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. 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.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and device performance:

It's important to note that the provided document is a 510(k) summary for a medical device (a guide wire), not a publication about an AI/ML medical device. Therefore, many of the requested elements for AI/ML device studies (e.g., ground truth methods, expert qualifications, effect size for human readers with AI assistance) are not applicable to this document. This summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility assessments, not on the performance of a diagnostic or assistive AI system.

Here's the information that can be extracted from the document, with explanations for what cannot be:

1. A table of acceptance criteria and the reported device performance

The document states that "The in vitro bench tests demonstrated that the VASSALLO GT Crossing14 met all acceptance criteria and performed similarly to the predicate devices." However, the specific quantitative acceptance criteria for each test and the corresponding precise device performance values are not explicitly detailed in this 510(k) summary. It only lists the tests performed.

Acceptance Criteria (General)	Reported Device Performance (General)
Meets all specified acceptance criteria	Met all acceptance criteria for listed non-clinical tests.
Performs similarly to the predicate devices	Performed similarly to the predicate devices.
Functions as intended	Functions as intended.
Safety and effectiveness profile similar to predicate	Has a safety and effectiveness profile similar to the predicate devices.
Biocompatible	Biocompatibility of the subject device is supported by leveraging testing performed on the predicate device.
Sterilizable with existing validated cycle	The minor differences do not represent a greater sterilization challenge, and the device was adopted into a product family with a validated sterilization cycle.

Non-clinical tests performed (details on specific criteria and results are not provided):

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

Biocompatibility tests performed (details on specific criteria and results are not provided; leveraged from predicate):

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "non-clinical laboratory testing" and "in vitro bench tests." It does not specify sample sizes for these tests (e.g., how many guidewires were tested for tensile strength). Since these are bench tests, "data provenance" in terms of patient data (country of origin, retrospective/prospective) is not applicable. The tests were performed to support a device manufactured by FILMECC CO., LTD. in Japan.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as this is not an AI/ML medical device or a clinical study requiring expert ground truth for interpretation. The "ground truth" for these non-clinical tests would be the physical and chemical properties measured against established engineering and material standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not an AI/ML medical device or a clinical study involving subjective interpretation requiring adjudication.

5. 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 document describes a traditional medical device (guide wire) and does not involve AI assistance or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document describes a traditional medical device (guide wire) and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For non-clinical bench testing, the "ground truth" is defined by established engineering standards, material specifications, and physical/chemical measurements. For biocompatibility, it's defined by biological responses according to ISO standards for biocompatibility testing. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

	Prescription Use (Part 21 CFR 801 Subpart D)
	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.1703 Wakita-cho, Moriyama-kuNagoya-shi, Aichi 463-0024JapanTEL: +81-52-768-1212, FAX: +81-52-768-1222
Contact:	Noriaki TsuzukiRegulatory Affairs / Vigilance SectionFILMECC CO., LTD.1703 Wakita-cho, Moriyama-kuNagoya-shi, Aichi 463-0024JapanTEL: +81-52-768-1212, FAX: +81-52-768-1222e-mail: noriaki.tsuzuki@filmecc.com
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:

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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 andIndications	This product is intended to facilitate the placement and exchange of diagnostic andtherapeutic devices during intravascular procedures. This device is intended forperipheral vascular use only.
Nominal OD	0.36mm(0.014in)	0.36mm(0.014in)
Overall Length	190, 300cm
Outer Coil	Platinum-Nickel	Platinum or Platinum-Nickel andStainless 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.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
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.(b)
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.