(30 days)
No
The device description focuses on manual operation and mechanical components, with no mention of AI/ML or related concepts like algorithms, data processing, or learning.
Yes.
The device's intended use is to perform canaloplasty and trabeculotomy to reduce intraocular pressure in adult patients with primary open-angle glaucoma, directly treating a medical condition.
No
The device description and intended use clearly state that the OMNI Surgical System is a handheld, manually operated device used for surgical procedures (canaloplasty and trabeculotomy) to treat primary open-angle glaucoma by reducing intraocular pressure. It is not described as diagnosing a condition.
No
The device description clearly details a physical, handheld, manually operated surgical instrument with various hardware components (cannula, microcatheter, wheels, etc.) used for a surgical procedure. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce intraocular pressure in adult patients with primary open-angle glaucoma through surgical procedures (canaloplasty and trabeculotomy). This is a therapeutic intervention performed directly on the patient's eye.
- Device Description: The device is a surgical tool used by ophthalmologists to physically manipulate structures within the eye. It is not designed to analyze samples (like blood, urine, or tissue) outside of the body to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or functions related to in vitro analysis, such as reagents, sample collection, or measurement of biological markers.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a surgical instrument 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 the trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
Product codes (comma separated list FDA assigned to the subject device)
MRH, HMZ
Device Description
The Sight Sciences OMNI Surgical System 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 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 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. The stainless-steel cannula has a curved shape with a beveled tip for entry through the trabecular meshwork into Schlemm's canal. A single advancement wheel is located on each side of the handle. This allows the OMNI 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. 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 modified OMNI Surgical System (subject device) delivers a total viscoelastic fluid volume of 21 microliters throughout Schlemm's canal (approximately 10.5 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.
The modified OMNI Surgical System (catalog number 1-106) has the identical indications for use as the current OMNI Surgical System and similar design; the modified OMNI has the identical design as the OMNI PLUS Surgical System reference device which includes the ability to dispense a nominal volume of 21 microliters of viscoelastic fluid.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data - Bench Testing
The verification and validation activities were previously performed for the OMNI PLUS Surgical System reference device (cleared in K201953 on August 11, 2020) which is physically identical to the modified OMNI Surgical System (catalog # 1-106) and did not need to be repeated for this OMNI Surgical System (catalog number 1-106) device. The non-clinical bench testing of the OMNI PLUS device included design verification and functional product testing, sterilization, packaging and shelf-life testing, biocompatibility testing, bacterial endotoxin testing and simulated use (usability) testing in a bench model.
Additionally, the shelf life was extended to up to 37 months and testing was conducted by subjecting devices to worst-case radiation dosage exposure and simulated aging in a controlled environment. Subsequently, the devices underwent visual inspection , sterile barrier packaging testing, and functional performance testing.
Results of the nonclinical testing are directly applicable to the modified OMNI Surgical System and demonstrate that the modified OMNI Surgical System meets the defined specifications and functions as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 25, 2023
Sight Sciences, Inc. Ranjani Madhavan Senior Regulatory Affairs Specialist 4040 Campbell Ave.. Suite 100 Menlo Park, California 94025
Re: K232214
Trade/Device Name: OMNI Surgical System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRH Dated: July 25, 2023 Received: July 26, 2023
Dear Ranjani Madhavan:
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
1
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 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 (OS) 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,
Claudine H. Krawczyk -S
Claudine Krawczyk Acting 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
2
Indications for Use
510(k) Number (if known) K232214
Device Name OMNI Surgical System
Indications for Use (Describe)
The OMN® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of the 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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Image /page/3/Picture/1 description: The image contains the logo for Sight Sciences. The logo consists of a stylized blue symbol on the left, resembling three curved lines stacked on top of each other. To the right of the symbol is the company name, "SIGHT," in bold, followed by "SCIENCES" in a smaller font size directly below it. The overall design is clean and professional, suggesting a company in the science or technology sector.
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: | Ranjani Madhavan
Senior Regulatory Affairs specialist
4040 Campbell Ave., Suite 100
Menlo Park, CA 94025
Tel: 818-585-1124 |
| Date Prepared: | August 25, 2023 |
| Device Name and Classification | |
| Trade Name:
Common Name:
Classification Name:
Regulation Number:
Device Classification:
Primary Product Code:
Secondary Product Code: | OMNI® Surgical System
Ophthalmic Infusion Pump
Infusion Pump
21 CFR 880.5725
Class II
MRH
HMZ |
| Predicate Device | |
| Device Name:
510(k) Holder:
510(k) Number:
Clearance Date: | OMNI® Surgical System
Sight Sciences, Inc.
