Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and material properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No.
The device is described as an injector for delivering viscoelastic fluid during ophthalmic surgery, which is a procedural tool rather than a device intended to provide therapy itself.

Diagnostic

No

Explanation: The device is designed to deliver viscoelastic fluid during ophthalmic surgery, which is a therapeutic function, not a diagnostic one. Its purpose is to physically inject a substance, not to analyze or identify a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, single-use disposable device comprised of a stainless steel cannula and polymer components, designed to mechanically deliver viscoelastic fluid. There is no mention of software as a component or function of the device.

IVD (In Vitro Diagnostic)

Based on the provided text, the Streamline® Viscoelastic Injector is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to "deliver small amounts of viscoelastic fluid during Ophthalmic Surgery." This describes a surgical tool used in vivo (within the body) during a procedure.
Device Description: The description details a mechanical device with a cannula designed for insertion into the eye to dispense fluid. This is consistent with a surgical instrument, not a device used to examine specimens in vitro (outside the body).
Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.

Therefore, the Streamline® Viscoelastic Injector is a surgical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Streamline® Viscoelastic Injector is a single-use disposable cannula for use during ophthalmic surgical procedures to deliver small amounts of viscoelastic fluid.

Product codes

MRH, HMX

Device Description

The Streamline® Viscoelastic Injector is a single use disposable device designed to deliver small amounts of viscoelastic fluid.

The device consists of a single-use disposable device comprised of a surgical grade stainless steel cannula and a polymer handset, actuator button and priming port (Figure 1). The cannula is comprised of a long thin neck with an outer sleeve at its tip and allows access through a minimum 1.8 mm clear corneal incision. The cannula is long enough to reach across the eye 180 degrees from the clear corneal incision.

The device outer sleeve is transparent which allows the dispensing cannula with a clearly identifiable color to be visible at 12X magnification.

The priming port allows interfacing with commonly used viscoelastic containers used during priming and filling of the device.

The actuator button is located at the top of the handset and is colored for easy identification and incorporates a slight depression giving the user a tactile feel and correct finger placement. Each actuation of the actuator button causes an internal mechanical cam to rotate causing a snap action which rapidly retracts the outer sleeve at the device's distal tip. This action allows the cannula to dispense viscoelastic fluid through opposing side outlets located at an acute angle from the perpendicular plane of tip (Figure 2).

The length of the gear assembly allows for up to eight (8) total activations of the device. Each activation of the delivers approximately 7 µL of OVD and approximately 56 µL of OVD for the total maximum 8 activations allowed by the device. Once all activations are completed the gear assembly will have reached the end of travel and cannot be reset. Additionally, activation of the actuator button causes the priming port to disengage from the fluid pathway, to prevent re-priming of the device. This prevents the device from further priming preventing re-use.

Materials used to manufacture the Streamline® Viscoelastic Injector are of medical grade quality and no toxic substances are used in the manufacturing process. The materials used in the Streamline® Viscoelastic Injector were selected from materials safe for use in a clinical setting. These materials include stainless steel, polycarbonate, ABS polymer and silicone.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Anterior Chamber

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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)

Functional Performance Testing, Design Verification:
Testing was based on all applicable standards, as well as, testing to demonstrate conformance to design specifications. Test samples exposed to maximum gamma sterilization simulation, environmental conditioning, and accelerated aging for 1-year shelf life.

