(59 days)
Not Found
No
The description focuses on the mechanical operation of a manually operated surgical device and does not mention any computational or learning components.
Yes
The device is used to deliver viscoelastic fluid during ophthalmic surgery and to cut trabecular meshwork tissue during trabeculotomy procedures, both of which are therapeutic interventions.
No
The device is described as a "manually operated device for delivery of small amounts of viscoelastic fluid" and for "cut[ting] trabecular meshwork tissue during trabeculotomy procedures." These functions are therapeutic interventions, not diagnostic ones.
No
The device description clearly outlines a physical, manually operated instrument with components like a cannula, microcatheter, reservoir, and finger wheels, indicating it is a hardware device.
Based on the provided information, the OMNI™ Surgical System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for delivering viscoelastic fluid and cutting trabecular meshwork tissue during ophthalmic surgery. This is a surgical procedure performed directly on the patient's eye.
- Device Description: The device is described as a manually operated instrument used by ophthalmologists for surgical procedures. It involves mechanical actions (delivering fluid, cutting tissue) within the eye.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) to provide diagnostic information about a patient's health status. IVD devices are specifically designed for in vitro (outside the body) diagnostic testing.
Therefore, the OMNI™ Surgical System is a surgical device, not an IVD.
N/A
Intended Use / 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.
Product codes
MRH, HMZ
Device Description
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.
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 / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image 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.
1
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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3
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 Road
Building 3, Suite 105
Menlo Park, CA 94025
Tel: (877) 266-1144 | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------|
| OFFICIAL
CORRESPONDENT | Anne-Marie Ripley
Sight Sciences, Inc.
3000 Sand Hill Road
Bldg. 3, Suite 105
Menlo Park, CA 94025 | |
| | Anne@sightsciences.com
Mobile: 661-645-8546 | |
| DATE SUMMARY WAS
PREPARED: | December 21, 2017 | |
| TRADE NAME: | OMNI™ Surgical System | |
| CLASSIFICATION NAMES | Infusion Pump | Manual Ophthalmic
Instrument |
| 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.
5
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.
6
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'
VISCO360
Viscosurgical System
(Predicate Device) | Katena's Harms
Trabeculotomy
Probe
(Reference Device) | New World
Medical's
Kahook Dual Blade
(Reference Device) | Nylon or Prolene
Suture
(Reference Device) |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | • Delivery of small
amounts of
viscoelastic fluid
during ophthalmic
surgery
• Cutting of trabecular
meshwork when a
trabeculotomy is
indicated | • Delivery of small
amounts of
viscoelastic fluid
during ophthalmic
surgery | • Delivery of small
amounts of
viscoelastic fluid
during ophthalmic
surgery | • Cutting of
trabecular
meshwork when a
trabeculotomy is
indicated | • Cutting of
trabecular
meshwork when
a trabeculotomy
is indicated | • Soft tissue
approximation
and various
other uses
including cutting
of trabecular
meshwork when
a trabeculotomy
is indicated |
| Indication for
Use | The OMNI System is a
manually operated
device for delivery of
small amounts of
viscoelastic fluid, for
example Healon or
HealonGV 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 iScience
Interventional
Canaloplasty
Microcatheter is
indicated for fluid
infusion and aspiration
during surgery. The
iScience Interventional
Canaloplasty
Microcatheter is
indicated for
catheterization and
viscodilation of
Schlemm's canal to
reduce intraocular
pressure in adult
patients with open
angle glaucoma. | The VISCO360
Viscosurgical System
is a manually
operated device for
delivery of small
amounts of
viscoelastic fluid, for
example Healon or
HealonGV from
Abbott Medical Optics
(AMO), Amvisc from
Bausch & Lomb, or
PROVISC from Alcon,
during ophthalmic
surgery. | Cutting of trabecular
meshwork when a
trabeculotomy is
indicated | Cutting of trabecular
meshwork when a
trabeculotomy is
indicated | Soft tissue
approximation and
various other uses
including cutting of
trabecular
meshwork when a
trabeculotomy is
indicated |
| Characteristic | OMNI Surgical System | Ellex's (iScience) iTrack
(Primary Predicate) | Sight Sciences'
VISCO360
Viscosurgical System
(Predicate Device) | Katena's Harms
Trabeculotomy
Probe
(Reference Device) | New World
Medical's
Kahook Dual Blade
(Reference Device) | Nylon or Prolene
