key technological characteristics. The indications for use differ from that of the predicate OMNI Surgical System, however, the differences do not alter the intended use and are supported by bench simulated use and clinical performance data that demonstrate the ability of the OMNI Surgical System to access Schlemm's canal, navigate the canal with the microcatheter, perform canaloplasty by delivering commercially available viscoelastic fluid upon retraction of the microcatheter from the canal, and regain access to Schlemm's canal with the microcatheter to perform a trabeculotomy.
The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to the legally marketed OMNI Surgical System.
The clinical performance data collected in the ROMEO study for the OMNI Surgical System suggest clinically significant IOP reduction in both the cataract and standalone arms for up to 12 months for the intended population of adult patients with primary open-angle glaucoma.
The OMNI Surgical System is substantially equivalent to the legally-marketed OMNI Surgical System predicate device cleared under 510(k) K173332.
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