(30 days)
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.
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.
The provided text describes a new version of the OMNI Surgical System (catalog #1-106) and compares its features and performance to predicate and reference devices to demonstrate substantial equivalence for FDA clearance.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate OMNI Surgical System (K202678) and the reference OMNI PLUS Surgical System (K201953), which have already met their own performance requirements. The key performance change for the subject device is the volume of viscoelastic fluid dispensed.
| Characteristic / Acceptance Criteria | Reported Device Performance (OMNI Surgical System, Catalog #1-106) |
|---|---|
| Intended Use | Ophthalmic surgical tool for delivery of controlled amounts of viscoelastic fluid into the anterior segment and cutting of trabecular meshwork when a trabeculotomy is indicated. |
| Indications for Use | 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. (Identical to predicate) |
| Volume of Viscoelastic Fluid (OVD) Dispensed | 21 ± 3 µL (10.5 µL on first microcatheter retraction cycle and 10.5 µL on the second cycle). (This is the primary change from the predicate and is identical to the OMNI PLUS reference device). |
| Design/Mechanism of Action | Flexible microcatheter with rounded, atraumatic tip for dispensing 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 for advancing/retracting microcatheter up to 20mm using rack and pinion. Tactile and audible clicks indicate precise advancement. Viscoelastic dispensed during retraction of first two cycles after priming. Flexible microcatheter used to cut trabecular meshwork. (Similar to predicate, with dimensional changes for OVD volume) |
| Dispensing Control | Manual rotation of advancement wheels. Ovoid handle allows single advancement wheel on each side for ambidextrous use. Synchronization of advancement wheels and microcatheter movement via gear in rack and pinion. |
| Dispensing Mechanism | Internal reservoir with plunger tube (syringe-like volume exchange). Three components (Reservoir, Plunger Tube, and Distal O-Ring) have modified dimensions to contain and dispense larger volume of OVD. |
| Viscoelastic Fluid (OVD) and Priming Method | Cohesive viscoelastic fluid (OVD) supplied separately. Loaded into device (primed) prior to use by attaching OVD cartridge directly to Luer fitting. |
| Materials | Medical grade materials, including ABS, polycarbonate, stainless steel, silicone, parylene coating, cyanoacrylate, acrylated urethane, polyimide. (Similar to predicate) |
| User Interface | Handheld. (Identical to predicate) |
| Microcatheter Shaft Outer Diameter | 200 microns. (Identical to predicate) |
| Microcatheter Tip Outer Diameter Range | 0.0090 to 0.0110 inches. (Identical to predicate) |
| Sterile and Single Use | Provided sterile. Single patient use. (Identical to predicate) |
| Sterilization Method | Gamma radiation. (Identical to predicate) |
| Sterility Assurance Level | $10^{-6}$. (Identical to predicate) |
| Packaging | Thermoformed plastic tray with heat-sealed Tyvek lid. (Identical to predicate) |
| Shelf Life | 37 Months. (Extended from predicate's 13 months, supported by additional testing). |
| Risk Management | Complies with ISO 14971:2019. Risk management report reviewed, no new risks identified. FMEAs reviewed, no updates required. Overall residual risk acceptable. |
| Non-clinical Bench Testing | Met defined specifications and functions as intended, leveraging testing conducted on the physically identical OMNI PLUS Surgical System (K201953). This included design verification, functional product testing, sterilization, packaging and shelf-life testing, biocompatibility testing, bacterial endotoxin testing, and simulated use (usability) testing. |
| Clinical Assessment for OVD Delivery Change (Implied criteria) | A clinical assessment comparing the predicate OMNI device and reference iTrack device was used to evaluate the effect on clinical outcomes from changing the OVD delivery volume. This assessment, combined with the similarity to the OMNI PLUS (which delivers the same volume), supports the safety and effectiveness of the increased volume. (The document does not detail the clinical outcomes or specific criteria from this assessment, but notes it was leveraged). |
2. Sample Size Used for the Test Set and the Data Provenance
The document states that formal test sets (in the sense of independent clinical trials specifically for this K232214 submission) were not conducted for the subject device. Instead, the clearance relies on:
-
Bench Testing: Leveraged from the OMNI PLUS Surgical System (K201953), which is physically identical. No specific sample sizes for these bench tests are detailed in the provided text, but it included design verification, functional product testing, sterilization, packaging and shelf-life testing, biocompatibility testing, bacterial endotoxin testing, and simulated use testing. Extended shelf-life testing involved subjecting devices to worst-case radiation and simulated aging.
