(28 days)
Not Found
No
The device description focuses on mechanical operation and fluid dynamics, with no mention of AI/ML terms or functionalities.
No.
The device is a surgical tool used to deliver fluid and cut tissue during ophthalmic surgery, which are procedural steps rather than direct therapeutic actions or long-term therapeutic effects.
No
Explanation: The device is described as an ophthalmic surgical tool used to deliver viscoelastic fluid and cut trabecular meshwork. Its function is to perform surgical procedures, not to diagnose a condition.
No
The device description clearly outlines a physical, manually operated surgical instrument with components like a cannula, microcatheter, reservoir, and advancement wheels. It is a hardware device used for fluid delivery and tissue cutting.
Based on the provided information, the OMNI® PLUS Surgical System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is described as 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." This describes a surgical procedure performed directly on the patient's eye.
- Device Description: The device description details a surgical instrument used for fluid delivery and tissue cutting within the eye. It interacts directly with the patient's anatomy during surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. The OMNI® PLUS Surgical System is a surgical tool used for treatment and manipulation of tissue within the eye, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The OMNI® PLUS 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MRH, HMZ
Device Description
The OMNI PLUS Surgical System is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small, controlled amounts of viscoelastic fluid into the anterior segment of the eye during ophthalmic surgery and cut trabecular meshwork tissue during trabeculotomy procedures. The OMNI PLUS device is provided sterile and disposed after single-patient use. The device is fabricated from biocompatible materials standard to the medical device industry. The OMNI PLUS Surgical System dispenses fluid on the principle of exchanging volumes much like a syringe and are designed to function with commercially available cohesive viscoelastic fluids (also known as an ophthalmic viscosurgical device, or “OVD”) that are commercially available from companies such as Johnson & Johnson, Bausch & Lomb, and Alcon.
The OMNI PLUS device includes a stainless-steel cannula, polymeric microcatheter, removable priming lock, internal reservoir and plunger tube, a Luer fitting for direct connection with an OVD cartridge to prime the internal reservoir, and two advancement wheels. A single advancement wheel is located on each side of the handle. This allows the OMNI PLUS device to be used in either eye (OD or OS) and in either hand of the surgeon (left or right), by turning the device 180 degrees along its vertical axis. These wheels are used to advance and retract the microcatheter.
The microcatheter can be advanced/retracted up to 20 mm per cycle by manually rotating either 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. When the OMNI PLUS device is being used to deliver viscoelastic fluid, retraction of the microcatheter causes a plunger tube to advance into the viscoelastic fluid reservoir thereby automatically dispensing viscoelastic fluid as the microcatheter is being retracted back into the stainless-steel cannula.
When the OMNI PLUS Surgical System is used to perform a trabeculotomy procedure, the beveled tip of the curved stainless-steel cannula is used to enter Schlemm’s canal through the trabecular meshwork. The polymeric microcatheter is 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 OMNI PLUS Surgical System is an additional model based on the current OMNI Surgical System design; OMNI PLUS is designed 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
Anterior Segment including Schlemm's Canal/Trabecular Meshwork
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Ophthalmologists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench testing included design verification and functional product testing, sterilization validation, packaging and shelf life testing, biocompatibility testing, bacterial endotoxin testing and simulated use (usability) testing in a bench model. Results of the nonclinical testing demonstrate that the OMNI PLUS Surgical System meets the defined specifications and functioned as intended.
Design verification testing was performed to demonstrate the OMNI PLUS Surgical System device meets the performance requirements described in the Product Specification after the following conditioning: worst-case dosage sterilization cycle, extreme conditions environmental exposure, simulated transit and accelerated and real-time aging. After conditioning and accelerated aging, test samples were subjected to a variety of tests including mechanical integrity assessment, sterile barrier packaging testing, physical requirements, product inspections and specification verifications. The results establish that the OMNI PLUS Surgical System functioned as intended and complies with the applicable requirements.
The OMNI PLUS Surgical System was adopted into the sterilization process that was validated for the predicate OMNI device in K173332. Sterilization is performed by the same approved contractor. The rationale for adoption was based on similarities in mass and product-related variables that affect bioburden. In addition to a written justification for adoption of the OMNI PLUS Surgical System, representative device samples were tested for bioburden and subjected to a verification dose experiment as a demonstration of process effectiveness. The tested units were found to be sterile after processing with the sub-lethal dose, confirming that the product may be labeled "Sterile" per ANSI/AAMI/ISO 11137-2:2013.
