(59 days)
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 (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.
The Sight Sciences OMNI™ Surgical System ("OMNI") is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small, controlled amounts of viscoelastic into the anterior segment of the eye during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures. The OMNI is designed to function with commonly used viscoelastic fluids made commercially available by companies such as Abbott Medical Optics (AMO), Bausch & Lomb, and Alcon. The OMNI dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, microcatheter, internal reservoir and plunger tube, and finger wheels. The finger wheels on the handle of the device are used advance and retract the microcatheter. In addition, when the device is being used to deliver viscoelastic, retraction of the microcatheter causes the plunger tube to advance into the viscoelastic fluid reservoir thereby dispensing viscoelastic fluid.
The provided document is a 510(k) summary for the OMNI Surgical System, a medical device. It describes the device, its intended use, and comparisons to predicate and reference devices. However, it does not contain the detailed clinical study information typically provided for AI/ML-driven devices to demonstrate performance against acceptance criteria.
The document states:
- Performance Data: "The OMNI's descriptive characteristics are well-defined and adequate to ensure equivalence to the predicate devices. Additionally, the following performance testing and inspection was conducted on the OMNI device: dimensional and visual inspections, visual inspection of labeling and component inspections, mechanical testing of joint strength and actuation force, simulated use testing, and human cadaver eye performance testing. Acceptance criteria was based on predicate VISCO360's dispensing performance, intrinsic strength of the materials, and the load and conditions to which the OMNI would be subjected during use. Testing demonstrated that the OMNI performs as intended and is functionally equivalent to the predicate devices."
Based on this, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document describes "performance testing" and "acceptance criteria based on predicate VISCO360's dispensing performance, intrinsic strength of the materials, and the load and conditions to which the OMNI would be subjected during use." However, it does not provide specific numerical acceptance criteria or detailed quantitative performance results in the format typically expected for AI/ML device evaluations (e.g., sensitivity, specificity, AUC). Instead, it makes a general statement of functional equivalence.
| Acceptance Criteria (Not explicitly stated numerically, but inferred from text) | Reported Device Performance (Summary Statement) |
|---|---|
| Equivalence to predicate VISCO360's dispensing performance | Functionally equivalent to the predicate devices. |
| Intrinsic strength of materials met | Performed as intended. |
| Withstood load and conditions during simulated use | Performed as intended. |
| Dimensional and visual inspections within specifications | Performed as intended. |
| Labeling and component inspections within specifications | Performed as intended. |
| Mechanical testing of joint strength and actuation force met | Performed as intended. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. The phrase "human cadaver eye performance testing" indicates a form of testing but doesn't quantify the sample size.
- Data Provenance: "Human cadaver eye performance testing." This implies the data was collected in a laboratory setting using cadaveric eyes. The country of origin is not specified, but the submission is to the U.S. FDA. Retrospective/prospective is not applicable as this is a device performance test on cadavers, not a clinical data study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Self-correction: For this type of mechanical device testing, "ground truth" would likely be established by engineering measurements and observations rather than expert clinical consensus as might be the case for image-based AI/ML devices.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. The testing described (dimensional, mechanical, simulated use, cadaver eye performance) would involve objective measurements and observations against pre-defined engineering or performance specifications, not a consensus-based adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable. This device is a manually operated surgical tool, not an AI/ML algorithm intended to assist human readers in interpretation tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- Standalone Study: No, this is not an AI/ML algorithm. The device is a physical, manually operated surgical instrument.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the mechanical and simulated use testing, the ground truth would be based on engineering specifications, direct measurements, and observations of physical performance (e.g., dispensing volume accuracy, force required for actuation, structural integrity, cutting efficacy in cadaveric tissue) rather than clinical outcomes, pathology, or expert consensus on diagnostic interpretations.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning. The device design and verification would rely on engineering principles, material science, and iterative testing/refinement.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth was Established: Not applicable, as there is no training set in the AI/ML sense. Device design and validation would follow standard medical device development processes.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2017
Sight Sciences, Inc. Anne-Marie Ripley VP, Clinical & Regulatory Affairs 3000 Sand Hill Road Building 3, Suite 105 Menlo Park, CA 94025
Re: K173332
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: October 19, 2017 Received: October 23, 2017
Dear Anne-Marie Ripley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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. 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.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley S. Cunningham -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173332
Device Name OMNI™ Surgical System
Indications for Use (Describe)
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 (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.