K202678
March 1, 2021 |
| Reference Device | |
| Device Name
510(k) Holder
510(k) Number
Clearance Date | OMNI® PLUS Surgical System
Sight Sciences, Inc.
K201953
August 11, 2020 |
| Reference Device | |
| Device Name
510(k) Holder
510(k) Number
Clearance Date | ISCIENCE Interventional Ophthalmic Microcatheter
ISCIENCE Interventional#
K080067
July 18, 2008 |
Note: *commercially available now as iTrack™ #IScience Interventional is now Nova Eye Medical
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Image /page/4/Picture/0 description: The image contains the logo for Sight Sciences. The logo features a stylized blue symbol resembling three curved lines stacked on top of each other. To the right of the symbol, the word "SIGHT" is written in bold, dark blue capital letters. Below "SIGHT", the word "SCIENCES" is written in smaller, dark blue capital letters.
Intended Use
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 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 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 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. The stainless-steel cannula has a curved shape with a beveled tip for entry through the trabecular meshwork into Schlemm's canal. A single advancement wheel is located on each side of the handle. This allows the OMNI 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. 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 modified OMNI Surgical System (subject device) delivers a total viscoelastic fluid volume of 21 microliters throughout Schlemm's canal (approximately 10.5 microliters for each of the first two advancement/retraction cycles).
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Image /page/5/Picture/1 description: The image shows the logo for Sight Sciences. The logo consists of a blue abstract symbol on the left, resembling interconnected waves or curves. To the right of the symbol is the company name, "SIGHT" in bold, uppercase letters, stacked above the word "SCIENCES" in a smaller font size.
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.
The modified OMNI Surgical System (catalog number 1-106) has the identical indications for use as the current OMNI Surgical System and similar design; the modified OMNI has the identical design as the OMNI PLUS Surgical System reference device which includes the ability to dispense a nominal volume of 21 microliters of viscoelastic fluid.
Comparison of Technological Characteristics with the Predicate Device
The modified OMNI Surgical System (catalog number 1-106) has the same indications for use and similar technological characteristics as the OMNI Surgical System (cleared by FDA in K202678 on March 1, 2021). The primary functional difference between the predicate device and subject device is the volume of viscoelastic fluid that can be delivered during use. The technical features of the modified OMNI Surgical System are substantially equivalent (identical including the volume of viscoeleastic fluid that can be delivered during use) to the OMNI PLUS Surgical System reference device (cleared by FDA in K201953 on August 11, 2020). The predicate OMNI Surgical System delivers a nominal volume of approximately 11 microliters of viscoelastic fluid, whereas the subject OMNI design can deliver a nominal volume of approximately 21 microliters of viscoelastic fluid (this volume is identical to the volume that can be delivered by the reference device OMNI PLUS). In order to deliver the additional viscoelastic fluid, three internal components, consisting of the reservoir, plunger tube and distal O-ring, have modified dimensions to contain and dispense additional viscoelastic fluid as compared to the predicate OMNI device. Additionally, the technical features of the subject OMNI surgical system are similar, but not identical to the commercially available interventional ophthalmic microcatheter-iTrack reference device (K080067, formerly the iScience Interventional Canaloplasty Microcatheter). The subject OMNI surgical system and the iTrack device are both manually operated devices that utilize a microcatheter to access the 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 dispenses 2.25 microliters of viscoelastic fluid per click of the visco injector (without any limitation on the amount of OVD that can be delivered). The iTrack device serves as a reference device to support the scientific method used to assess substantial equivalence of the subject device that delivers a nominal 21 microliters 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. The technological attributes comparison between the modified OMNI Surgical System (subject device) with the OMNI Surgical system (predicate device), OMNI Plus Surgical System (reference Device) and the iTrack (reference device) are presented in Table 1 below.
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Image /page/6/Picture/1 description: The image contains the logo for Sight Sciences. The logo consists of a blue abstract symbol on the left, resembling interconnected rings or a stylized eye. To the right of the symbol, the words "SIGHT" and "SCIENCES" are stacked vertically, both in a bold, sans-serif font and in the same shade of blue as the symbol.