The OMNI PLUS Surgical System is currently validated for total shelf life of 13 months. The device packaging is labeled with an expiration date of 12 months, providing a one-month safety factor. The shelf life study evaluated the functional performance of the OMNI PLUS Surgical System, as well as the packaging integrity of the tray sealed with the Tyvek lid after test samples were subjected to worst-case dosage sterilization cycle, extreme conditions environmental exposure, simulated transit conditioning, and real-time aging. After conditioning and real-time aging for a minimum of 13 months, OMNI samples were subjected to a variety of tests related to shelf life including visual verification of packaging, labeling and device integrity, sterile barrier packaging testing, and functional performance testing.
Biocompatibility of the OMNI PLUS Surgical System was demonstrated through testing in accordance with ISO 10993-1:2009/(R)2013 "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process." Testing was performed by an approved contract laboratory on all components that have direct or indirect contact with the patient. Test results demonstrated that the device materials have an acceptable biocompatibility profile and met the requirements of the ISO standard. Additionally, OMNI PLUS devices were tested for bacterial endotoxin according to USP :2011 "Bacterial Endotoxin Test" and ANSI/AAMI ST72:2011/(R)2016 "Bacterial endotoxins – Test methodologies, routine monitoring, and alternatives to batch testing." Test results demonstrated that the samples do not have an unacceptable level of bacterial endotoxin and met the endotoxin limit requirement of
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is a blue square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Sight Sciences, Inc. Mr. Edward Sinclair Vice President, Regulatory Affairs 4040 Campbell Ave., Suite 100 Menlo Park, CA 94025
Re: K201953
Trade/Device Name: OMNI PLUS Surgical System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: MRH, HMZ Dated: July 13, 2020 Received: July 14, 2020
Dear Mr. Sinclair:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm_identifies_combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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.
for LT Charles Chiang Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
3
510(k) SUMMARY
Submitter Information
| 510(k) Owner: | Sight Sciences, Inc.
4040 Campbell Ave., Suite 100
Menlo Park, CA 94025
Tel: (877) 266-1144 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Edward J. Sinclair
Vice President, Regulatory Affairs
4040 Campbell Ave., Suite 100
Menlo Park, CA 94025
Tel: 650-218-9149 |
| Date Prepared: | June 23, 2020 |
Device Name and Classification
| Trade Name: | OMNI® PLUS Surgical System |
|---|---|
| Common Name: | Ophthalmic Infusion Pump |
| Classification Name: | Infusion Pump |
| Regulation Number: | 21 CFR 880.5725 |
| Device Classification: | Class II |
| Primary Product Code: | MRH |
| Secondary Product Code: | HMZ |
Predicate Device
| Device Name: | OMNI® Surgical System |
|---|---|
| 510(k) Holder: | Sight Sciences, Inc. |
| 510(k) Number: | K173332 |
| Clearance Date: | December 21, 2017 |
Intended Use
The OMNI® PLUS 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® 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,
4
Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.
Device Description
The OMNI PLUS Surgical System is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small, controlled amounts of viscoelastic fluid into the anterior segment of the eye during ophthalmic surgery and cut trabecular meshwork tissue during trabeculotomy procedures. The OMNI PLUS device is provided sterile and disposed after singlepatient use. The device is fabricated from biocompatible materials standard to the medical device industry. The OMNI PLUS Surgical System dispenses fluid on the principle of exchanging volumes much like a syringe and are designed to function with commercially available cohesive viscoelastic fluids (also known as an ophthalmic viscosurgical device, or "OVD") that are commercially available from companies such as Johnson & Johnson, Bausch & Lomb, and Alcon.
The OMNI PLUS device includes a stainless-steel cannula, polymeric microcatheter, removable priming lock, internal reservoir and plunger tube, a Luer fitting for direct connection with an OVD cartridge to prime the internal reservoir, and two advancement wheels. A single advancement wheel is located on each side of the handle. This allows the OMNI PLUS device to be used in either eye (OD or OS) and in either hand of the surgeon (left or right), by turning the device 180 degrees along its vertical axis. These wheels are used to advance and retract the microcatheter.
The microcatheter can be advanced/retracted up to 20 mm per cycle by manually rotating either 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. When the OMNI PLUS device is being used to deliver viscoelastic fluid, retraction of the microcatheter causes a plunger tube to advance into the viscoelastic fluid reservoir thereby automatically dispensing viscoelastic fluid as the microcatheter is being retracted back into the stainless-steel cannula.
When the OMNI PLUS Surgical System is used to perform a trabeculotomy procedure, the beveled tip of the curved stainless-steel cannula is used to enter Schlemm's canal through the trabecular meshwork. The polymeric microcatheter is 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 OMNI PLUS Surgical System is an additional model based on the current OMNI Surgical System design; OMNI PLUS is designed to dispense a nominal volume of 21 microliters of viscoelastic fluid.