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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1. 510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Sight Sciences, Inc.3000 Sand Hill RoadBuilding 3, Suite 105Menlo Park, CA 94025Tel: (877) 266-1144 | |
|---|---|---|
| OFFICIALCORRESPONDENT | Anne-Marie RipleySight Sciences, Inc.3000 Sand Hill RoadBldg. 3, Suite 105Menlo Park, CA 94025 | |
| Anne@sightsciences.comMobile: 661-645-8546 | ||
| DATE SUMMARY WASPREPARED: | December 21, 2017 | |
| TRADE NAME: | OMNI™ Surgical System | |
| CLASSIFICATION NAMES | Infusion Pump | Manual OphthalmicInstrument |
| REGULATION NUMBERS | 21 CFR 880.5725 | 21 CFR 886.4350 |
| DEVICE CLASSIFICATIONS | Class II | Class I |
| PRODUCT CODES | MRH (Pump, infusion,ophthalmic) | HMZ (Trabeculotome) |
| DEVICE NAME | 510(k) NUMBER | |
|---|---|---|
| PREDICATE DEVICES: | iTrack Catheter (Ellex)* primary predicate device | K080067 |
| VISCO360 Viscosurgical System(Sight Sciences) | K171905 | |
| REFERENCE DEVICES: | DEVICE NAME | 510(k) NUMBER |
| Harms Trabeculotomy Probe (Katena) | Class I exempt | |
| Kahook Dual Blade(New World Medical) | Class I exempt | |
| Nylon or Prolene Suture | Multiple |
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Description Of The Device:
The Sight Sciences OMNI™ Surgical System ("OMNI") is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small, controlled amounts of viscoelastic into the anterior segment of the eye during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.
The OMNI is designed to function with commonly used viscoelastic fluids made commercially available by companies such as Abbott Medical Optics (AMO), Bausch & Lomb, and Alcon. The OMNI dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, microcatheter, internal reservoir and plunger tube, and finger wheels. The finger wheels on the handle of the device are used advance and retract the microcatheter. In addition, when the device is being used to deliver viscoelastic, retraction of the microcatheter causes the plunger tube to advance into the viscoelastic fluid reservoir thereby dispensing viscoelastic fluid.
The microcatheter can be advanced/retracted up to 20 mm per cycle. The microcatheter can be fully advanced/retracted up to 5 times (i.e. 5 full cycles of 20 mm each). Dispensation of viscoelastic can only occur during the first two 20-mm cycles.
The wheels are located on both sides 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.
Image /page/4/Figure/6 description: This image shows a diagram of the OMNI Surgical System. The diagram labels the different parts of the system, including the retainer pin, reservoir, cannula, microcatheter, and viscoelastic fluid. The diagram also shows the advancement wheels and the inside handle shell.
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Indications For Use:
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 (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.
Intended Use (in comparison to predicate):
The OMNI Surgical System and the predicate devices (iTrack and VISCO360) are surgical tools for delivery of small amounts of viscoelastic fluid into the anterior segment. Like the reference devices (Harms Trabeculotome, Kahook Dual Blade, and prolene/nylon sutures), the OMNI device may also be used to cut trabecular meshwork when a trabeculotomy is indicated.
Technical Characteristics (in comparison to predicate):
The technical features of the OMNI Surgical System are substantially equivalent to the Ellex iTrack™ Interventional Canaloplasty Microcatheter (K080067) and the Sight Sciences VISCO360® Viscosurgical System (K171905). Both are manually operated devices for the controlled delivery of small amounts of viscoelastic fluid. Fluid is dispensed from each system on the principle of exchanging volumes much like a syringe.
The intended use and technical features of the OMNI are also substantially equivalent to the following reference devices: Katena Harms Trabeculotomy Probe (Class I Exempt), the New World Medical Kahook Dual Blade (Class I Exempt), and Nylon or Prolene Sutures (Class II). All of these devices are manually operated for the cutting of trabecular meshwork when a trabeculotomy is indicated.
Table 1 compares the attributes of the OMNI with these predicate and reference devices.
