ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System

K221872 · Nova Eye Inc. (Business Name Nova Eye Medical) · MPA · Mar 30, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K221872
• Device Name: ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
• Applicant: Nova Eye Inc. (Business Name Nova Eye Medical)
• Product Code: MPA · Gastroenterology, Urology
• Decision Date: Mar 30, 2023
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

iTrack™ Advance is a sterile, single-use manual ophthalmic instrument for canaloplasty. It consists of a handpiece preloaded with an illuminated, flexible microcatheter. Used by ophthalmologists in surgical settings; the device allows single-handed delivery of the microcatheter into the eye. The surgeon uses an actuator on the handpiece to advance the catheter 360 degrees around Schlemm's canal; retracting the actuator withdraws the catheter while simultaneously injecting viscoelastic fluid via a connected Ophthalmic ViscoInjector™. The device is used with an iLumin™ Fiberoptic Illuminator to visualize the catheter tip. By viscodilating the canal, the device reduces intraocular pressure in adult patients with open-angle glaucoma. The ergonomic handpiece improves user interface compared to previous manual methods requiring forceps.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993), sterilization validation (ISO 11137), shelf-life testing, mechanical/dimensional verification, and human factors engineering validation in a simulated surgical environment. Ex-vivo testing in human cadaver eyes confirmed 360° cannulation, visualization, and viscoelastic injection capabilities.

Technological Characteristics

Manual ophthalmic surgical instrument. Materials: stainless steel, nitinol, polycarbonate, Pebax®, PMMA, polyimide, polystyrene, PVDF, polypropylene, polyketone. Features: ergonomic handpiece with actuator, illuminated microcatheter (200-micron shaft), Luer infusion line. Energy: fiberoptic illumination (iLumin™). Sterilization: Gamma radiation (SAL 10^-6). Connectivity: manual interface with Ophthalmic ViscoInjector™ and fiberoptic light source.

Indications for Use

Indicated for fluid infusion or aspiration during surgery. Indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open-angle glaucoma.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Nova Eye Inc, Canaloplasty Microcatheter iTrack™ 250A (K080067)

Reference Devices

• Ophthalmic ViscoInjector™ (K050716)
• iLumin™ Fiberoptic Illuminator (K062259)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| <div> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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 Medical<br>41316 Christy Street<br>Fremont, CA 94538<br>1-800-391-2316 |
|--------------------|---------------------------------------------------------------------------------|
| Contact: | Don Watton<br>Head of Global Operations<br>Nova Eye Medical<br>1-800-391-2316 |

#### Device Name and Classification:

| Trade/Proprietary Name: | iTrack™ Advance - Canaloplasty Microcatheter with Advanced<br>Delivery 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:

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).

