(275 days)
No
The description focuses on a manual, mechanical device for surgical procedures and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is used to reduce intraocular pressure and place a tensioning suture, which are therapeutic actions aimed at treating open-angle glaucoma.
No
Explanation: The device is indicated for fluid infusion or aspiration during surgery and catheterization of Schlemm's Canal to reduce intraocular pressure. These are therapeutic and surgical interventions, not diagnostic procedures.
No
The device description clearly outlines a physical, sterile, single-use manual handheld ophthalmic instrument made of materials like stainless steel, nitinol, and thermoplastics. It also mentions a handpiece, microcatheter, and cannula, all of which are hardware components.
Based on the provided information, the Nova Eye iTrack™ Advance is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The intended uses are for fluid infusion/aspiration during surgery and for catheterization of Schlemm's Canal to reduce intraocular pressure. These are surgical procedures performed directly on the patient's body.
- Device Description: The device is a surgical instrument used for physical manipulation within the eye (catheterization, viscodilation, suture placement). It is used in conjunction with other surgical tools (infusion pump, illuminator).
- Lack of In Vitro Testing: The description does not mention any use of the device to examine specimens (like blood, tissue, or other bodily fluids) outside of the body to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on functional performance, safety, mechanical properties, and simulated use, which are typical for surgical instruments, not IVDs.
IVD devices are specifically designed to perform tests on specimens taken from the human body in vitro (outside the body) to provide information about a person's health. The iTrack™ Advance is a surgical tool used in vivo (within the body) to perform a therapeutic procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MPA, HMX
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Schlemm's Canal
Indicated Patient Age Range
adults
Intended User / Care Setting
ophthalmologists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
41316 Christy Street
Fremont, CA 94538
1-800-391-2316 |
|--------------------|---------------------------------------------------------------------------------|
| Contact: | Don Watton
Head of Global Operations
Nova Eye Medical
1-800-391-2316 |
Device Name and Classification:
| Trade/Proprietary Name: | iTrack™ Advance - Canaloplasty Microcatheter with Advanced
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:
4
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
5
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).
6
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.
7
K221872 Page 5 of 10
TABLE 5-1 DEVICE TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE
| Characteristic | Nova Eye Canaloplasty Microcatheter with Advanced Delivery
System - iTrack™ Advance (K221872) | Nova Eye Canaloplasty Microcatheter -iTrack™ 250A
(K080067) |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SUBJECT DEVICE | PRIMARY PREDICATE |
| Device | Image: Cannula Cover
Image: Nozzle
Image: Cannula
Image: Handheld Cannula Actuator
Image: Illuminated Catheter Tip
Image: Hub Retainer Clip
Image: Luer Infusion line
Image: POF Connector | Image: Light Source Connector
Image: Female Luer Connector
Image: Hub & Hub Jacket
Image: Catheter |
| Intended Use | Delivery of controlled amounts of viscoelastic
fluid during ophthalmic surgery, fluid infusion and aspiration, and
catheterization and viscodilation (canaloplasty) to reduce intraocular
pressure. | Delivery of controlled amounts of viscoelastic
fluid during ophthalmic surgery, fluid infusion and aspiration, and
catheterization and viscodilation (canaloplasty) to reduce intraocular
pressure. |
| Indications for Use | The Nova Eye iTrack™ Advance Canaloplasty Microcatheter is indicated
for fluid infusion or aspiration during surgery.
The Nova Eye iTrack™ Advance Canaloplasty Microcatheter is indicated
for catheterization and viscodilation of Schlemm's canal (canaloplasty) to
reduce intraocular pressure in adult patients with open-angle glaucoma. | The Nova Eye iTrack™ Advance Canaloplasty Microcatheter is indicated
for fluid infusion or aspiration during surgery.
The Nova Eye iTrack™ Canaloplasty Microcatheter is indicated for
catheterization and viscodilation of Schlemm's canal (canaloplasty) to
reduce intraocular pressure in adult patients with open-angle glaucoma. |
| Characteristic | Nova Eye Canaloplasty Microcatheter with Advanced Delivery
System - iTrack™ Advance (K221872)
SUBJECT DEVICE | Nova Eye Canaloplasty Microcatheter -iTrack™ 250A
(K080067)
PRIMARY PREDICATE |
| Regulation | 876.1500 (Endoscope and accessories)
886.4350 (Manual ophthalmic surgical
instrument) | 876.1500 (Endoscope and accessories)
886.4350 (Manual ophthalmic surgical
instrument) |
| Device Class | Class II | Class II |
| Product Code | MPA (Endoscope)
HMX (Manual Ophthalmic Surgical
Instrument) | MPA (Endoscope)
HMX (Manual Ophthalmic Surgical
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.
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 amounts
viscoelastic fluid | Manual rotation of ViscoInjector™ knob to dispense controlled amounts
viscoelastic fluid |
| User determines amount of
fluid to dispense | Yes, by rotating the proximal knob on the ViscoInjector™ | Yes, by rotating the proximal knob on the ViscoInjector™ |
| Passive or Energized
Device to Dispense
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
System - iTrack™ Advance (K221872) | Nova Eye Canaloplasty Microcatheter -iTrack™ 250A
(K080067) |
| | SUBJECT DEVICE | PRIMARY PREDICATE |
| Operating Principle | Manual | Manual |
| Mechanism
Of Action | Ophthalmic Microcatheter and Handheld Ophthalmic Cannula
Mechanism of action | Ophthalmic Microcatheter |
| | • The Microcatheter is connected to the ViscoInjector™ and primed with
viscoelastic fluid from a cartridge retained with the ViscoInjector.
• The Microcatheter is connected to a powered iLumin™ Fiberoptic
Illuminator which illuminates the Microcatheter tip.
• The surgeon holds the handheld ophthalmic cannula like a pen and
aligns the catheter into the scleral dissection and into the ostium of the
Schlemm's canal.
• The surgeon advances the microcatheter inside the ostium of the
Schlemm's canal by sliding forward the manually controlled actuator on
the 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 by
sliding the manually controlled actuator on the handheld ophthalmic
cannula.
• As the microcatheter is withdrawn from the Schlemm's canal,
viscoelastic fluid is delivered into canal space by manual clockwise
rotation of the knob on the ViscoInjector™
• Clicks on the ViscoInjector™ tactilely indicate precise delivery of
viscoelastic fluid. | Mechanism of action
• The Microcatheter is connected to the ViscoInjector™ and primed with
viscoelastic fluid from a cartridge retained with the ViscoInjector.
• The Microcatheter is connected to a powered iLumin™ Fiberoptic
Illuminator which illuminates the Microcatheter tip.
• The surgeon directs the microcatheter using micro forceps through the
surgical 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 manual
clockwise rotation of the knob on ViscoInjector.
• Clicks on the ViscoInjector™ tactilely indicate precise delivery of
viscoelastic 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 Delivery
System - iTrack™ Advance (K221872) | Nova Eye Canaloplasty Microcatheter -iTrack™ 250A
(K080067) |
| | SUBJECT DEVICE | PRIMARY PREDICATE |
| User Interface | Handheld | Handheld |
| Microcatheter Shaft Outer
Diameter | 200 microns | 200 microns |
| Microcatheter Tip Outer
Diameter Range | 0.0098 inches | 0.0098 inches |
| Length of microcatheter
available 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 |
8
9
10
K221872
Page 8 of 10
11
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
12
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.