The Nova Eye iTrack™ Advance is indicated for catheterization of Schlemm's Canal to reduce intraocular pressure in adults patients with open-angle glaucoma.

Device Description

The iTrack™ Advance is a sterile, single-use manual handheld ophthalmic instrument used by ophthalmologists for infusion and aspiration of fluids during ophthalmic surgery and for catheterization and viscodilation of the Schlemm's canal (Canaloplasty) to reduce intraocular pressure in adults with open-angle glaucoma. After catheterization and viscodilation of the entire circumference of Schlemm's canal, the device may also be used to place a tensioning suture within the canal.

The iTrack™ Advance has a handpiece preloaded with an illuminated and flexible microcatheter. The addition of the handpiece provides for improved ergonomics and user interface by allowing single handed delivery of the microcatheter into the eye. The actuator on the handpiece is pushed forward slowly and this advances the catheter around the Schlemm's canal the full 360 degrees. By then sliding the actuator on the handpiece back the catheter is withdrawn back into the handpiece and as this takes place the viscoelastic is injected into the canal using the Ophthalmic ViscoInjector.

The iTrack™ Advance is manufactured from biocompatible materials, common within the medical device industry, such as stainless steel, nitinol, and thermoplastics such as polycarbonate, Pebax®, and polymethyl methacrylate (PMMA). The device includes a stainlesssteel cannula, a composite microcatheter, and a polymeric manual handpiece.

Additionally, the device is used with a single use manually operated infusion pump (the Ophthalmic ViscoInjector™) and the iLumin™ Fiberoptic Illuminator console (cleared separately in K050716 and K062259 and as a kit in iTrack™ 510(k) K080067).

AI/ML Overview

The provided document describes the Nova Eye iTrack™ Advance Canaloplasty Microcatheter with Advanced Delivery System, and compares it to its predicate device, the iTrack™ 250A. The document primarily focuses on demonstrating substantial equivalence through non-clinical performance testing.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Implied / Stated)	Reported Device Performance
Biocompatibility	Meets requirements of ISO 10993-1, 21 CFR 58, ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization).	Testing completed per ISO 10993-1, 21 CFR 58, ISO 10993-5, and ISO 10993-10. (Implied: Meets requirements as no non-conformance is stated).
Sterilization	Sterility Assurance Level (SAL) of 10⁻⁶; Meets requirements of ANSI/AAMI/ISO 11737-1, 11737-2, 11137-1, 11137-2.	Device maintains a sterility assurance level of SAL 10⁻⁶. Testing completed per ANSI/AAMI/ISO 11737-1, 11737-2, 11137-1, 11137-2. (Implied: Meets requirements).
Shelf-Life	Maintains package integrity and meets requirements of EN ISO 11607-1 and EN ISO 11607-2 for 2 years.	Demonstration of package integrity for materials, sterile barrier systems, and packaging systems after gamma sterilization, distribution simulation, and environmental conditioning. Shelf life is 2 years. (Implied: Meets requirements for 2-year shelf life).
Endotoxin Levels	Meets FDA recommended endotoxin levels.	Endotoxin testing demonstrated that the iTrack™ Advance was able to meet FDA recommended endotoxin levels.
Human Factors Engineering (HFE)	No unacceptable use-related risks remaining, successful completion of validation testing per IEC 62366-1.	Human Factors Engineering Evaluation performed per IEC 62366-1. Validation testing completed successfully, and there were no unacceptable use-related risks remaining.
Endurance and Cycle Test	Device can withstand repeated advancement and withdrawal of the microcatheter; no compromised components.	Device was able to meet acceptance criteria after being inserted into a model eye, ensuring 360° catheter advancement and retraction, and inspection for compromised components.
Ex-Vivo and Simulated Use Testing	Capable of: 1) visualization of illuminated microcatheter tip, 2) ability to inject viscoelastic, 3) 360° cannulation. Device can be appropriately used by trained physicians as intended.	Performed in human cadaver eyes. The study demonstrated the device's capability for 1) visualization of the illuminated microcatheter tip, 2) ability to inject viscoelastic, and 3) 360° cannulation. The study ensures that the device could be appropriately used by trained physicians as intended. (Implied: Met all criteria).
Mechanical and Dimensional Testing	Meets all specifications and acceptance criteria for critical dimensions, drop test, actuator retraction, pull force, tensile strength, burst test, fluid infusion, line leakage, and aspiration.	Results show that the device met all specifications and acceptance criteria for microcatheter, cannula, and handpiece critical dimensions, drop test, actuator retraction, pull force, tensile strength, burst test, fluid infusion, line leakage, and aspiration.
Actuator Force Testing	Establishes limits for force required to advance and retract microcatheter from handpiece.	Testing performed to evaluate the force required to advance and retract the microcatheter from the handpiece via the cannula and to establish limits for these forces. (Implied: Limits were established and satisfactory).
Light Hazard Assessment	Classified as a Group 1 device per ANSI Z80.36 and ISO 15752.	The iTrack™ Advance is a Group 1 device for Light Hazard.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes for most of the performance tests (e.g., biocompatibility animal numbers, number of devices for sterilization, endurance, mechanical, or actuator force testing).