Suture
(Reference Device) |
| Regulation | Primary: 880.5725
(Infusion Pump)
Secondary: 886.4350
(Manual ophthalmic
surgical instrument) | Primary: 876.1500
(Endoilluminator)
Secondary: 886.4350
(Manual ophthalmic
surgical instrument) | 880.5725 (Infusion
Pump) | 886.4350 (Manual
ophthalmic surgical
instrument) | 886.4350 (Manual
ophthalmic surgical
instrument) | 878.5010 and
878.5020
(Nonabsorbable
surgical suture) |
| Device Class | Class II | Class II | Class II | Class I, exempt | Class I, exempt | Class II |
| Product Code | Primary: MRH
(Ophthalmic Infusion
Pump, Class II)
Secondary: HMZ
(Trabeculotome, Manual
ophthalmic surgical
instrument, Class I
exempt) | Primary: MPA (for
endoilluminator, Class
II)
Secondary: HMX
(Ophthalmic Cannula,
Manual ophthalmic
surgical instrument,
Class I Exempt) | MRH (Ophthalmic
Infusion Pump, Class
II) | HMZ
(Trabeculotome,
Manual ophthalmic
surgical instrument,
Class I exempt) | HNN (Ophthalmic
Knife, Manual
ophthalmic surgical
instrument, Class I
exempt) | GAW and GAR
(Nonabsorbable,
Synthetic Suture,
Class II) |
| Target
Anatomy | Anterior Segment
including Schlemm's
Canal/Trabecular
Meshwork | Schlemm's
Canal/Trabecular
Meshwork | Anterior Segment
including Schlemm's
Canal | Schlemm's
Canal/Trabecular
Meshwork | Schlemm's
Canal/Trabecular
Meshwork | Anywhere, including
Schlemm's
Canal/Trabecular
Meshwork |
| Operating
Principle | Manual | · Manual (microcatheter)
• Powered
(endoilluminator) | Manual | Manual | Manual | Manual |
| Characteristic | OMNI Surgical System | Ellex's (iScience) iTrack
(Primary Predicate) | Sight Sciences'
VISCO360
Viscosurgical System
(Predicate Device) | Katena's Harms
Trabeculotomy
Probe
(Reference Device) | New World
Medical's
Kahook Dual Blade
(Reference Device) | Nylon or Prolene
Suture
(Reference Device) |
| Design/Mechanism of Action | • Flexible microcatheter for
dispensation of
viscoelastic
• Microcatheter has a
round, bolus, atraumatic
tip
• Proximal handle
• Handle has internal
viscoelastic reservoir and
plunger tube
• Finger wheel for
advancing and retracting
microcatheter.
• Tactile and audible clicks
indicate precise
advancement.
• Viscoelastic dispensed
during retraction
• Flexible microcatheter
introduced into
Schlemm's canal and
pulled through to cut
trabecular meshwork | • Flexible microcatheter
for dispensation of
viscoelastic
• Microcatheter has a
round, bolus,
atraumatic tip
• Microcatheter attaches
at proximal end to Ellex
Viscolnjector to
dispense viscoelastic
using a knob
• Microcatheter manually
advanced by clinician
• Tactile and audible
clicks indicate precise
advancement.
• Optical fiber provide
illumination at tip of
catheter | • Flexible microcatheter
for dispensation of
viscoelastic
• Microcatheter has a
round, bolus,
atraumatic tip
• Proximal handle
• Handle has internal
viscoelastic reservoir
and plunger tube
• Finger wheel for
advancing and
retracting
microcatheter.
• Tactile and audible
clicks indicate precise
advancement.
• Viscoelastic dispensed
during retraction | • Proximal handle
• Distal blunt end
manually pulled
through trabecular
meshwork with
proximal handle | • Proximal handle
• Distal sharp end
manually pushed
through trabecular
meshwork with
proximal handle | Nonabsorbable,
sterile, flexible
thread pulled
through trabecular
meshwork |
| Viscoelastic | Supplied separately.
Viscoelastic loaded into
device prior to use. | Supplied
separately.
Cartridge attaches
to the device. | Supplied
separately.
Viscoelastic
loaded into device
prior to use. | N/A | N/A | N/A |
| Sterile and
Single 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'
VISCO360
Viscosurgical System
(Predicate Device) | Katena's Harms
Trabeculotomy
Probe
(Reference Device) | New World
Medical's
Kahook Dual Blade
(Reference Device) | Nylon or Prolene
Suture
(Reference Device) |
| Passive or
Energized
Device to
Dispense
Viscoelastic | Passive | Passive | Passive | N/A | N/A | N/A |
| Dispensing
Control | Manual rotation of the
finger wheel at the distal
end of the device | Rotational action
via a knob on the
ViscoInjector to
dispense
viscoelastic fluid | Manual rotation
of the finger
wheel at the distal
end of the device | N/A | N/A | N/A |
| Dispensing
Mechanism | Syringe (Volume
exchange) | Syringe (Volume
exchange) | Syringe (Volume
exchange) | N/A | N/A | N/A |
| Materials | Cannula - Stainless steel
Microcatheter -
Polyamide (Nylon) | Microcatheter –
polyamide | Cannula - Stainless
steel
Microcatheter - Nylon | Stainless Steel &
Titanium | Stainless steel | Polypropylene or
nylon |
| Interface | Handheld | Handheld | Handheld | Handheld | Handheld | Handheld |
| Microcatheter
shaft/Probe
OD | 200 microns | 200 microns | 200 microns | 300 microns | N/A | Varies (typically 4-0
or 200 microns or 5-
0 or 150 microns for
suture
trabeculotomy) |
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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.