-
Clinical Data Leverage: "[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."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the given text. The document refers to "clinical data used in support of the cleared predicate device" and a "clinical assessment comparison of the predicate OMNI device and reference iTrack device" to justify the change in OVD volume. Details about the ground truth establishment for these underlying clinical studies, including the number and qualifications of experts, are not present.
4. Adjudication Method for the Test Set
This information is not provided in the given text. Since direct clinical test sets or studies for this specific K232214 submission are not detailed, any adjudication methods for those would be found in the documentation of the predicate or reference device studies.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This information is not applicable as the device described (OMNI Surgical System) is a surgical tool, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This information is not applicable for the same reason as point 5. The OMNI Surgical System is a manually operated surgical device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
For the non-clinical (bench) testing, the "ground truth" would be established by:
- Defined Specifications: The device meeting its engineering and design specifications (e.g., volume dispensed, material properties, sterility levels).
- Functional Performance: Proper operation of mechanical components in simulated use.
For the leveraged clinical data, the ground truth would likely be outcomes data related to intraocular pressure (IOP) reduction in adult patients with primary open-angle glaucoma, as stated in the Indications for Use. However, the specific details of how this ground truth was established for the predicate's clinical studies are not in this document.
8. The Sample Size for the Training Set
This information is not provided as there is no mention of a "training set" in the context of an algorithm or AI model development for this device. The device is a surgical instrument.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for an AI/algorithm mentioned.
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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
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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
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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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510(k) SUMMARY
Submitter Information
| 510(k) Owner: | Sight Sciences, Inc.4040 Campbell Ave., Suite 100Menlo Park, CA 94025Tel: (877) 266-1144 |
|---|---|
| Contact Person: | Ranjani MadhavanSenior Regulatory Affairs specialist4040 Campbell Ave., Suite 100Menlo Park, CA 94025Tel: 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 SystemOphthalmic Infusion PumpInfusion Pump21 CFR 880.5725Class IIMRHHMZ |
| Predicate Device | |
| Device Name:510(k) Holder:510(k) Number:Clearance Date: | OMNI® Surgical SystemSight Sciences, Inc.K202678March 1, 2021 |
| Reference Device | |
| Device Name510(k) Holder510(k) NumberClearance Date | OMNI® PLUS Surgical SystemSight Sciences, Inc.K201953August 11, 2020 |
| Reference Device | |
| Device Name510(k) Holder510(k) NumberClearance Date | ISCIENCE Interventional Ophthalmic MicrocatheterISCIENCE Interventional#K080067July 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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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 fordelivery of controlled amountsof viscoelastic fluid into theanterior segment and used tocut trabecular meshwork when atrabeculotomy is indicated | Ophthalmic surgical tool fordelivery of controlled amounts ofviscoelastic fluid into the anteriorsegment and used to cuttrabecular meshwork when atrabeculotomy is indicated | Ophthalmic surgical tool for delivery ofcontrolled amounts of viscoelastic fluidinto the anterior segment and used tocut trabecular meshwork when atrabeculotomy is indicated | Delivery of controlled amounts ofViscoelastic fluid during ophthalmicsurgery |
| Indications for | The OMNI® Surgical System isindicated for canaloplasty(micro-catheterization andtransluminal viscodilation ofSchlemm's canal) followedby trabeculotomy (cutting oftrabecular meshwork) to reduceintraocular pressurein adult patients with primaryopen-angle glaucoma | The OMNI® Surgical System isindicated for canaloplasty(micro-catheterization andtransluminal viscodilation ofSchlemm's canal) followedby trabeculotomy (cutting oftrabecular meshwork) to reduceintraocular pressurein adult patients with primaryopen-angle glaucoma | The OMNI PLUS Surgical System isa manually operated device fordelivery of small amounts ofviscoelastic fluid, for example Healon®PRO or Healon GV® PRO from Johnson& Johnson Vision, Amvisc® fromBausch & Lomb, or PROVISC® fromAlcon, during ophthalmic surgery. Itis also indicated to cut trabecularmeshwork tissue duringtrabeculotomy procedures | The iScience InterventionalCanaloplasty Microcatheter isindicated for fluid infusion andaspiration during surgery. The iScienceInterventional CanaloplastyMicrocatheter is indicated forcatheterization and viscodilation ofSchlemm's canal to reduceintraocular pressure in adult patientswith open angle glaucoma |