Human Factors Evaluation: Utilized "trained surgeons" in a "simulated surgical environment." The specific number of surgeons is not provided.
Ex-Vivo and Simulated Use Testing: Performed in "human cadaver eyes." The specific number of cadaver eyes used is not provided.
Data Provenance: The studies are described as non-clinical performance and preclinical studies, likely conducted in a controlled laboratory setting (e.g., "model eye," "human cadaver eyes"). There is no mention of country of origin for the cadaver eyes or data, nor whether the data is retrospective or prospective, though performance testing is inherently prospective.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Human Factors Evaluation: "Trained surgeons" were used. Their specific qualifications (e.g., years of experience, subspecialty) are not detailed beyond being "trained."
Ex-Vivo and Simulated Use Testing: "Trained physicians" were involved. Their specific qualifications are not detailed.
For other tests (biocompatibility, sterilization, mechanical), the ground truth is based on established international standards (ISO, AAMI, EN, FDA regulations) and internal device specifications, which are typically evaluated by qualified engineers and scientists rather than clinical experts.

4. Adjudication Method for the Test Set

The document does not describe any adjudication methods (like 2+1 or 3+1) for the performance tests. These methods are typically associated with subjective assessments by multiple reviewers, common in clinical imaging studies. The performance tests described here are primarily objective and based on established physical, chemical, and biological standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission is a 510(k) for a device with physical and mechanical characteristics, not an AI or imaging diagnostic device that would typically require such a study demonstrating human reader improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a manual surgical instrument, not an algorithm or AI system. Its performance is inherently tied to human use.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance tests is based on:

Established Standards: International and national standards (ISO, AAMI, EN, FDA regulations) for biocompatibility, sterilization, shelf-life, endotoxin levels, human factors, and light hazard.
Device Specifications: Internal specifications for mechanical, dimensional, endurance, and actuator force testing.
Simulated Use Outcomes: For ex-vivo testing, the ability to achieve specified surgical tasks (visualization, viscoelastic injection, 360° cannulation) in cadaver eyes.

8. Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set. The "design input" and "bench testing" phases would be somewhat analogous to training in terms of iterative refinement, but there's no data training set in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of medical device. Product specifications and design requirements would be established through a combination of engineering analysis, clinician feedback, and regulatory standards.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 30, 2023

Nova Eye Inc. (Business name Nova Eye Medical) % Evelyn De La Vega Stewart Consultant EDS Regulatory Consulting Inc. 95 Bryce Run Lake Forest, California 92630

Re: K221872

Trade/Device Name: iTrack™ Advance Canaloplasty Microcatheter with Advanced Delivery System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: MPA, HMX Dated: February 27, 2023 Received: March 1, 2023

Dear Ms. Evelyn De La Vega Stewart:

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

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Image /page/1/Picture/6 description: The image shows a digital signature for Bennett N. Walker. The signature indicates that it was digitally signed by Bennett N. Walker -S. The date of the signature is 2023.03.30, and the timestamp is 10:20:42 -04'00'.

