(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):
-
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.
-
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.
-
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.
-
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.
-
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.
-
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."
-
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.
-
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 14, 2025
New World Medical, Inc. Victor Arellano Senior Manager, Global Regulatory Affairs 10763 Edison Court Rancho Cucamonga, California 91730
Re: K243503
Trade/Device Name: VIA360TM Surgical System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRH, HMZ Dated: January 6, 2025 Received: January 7, 2025
Dear Victor Arellano:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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3
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,
CLAUDINE H. KRAWCZYK -S
Claudine Krawczyk Assistant 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) K243503
Device Name VIA360™ Surgical System
Indications for Use (Describe)
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.
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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Image /page/4/Picture/0 description: The image shows the logo for New World Medical. The logo consists of a green, abstract, circular shape on the left, followed by the words "NEW WORLD" in a sans-serif font. Below "NEW WORLD" is the word "MEDICAL" in a smaller font size.
1. 510K Summary
| 510(K) Owner: | New World Medical, Inc.10763 Edison CourtRancho Cucamonga, CA 91730 |
|---|---|
| Contact Person: | Victor ArellanoSr. Manager, Global Regulatory AffairsContact Information: 909-466-4304 ext. 118 |
| Date Prepared: | 12 JUL 2024 |
| Device Trade Name: | VIA360™ Surgical System |
| Classification Number: | 21 CFR 880.5725 – Infusion Pump |
| Product Code: | MRH, HMZ |
| Regulation Number: | 21 CFR 880.5725, 21 CFR 886.4350 |
| Predicate Device | K173332 (OMNI Surgical System) |
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1.1. Device Description
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.
1.2. Indications for Use
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.
1.3. Summary of Non-Clinical Data
Non-clinical performance verification testing was performed to demonstrate that the subject, The VIA360™ Surgical System is substantially equivalent to the predicate device. Performance testing included joint strength testing, actuation force testing, priming and dispense volume testing, and simulated use testing.
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| Test Performed | Standard/Guidance | Results |
|---|---|---|
| Visual Inspection | ASTM F1886 Standard Test Method forDetermining Integrity of Seals for FlexiblePackaging by Visual Inspection | All samples met theacceptance criteria |
| Seal Strength | ASTM F88 Standard Test Method for SealStrength of Flexible Barrier Materials | All units had a sealstrength > 0.75 lbf/in. |
| Bubble leak test | ASTM F2096 Standard Test Method for DetectingGross Leaks in Packaging by InternalPressurization (Bubble Test) | All samples met theacceptance criteria |
Package integrity testing includes:
Biocompatibility testing included:
| Test Performed | Standard/Guidance | Results |
|---|---|---|
| Cytotoxicity | ISO 10993-5 - Biological evaluation of medicaldevices - Part 5: Tests for in vitro cytotoxicity | Non-Cytotoxic |
| Sensitization | ISO 10993-10 - Biological evaluation of medicaldevices - Part 10: Tests for irritation and skinsensitization | Non-Sensitizer |
| Irritation | ISO 10993-10 - Biological evaluation of medicaldevices - Part 10: Tests for irritation and skinsensitization | Non-irritant |
| Acute Systemic Toxicity | ISO 10993-11 - Biological evaluation of medicaldevices - Part 11: Tests for systemic toxicity | Non-toxic |
| Material-MediatedPyrogenicity | ISO 10993-11 - Biological evaluation of medicaldevices - Part 11: Tests for systemic toxicity | Non-pyrogenic |
| Sterilization | ISO 11137-1 - Sterilization of health care products- Radiation - Part 1ISO 11137-2 -- Sterilization of health careproducts. Radiation - Part 2: Establishing thesterilization dose | Assurance level of10-6 |
Acceptance criteria were based on the ability of the device to perform as intended under its usage conditions and based on predicate device characteristics. The test results show that the VIA360™ Surgical System met all acceptance criteria and performs as intended.
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1.4. Summary of Clinical Data:
Clinical data is not included in this submission and is not required. Substantial equivalence is based on technological comparison.
1.5. Comparison of Technological Characteristics with the Predicate Device:
As was established in this submission, the subject device - The VIA360™ Surgical System is substantially equivalent to the predicate K173332 (OMNI™ Surgical System) previously cleared by FDA. The subject device has been shown to be substantially equivalent and has equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, principles of operation, materials, and function. Additional information can be seen in table 1.6 below.