| Regulation | 880.5725 (Infusion Pump) | 880.5725 (Infusion Pump) | Primary: 880.5725 (Infusion Pump)Secondary: 886.4350 (Manualophthalmic surgical instrument) | 886.4350 (Manual ophthalmic surgicalinstrument) 876.1500 (Endoscope andaccessories) |
| Device Class | Class II | Class II | Class II | Class II |
| Product Code | Primary: MRH (OphthalmicInfusion Pump)Secondary: HMZ(Trabeculotome) | Primary: MRH (OphthalmicInfusion Pump)Secondary: HMZ(Trabeculotome) | Primary: MRH (Ophthalmic InfusionPump)Secondary: HMZ(Trabeculotome) | Primary: MPA (Endoscope) Secondary:HMX (Manual Ophthalmic Surgical Instrument) |
| Prescription | Prescription use only | Prescription use only | Prescription use only | Prescription use only |
| Status | ||||
| Target Anatomy | Schlemm's Canal and TrabecularMeshwork | Schlemm's Canal and TrabecularMeshwork | Anterior Segment including Schlemm'sCanal/Trabecular Meshwork | Schlemm's Canal and Trabecular Meshwork |
| 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 SystemPredicate(K202678) | OMNI PLUS Surgical SystemReference Device(K201953) | ISCIENCE INTERVENTIONALOPHTHALMIC MICROCATHETERReference Device(K080067) |
|---|---|---|---|---|
| Design/ Mechanism of Action | • Flexible microcatheter withrounded, atraumatic tip fordispensing of viscoelastic• Proximal handle – changedto ovoid shape• Handle has internalviscoelastic reservoir andplunger tube withdimensional changes to allowdispensing of additionalviscoelastic• Two advancement wheels(finger wheels) for advancingand retractingmicrocatheter up to 20mmusing a rack and pinionmechanism• Tactile and audible clicksindicate preciseadvancement• Viscoelastic dispensed duringretraction of first twocycles after priming withviscoelastic fluid• Flexible microcatheterintroduced into Schlemm'scanal and pulled through tocut trabecular meshwork | • Flexible microcatheter withrounded, atraumatic tip fordispensing of viscoelastic• Proximal handle – changed toovoid shape• Handle has internal viscoelasticreservoir and plunger tube withdimensional changes to allowdispensing of additionalviscoelastic• Two advancement wheels(finger wheels) for advancingand retractingmicrocatheter up to 20mmusing a rack and pinionmechanism• Tactile and audible clicksindicate precise advancement• Viscoelastic dispensed duringretraction of first twocycles after priming withviscoelastic fluid• Flexible microcatheterintroduced into Schlemm'scanal and pulled through tocut trabecular meshwork | • Flexible microcatheter with rounded,atraumatic tip for dispensing ofviscoelastic• Proximal handle – changed to ovoidshape• Handle has internal viscoelasticreservoir and plunger tube withdimensional changes to allowdispensing of additional viscoelastic• Two advancement wheels (fingerwheels) for advancing and retractingmicrocatheter up to 20mm using arack and pinion mechanism• Tactile and audible clicks indicateprecise advancement• Viscoelastic dispensed duringretraction of first two cycles afterpriming with viscoelastic fluid• Flexible microcatheter introducedinto Schlemm's canal and pulledthrough to cut trabecular meshwork | • Flexible microcatheter fordispensation of viscoelastic fluid• Microcatheter has a round, bolus,atraumatic tip• The Microcatheter is connected tothe ViscoInjector™ and primed withviscoelastic fluid from a cartridgeretained with the ViscoInjector.• The Microcatheter is connected to apowered iLumin™ FiberopticIlluminator which illuminates theMicrocatheter tip.• The surgeon directs themicrocatheter using micro forcepsthrough the surgical incision into theostium of the Schlemm's canal.• The Microcatheter can access 360° ofthe Schlemm's canal in one pass.• As surgeon withdraws themicrocatheter from the Schlemm'scanal, viscoelastic fluid is deliveredinto the canal by the surgeon bymanual clockwise rotation of theknob on ViscoInjector.• Clicks on the ViscoInjector™ tactilelyindicate precise delivery ofviscoelastic fluid. |
| DispensingControl | After priming, viscoelastic fluiddispensing control occursthrough manual rotation ofthe advancement wheels at thedistal end of the device. The | After priming, viscoelastic fluiddispensing control occursthrough manual rotation ofthe advancement wheels at thedistal end of the device. The ovoid | After priming, viscoelastic fluiddispensing control occursthrough manual rotation ofthe advancement wheels at the distalend of the device. The ovoid shape of | Rotational action via a knob on the ViscoInjector to dispense viscoelastic fluid |