Joint Strength Testing:
- Quantitative tensile strength testing of all patient interfacing cannula and over-molded polymer O joints using Instron with validated test methods, assuring cannula integrity for anticipated forces during use.
- Bend testing of patient interfacing cannula under maximum expected loading during use, using O Instron with validated test method.
- Strength of priming port interface qualitatively confirmed for all test units through simulated use O and visual inspection under protocol.
Drivetrain motion functional testing:
- Oualitatively verify activation of the Actuator Button causes the desired drivetrain motion via O visual inspection during multiple button actuations, with one side housing removed (100% of units during sample build).
- Verify Maximum Recommended Cycles Qualitatively verify activation of Actuator Button O results in fluid being dispensed and mechanism resets for maximum number of cycles recommended in IFU.
Actuator Button force:
- Quantitative test measuring force required to fully depress Actuator Button using Instron, O validated test method, and a range of viscoelastic fluids.
- Visually verify units dispense fluid and the mechanism resets for maximum number of cycles O recommended in the IFU.
Dispense volume testing:
- Ouantitatively test under validated test methods measuring amount of dispensed viscoelastic fluid O per Actuator Button activation for different viscoelastic fluids over maximum number of cycles recommended in the IFU.
Leak Testing:
- Quantitatively test fluid pathway seals and duckbill valve via 100% pressure decay tests during O sample build.
Cadaver evaluation:
- Qualitatively verify delivery using viscoelastic fluid dyed with Trypan Blueon cadaver eyes. O
Human Factors Engineering Evaluation:
- Human Factors Engineering evaluation utilizing 15 surgeons in simulated surgical suite, working O through all stages of unpacking, presenting to sterile field, priming and using device per label/ instructions for use.
Biocompatibility:
- Biocompatibility assessment within a risk management framework per ISO 10993-1 Fifth Edition O 2018-08. The following tests will be completed:
  - Cytotoxicity as per the requirements established in ISO 10993-5, Biological Evaluation of O Medical Devices -- Part 5, Annex C : MTT Cytotoxicity test.
  - Sensitization as per the requirements established in 10993-10. Biological Evaluation of Medical O Devices -- Part 10: Tests For Irritation And Skin Sensitization.
  - Irritation or Intracutaneous Reactivity in accordance with FDA GLP Regulations, 21 CFR 58 O
  - Acute Systemic Toxicity as per the requirements established in 10993-11, Biological Evaluation O of Medical Devices -- Part 11: Tests for Systemic Toxicity.
  - Material-Mediated Pyrogenicity as per the requirements established in 10993-11, Biological O Evaluation of Medical Devices -- Part 11: Tests For Systemic Toxicity, and USP 43-NF 38 General Chapter , Pyrogen Test.
Chemical characterization testing of materials per EN ISO 10993-18:2009.
Package Integrity for 1-year shelf life:
- Demonstration of package integrity per EN ISO 11607-1 and 2:2019, Requirements for materials, O sterile barrier systems and packaging systems. after maximum gamma sterilization, distribution simulation and environmental conditioning. Samples aged in compliance to ASTM F1980-16
  - Visible inspection of seals per ASTM F1886-16
  - Seal strength per ASTM F88-15
  - Seal integrity per ASTM F2096-11
Luer Fitting Compliance:
- Priming port, female luer connection, confirmed compliance to ISO 80369-7:2016 O
- Stainless Steel Cannula compliance to ISO 9626:2016

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K173332

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

October 8, 2021

New World Medical, Inc. Victor Arellano Global Regulatory Affairs Manager 10763 Edison Court Rancho Cucamonga, California 91730

Re: K211680

Trade/Device Name: Streamline® Surgical System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRH, HMX Dated: August 27, 2021 Received: September 1, 2021

Dear Victor Arellano:

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

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for LCDR 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

Indications for Use

510(k) Number (if known) K211680

Device Name Streamline® Viscoelastic Injector

Indications for Use (Describe)

The Streamline® Viscoelastic Injector is a single-use disposable cannula for use during ophthalmic surgical procedures to deliver small amounts of viscoelastic fluid.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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3

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Submitter Information

| 510(K) Owner Name: | New World Medical, Inc
10763 Edison Court
Rancho Cucamonga, CA 91730
USA (909) 466-4304 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Victor Arellano
Global Regulatory Affairs Manager
New World Medical, Inc.
Phone: (909) 466-4304 Ext118
Email: varellano@newworldmedical.com |

October 7, 2021

Date Prepared:

Device Name and Classification

Trade / Proprietary Name:	Streamline® Viscoelastic Injector
Device Common Name:	Viscoelastic Injector
Classification Names:	Pump, Infusion	Cannula, Ophthalmic
Regulation Numbers	21 CFR 880.5725	21 CFR 886.4350
Device Classification:	Class II	Class I
Product Codes	MRH (Infusion Pump, Ophthalmic)	HMX (Ophthalmic Cannula)

Predicate Device:	Image: box
-------------------	------------

Device Name	510(k) Number
OMNI™ Surgical System	K173332

4

Intended Use

The Streamline® Viscoelastic Injector is intended to deliver small amounts of viscoelastic fluid during Ophthalmic Surgery.

Indications for Use

The Streamline® Surgical System is a single-use disposable cannula for use during ophthalmic surgical procedures to deliver small amounts of viscoelastic fluid.

Device Description and Technological Characteristics

The Streamline® Viscoelastic Injector is a single use disposable device designed to deliver small amounts of viscoelastic fluid.

The device consists of a single-use disposable device comprised of a surgical grade stainless steel cannula and a polymer handset, actuator button and priming port (Figure 1). The cannula is comprised of a long thin neck with an outer sleeve at its tip and allows access through a minimum 1.8 mm clear corneal incision. The cannula is long enough to reach across the eye 180 degrees from the clear corneal incision.

The device outer sleeve is transparent which allows the dispensing cannula with a clearly identifiable color to be visible at 12X magnification.

