(94 days)
Not Found
No
The device description and performance studies focus on mechanical operation and fluid delivery, with no mention of AI/ML terms or functionalities.
Yes
The device is used to deliver viscoelastic fluid and cut trabecular meshwork tissue, which are procedures intended to treat or improve a medical condition (e.g., glaucoma), fitting the definition of a therapeutic device.
No
The device is a surgical instrument used to deliver fluid and cut tissue during ophthalmic surgery. Its function is interventional, not diagnostic (identifying a disease or condition).
No
The device description clearly outlines physical components like a stainless steel cannula, nylon microcatheter, nose piece, scroll wheel, and external reservoir, indicating it is a hardware device.
Based on the provided information, the VIA360™ Surgical System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for delivering viscoelastic fluid and cutting trabecular meshwork tissue during ophthalmic surgery. This is a surgical intervention performed directly on the patient's eye.
- Device Description: The device is described as a surgical instrument used by ophthalmologists to perform a surgical procedure. It involves mechanical actions (advancing/retracting a microcatheter, dispensing fluid, cutting tissue).
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor a disease, or screen for a health issue.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. The VIA360™ Surgical System is a surgical tool used for treatment and manipulation of tissue within the body during a surgical procedure.
N/A
Intended Use / 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.
Product codes
MRH, HMZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior Segment including Schlemm's Canal/Trabecular Meshwork
Indicated Patient Age Range
Not Found
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
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.
Package integrity testing included:
Visual Inspection, ASTM F1886 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection, Results: All samples met the acceptance criteria
Seal Strength, ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials, Results: 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), Results: All samples met the acceptance criteria
Biocompatibility testing included:
Cytotoxicity, ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, Results: Non-Cytotoxic
Sensitization, ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, Results: Non-Sensitizer
Irritation, ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, Results: Non-irritant
Acute Systemic Toxicity, ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity, Results: Non-toxic
Material-Mediated Pyrogenicity, ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity, Results: 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, Results: Assurance level of 10-6
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.
Key Metrics
Not Found
Predicate Device(s)
K173332 (OMNI Surgical System)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
1
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.
2
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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
3
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 Court
Rancho Cucamonga, CA 91730 |
|------------------------|---------------------------------------------------------------------------------------------------------|
| Contact Person: | Victor Arellano
Sr. Manager, Global Regulatory Affairs
Contact 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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Image /page/5/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 on the right. The text is in a simple, sans-serif font and is aligned horizontally with the circular design.
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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Image /page/6/Picture/1 description: The image contains the logo for New World Medical. On the left side of the logo is a green circular graphic that is made up of three curved lines. To the right of the graphic is the text "NEW WORLD MEDICAL" in a sans-serif font. The word "MEDICAL" is stacked below "NEW WORLD" and is in a smaller font size.
| Test Performed | Standard/Guidance | Results |
|---|---|---|
| Visual Inspection | ASTM F1886 Standard Test Method for | |
| Determining Integrity of Seals for Flexible | ||
| Packaging by Visual Inspection | All samples met the | |
| acceptance criteria | ||
| Seal Strength | ASTM F88 Standard Test Method for Seal | |
| Strength of Flexible Barrier Materials | 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) | All samples met the | |
| acceptance criteria |
Package integrity testing includes:
Biocompatibility testing included:
| Test Performed | Standard/Guidance | Results |
|---|---|---|
| Cytotoxicity | ISO 10993-5 - Biological evaluation of medical | |
| devices - Part 5: Tests for in vitro cytotoxicity | Non-Cytotoxic | |
| Sensitization | ISO 10993-10 - Biological evaluation of medical | |
| devices - Part 10: Tests for irritation and skin | ||
| sensitization | Non-Sensitizer | |
| Irritation | ISO 10993-10 - Biological evaluation of medical | |
| devices - Part 10: Tests for irritation and skin | ||
| sensitization | Non-irritant | |
| Acute Systemic Toxicity | ISO 10993-11 - Biological evaluation of medical | |
| devices - Part 11: Tests for systemic toxicity | Non-toxic | |
| Material-Mediated | ||
| Pyrogenicity | ISO 10993-11 - Biological evaluation of medical | |
| devices - Part 11: Tests for systemic toxicity | 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 |
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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Image /page/7/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 simple, sans-serif font. Below "NEW WORLD" is the word "MEDICAL" in a smaller font size.
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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Image /page/8/Picture/0 description: The image shows the logo for New World Medical. The logo consists of a green, abstract, spherical shape on the left, resembling intertwined ribbons or strands. To the right of the shape, the words "NEW WORLD" are stacked above the word "MEDICAL", with the latter in a smaller font size. The text is in a simple, sans-serif typeface.
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 ophthalmic | ||
| surgical instrument, Class I exempt) | Primary: MRH (Ophthalmic Infusion Pump, Class II) | |
| Secondary: HMZ (Trabeculotomy, Manual ophthalmic | ||
| surgical instrument, Class I exempt) | ||
| Regulation | Primary: 880.5725 (Infusion Pump) | |
| Secondary: 886.4350 (Manual ophthalmic surgical | ||
| instrument) | Primary: 880.5725 (Infusion Pump) | |
| Secondary: 886.4350 (Manual ophthalmic surgical | ||
| instrument) | ||
| Intended Use | Delivery of controlled amounts of viscoelastic fluid | |
| during ophthalmic surgery | ||
| Cutting of trabecular meshwork when a trabeculotomy is | ||
| indicated | Delivery of small amounts of viscoelastic fluid during | |
| ophthalmic surgery | ||
| Cutting of trabecular meshwork when a trabeculotomy is | ||
| indicated | ||
| 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. | The OMNI™ Surgical System is a manually operated | |
| device for delivery of small amounts of viscoelastic fluid, | ||
| for example Healon® or Healon GV® from Abbott | ||
| Medical Optics (AMO), Amvisc® from Bausch & Lomb, | ||
| or PROVISC® from Alcon, during ophthalmic surgery. It | ||
| is also indicated to cut trabecular meshwork tissue during | ||
| trabeculotomy procedures. | ||
| Target Anatomy | Anterior Segment including Schlemm's Canal/Trabecular | |
| Meshwork | Anterior Segment including Schlemm's Canal/Trabecular | |
| Meshwork | ||
| Operating Principle | Manual | Manual |
| Dispensing | ||
| Mechanism | Depression of the scroll wheel/surrounding button to | |
| actuate the pump | Manual rotation of the finger wheel (dispensed upon | |
| catheter 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 canal | ||
| and pulled through to cut trabecular meshwork | Flexible microcatheter introduced into Schlemm's canal | |
| and 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 scroll | ||
| wheel/surrounding button. | Viscoelastic dispensed during retraction | |
| The device contains a separate external reservoir | Handle has internal viscoelastic reservoir and plunger | |
| tube | ||
| 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 Steel | |
| Microcatheter – Polyamide (Nylon) | Cannula - Stainless Steel | |
| Microcatheter – Polyamide (Nylon) | ||
| Passive or Energized | ||
| Device to Dispense | ||
| Viscoelastic | Passive | Passive |
| Dispensing control | Pressing of the scroll wheel/surrounding button to actuate | |
| the pump | Manual rotation of the finger wheel at the distal end of | |
| the device | ||
| Dispensing Mechanism | Positive displacement pump | Syringe (Volume exchange) |
| Interface | Handheld | Handheld |
| Characteristics | Subject Device | Predicate Device |
| Microcatheter | ||
| shaft/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.