Table 1: Technological Characteristics Comparison Modified OMNI Surgical System and Predicate Devices
| OMNI Surgical System | OMNI Surgical System | OMNI PLUS Surgical System | ISCIENCE INTERVENTIONAL | |
|---|---|---|---|---|
| Characteristic | (Catalog #1-106) | Predicate | Reference Device | OPHTHALMIC MICROCATHETER |
| SUBJECT DEVICE | (K202678) | (K201953) | Reference Device | |
| (K080067) | ||||
| Intended Use | 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 | 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 | 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 | 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 primary | ||||
| open-angle glaucoma | 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 primary | ||||
| open-angle glaucoma | The OMNI PLUS Surgical System is | |||
| a manually operated device for | ||||
| delivery of small amounts of | ||||
| viscoelastic fluid, for example Healon® | ||||
| PRO or Healon GV® PRO from Johnson | ||||
| & Johnson Vision, 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) | Primary: 880.5725 (Infusion Pump) | |
| Secondary: 886.4350 (Manual | ||||
| ophthalmic surgical instrument) | 886.4350 (Manual ophthalmic surgical | |||
| instrument) 876.1500 (Endoscope and | ||||
| accessories) | ||||
| Device Class | Class II | 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: MRH (Ophthalmic Infusion | |||
| Pump) | ||||
| Secondary: HMZ | ||||
| (Trabeculotome) | Primary: MPA (Endoscope) Secondary: | |||
| HMX (Manual Ophthalmic Surgical Ins | ||||
| trument) | ||||
| Prescription | Prescription use only | Prescription use only | Prescription use only | Prescription use only |
| Status | ||||
| Target Anatomy | Schlemm's Canal and Trabecular | |||
| Meshwork | Schlemm's Canal and Trabecular | |||
| Meshwork | Anterior Segment including Schlemm's | |||
| Canal/Trabecular Meshwork | Schlemm's Canal and Trabecular Mesh | |||
| work | ||||
| Operating | Manual | Manual | Manual | Manual |
| Principle |
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Image /page/7/Picture/0 description: The image contains the logo for Sight Sciences. The logo consists of a blue, stylized "S" symbol on the left, followed by the words "SIGHT" and "SCIENCES" stacked on top of each other in a sans-serif font. The color scheme is primarily blue, giving the logo a clean and professional appearance.
OMNI Surgical System
| Characteristic | OMNI Surgical System
(Catalog #1-106)
SUBJECT DEVICE | OMNI Surgical System
Predicate
(K202678) | OMNI PLUS Surgical System
Reference Device
(K201953) | ISCIENCE INTERVENTIONAL
OPHTHALMIC MICROCATHETER
Reference Device
(K080067) |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design/ Mechanis
m of Action | • Flexible microcatheter with
rounded, atraumatic tip for
dispensing of viscoelastic
• Proximal handle – changed
to ovoid shape
• Handle has internal
viscoelastic reservoir and
plunger tube with
dimensional changes to allow
dispensing of additional
viscoelastic
• Two 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 | • Flexible microcatheter with
rounded, atraumatic tip for
dispensing of viscoelastic
• Proximal handle – changed to
ovoid shape
• Handle has internal viscoelastic
reservoir and plunger tube with
dimensional changes to allow
dispensing of additional
viscoelastic
• Two 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 | • Flexible microcatheter with rounded,
atraumatic tip for dispensing of
viscoelastic
• Proximal handle – changed to ovoid
shape
• Handle has internal viscoelastic
reservoir and plunger tube with
dimensional changes to allow
dispensing of additional viscoelastic
• Two 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 | • Flexible microcatheter for
dispensation of viscoelastic fluid
• Microcatheter has a round, bolus,
atraumatic tip
• The Microcatheter is connected to
the ViscoInjector™ and primed with
viscoelastic fluid from a cartridge
retained with the ViscoInjector.
• The Microcatheter is connected to a
powered iLumin™ Fiberoptic
Illuminator which illuminates the
Microcatheter tip.
• The surgeon directs the
microcatheter using micro forceps
through the surgical incision into the
ostium of the Schlemm's canal.
• The Microcatheter can access 360° of
the Schlemm's canal in one pass.
• As surgeon withdraws the
microcatheter from the Schlemm's
canal, viscoelastic fluid is delivered
into the canal by the surgeon by
manual clockwise rotation of the
knob on ViscoInjector.