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1.6. Predicate Device Comparison Chart
| Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Class | II | II |
| Product Code | Primary: MRH (Ophthalmic Infusion Pump, Class II)Secondary: HMZ (Trabeculotomy, Manual ophthalmicsurgical instrument, Class I exempt) | Primary: MRH (Ophthalmic Infusion Pump, Class II)Secondary: HMZ (Trabeculotomy, Manual ophthalmicsurgical instrument, Class I exempt) |
| Regulation | Primary: 880.5725 (Infusion Pump)Secondary: 886.4350 (Manual ophthalmic surgicalinstrument) | Primary: 880.5725 (Infusion Pump)Secondary: 886.4350 (Manual ophthalmic surgicalinstrument) |
| Intended Use | Delivery of controlled amounts of viscoelastic fluidduring ophthalmic surgeryCutting of trabecular meshwork when a trabeculotomy isindicated | Delivery of small amounts of viscoelastic fluid duringophthalmic surgeryCutting of trabecular meshwork when a trabeculotomy isindicated |
| Indications For Use | The VIA360™ Surgical System is indicated for deliveryof controlled amounts of viscoelastic fluid duringophthalmic surgery. It is also indicated to cut trabecularmeshwork tissue during trabeculotomy procedures. | The OMNI™ Surgical System is a manually operateddevice for delivery of small amounts of viscoelastic fluid,for example Healon® or Healon GV® from AbbottMedical Optics (AMO), Amvisc® from Bausch & Lomb,or PROVISC® from Alcon, during ophthalmic surgery. Itis also indicated to cut trabecular meshwork tissue duringtrabeculotomy procedures. |
| Target Anatomy | Anterior Segment including Schlemm's Canal/TrabecularMeshwork | Anterior Segment including Schlemm's Canal/TrabecularMeshwork |
| Operating Principle | Manual | Manual |
| DispensingMechanism | Depression of the scroll wheel/surrounding button toactuate the pump | Manual rotation of the finger wheel (dispensed uponcatheter retraction) |
| Characteristics | Subject Device | Predicate Device |
| Design | Flexible microcatheter for dispensation of viscoelastic | Flexible microcatheter for dispensation of viscoelastic |
| Microcatheter has a round, bolus, atraumatic tip | Microcatheter has a round, bolus, atraumatic tip | |
| Proximal handle | Proximal handle | |
| Flexible microcatheter introduced into Schlemm's canaland pulled through to cut trabecular meshwork | Flexible microcatheter introduced into Schlemm's canaland pulled through to cut trabecular meshwork | |
| Finger wheel for advancing and retracting microcatheter | Finger wheel for advancing and retracting microcatheter | |
| Viscoelastic fluid is dispensed using scrollwheel/surrounding button. | Viscoelastic dispensed during retraction | |
| The device contains a separate external reservoir | Handle has internal viscoelastic reservoir and plungertube | |
| Viscoelastic | Supplied separately.Viscoelastic loaded into the device prior to use. | Supplied separately.Viscoelastic loaded into the device prior to use. |
| Sterile and Single Use | Provided Sterile. Single Use | Provided Sterile. Single Use |
| Material | Cannula - Stainless SteelMicrocatheter – Polyamide (Nylon) | Cannula - Stainless SteelMicrocatheter – Polyamide (Nylon) |
| Passive or EnergizedDevice to DispenseViscoelastic | Passive | Passive |
| Dispensing control | Pressing of the scroll wheel/surrounding button to actuatethe pump | Manual rotation of the finger wheel at the distal end ofthe device |
| Dispensing Mechanism | Positive displacement pump | Syringe (Volume exchange) |
| Interface | Handheld | Handheld |
| Characteristics | Subject Device | Predicate Device |
| Microcathetershaft/Probe OD | 200 Microns | 200 Microns |
| Cannula | Curved distal end with sharp edge to create incisions | Curved distal end with sharp edge to create incisions |
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Image /page/9/Picture/0 description: The image contains the logo for New World Medical. The logo consists of a green, abstract, circular shape on the left, resembling a stylized globe or organic form. To the right of the shape, the words "NEW WORLD" are stacked above the word "MEDICAL", with the word "MEDICAL" in a smaller font size.
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Image /page/10/Picture/0 description: The image contains the logo for New World Medical. The logo consists of a green, abstract, circular shape on the left, followed by the text "NEW WORLD" in a larger font and "MEDICAL" in a smaller font below it. The text is in a simple, sans-serif typeface and is colored in a dark gray or black.
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Image /page/11/Picture/0 description: The image contains the logo for New World Medical. The logo consists of a green, abstract, circular design on the left, followed by the text "NEW WORLD" in a larger font and "MEDICAL" in a smaller font below it. The text is in a simple, sans-serif typeface and is positioned to the right of the circular design.
1.7. Conclusion
Based on the indications for use, technological characteristics, non-clinical performance data, and a comparison to the predicate device, the subject device - The VIA360™ Surgical System has been shown to be substantially equivalent to the legally marketed predicate device for its intended use.
§ 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).