For Tieuvi Nguyen, Ph.D. 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

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Indications for Use

510(k) Number (if known) K221872

Device Name

iTrack™ Advance Canaloplasty Microcatheter with Advanced Delivery System

Indications for Use (Describe)

The Nova Eye iTrack™ Advance is indicated for fluid infusion or aspiration during surgery.

The Nova Eye iTrack™ Advance is indicated for catheterization of Schlemm's Canal to reduce intraocular pressure in adults patients with open-angle glaucoma.

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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510(K) SUMMARY

October 21, 2022

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

Submitter Information:

510(k) Owner Name:	Nova Eye Medical41316 Christy StreetFremont, CA 945381-800-391-2316
Contact:	Don WattonHead of Global OperationsNova Eye Medical1-800-391-2316

Device Name and Classification:

Trade/Proprietary Name:	iTrack™ Advance - Canaloplasty Microcatheter with AdvancedDelivery System
Device Common Name:	Ophthalmic Microcatheter
Model Number	iTrack™ ADS
Classification Names:	Endoscope and accessories	Manual ophthalmic surgical instrument, cannula
Regulations:	21 CFR 876.1500	21 CFR 886.4350
Classification	Class II	Class I
Product Codes:	MPA	HMX

Predicate Device:

Device Name:	510(k) Number
Nova Eye Inc, Canaloplasty Microcatheter iTrack™ 250A	K080067 (Predicate)

Intended Use:

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K221872 Page 2 of 10

The iTrack™ Advance is intended for the delivery of controlled amounts of viscoelastic fluid during ophthalmic surgery, and for the microcatheterization and viscodilation of Schlemm's Canal (Canaloplasty) to reduce intraocular pressure.

Indications for Use:

The Nova Eve iTrack™ Advance is indicated for fluid infusion or aspiration during surgery.

The Nova Eye iTrack™ Advance is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open-angle glaucoma.

Device Description:

Figure 5-1: iTrack™ Advance - Canaloplasty Microcatheter with Advanced Delivery System

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Image /page/5/Figure/1 description: This image shows a medical device with several labeled components. The device includes a handheld cannula with an actuator, a nozzle, and a cannula. There is also a cannula cover, an illuminated catheter tip, a hub retainer clip, a Luer infusion line, and a POF connector.

Figure 5-2: Schematic of the iTrack™ Advance with iLumin™ Endoilluminator

Image /page/5/Figure/3 description: The image shows the iTrack Advance Handheld Cannula & Microcatheter, ViscoInjector, iLumin Endoilluminator, Luer Infusion line, and POF Connector to Fiber Illuminator. The iTrack Advance Handheld Cannula & Microcatheter and ViscoInjector are placed on top of the iLumin Endoilluminator. The iLumin Endoilluminator is labeled as reusable. The Luer Infusion line and POF Connector to Fiber Illuminator are connected to the iTrack Advance Handheld Cannula & Microcatheter and iLumin Endoilluminator, respectively.

Technological Characteristics (in comparison to predicate):

The technical features of the subject device (iTrack™ Advance) compared to the predicate device (iTrack™ 250A) are substantially equivalent. The iTrack™ Advance microcatheter retains the same materials, design, and accessories as the predicate, and comprises a handpiece to allow manipulation of the catheter without the need for surgical forceps when performing canaloplasty. Both the predicate and subject devices maintain the same indications for use and intended use. Both are manually operated devices that are intended for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open-angle glaucoma (canaloplasty).