• Clicks on the ViscoInjector™ tactilely
indicate precise delivery of
viscoelastic fluid. |
| Dispensing
Control | After priming, viscoelastic fluid
dispensing control occurs
through manual rotation of
the advancement wheels at the
distal end of the device. The | After priming, viscoelastic fluid
dispensing control occurs
through manual rotation of
the advancement wheels at the
distal end of the device. The ovoid | After priming, viscoelastic fluid
dispensing control occurs
through manual rotation of
the advancement wheels at the distal
end of the device. The ovoid shape of | Rotational action via a knob on the Visco
Injector to dispense viscoelastic fluid |
| Characteristic | OMNI Surgical System
(Catalog #1-106)
SUBJECT DEVICE | OMNI Surgical System
Predicate
(K202678) | OMNI PLUS Surgical System
Reference Device
(K201953) | ISCIENCE INTERVENTIONAL
OPHTHALMIC MICROCATHETER
Reference Device
(K080067) |
| | ovoid shape of the handle allows
a single advancement wheel on
each side of the handle while
maintaining the ability for
ambidextrous use in either
patient eye. Synchronization of
the advancement wheels and
microcatheter movement
was achieved for ease of use by
adding a gear in the rack and
pinion mechanism. | shape of the handle allows a
single advancement wheel on
each side of the handle while
maintaining the ability for
ambidextrous use in either patient
eye. Synchronization of the
advancement wheels and
microcatheter movement
was achieved for ease of use by
adding a gear in the rack and
pinion mechanism. | the handle allows a single advancement
wheel on each side of the handle while
maintaining the ability for ambidextrous
use in either patient
eye. Synchronization of the
advancement wheels and microcatheter
movement was achieved for ease of
use by adding a gear in the rack and
pinion mechanism. | |
| Dispensing
Mechanism | Internal reservoir with plunger
tube (syringe-like volume
exchange). Three components
consisting of the
Reservoir, Plunger Tube
and Distal O-Ring have modified
dimensions to contain and
dispense larger volume
of viscoelastic fluid (OVD) | Internal reservoir with plunger
tube (syringe-like volume
exchange). | Internal reservoir with plunger tube
(syringe-like volume exchange). Three
components consisting of the
Reservoir, Plunger Tube and Distal O-
Ring have modified dimensions to
contain and dispense larger volume
of viscoelastic fluid (OVD) | OVD cartridge attaches to the device,
inside the 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 Luer fitting on proximal end
of OMNI device handle | 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 Luer
fitting on proximal end of OMNI
device handle | 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
Luer fitting on proximal end of OMNI
device handle | Cohesive viscoelastic fluid (OVD or oph
thalmic viscosurgical device) is supplied
separately. OVD cartridge attaches to
the device inside the Ellex ViscoInjector |
| OVD Volume
Dispensed | $21 ± 3 µL$ (10.5 $µL$ on first
microcatheter retraction cycle
and 10.5 $µL$ on the second cycle) | $11 µL$ | $21 ± 3 µL$ (10.5 $µL$ on first
microcatheter retraction cycle
and 10.5 $µL$ on the second cycle) | 2.25 $µL$ per click of the Viscoinjector (no
limit of total volume that can be
delivered) |
| Materials | Medical grade materials,
including ABS, polycarbonate,
stainless steel, | Medical grade materials,
including ABS, polycarbonate,
stainless steel, silicone, parylene | Medical grade materials, including
ABS, polycarbonate, stainless steel,
silicone, parylene coating. | Microcatheter – polyimide tubing and
an outer sheath of polyethylene |
| Characteristic | OMNI Surgical System
(Catalog #1-106)
SUBJECT DEVICE | OMNI Surgical System
Predicate
(K202678) | OMNI PLUS Surgical System
Reference Device
(K201953) | ISCIENCE INTERVENTIONAL
OPHTHALMIC MICROCATHETER
Reference Device
(K080067) |
| | silicone, parylene coating,
cyanoacrylate, acrylated uretha
ne, polyimide. | coating, cyanoacrylate, acrylated
urethane, polyimide. | cyanoacrylate, acrylated urethane,
polyimide. | terephthalate (PET) shrink tubing, with
a lubricious coating |
| User Interface | Handheld | Handheld | Handheld | Handheld |
| Microcatheter Shaft
Outer Diameter | 200 microns | 200 microns | 200 microns | 200 microns |
| Microcatheter Tip
Outer Diameter
Range | 0.0090 to 0.0110 inches | 0.0090 to 0.0110 inches | 0.0090 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 | Provided sterile. Single patient use |
| Sterilization
Method | Gamma radiation | Gamma radiation | Gamma radiation | Gamma radiation |
| Sterility Assurance
Level | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ |
| Packaging | Thermoformed plastic tray with
heat-sealed Tyvek lid | Thermoformed plastic tray with
heat-sealed Tyvek lid | Thermoformed plastic tray with heat-
sealed Tyvek lid | Tray inside a sealed pouch |
| Shelf Life | 37 Months | 13 Months | 13 months | Unknown |
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Image /page/8/Picture/0 description: The image contains the logo for Sight Sciences. The logo consists of a blue abstract symbol on the left and the text "SIGHT SCIENCES" on the right. The symbol is made up of three curved lines that are stacked on top of each other. The text is in a sans-serif font, with "SIGHT" on the top line and "SCIENCES" on the bottom line.
