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 018 Peripheral Guide Wire in this submission is a steerable guide wire with a maximum diameter of 0.018" (0.45mm) and available in lengths of 190cm and 300cm. The device has a solid core with a hydrophilic coated coil-type distal end. The coil is partly or entirely 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 2cm 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 300 cm. A Torque device is included in the same package.

AI/ML Overview

The provided document describes the VASSALLO GT 018 Floppy peripheral guide wire. It does not describe an AI/ML powered device, but rather a medical device that facilitates the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. Therefore, many of the requested elements for AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this submission.

However, I can provide information based on the non-clinical testing performed for the device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The in vitro bench tests demonstrated that the VASSALLO GT 018 met all acceptance criteria and performed similarly to the predicate and reference devices." However, specific quantitative acceptance criteria and their corresponding reported device performance values are not detailed in this document. The document only lists the types of tests performed.

Test Category	Acceptance Criteria (General Description)	Reported Device Performance (General Description)	Specific Quantitative Data Provided?
Dimensional Verification	Device dimensions meet specifications	Met all acceptance criteria	No
Visual Inspection	Device free from defects	Met all acceptance criteria	No
Tensile Strength / Tip Pull	Adequate tensile strength and tip integrity	Met all acceptance criteria	No
Torque Strength	Adequate torque strength	Met all acceptance criteria	No
Torqueability	Device can be torqued effectively	Met all acceptance criteria	No
Coating Adhesion/Integrity	Coating remains intact and adheres	Met all acceptance criteria	No
Particulate	Minimal particulate matter	Met all acceptance criteria	No
Catheter Compatibility / Lubricity	Compatible with catheters and lubricious	Met all acceptance criteria	No
Corrosion Resistance	Resists corrosion	Met all acceptance criteria	No
Kink Resistance	Resists kinking	Met all acceptance criteria	No
Tip Flexibility	Adequate tip flexibility	Met all acceptance criteria	No
Radiopacity	Visible under fluoroscopy	Met all acceptance criteria	No
Biocompatibility Tests (Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Partial Thromboplastin Time, In Vivo Thromboresistance, SC5b-9 Complement Activation)	Biocompatible with human tissue and blood	Determined to be biocompatible	No

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for each non-clinical bench test. The data provenance is not explicitly stated in terms of country of origin for the testing, but the applicant company, FILMECC CO., LTD., is based in Japan. These would be considered prospective tests conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device and the tests are non-clinical bench tests (e.g., tensile strength, corrosion resistance). "Ground truth" in the context of expert consensus is not relevant here; the tests have objective physical or chemical measurements.

4. Adjudication method for the test set

Not applicable, as this refers to expert review processes for complex diagnostic outputs, not physical device performance tests.

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 device is not an AI/ML diagnostic tool.

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

Not applicable. This device is not an AI/ML algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is established by standard engineering and biocompatibility testing protocols and specifications. For example, for "Tensile Strength," the ground truth would be a pre-defined range of acceptable tensile forces according to relevant standards for guide wires. For biocompatibility, the ground truth is the absence of cytotoxicity, irritation, etc., according to recognized international standards (e.g., ISO 10993).

8. The sample size for the training set

Not applicable. This device does not involve machine learning and therefore has no "training set."

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

Not applicable. There is no training set for this device.

Summary

{0}------------------------------------------------

June 30, 2022

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are displayed side-by-side.

Filmecc Co., Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants, LLC 1783 Forest Drive, Suite 200 Annapolis. Marvland 21401

Re: K213949

Trade/Device Name: VASSALLO GT 018 Floppy Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: June 2, 2022 Received: June 3, 2022

Dear Candace Cederman:

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 (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 located 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.

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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 (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 re gulatory 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,

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K213949

Device Name VASSALLO GT 018 Floppy Peripheral Guide Wire

Indications for Use (Describe)

This product is intended to facilitate the placement and exchange of diagnostic 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 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summarv (as required by 21 CFR 807.92)

Image /page/3/Picture/2 description: The image shows the logo for Filmecc. The logo consists of a red curved line on the left, followed by the word "Filmecc" in black, with a red square on top of the "i". The logo is simple and modern, and the use of red and black gives it a bold and professional look.

PERIPHERAL GUIDE WIR VASSALLO GT 018

510(k) K213949

Date Prepared:	June 29, 2022
Applicant:	FILMECC CO., LTD.
	1703 Wakita-cho, Moriyama-ku
	Nagoya-shi, Aichi 463-0024
	Japan
	TEL : +81-52-768-1212, FAX : +81-52-768-1222
Contact:	Takahiro Kuroiwa
	Regulatory Affairs
	FILMECC CO., LTD.
	1703 Wakita-cho, Moriyama-ku
	Nagoya-shi, Aichi 463-0024
	Japan
	TEL : +81-52-768-1212, FAX : +81-52-768-1222
	e-mail: takahiro.kuroiwa@filmecc.com
Trade Name:	VASSALLO GT 018 Floppy
Device Classification:	Class II per 21 CFR §870.1330
Classification Name:	Catheter, Guide, Wire
Product Code:	DQX - Catheter Guide Wire
Predicate Devices:	Filmecc VASSALLO GT (K203533)
Reference Device:	ASAHI Peripheral Guide Wires (K150445 and
	K163426)

INTENDED USE/INDICATIONS FOR USE:

VASSALLO GT 018 Floppy

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 018 Peripheral Guide Wire in this submission is a steerable guide wire with a maximum diameter of 0.018" (0.45mm) and available in lengths of 190cm and 300cm.

FILMECC CO., LTD.

{4}------------------------------------------------

The device has a solid core with a hydrophilic coated coil-type distal end. The coil is partly or entirely 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 2cm 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 300 cm. A Torque device is included in the same package.

COMPARISON WITH PREDICATE DEVICES:

Comparison of the VASSALLO GT 018 Floppy and predicate devices 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 ofDevices	VASSALLO GT 018Floppy	VASSALLO GT	ASAHI PeripheralGuidewires
	Subject	Primary Predicate	Reference Device
510(k)	K213949	K203533	K150445 and K163426
Intended Useand Indications	This product is intended to facilitate the placement and exchange of diagnostic andtherapeutic devices during intravascular procedures. This device is intended for peripheralvascular use only.
Nominal OD	0.45mm(0.018in)	0.36mm(0.014in)	0.36-0.45mm(0.014 - 0.018in)
Overall Length	190, 300cm		180 - 300cm
Outer Coil	Platinum	Platinum orPlatinum-Nickel and Stainless Steel
Tapered CoreWire	Stainless Steel
Tip Shape	Straight (shapeable)		Straight (pre-shaped)
Coating	Hydrophilic, Hydrophobic
Sterilization	Ethylene Oxide

NON-CLINICAL TESTING/PERFORMANCE DATA:

Non-clinical laboratory testing was performed on the VASSALLO GT 018 to determine substantial equivalence. The following testing/assessments were performed:

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

FILMECC CO., LTD.

{5}------------------------------------------------

The in vitro bench tests demonstrated that the VASSALLO GT 018 met all acceptance criteria and performed similarly to the predicate and reference devices. Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate and reference devices.

BIOCOMPATIBILITY:

Testing was performed to assess biocompatibility of the VASSALLO GT 018. The following tests were performed:

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

The results from the testing performed showed the VASSALLO GT 018 Floppy to be biocompatible.

CONCLUSION:

The VASSALLO GT 018 peripheral guidewire 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 018 is as safe, as effective, and performs as well as or better than the legally marketed predicate and reference devices.

Therefore, the VASSALLO GT 018 Floppy 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.