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K221872 Page 4 of 10

The subject and predicate device maintain the same manual principle of operation and engage the use of an ergonomic handpiece to assist in the delivery of viscoelastic in target intraocular spaces.

The following table compares the characteristics of the iTrack™ Advance with the predicate device iTrack™ 250A (K080067). See Table 5-1.

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K221872 Page 5 of 10

TABLE 5-1 DEVICE TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE

Characteristic	Nova Eye Canaloplasty Microcatheter with Advanced DeliverySystem - iTrack™ Advance (K221872)	Nova Eye Canaloplasty Microcatheter -iTrack™ 250A(K080067)
	SUBJECT DEVICE	PRIMARY PREDICATE
Device	Image: Cannula CoverImage: NozzleImage: CannulaImage: Handheld Cannula ActuatorImage: Illuminated Catheter TipImage: Hub Retainer ClipImage: Luer Infusion lineImage: POF Connector	Image: Light Source ConnectorImage: Female Luer ConnectorImage: Hub & Hub JacketImage: Catheter
Intended Use	Delivery of controlled amounts of viscoelasticfluid during ophthalmic surgery, fluid infusion and aspiration, andcatheterization and viscodilation (canaloplasty) to reduce intraocularpressure.	Delivery of controlled amounts of viscoelasticfluid during ophthalmic surgery, fluid infusion and aspiration, andcatheterization and viscodilation (canaloplasty) to reduce intraocularpressure.
Indications for Use	The Nova Eye iTrack™ Advance Canaloplasty Microcatheter is indicatedfor fluid infusion or aspiration during surgery.The Nova Eye iTrack™ Advance Canaloplasty Microcatheter is indicatedfor catheterization and viscodilation of Schlemm's canal (canaloplasty) toreduce intraocular pressure in adult patients with open-angle glaucoma.	The Nova Eye iTrack™ Advance Canaloplasty Microcatheter is indicatedfor fluid infusion or aspiration during surgery.The Nova Eye iTrack™ Canaloplasty Microcatheter is indicated forcatheterization and viscodilation of Schlemm's canal (canaloplasty) toreduce intraocular pressure in adult patients with open-angle glaucoma.
Characteristic	Nova Eye Canaloplasty Microcatheter with Advanced DeliverySystem - iTrack™ Advance (K221872)SUBJECT DEVICE	Nova Eye Canaloplasty Microcatheter -iTrack™ 250A(K080067)PRIMARY PREDICATE
Regulation	876.1500 (Endoscope and accessories)886.4350 (Manual ophthalmic surgicalinstrument)	876.1500 (Endoscope and accessories)886.4350 (Manual ophthalmic surgicalinstrument)
Device Class	Class II	Class II
Product Code	MPA (Endoscope)HMX (Manual Ophthalmic SurgicalInstrument)	MPA (Endoscope)HMX (Manual Ophthalmic SurgicalInstrument)
Prescription Status	Prescription use only	Prescription use only
Target Anatomy	Schlemm's Canal	Schlemm's Canal
Accessories	For use as part of a system/kit including:	For use as part of a system /kit including:
	Manual Accessory: Ophthalmic ViscoInjector™ (K050716)	Manual Accessory: Ophthalmic ViscoInjector™ (K050716)
	Powered Accessory: iLumin™ Fiberoptic Illuminator (K062259).	Powered Accessory: iLumin™ Fiberoptic Illuminator (K062259).
Viscoelastic	Viscoelastic is supplied separately from unaffiliated manufacturers.Viscoelastic is delivered to/attaches to device via luer fitting.	Viscoelastic is supplied separately from unaffiliated manufacturers.Viscoelastic is delivered to/attaches to device via luer fitting.