Comparison of Technological Characteristics with the Predicate Device
The technical features of the OMNI PLUS Surgical System are substantially equivalent to the OMNI Surgical System predicate device (cleared by FDA in K173332 on December 21, 2017). The OMNI
5
PLUS Surgical System is an additional model based on the OMNI Surgical System design. The primary functional difference between the predicate device and subject device is the volume of viscoelastic fluid that can be delivered during use. The predicate OMNI Surgical System delivers a nominal volume of approximately 9 microliters of viscoelastic fluid, whereas the subject OMNI PLUS design can deliver a nominal volume of approximately 21 microliters of viscoelastic fluid. 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 in the OMNI PLUS device. Other changes were made to improve the aesthetics, ergonomics and manufacturability of the device. These include the handle shape and materials, reduced number of advancement wheels, addition of a proximal Luer fitting to aid priming and a packaging tray with a heat-sealed Tyvek lid. Other minor changes are included in the technological attributes comparison between the OMNI PLUS Surgical System (subject device) with the OMNI Surgical System (predicate device) in Table 1 below.
| Characteristic | OMNI PLUS Surgical System | OMNI Surgical System (K173332) |
|---|---|---|
| SUBJECT DEVICE | PREDICATE DEVICE | |
| 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 | ||
| Indications for | ||
| Use | The indications were updated to reflect a | |
| change in manufacturer of the Healon | ||
| viscoelastic fluids from Abbott Medical Optics | ||
| to Johnson & Johnson, as well as to add the | ||
| OMNI PLUS Surgical System as follows: |
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 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 |
| Regulation | 880.5725 (Infusion Pump) | 880.5725 (Infusion Pump) |
| Device Class | Class II | Class II |
| Product Code | Primary: MRH
Secondary: HMZ | Primary: MRH
Secondary: HMZ |
| Prescription
Status | Prescription use only | Prescription use only |
| Target
Anatomy | Anterior Segment including Schlemm's
Canal/Trabecular Meshwork | Anterior Segment including Schlemm's
Canal/Trabecular Meshwork |
| Operating
Principle | Manual | Manual |
| | OMNI PLUS Surgical System | OMNI Surgical System (K173332) |
| Characteristic | SUBJECT DEVICE | PREDICATE DEVICE |
| Design/
Mechanism 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 – rectangular shape
• Handle has internal viscoelastic reservoir and
plunger tube
• Four advancement wheels (finger wheels) for
advancing and retracting microcatheter up to
20mm using a rack and pinion mechanism
• Tactile and audible clicks indicate precise
advancement
• Viscoelastic dispensed during retraction of first
two cycles after priming with viscoelastic fluid
• Flexible microcatheter introduced into
Schlemm's canal and pulled through to cut
trabecular meshwork |
| Dispensing
Control | 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 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. | After priming, viscoelastic fluid dispensing
control occurs through manual rotation of the
advancement wheels at the distal end of the
device. The rectangular shape of the handle
required two advancement wheels on each side
of the handle for ambidextrous use in either
patient eye |
| 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) |
| 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 to a supplied
nozzle and advancing into proximal end of
OMNI device handle |
| OVD Volume
Dispensed | $21 \pm 3$ µL (10.5 µL on first microcatheter
retraction cycle and 10.5 µL on the second
cycle) | $9 \pm 3$ µL (4.5 µL on first microcatheter
retraction cycle and 4.5 µL on the second cycle) |
| | OMNI PLUS Surgical System | OMNI Surgical System (K173332) |
| Characteristic | SUBJECT DEVICE | PREDICATE DEVICE |
| Materials | Medical grade materials, including ABS,
polycarbonate, stainless steel, silicone,
parylene coating, cyanoacrylate, acrylated
urethane, polyimide. Minor changes were
made to the materials in the handle, reservoir,
Luer fitting and a new bonding adhesive was
used | Medical grade materials, including ABS,
polycarbonate, stainless steel, silicone,
parylene coating, cyanoacrylate, acrylated
urethane, polyimide |
| User Interface | Handheld | Handheld |
| Microcatheter
Shaft Outer
Diameter | 200 microns | 200 microns |
| Microcatheter
Tip Outer
Diameter Range | 0.0090 to 0.0110 inches. The lower
specification limit was reduced by 0.0005
inches | 0.0095 to 0.0110 inches |
| Sterile and
Single Use | Provided sterile. Single patient use | Provided sterile. Single patient use |
| Sterilization
Method | Gamma radiation | Gamma radiation |
| Sterility
Assurance Level | 10-6 | 10-6 |
| Packaging | Thermoformed plastic tray with heat-sealed
Tyvek lid | Tyvek pouch with a polymer tray card |
| Shelf Life | 13 months | 6 months |
Table 1: Technological Characteristics Comparison OMNI PLUS Surgical System and Predicate Device
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Risk Management
The risk management process at Sight Sciences complies with ISO 14971:2012 "Medical devices --Application of risk management to medical devices." As required by this standard, risk analyses are conducted according to defined procedures, using experienced, qualified personnel from multiple functions throughout the organization with prior experience in risk assessment.
