(275 days)
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.
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 By then sliding the actuator on the handpiece back the catheter is withdrawn back into the handpiece and as this takes place the viscoelastic is injected into the canal using the Ophthalmic ViscoInjector.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).
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.
§ 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.