Dispensing control	Manual rotation of ViscoInjector™ knob to dispense controlled amountsviscoelastic fluid	Manual rotation of ViscoInjector™ knob to dispense controlled amountsviscoelastic fluid
User determines amount offluid to dispense	Yes, by rotating the proximal knob on the ViscoInjector™	Yes, by rotating the proximal knob on the ViscoInjector™
Passive or EnergizedDevice to DispenseViscoelastic	Passive	Passive
Volume Dispensed	2.25µL per click of the VI	2.25µL per click of the VI
Dispensing Mechanism	Syringe volume exchange	Syringe volume exchange
Characteristic	Nova Eye Canaloplasty Microcatheter with Advanced DeliverySystem - iTrack™ Advance (K221872)	Nova Eye Canaloplasty Microcatheter -iTrack™ 250A(K080067)
	SUBJECT DEVICE	PRIMARY PREDICATE
Operating Principle	Manual	Manual
MechanismOf Action	Ophthalmic Microcatheter and Handheld Ophthalmic CannulaMechanism of action	Ophthalmic Microcatheter
	• The Microcatheter is connected to the ViscoInjector™ and primed withviscoelastic fluid from a cartridge retained with the ViscoInjector.• The Microcatheter is connected to a powered iLumin™ FiberopticIlluminator which illuminates the Microcatheter tip.• The surgeon holds the handheld ophthalmic cannula like a pen andaligns the catheter into the scleral dissection and into the ostium of theSchlemm's canal.• The surgeon advances the microcatheter inside the ostium of theSchlemm's canal by sliding forward the manually controlled actuator onthe handheld ophthalmic cannula.• The Microcatheter can access 360° of the Schlemm's canal in one pass.• The surgeon withdraws the microcatheter from the Schlemm's canal bysliding the manually controlled actuator on the handheld ophthalmiccannula.• As the microcatheter is withdrawn from the Schlemm's canal,viscoelastic fluid is delivered into canal space by manual clockwiserotation of the knob on the ViscoInjector™• Clicks on the ViscoInjector™ tactilely indicate precise delivery ofviscoelastic fluid.	Mechanism of action• The Microcatheter is connected to the ViscoInjector™ and primed withviscoelastic fluid from a cartridge retained with the ViscoInjector.• The Microcatheter is connected to a powered iLumin™ FiberopticIlluminator which illuminates the Microcatheter tip.• The surgeon directs the microcatheter using micro forceps through thesurgical incision into the ostium of the Schlemm's canal.• The Microcatheter can access 360° of the Schlemm's canal in one pass.• As surgeon withdraws the microcatheter from the Schlemm's canal,viscoelastic fluid is delivered into the canal by the surgeon by manualclockwise rotation of the knob on ViscoInjector.• Clicks on the ViscoInjector™ tactilely indicate precise delivery ofviscoelastic fluid.
Materials	Medical grade materials including:Polyimide, Polycarbonate, Pebax, Stainless Steel, Polystyrene, PMMA,PVDF, Polypropylene, Polyketone, Nitinol	Medical grade materials including:Polyimide, Polycarbonate, Pebax, Stainless Steel, Polystyrene, PMMA,PVDF
Characteristic	Nova Eye Canaloplasty Microcatheter with Advanced DeliverySystem - iTrack™ Advance (K221872)	Nova Eye Canaloplasty Microcatheter -iTrack™ 250A(K080067)
	SUBJECT DEVICE	PRIMARY PREDICATE
User Interface	Handheld	Handheld
Microcatheter Shaft OuterDiameter	200 microns	200 microns
Microcatheter Tip OuterDiameter Range	0.0098 inches	0.0098 inches
Length of microcatheteravailable for surgery	45mm	45mm
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	Closed tray inside a sealed Tyvek pouch	Closed tray inside a sealed Tyvek pouch
Shelf Life	2 years	2 years

