VASSALLO GT Crossing14

K232574 · Filmec Co. , Ltd. · DQX · Oct 11, 2023 · Cardiovascular

Device Facts

• Record ID: K232574
• Device Name: VASSALLO GT Crossing14
• Applicant: Filmec Co. , Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 11, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

Device Story

Steerable guide wire; 0.014-inch diameter; 190cm or 300cm lengths. Used in peripheral vascular procedures to facilitate placement/exchange of diagnostic/therapeutic devices. Features solid core, hydrophilic-coated coil-type distal end, and PTFE-coated core shaft. Radiopaque distal end allows fluoroscopic visualization for vessel selection and positioning. Includes detachable extension wire and torque device. Operated by physicians in clinical settings. Provides mechanical support and guidance for interventional devices; benefits patient by enabling access to peripheral vasculature.

Clinical Evidence

Bench testing only. Tests included dimensional verification, visual inspection, tensile strength/tip pull, torque strength, torqueability, coating adhesion/integrity, catheter compatibility/lubricity, corrosion resistance, kink resistance, tip flexibility, and radiopacity. Results demonstrated the device met all acceptance criteria and performed similarly to the predicate.

Technological Characteristics

Steerable guide wire; 0.014" (0.36mm) OD. Materials: Platinum-Nickel outer coil, stainless steel tapered core wire. Coatings: PTFE (shaft), hydrophilic (distal end). Sterilization: Ethylene Oxide (validated per AAMI TIR28). Form factor: 190cm/300cm lengths. Mechanical sensing/actuation via manual torque and navigation.

Indications for Use

Indicated for patients undergoing intravascular procedures requiring the placement and exchange of diagnostic and therapeutic devices in the peripheral vasculature.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Filmecc VASSALLO GT (K203533)

Submission Summary (Full Text)

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October 11, 2023

Filmec Co. Ltd. Meagan Fagan Principal Consultant CardioMed Device Consultants 1783 Forest Drive Suite 254 Annapolis. Maryland 21401

#### Re: K232574

Trade/Device Name: Vassallo GT Crossing14 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: August 24, 2023 Received: August 25, 2023

#### Dear Meagan Fagan:

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.

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).

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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 OS 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.

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.

For comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Image /page/1/Picture/5 description: The image shows the end of a letter. The text "Sincerely," is at the top, followed by the name "Lydia S. Glaw -S" in a larger font. The name is split across three lines.

Digitally signed by Lydia S. Glaw -S Date: 2023.10.11 14:38:35 -04'00'

Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Enclosure

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## Indications for Use

510(k) Number (if known) K232574

Device Name VASSALLO® GT Crossing14

Indications for Use (Describe)

This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

Type of Use (Select one or both, as applicable)

| <span></span> | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------------------------------------------|
| <span></span> | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) Summary

Image /page/4/Picture/1 description: The image shows the logo for "Filmecc". The logo consists of a red abstract shape on the left, resembling a stylized letter "A" or an incomplete circle. To the right of this shape is the word "Filmecc" in black, with a small red square above the "i". The font is bold and sans-serif, giving the logo a modern and professional appearance.

# VASSALLO® GT G14

| Date Prepared: | August 24, 2023 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | FILMECC CO., LTD.<br>1703 Wakita-cho, Moriyama-ku<br>Nagoya-shi, Aichi 463-0024<br>Japan<br>TEL: [phone], FAX: [phone] |
| Contact: | Noriaki Tsuzuki<br>Regulatory Affairs / Vigilance Section<br>FILMECC CO., LTD.<br>1703 Wakita-cho, Moriyama-ku<br>Nagoya-shi, Aichi 463-0024<br>Japan<br>TEL: [phone], FAX: [phone]<br>e-mail: [e-mail] |
| Trade Name: | VASSALLO® GT Crossing14 |
| Device Classification: | Class 2 per 21 CFR §870.1330 |
| Classification Name: | Catheter, Guide, Wire |
| Product Code: | DQX - Catheter Guide Wire |
| Predicate Devices: | Filmecc VASSALLO GT (K203533) |

#### INTENDED USE/INDICATIONS FOR USE:

#### VASSALLO® GT Crossing14

This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

### DEVICE DESCRIPTION:

The VASSALLO® GT Crossing14 Peripheral Guide Wire in this submission is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) in available lengths of 190cm and 300cm. The outer coil wire diameter has been modified to 0.072 mm.

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The devices have a solid core with a hvdrophilic coated coil-type distal end. The coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy.

The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2 cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the quide wire with a length of less than 300cm. A Torque device is included in the same package.

## COMPARISON WITH PREDICATE DEVICE:

Comparisons of the VASSALLO® GT Crossing14 and predicate device show that the technological characteristics of the subject device such as the components, design, materials, sterilization method, shelf life and operating principle are similar, if not identical, to the currently marketed predicate device. The intended use of the subject device and its predicate are the same.

| Name of Devices | VASSALLO® GT Crossing14 | VASSALLO GT |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| | Subject | Predicate |
| 510(k) | K232574 | K203533 |
| Intended Use and<br>Indications | This product is intended to facilitate the placement and exchange of diagnostic and<br>therapeutic devices during intravascular procedures. This device is intended for<br>peripheral vascular use only. | |
| Nominal OD | 0.36mm<br>(0.014in) | 0.36mm<br>(0.014in) |
| Overall Length | 190, 300cm | |
| Outer Coil | Platinum-Nickel | Platinum or Platinum-Nickel and<br>Stainless Steel |
| Outer Coil Diameter | 0.072 mm | 0.060 mm - 0.080 mm |
| Tapered Core Wire | Stainless Steel | |
| Tip Shape | Straight | |
| Coating | Hydrophilic, Hydrophobic | |
| Sterilization | Ethylene Oxide | |

#### NON-CLINICAL TESTING/PERFORMANCE DATA:

Non-clinical laboratory testing was performed on the VASSALLO® GT Crossing14 to determine substantial equivalence to the predicate device. The following testing/assessments were performed:

- Dimensional Verification ●
- Visual Inspection .
- Tensile Strength / Tip Pull
- Torque Strength
- Torqueability ●
- . Coating Adhesion/Integrity
- Catheter Compatibility / ● Lubricity
- Corrosion Resistance
- Kink Resistance ●
- Tip Flexibility ●
- Radiopacity ●

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The in vitro bench tests demonstrated that the VASSALLO GT Crossing14 met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate devices.

### BIOCOMPATIBILITY:

Testing was performed to assess biocompatibility of the predicate VASSALLO GT. The following tests were performed:

- Cytotoxicity ●
- Sensitization
- Intracutaneous Irritation ●
- Acute Systemic Toxicity ●
- Material Mediated ● Pyrogenicity
- Hemolysis
- Partial Thromboplastin Time
- In Vivo Thromboresistance
- Complement Activation (SC5b-9)

The results from this testing are being leveraged for the subject device and support the biocompatibility of the VASSALLO GT Crossing14.

#### STERILIZATION:

The minor differences of the subject device do not represent a greater sterilization challenge than the predicate VASSALLO GT quide wires. As such, no additional sterilization validation was required, and the subject device was adopted into the product family for which a sterilization cycle was validated in accordance with AAMI TIR28.

#### CONCLUSION:

The VASSALLO GT Crossing14 has the same intended use and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate device. Performance data demonstrates that the device functions as intended. The conclusions drawn from the nonclinical tests demonstrate that the VASSALLO GT Crossing14 is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

Therefore, the VASSALLO GT Crossing14 is substantially equivalent to the predicate devices.