Image /page/4/Picture/9 description: The image shows a white medical device with blue accents. The device has a dispensing cannula on the left side, an actuator button on the top, and a priming port on the right side. The device is labeled "STREAMLINE".

Image /page/4/Figure/10 description: The image shows the text "Figure 1" in a bold, sans-serif font. The word "Figure" is larger than the number "1". The text is black against a white background.

The priming port allows interfacing with commonly used viscoelastic containers used during priming and filling of the device.

The actuator button is located at the top of the handset and is colored for easy identification and incorporates a slight depression giving the user a tactile feel and correct finger placement. Each actuation of the actuator button causes an internal mechanical cam to rotate causing a snap action which rapidly retracts the outer sleeve at the device's distal tip. This action allows the cannula to dispense viscoelastic fluid through opposing side outlets located at an acute angle from the perpendicular plane of tip (Figure 2).

5

Image /page/5/Picture/1 description: The image shows three different states of a dispensing canula. The first state is the tip in its initial state. The second state shows the dispensing canula deployed. The third state shows the viscoelastic fluid being dispensed.

Image /page/5/Figure/2 description: The image shows the text "Figure 2" in a bold, sans-serif font. The word "Figure" is on the first line, and the number "2" is on the second line. The text is black against a white background.

The length of the gear assembly allows for up to eight (8) total activations of the device. Each activation of the delivers approximately 7 µL of OVD and approximately 56 µL of OVD for the total maximum 8 activations allowed by the device. Once all activations are completed the gear assembly will have reached the end of travel and cannot be reset. Additionally, activation of the actuator button causes the priming port to disengage from the fluid pathway, to prevent re-priming of the device. This prevents the device from further priming preventing re-use.

Materials used to manufacture the Streamline® Viscoelastic Injector are of medical grade quality and no toxic substances are used in the manufacturing process. The materials used in the Streamline® Viscoelastic Injector were selected from materials safe for use in a clinical setting. These materials include stainless steel, polycarbonate, ABS polymer and silicone.

Comparison of Technological Characteristics with the Predicate Device

The technical features of the Streamline® Viscoelastic Injector are substantially equivalent to the predicate device Sight Sciences Omni Surgical System (K173332).

The Streamline® Viscoelastic Injector and predicate device Sight Sciences Omni Surgical is a manually operated device for the controlled delivery of small amounts of viscoelastic fluid and dispenses these fluids based on the principle of exchanging volumes much like a syringe.

The following Table 2 compares the attributes of the Streamline® Viscoelastic Injector with the predicate device.