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Image /page/9/Picture/0 description: The image contains the logo for Sight Sciences. The logo consists of a stylized blue symbol resembling three overlapping waves or curves, followed by the words "SIGHT" in bold, uppercase blue letters above the word "SCIENCES" in smaller, uppercase blue letters. The overall design is clean and modern, suggesting a focus on vision or scientific innovation.
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Image /page/10/Picture/0 description: The image shows the logo for Sight Sciences. The logo consists of a stylized blue "S" made of three curved lines on the left, followed by the word "SIGHT" in bold, dark blue letters. Below "SIGHT" is the word "SCIENCES" in a smaller, lighter blue font. The logo is clean and modern, conveying a sense of vision and scientific expertise.
Risk Management
The risk management process at Sight Sciences complies with ISO 14971:2019 "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.
Per the product development plan for this modified OMNI Surgical system, the following risk management activities were conducted:
- . Per the plan, the Risk Management Report was reviewed, and no new risks were identified. The Risk Management Report was updated to reflect this new OMNI catalog/part number and to add reference to the supporting clinical study reports. Reference to the clinical assessment associated with Larger (21 uL) OVD Delivery was also added to the risk management report.
- . All identified hazards associated with the OMNI devices were evaluated and no updates to the FMEAs were required.
All the previously identified hazards were mitigated to an acceptable level of risk. The potential benefits to patients outweigh the overall residual risk, taking into account the design changes and the indications for use of the OMNI devices.
Performance Data - Bench Testing
The verification and validation activities were previously performed for the OMNI PLUS Surgical System reference device (cleared in K201953 on August 11, 2020) which is physically identical to the modified OMNI Surgical System (catalog # 1-106) and did not need to be repeated for this OMNI Surgical System (catalog number 1-106) device. The non-clinical bench testing of the OMNI PLUS device included design verification and functional product testing, sterilization, packaging and shelf-life testing, biocompatibility testing, bacterial endotoxin testing and simulated use (usability) testing in a bench model.
Additionally, the shelf life was extended to up to 37 months and testing was conducted by subjecting devices to worst-case radiation dosage exposure and simulated aging in a controlled environment. Subsequently, the devices underwent visual inspection , sterile barrier packaging testing, and functional performance testing.
Results of the nonclinical testing are directly applicable to the modified OMNI Surgical System and demonstrate that the modified OMNI Surgical System meets the defined specifications and functions as intended.
Conclusions
Based on the testing conducted on the physically identical OMNI PLUS Surgical System, the Sight Sciences modified OMNI Surgical System has met all product design requirements and applicable standards as the predicate OMNI and the reference OMNI PLUS Surgical System. The subject device shares the same principle of operation, intended use, indications for use, and many of the same key technological characteristics as the predicate device. The conclusions drawn from the
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Image /page/11/Picture/0 description: The image shows the logo for Sight Sciences. The logo consists of a stylized blue symbol on the left, resembling three stacked, curved shapes. To the right of the symbol is the company name, "SIGHT" in a larger, bolder font, stacked above the word "SCIENCES" in a smaller font. The overall design is clean and professional, suggesting a focus on vision-related products or services.
non-clinical bench performance tests demonstrate that the modified OMNI Surgical System meets the defined specifications and performs as intended. Based on the changes made as compared to the cleared predicate and the evaluation of the effect on the clinical outcomes from the change to increase the delivery volume of OVD provided in the clinical assessment comparison of the predicate OMNI device and reference iTrack device, it was appropriate to leverage the clinical data used in support of the cleared predicate device. Therefore, the OMNI Surgical System is substantially equivalent to the legally marketed OMNI Surgical System predicate device cleared under K202678.