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 Delivery<br>System - iTrack™ Advance (K221872) | Nova Eye Canaloplasty Microcatheter -iTrack™ 250A<br>(K080067) |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SUBJECT DEVICE | PRIMARY PREDICATE |
| Device | Image: Cannula Cover<br>Image: Nozzle<br>Image: Cannula<br>Image: Handheld Cannula Actuator<br>Image: Illuminated Catheter Tip<br>Image: Hub Retainer Clip<br>Image: Luer Infusion line<br>Image: POF Connector | Image: Light Source Connector<br>Image: Female Luer Connector<br>Image: Hub & Hub Jacket<br>Image: Catheter |
| Intended Use | Delivery of controlled amounts of viscoelastic<br>fluid during ophthalmic surgery, fluid infusion and aspiration, and<br>catheterization and viscodilation (canaloplasty) to reduce intraocular<br>pressure. | Delivery of controlled amounts of viscoelastic<br>fluid during ophthalmic surgery, fluid infusion and aspiration, and<br>catheterization and viscodilation (canaloplasty) to reduce intraocular<br>pressure. |
| Indications for Use | The Nova Eye iTrack™ Advance Canaloplasty Microcatheter is indicated<br>for fluid infusion or aspiration during surgery.<br>The Nova Eye iTrack™ Advance Canaloplasty Microcatheter is indicated<br>for catheterization and viscodilation of Schlemm's canal (canaloplasty) to<br>reduce intraocular pressure in adult patients with open-angle glaucoma. | The Nova Eye iTrack™ Advance Canaloplasty Microcatheter is indicated<br>for fluid infusion or aspiration during surgery.<br>The Nova Eye iTrack™ Canaloplasty Microcatheter is indicated for<br>catheterization and viscodilation of Schlemm's canal (canaloplasty) to<br>reduce intraocular pressure in adult patients with open-angle glaucoma. |
| Characteristic | Nova Eye Canaloplasty Microcatheter with Advanced Delivery<br>System - iTrack™ Advance (K221872)<br><br>SUBJECT DEVICE | Nova Eye Canaloplasty Microcatheter -iTrack™ 250A<br>(K080067)<br><br>PRIMARY PREDICATE |
| Regulation | 876.1500 (Endoscope and accessories)<br>886.4350 (Manual ophthalmic surgical<br>instrument) | 876.1500 (Endoscope and accessories)<br>886.4350 (Manual ophthalmic surgical<br>instrument) |
| Device Class | Class II | Class II |
| Product Code | MPA (Endoscope)<br>HMX (Manual Ophthalmic Surgical<br>Instrument) | MPA (Endoscope)<br>HMX (Manual Ophthalmic Surgical<br>Instrument) |
| 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.<br>Viscoelastic is delivered to/attaches to device via luer fitting. | Viscoelastic is supplied separately from unaffiliated manufacturers.<br>Viscoelastic is delivered to/attaches to device via luer fitting. |
| Dispensing control | Manual rotation of ViscoInjector™ knob to dispense controlled amounts<br>viscoelastic fluid | Manual rotation of ViscoInjector™ knob to dispense controlled amounts<br>viscoelastic fluid |
| User determines amount of<br>fluid to dispense | Yes, by rotating the proximal knob on the ViscoInjector™ | Yes, by rotating the proximal knob on the ViscoInjector™ |
| Passive or Energized<br>Device to Dispense<br>Viscoelastic | 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 Delivery<br>System - iTrack™ Advance (K221872) | Nova Eye Canaloplasty Microcatheter -iTrack™ 250A<br>(K080067) |
| | SUBJECT DEVICE | PRIMARY PREDICATE |
| Operating Principle | Manual | Manual |
| Mechanism<br>Of Action | Ophthalmic Microcatheter and Handheld Ophthalmic Cannula<br>Mechanism of action | Ophthalmic Microcatheter |
| | • The Microcatheter is connected to the ViscoInjector™ and primed with<br>viscoelastic fluid from a cartridge retained with the ViscoInjector.<br>• The Microcatheter is connected to a powered iLumin™ Fiberoptic<br>Illuminator which illuminates the Microcatheter tip.<br>• The surgeon holds the handheld ophthalmic cannula like a pen and<br>aligns the catheter into the scleral dissection and into the ostium of the<br>Schlemm's canal.<br>• The surgeon advances the microcatheter inside the ostium of the<br>Schlemm's canal by sliding forward the manually controlled actuator on<br>the handheld ophthalmic cannula.<br>• The Microcatheter can access 360° of the Schlemm's canal in one pass.<br>• The surgeon withdraws the microcatheter from the Schlemm's canal by<br>sliding the manually controlled actuator on the handheld ophthalmic<br>cannula.<br>• As the microcatheter is withdrawn from the Schlemm's canal,<br>viscoelastic fluid is delivered into canal space by manual clockwise<br>rotation of the knob on the ViscoInjector™<br>• Clicks on the ViscoInjector™ tactilely indicate precise delivery of<br>viscoelastic fluid. | Mechanism of action<br>• The Microcatheter is connected to the ViscoInjector™ and primed with<br>viscoelastic fluid from a cartridge retained with the ViscoInjector.<br>• The Microcatheter is connected to a powered iLumin™ Fiberoptic<br>Illuminator which illuminates the Microcatheter tip.<br>• The surgeon directs the microcatheter using micro forceps through the<br>surgical incision into the ostium of the Schlemm's canal.<br>• The Microcatheter can access 360° of the Schlemm's canal in one pass.<br>• As surgeon withdraws the microcatheter from the Schlemm's canal,<br>viscoelastic fluid is delivered into the canal by the surgeon by manual<br>clockwise rotation of the knob on ViscoInjector.<br>• Clicks on the ViscoInjector™ tactilely indicate precise delivery of<br>viscoelastic fluid. |
| Materials | Medical grade materials including:<br>Polyimide, Polycarbonate, Pebax, Stainless Steel, Polystyrene, PMMA,<br>PVDF, Polypropylene, Polyketone, Nitinol | Medical grade materials including:<br>Polyimide, Polycarbonate, Pebax, Stainless Steel, Polystyrene, PMMA,<br>PVDF |
| Characteristic | Nova Eye Canaloplasty Microcatheter with Advanced Delivery<br>System - iTrack™ Advance (K221872) | Nova Eye Canaloplasty Microcatheter -iTrack™ 250A<br>(K080067) |
| | SUBJECT DEVICE | PRIMARY PREDICATE |
| User Interface | Handheld | Handheld |
| Microcatheter Shaft Outer<br>Diameter | 200 microns | 200 microns |
| Microcatheter Tip Outer<br>Diameter Range | 0.0098 inches | 0.0098 inches |
| Length of microcatheter<br>available for surgery | 45mm | 45mm |
| Sterile and Single Use | Provided sterile. Single patient use…