| Characteristic | OMNI Surgical System(Catalog #1-106)SUBJECT DEVICE | OMNI Surgical SystemPredicate(K202678) | OMNI PLUS Surgical SystemReference Device(K201953) | ISCIENCE INTERVENTIONALOPHTHALMIC MICROCATHETERReference Device(K080067) |
| ovoid shape of the handle allowsa single advancement wheel oneach side of the handle whilemaintaining the ability forambidextrous use in eitherpatient eye. Synchronization ofthe advancement wheels andmicrocatheter movementwas achieved for ease of use byadding a gear in the rack andpinion mechanism. | shape of the handle allows asingle advancement wheel oneach side of the handle whilemaintaining the ability forambidextrous use in either patienteye. Synchronization of theadvancement wheels andmicrocatheter movementwas achieved for ease of use byadding a gear in the rack andpinion mechanism. | the handle allows a single advancementwheel on each side of the handle whilemaintaining the ability for ambidextroususe in either patienteye. Synchronization of theadvancement wheels and microcathetermovement was achieved for ease ofuse by adding a gear in the rack andpinion mechanism. | ||
| DispensingMechanism | Internal reservoir with plungertube (syringe-like volumeexchange). Three componentsconsisting of theReservoir, Plunger Tubeand Distal O-Ring have modifieddimensions to contain anddispense larger volumeof viscoelastic fluid (OVD) | Internal reservoir with plungertube (syringe-like volumeexchange). | Internal reservoir with plunger tube(syringe-like volume exchange). Threecomponents consisting of theReservoir, Plunger Tube and Distal O-Ring have modified dimensions tocontain and dispense larger volumeof viscoelastic fluid (OVD) | OVD cartridge attaches to the device,inside the ViscoInjector (syringe-like volume exchange) |
| Viscoelastic Fluid(OVD) andPriming Method | Cohesive viscoelastic fluid (OVDor ophthalmicviscosurgical device) is suppliedseparately.Viscoelastic loaded intodevice (primed) prior to use byattaching OVD cartridge directlyto Luer fitting on proximal endof OMNI device handle | Cohesive viscoelastic fluid (OVDor ophthalmic viscosurgicaldevice) is supplied separately.Viscoelastic loaded into device(primed) prior to use by attachingOVD cartridge directly to Luerfitting on proximal end of OMNIdevice handle | Cohesive viscoelastic fluid (OVDor ophthalmic viscosurgical device) issupplied separately. Viscoelastic loadedinto device (primed) prior to use byattaching OVD cartridge directly toLuer fitting on proximal end of OMNIdevice handle | Cohesive viscoelastic fluid (OVD or ophthalmic viscosurgical device) is suppliedseparately. OVD cartridge attaches tothe device inside the Ellex ViscoInjector |
| OVD VolumeDispensed | $21 ± 3 µL$ (10.5 $µL$ on firstmicrocatheter retraction cycleand 10.5 $µL$ on the second cycle) | $11 µL$ | $21 ± 3 µL$ (10.5 $µL$ on firstmicrocatheter retraction cycleand 10.5 $µL$ on the second cycle) | 2.25 $µL$ per click of the Viscoinjector (nolimit of total volume that can bedelivered) |
| Materials | Medical grade materials,including ABS, polycarbonate,stainless steel, | Medical grade materials,including ABS, polycarbonate,stainless steel, silicone, parylene | Medical grade materials, includingABS, polycarbonate, stainless steel,silicone, parylene coating. | Microcatheter – polyimide tubing andan outer sheath of polyethylene |
| Characteristic | OMNI Surgical System(Catalog #1-106)SUBJECT DEVICE | OMNI Surgical SystemPredicate(K202678) | OMNI PLUS Surgical SystemReference Device(K201953) | ISCIENCE INTERVENTIONALOPHTHALMIC MICROCATHETERReference Device(K080067) |
| silicone, parylene coating,cyanoacrylate, acrylated urethane, polyimide. | coating, cyanoacrylate, acrylatedurethane, polyimide. | cyanoacrylate, acrylated urethane,polyimide. | terephthalate (PET) shrink tubing, witha lubricious coating | |
| User Interface | Handheld | Handheld | Handheld | Handheld |
| Microcatheter ShaftOuter Diameter | 200 microns | 200 microns | 200 microns | 200 microns |
| Microcatheter TipOuter DiameterRange | 0.0090 to 0.0110 inches | 0.0090 to 0.0110 inches | 0.0090 to 0.0110 inches | 0.0098 inches |
| Sterile and SingleUse | Providedsterile. Single patient use | Providedsterile. Single patient use | Provided sterile. Single patient use | Provided sterile. Single patient use |
| SterilizationMethod | Gamma radiation | Gamma radiation | Gamma radiation | Gamma radiation |
| Sterility AssuranceLevel | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ |
| Packaging | Thermoformed plastic tray withheat-sealed Tyvek lid | Thermoformed plastic tray withheat-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.
§ 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).