Risk management activities were first documented in a Risk Management Plan. This plan specified the risk management activities to be conducted based on the cleared OMNI Surgical System that resulted in the OMNI PLUS Surgical System design. The following activities were completed:
- . The Clinical Hazard Analysis for the OMNI Surgical System changes and the OMNI PLUS Surgical System was re-assessed by qualified personnel with respect to all changes.
- . All identified hazards associated with the OMNI devices were evaluated and recorded along with potential harm and effects resulting from the hazard and the severity ranking of each hazard in Failure Modes Effect Analyses (FMEAs).
- . Potential hazards were mitigated through the device design and manufacturing processes and any mitigations were subsequently verified.
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All the identified hazards were mitigated to an acceptable level of risk. The potential benefits to patients outweigh the low residual risk of the design changes and taking into consideration the indications for use of the OMNI devices.
Performance Data – Bench Testing
Non-clinical bench testing included design verification and functional product testing, sterilization validation, packaging and shelf life testing, biocompatibility testing, bacterial endotoxin testing and simulated use (usability) testing in a bench model. Results of the nonclinical testing demonstrate that the OMNI PLUS Surgical System meets the defined specifications and functioned as intended.
Design Verification and Functional Product Testing
Design verification testing was performed to demonstrate the OMNI PLUS Surgical System device meets the performance requirements described in the Product Specification after the following conditioning: worst-case dosage sterilization cycle, extreme conditions environmental exposure, simulated transit and accelerated and real-time aging. After conditioning and accelerated aging, test samples were subjected to a variety of tests including mechanical integrity assessment, sterile barrier packaging testing, physical requirements, product inspections and specification verifications. The results establish that the OMNI PLUS Surgical System functioned as intended and complies with the applicable requirements.
Sterilization Validation
The OMNI PLUS Surgical System was adopted into the sterilization process that was validated for the predicate OMNI device in K173332. Sterilization is performed by the same approved contractor. The rationale for adoption was based on similarities in mass and product-related variables that affect bioburden. In addition to a written justification for adoption of the OMNI PLUS Surgical System, representative device samples were tested for bioburden and subjected to a verification dose experiment as a demonstration of process effectiveness. The tested units were found to be sterile after processing with the sub-lethal dose, confirming that the product may be labeled "Sterile" per ANSI/AAMI/ISO 11137-2:2013.
Packaging and Shelf Life Testing
The OMNI PLUS Surgical System is currently validated for total shelf life of 13 months. The device packaging is labeled with an expiration date of 12 months, providing a one-month safety factor. The shelf life study evaluated the functional performance of the OMNI PLUS Surgical System, as well as the packaging integrity of the tray sealed with the Tyvek lid after test samples were subjected to worst-case dosage sterilization cycle, extreme conditions environmental exposure, simulated transit conditioning, and real-time aging. After conditioning and real-time aging for a minimum of 13 months, OMNI samples were subjected to a variety of tests related to shelf life including visual verification of packaging, labeling and device integrity, sterile barrier packaging testing, and functional performance testing.
Biocompatibility and Bacterial Endotoxin Testing
Biocompatibility of the OMNI PLUS Surgical System was demonstrated through testing in accordance with ISO 10993- 1:2009/(R)2013 "Biological Evaluation of Medical Devices – Part 1:
9
Evaluation and testing within a risk management process." Testing was performed by an approved contract laboratory on all components that have direct or indirect contact with the patient. Test results demonstrated that the device materials have an acceptable biocompatibility profile and met the requirements of the ISO standard. Additionally, OMNI PLUS devices were tested for bacterial endotoxin according to USP :2011 "Bacterial Endotoxin Test" and ANSI/AAMI ST72:2011/(R)2016 "Bacterial endotoxins – Test methodologies, routine monitoring, and alternatives to batch testing." Test results demonstrated that the samples do not have an unacceptable level of bacterial endotoxin and met the endotoxin limit requirement of ≤0.2 EU/device.
Conclusions
The Sight Sciences OMNI PLUS Surgical System meets all product design requirements and applicable standards as the predicate OMNI Surgical System. The subject device shares the same principle of operation, intended use/indications and many of same key technological characteristics as the predicate device. Differences in technological characteristics were evaluated using the same recognized consensus standards and scientific methods used to clear the predicate device in K173332. The conclusions drawn from the non-clinical bench performance tests demonstrate that the OMNI PLUS Surgical System meets the defined specifications and performs as intended.
The OMNI PLUS Surgical System is substantially equivalent to the legally-marketed OMNI Surgical System predicate device cleared under 510(k) K173332.