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Table 1: Technological Characteristics Comparison Sight Sciences OMNI Surgical System and the Predicate and Reference Devices
| Characteristic | OMNI Surgical System | Ellex's (iScience) iTrack(Primary Predicate) | Sight Sciences'VISCO360Viscosurgical System(Predicate Device) | Katena's HarmsTrabeculotomyProbe(Reference Device) | New WorldMedical'sKahook Dual Blade(Reference Device) | Nylon or ProleneSuture(Reference Device) |
|---|---|---|---|---|---|---|
| Intended Use | • Delivery of smallamounts ofviscoelastic fluidduring ophthalmicsurgery• Cutting of trabecularmeshwork when atrabeculotomy isindicated | • Delivery of smallamounts ofviscoelastic fluidduring ophthalmicsurgery | • Delivery of smallamounts ofviscoelastic fluidduring ophthalmicsurgery | • Cutting oftrabecularmeshwork when atrabeculotomy isindicated | • Cutting oftrabecularmeshwork whena trabeculotomyis indicated | • Soft tissueapproximationand variousother usesincluding cuttingof trabecularmeshwork whena trabeculotomyis indicated |
| Indication forUse | The OMNI System is amanually operateddevice for delivery ofsmall amounts ofviscoelastic fluid, forexample Healon orHealonGV from AbbottMedical Optics (AMO),Amvisc from Bausch &Lomb, or PROVISC fromAlcon, during ophthalmicsurgery. It is alsoindicated to cuttrabecular meshworktissue duringtrabeculotomyprocedures. | The iScienceInterventionalCanaloplastyMicrocatheter isindicated for fluidinfusion and aspirationduring surgery. TheiScience InterventionalCanaloplastyMicrocatheter isindicated forcatheterization andviscodilation ofSchlemm's canal toreduce intraocularpressure in adultpatients with openangle glaucoma. | The VISCO360Viscosurgical Systemis a manuallyoperated device fordelivery of smallamounts ofviscoelastic fluid, forexample Healon orHealonGV fromAbbott Medical Optics(AMO), Amvisc fromBausch & Lomb, orPROVISC from Alcon,during ophthalmicsurgery. | Cutting of trabecularmeshwork when atrabeculotomy isindicated | Cutting of trabecularmeshwork when atrabeculotomy isindicated | Soft tissueapproximation andvarious other usesincluding cutting oftrabecularmeshwork when atrabeculotomy isindicated |
| Characteristic | OMNI Surgical System | Ellex's (iScience) iTrack(Primary Predicate) | Sight Sciences'VISCO360Viscosurgical System(Predicate Device) | Katena's HarmsTrabeculotomyProbe(Reference Device) | New WorldMedical'sKahook Dual Blade(Reference Device) | Nylon or ProleneSuture(Reference Device) |
| Regulation | Primary: 880.5725(Infusion Pump)Secondary: 886.4350(Manual ophthalmicsurgical instrument) | Primary: 876.1500(Endoilluminator)Secondary: 886.4350(Manual ophthalmicsurgical instrument) | 880.5725 (InfusionPump) | 886.4350 (Manualophthalmic surgicalinstrument) | 886.4350 (Manualophthalmic surgicalinstrument) | 878.5010 and878.5020(Nonabsorbablesurgical suture) |
| Device Class | Class II | Class II | Class II | Class I, exempt | Class I, exempt | Class II |
| Product Code | Primary: MRH(Ophthalmic InfusionPump, Class II)Secondary: HMZ(Trabeculotome, Manualophthalmic surgicalinstrument, Class Iexempt) | Primary: MPA (forendoilluminator, ClassII)Secondary: HMX(Ophthalmic Cannula,Manual ophthalmicsurgical instrument,Class I Exempt) | MRH (OphthalmicInfusion Pump, ClassII) | HMZ(Trabeculotome,Manual ophthalmicsurgical instrument,Class I exempt) | HNN (OphthalmicKnife, Manualophthalmic surgicalinstrument, Class Iexempt) | GAW and GAR(Nonabsorbable,Synthetic Suture,Class II) |
| TargetAnatomy | Anterior Segmentincluding Schlemm'sCanal/TrabecularMeshwork | Schlemm'sCanal/TrabecularMeshwork | Anterior Segmentincluding Schlemm'sCanal | Schlemm'sCanal/TrabecularMeshwork | Schlemm'sCanal/TrabecularMeshwork | Anywhere, includingSchlemm'sCanal/TrabecularMeshwork |
| OperatingPrinciple | Manual | · Manual (microcatheter)• Powered(endoilluminator) | Manual | Manual | Manual | Manual |
| Characteristic | OMNI Surgical System | Ellex's (iScience) iTrack(Primary Predicate) | Sight Sciences'VISCO360Viscosurgical System(Predicate Device) | Katena's HarmsTrabeculotomyProbe(Reference Device) | New WorldMedical'sKahook Dual Blade(Reference Device) | Nylon or ProleneSuture(Reference Device) |