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| Characteristic | NWM Streamline® Viscoelastic
Injector(Subject Device) | OMNI™ SurgicalSystem
(Primary Predicate)K173332 |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class | II | II |
| Product Code | Primary: MRH (Ophthalmic Infusion
Pump, Class II) | Primary: MRH (Ophthalmic Infusion
Pump) |
| | Secondary: HMX (Class I, Exempt) for
Ophthalmic Cannulas | Secondary: HMZ(Trabeculotome) |
| Regulation | Primary: 880.5725(Infusion Pump) | Primary: 880.5725(Infusion Pump) |
| | Secondary: 886.4350(Manual
Ophthalmicsurgical instrument) | Secondary: 886.4350(Manual
ophthalmic surgical instrument) |
| Intended Use | Delivery of small amounts of viscoelastic
fluid during Ophthalmic Surgery | Delivery of small amounts of viscoelastic
fluid during Ophthalmic Surgery Creation
of incisions within the trabecular
meshwork. |
| Indications forUse | The Streamline® Viscoelastic Injector isa
single-use disposablecannula for use
during ophthalmic surgical procedures to
deliver small amounts of viscoelastic
fluid. | 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
trabeculotomyprocedures. |
| Technical
Characteristics | • Cannula
• Internal reservoir
• Plunger tube
• Actuator Button | • Cannula
• Microcatheter
• Internal reservoir
• Plunger tube
• Finger wheel |
| Characteristic | NWM Streamline® Viscoelastic
Injector(Subject Device) | OMNI™ SurgicalSystem
(Primary Predicate)K173332 |
| Target Anatomy | Anterior Chamber | Schlemm's Canal/TrabecularMeshwork |
| Operating
Principle | Manual | Manual |
| Design / Mechanism
ofAction | • Lumen has a round, bolus, atraumatic tip
fordispensing of viscoelastic.
• Retractable medical grade transparent
colored outer sleeve to enhance visibility
undermagnification.
• Proximal handledesigned for
ambidextrous use.
• Handle has internalviscoelastic reservoir
and plunger tube
• Finger actuated buttonfor retracting
sleeve anddispensing viscoelastic fluid.
• Device cannula is long enough to reach
across the eye180 degrees from the corneal
incision.
• Device dispensing cannula has opposing
outlets at an acute angleto dispense
viscoelasticfluid.
• Device actuation button provides audible
click when activating. | • Stainless-steel cannulahas sharp tip that
can beused to pierce the trabecular
meshwork and provide access into
Schlemm's canal. Minordimensional
changes to cannula tip height and radius
• Flexible microcatheterwith rounded,
atraumatic tip for dispensing of viscoelastic
• Microcatheter is bluecolor to facilitate its
visibility in Schlemm'scanal as it is
advanced/retracted through the cannula
• Microcatheter allowsaccess to 360° of
Schlemm's canal in two 180° segments
• Proximal handle changed to ovoid shape
with elastomeric material for added grip
• Proximal handle allows ambidextrous use
ineither patient eye
• Internal viscoelastic reservoir and plunger
tube with dimensionalchanges to allow
dispensing ofviscoelastic |
| Characteristic | NWM Streamline® Viscoelastic
Injector(Subject Device) | OMNI™ SurgicalSystem
(Primary Predicate)K173332 |
| | | • Ovoid handle shape allows advancement
wheels (finger wheels) to be reduced to two
foradvancing and retracting microcatheter
up to 20mm using a rack and pinion
mechanism
• Tactile and audible clicks indicate precise
advancement
• Viscoelastic dispensedduring retraction of
firsttwo cycles after priming with
viscoelastic fluid
• Flexible microcatheterintroduced into
Schlemm's canal and pulled through to cut
trabecular meshwork
• Priming Lock moved to accommodate new
Luerfitting and prevents accidental
dispensing during viscoelastic priming
• Changes were made to the materials in the
handle, reservoir, Luer fitting and new
bonding adhesive wasused |
| Viscoelastic | Supplied separatelyfrom unaffiliated
manufacturers.
Viscoelastic loaded intodevice prior to
use by attaching OVD cartridge directly
to a Luer fitting located at the proximal
end of the device handle for easeof
priming. | Cohesive viscoelasticfluid
(OVD or ophthalmic viscosurgical device)
issupplied separately.
Viscoelastic loaded into device (primed)
prior to use by attachingOVD cartridge
directly to a Luer fitting that replaces the
cap on proximal end of OMNIdevice handle
for ease of priming |
| Characteristic | NWM Streamline® Viscoelastic Injector
(Subject Device) | OMNI™ SurgicalSystem
(Primary Predicate)K173332 |
| Sterile andSingle
Use | Provided sterile. Singleuse. | Provided sterile. Singleuse. |
| Passive or
Energized Device
to Dispense
Viscoelastic | Passive | Passive |
| DispensingControl | Manual depression ofActuator Button to
dispense viscoelastic fluid | After priming, viscoelastic dispensing
control occurs through manual rotationof
either advancement wheel at the distal end
of the device.
Synchronization of the two wheels was
reversed for ease of use |
| Dispensing
Mechanism | Syringe (Volumeexchange) | Syringe (Volumeexchange) |
| OVD Volume
Dispensed | 7 µL | 11 µL |
| Materials | Medical grade materialsincluding:
• Cannula - StainlessSteel
• Polycarbonate tipsleeve
• ABS molded primingport Silicone seals | Medical grade materials,including ABS,
polycarbonate,
stainless steel, silicone, parylene coating,
cyanoacrylate, acrylate edurethane,
polyimide |
| Interface | Handheld | Handheld |
| Catheter / Cannula
Shaft
/ Probe OD | 150 microns | 483 microns |
| MicrocatheterTip
Outer Diameter | ≤ 0.007 inches
(, Pyrogen Test.

Chemical characterization testing of materials per EN ISO 10993-18:2009. .
Package Integrity for 1-year shelf life ●
- Demonstration of package integrity per EN ISO 11607-1 and 2:2019, Requirements for materials, O sterile barrier systems and packaging systems. after maximum gamma sterilization, distribution simulation and environmental conditioning. Samples aged in compliance to ASTM F1980-16
  - Visible inspection of seals per ASTM F1886-16
  - Seal strength per ASTM F88-15 ●
  - Seal integrity per ASTM F2096-11 ●
. Luer Fitting Compliance
Priming port, female luer connection, confirmed compliance to ISO 80369-7:2016 O
Stainless Steel Cannula compliance to ISO 9626:2016

Substantial Equivalence

The Streamline® Viscoelastic Injector meets all product design requirements and applicable standards. The Streamline® Viscoelastic Injector has the same key technological characteristics, and principle of operation as the predicate device. Therefore, the device has been shown to be substantially equivalent to the predicate device.