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K221872

Page 8 of 10

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K221872 Page 9 of 10

Performance Testing

The device was subjected to testing to support and demonstrate substantial equivalence to the predicate device. The testing was performed as follows:

Functional Performance and Safety Testing

Biocompatibility testing was completed per .
- ISO 10993-1 Biological evaluation of medical devices -Part 1: Evaluation and o testing within a risk management process
- 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies. O
- Cytotoxicity as per the requirements established in ISO 10993-5, Biological o Evaluation of Medical Devices -- Part 5, Tests for in vitro cytotoxicity.
- Irritation and Sensitization as per the requirements established in 10993-10, o Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization.
Sterilization testing was completed per ●
- o ANSI/AAMI/ISO 11737-1:2018 Sterilization of health care products-Microbiological methods -Part 1: Determination of the population of microorganisms on product,
- o ANSI/AAMI/ISO 11737-2 Sterilization of medical devices -Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of sterilization process,
- 0 ANSI/AAMI/ISO 11137-1 Sterilization of health care products -Radiation -Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and
- ANSI/AAMI/ISO 11137-2 Sterilization of health care products- Radiations -Part o 2: Establishing the sterilization dose.
  - The device maintains a sterility assurance level of SAL 10-6. l
Shelf-Life testing was completed per
- 0 EN ISO 11607-1 EN 11607-1 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barriers and packaging systems and
- o EN ISO 11607-2 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes.
  - . Demonstration of package integrity for materials, sterile barrier systems and packaging systems after gamma sterilization, distribution simulation and environmental conditioning.
Endotoxin testing demonstrated that the iTrack™ Advance was able to meet FDA ● recommended endotoxin levels.
. Human Factors Engineering Evaluation was performed on the iTrack™ Advance per IEC 62366-1 Part 1: Application of Usability. The Validation Testing was completed successfully and there were no unacceptable use related risks remaining. The evaluation utilized trained surgeons in a simulated surgical environment, working through all stages of unpacking, presenting to sterile field, priming, and using the device as per instructions for use.
. An Endurance and Cycle Test was conducted to ensure that the device can withstand repeated advancement and withdrawal of the microcatheter from the handpiece. The

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iTrack™ Advance was inserted into the anterior segment of the model eye ensuring catheter advancement of 360° around the canal and retracted. After completion of the cycle, the device was inspected for any compromised components. Results show that the device was able to meet acceptance criteria.

. Ex-Vivo and Simulated Use Testing - Simulated use testing in human cadaver eyes was performed using the iTrack™ Advance. The study was performed to demonstrate that the iTrack™ Advance is capable of 1) visualization of the illuminated microcatheter tip 2) ability to inject viscoelastic and 3) 360° cannulation. The study ensures that the device could be appropriately used by trained physicians as intended.
Mechanical and Dimensional Testing -The microcatheter, cannula and handpiece were ● tested to verify several critical dimensions. Additionally, mechanical testing was performed including a drop test, verification of actuator retraction, pull force, tensile strength, burst test, fluid infusion, line leakage and aspiration testing verification. Results show that the device met all specifications and acceptance criteria.
Actuator Force Testing This testing was performed to evaluate the force required to ● advance and retract the microcatheter from the handpiece via the cannula and to establish limits for these forces.
Light Hazard Assessment in accordance with ANSI Z80.36 Light Protection for . Ophthalmic Instruments and ISO 15752 Ophthalmic instruments – Endoilluminators Optical Radiation Safety Evaluation was carried out.
- o The iTrack™ Advance is a Group 1 device for Light Hazard.

Conclusions

The iTrack™ Advance is substantially equivalent to the currently cleared predicate device iTrack 250A Ophthalmic Microcatheter. The changes to the subject device did not raise new questions of safety and efficacy of the device. The iTrack™ Advance maintains the same indications, intended use, target population, target anatomy, principle of operation and key technological characteristics as the predicate device. Based on the changes made as compared to the cleared predicate, it was appropriate to leverage the clinical data used in support of the cleared predicate device. The mechanism of action for both the predicate and subject device is the same. Both devices are manually operated and utilize a microcatheter with illuminated tip to access the Schlemm's canal and deliver viscoelastic fluid. Non-clinical human factors data demonstrate that the iTrack™ Advance performs as intended.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.