| Design/Mechanism of Action | • Flexible microcatheter fordispensation ofviscoelastic• Microcatheter has around, bolus, atraumatictip• Proximal handle• Handle has internalviscoelastic reservoir andplunger tube• Finger wheel foradvancing and retractingmicrocatheter.• Tactile and audible clicksindicate preciseadvancement.• Viscoelastic dispensedduring retraction• Flexible microcatheterintroduced intoSchlemm's canal andpulled through to cuttrabecular meshwork | • Flexible microcatheterfor dispensation ofviscoelastic• Microcatheter has around, bolus,atraumatic tip• Microcatheter attachesat proximal end to EllexViscolnjector todispense viscoelasticusing a knob• Microcatheter manuallyadvanced by clinician• Tactile and audibleclicks indicate preciseadvancement.• Optical fiber provideillumination at tip ofcatheter | • Flexible microcatheterfor dispensation ofviscoelastic• Microcatheter has around, bolus,atraumatic tip• Proximal handle• Handle has internalviscoelastic reservoirand plunger tube• Finger wheel foradvancing andretractingmicrocatheter.• Tactile and audibleclicks indicate preciseadvancement.• Viscoelastic dispensedduring retraction | • Proximal handle• Distal blunt endmanually pulledthrough trabecularmeshwork withproximal handle | • Proximal handle• Distal sharp endmanually pushedthrough trabecularmeshwork withproximal handle | Nonabsorbable,sterile, flexiblethread pulledthrough trabecularmeshwork |
| Viscoelastic | Supplied separately.Viscoelastic loaded intodevice prior to use. | Suppliedseparately.Cartridge attachesto the device. | Suppliedseparately.Viscoelasticloaded into deviceprior to use. | N/A | N/A | N/A |
| Sterile andSingle Use | Provided sterile. Single use | Provided sterile.Single use. | Provided sterile.Single use. | Provided non-sterile.Reusable. | Provided sterile.Single use. | Provided sterile.Single use. |
| Characteristic | OMNI Surgical System | Ellex's (iScience) iTrack(Primary Predicate) | Sight Sciences'VISCO360Viscosurgical System(Predicate Device) | Katena's HarmsTrabeculotomyProbe(Reference Device) | New WorldMedical'sKahook Dual Blade(Reference Device) | Nylon or ProleneSuture(Reference Device) |
| Passive orEnergizedDevice toDispenseViscoelastic | Passive | Passive | Passive | N/A | N/A | N/A |
| DispensingControl | Manual rotation of thefinger wheel at the distalend of the device | Rotational actionvia a knob on theViscoInjector todispenseviscoelastic fluid | Manual rotationof the fingerwheel at the distalend of the device | N/A | N/A | N/A |
| DispensingMechanism | Syringe (Volumeexchange) | Syringe (Volumeexchange) | Syringe (Volumeexchange) | N/A | N/A | N/A |
| Materials | Cannula - Stainless steelMicrocatheter -Polyamide (Nylon) | Microcatheter –polyamide | Cannula - StainlesssteelMicrocatheter - Nylon | Stainless Steel &Titanium | Stainless steel | Polypropylene ornylon |
| Interface | Handheld | Handheld | Handheld | Handheld | Handheld | Handheld |
| Microcathetershaft/ProbeOD | 200 microns | 200 microns | 200 microns | 300 microns | N/A | Varies (typically 4-0or 200 microns or 5-0 or 150 microns forsuturetrabeculotomy) |
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Performance Data:
The OMNI's descriptive characteristics are well-defined and adequate to ensure equivalence to the predicate devices. Additionally, the following performance testing and inspection was conducted on the OMNI device: dimensional and visual inspections, visual inspection of labeling and component inspections, mechanical testing of joint strength and actuation force, simulated use testing, and human cadaver eye performance testing. Acceptance criteria was based on predicate VISCO360's dispensing performance, intrinsic strength of the materials, and the load and conditions to which the OMNI would be subjected during use.
Testing demonstrated that the OMNI performs as intended and is functionally equivalent to the predicate devices.
Conclusion:
The Sight Sciences OMNI Surgical System meets all product design requirements and applicable standards. The OMNI System shares the same intended use, key technological characteristics, and principle of operation as the predicate devices. Therefore, the device has been shown to be substantially equivalent to the predicate devices.
§ 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).