(94 days)
The VIA360™ Surgical System is indicated for delivery of controlled amounts of viscoelastic fluid during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.
The VIA360™ Surgical System is a manually operated surgical instrument used by ophthalmologists to deliver controlled amounts of ophthalmic viscoelastic fluid into the anterior segment of the eye. The VIA360™ Surgical System is comprised of a surgical-grade stainless steel cannula and a nylon microcatheter. The cannula is attached to a nose piece that can be rotated to a desired position for use in either eye. The microcatheter is advanced and retracted up to 40 mm per cycle by rotating the scroll wheel. The microcatheter has patterned markings every 10 mm to help measure the extended length. A controlled amount of viscoelastic fluid is dispensed through multiple outlets located on the microcatheter's distal tip by depressing the scroll wheel or the surrounding button. An external reservoir is included for the purpose of priming the device. The device is single-use only.
The provided text describes the 510(k) submission for the VIA360™ Surgical System. This device is a manually operated surgical instrument for ophthalmic procedures, specifically for delivering viscoelastic fluid and cutting trabecular meshwork tissue.
Based on the document, it's clear that this is not a submission for an AI/ML medical device. The device is a physical, manually operated surgical instrument. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, etc.) are not applicable to this submission.
The acceptance criteria and device performance evaluation detailed in the document are for a physical medical device, not a software or AI/ML product.
Here's a breakdown of the acceptance criteria and study information provided for the VIA360™ Surgical System, as it pertains to a physical device:
Acceptance Criteria and Reported Device Performance
| Test Performed | Standard/Guidance | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Functionality/Performance Tests | Based on ability to perform as intended and predicate device characteristics | Met all acceptance criteria and performs as intended | |
| Joint strength testing | (Standard/Guidance not specified, but implied) | (Criteria not explicitly stated, but implied as meeting functional requirements) | (Results imply satisfactory performance) |
| Actuation force testing | (Standard/Guidance not specified, but implied) | (Criteria not explicitly stated, but implied as meeting functional requirements) | (Results imply satisfactory performance) |
| Priming and dispense volume testing | (Standard/Guidance not specified, but implied) | (Criteria not explicitly stated, but implied as accurate fluid delivery) | (Results imply satisfactory performance) |
| Simulated use testing | (Standard/Guidance not specified, but implied) | (Criteria not explicitly stated, but implied as meeting functional requirements through use simulation) | (Results imply satisfactory performance) |
| Package Integrity Tests | |||
| Visual Inspection | ASTM F1886 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection | (Implied satisfactory visual inspection of seals) | All samples met the acceptance criteria |
| Seal Strength | ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials | > 0.75 lbf/in | All units had a seal strength > 0.75 lbf/in. |
| Bubble leak test | ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) | (Implied no gross leaks) | All samples met the acceptance criteria |
| Biocompatibility Tests | |||
| Cytotoxicity | ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Non-Cytotoxic | Non-Cytotoxic |
| Sensitization | ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Non-Sensitizer | Non-Sensitizer |
| Irritation | ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Non-irritant | Non-irritant |
| Acute Systemic Toxicity | ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Non-toxic | Non-toxic |
| Material-Mediated Pyrogenicity | ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Non-pyrogenic | Non-pyrogenic |
| Sterilization | ISO 11137-1 - Sterilization of health care products - Radiation - Part 1; ISO 11137-2 - Sterilization of health care products. Radiation - Part 2: Establishing the sterilization dose | Assurance level of 10^-6 (SAL) | Assurance level of 10^-6 |
Study Details (Non-AI/ML Device):
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Sample size used for the test set and the data provenance:
- The document does not specify a numerical sample size for "test sets" in the context of typical AI/ML validation datasets. Instead, it refers to "samples" or "units" for each specific non-clinical test (e.g., "All samples met the acceptance criteria" for visual inspection). The number of samples for each test is not detailed.
- Data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), as this is non-clinical performance and biocompatibility testing of a physical device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical device; ground truth in the AI/ML sense (e.g., for image annotations) is not relevant. The "ground truth" here is compliance with engineering specifications, material properties, and biological safety standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a human-in-the-loop diagnostic study requiring adjudication.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical surgical device, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. Again, this is not an algorithm. The "performance" is the physical function and safety of the device itself, evaluated through non-clinical bench testing.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For this physical medical device, the "ground truth" is defined by established engineering standards (ASTM, ISO), biocompatibility guidelines (ISO 10993 series), and the functional requirements of the device (e.g., accurate fluid dispense, sufficient joint strength). Compliance with these defined standards and specifications forms the basis of "truth."
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/ML model for this physical device. Device design and manufacturing processes are iterative but not "trained" in this manner.
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How the ground truth for the training set was established:
- Not applicable for the same reason as point 7.
Key takeaway from the document: The applicant demonstrates substantial equivalence for the VIA360™ Surgical System by comparing its design, materials, and non-clinical performance data to a legally marketed predicate device (OMNI Surgical System). The 510(k) summary explicitly states: "Clinical data is not included in this submission and is not required. Substantial equivalence is based on technological comparison." This further confirms that no AI/ML specific evaluations (which often require clinical data or extensive simulation/test data for model validation) were conducted or needed.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).