(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:
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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.
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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.
§ 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).