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 Peripheral Guide Wires in this submission are steerable guide wires with a maximum diameter of 0.014 inches (0.36mm) and available in 190cm and 300cm lengths. These devices have a solid core with a hydrophilic coil-type distal end. When wet, the hydrophilic coating increases the lubricity of the quidewire surface. Some models also include silicone coating on the distal tip. 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

This document is a 510(k) summary for the VASSALLO® GT Guide Wire. It details the device's characteristics, intended use, and substantial equivalence to predicate devices, based on non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The in vitro bench tests demonstrated that the VASSALLO GT met all acceptance criteria". However, it does not provide a specific table of acceptance criteria with corresponding performance values. It only lists the types of tests performed.

Test Performed	Acceptance Criteria	Reported Device Performance
Dimensional Verification	Not specified in document	Met acceptance criteria
Visual Inspection	Not specified in document	Met acceptance criteria
Simulated Use	Not specified in document	Met acceptance criteria
Tensile Strength / Tip Pull	Not specified in document	Met acceptance criteria
Torque Strength	Not specified in document	Met acceptance criteria
Torqueability	Not specified in document	Met acceptance criteria
Coating Integrity	Not specified in document	Met acceptance criteria
Coating Adhesion	Not specified in document	Met acceptance criteria
Catheter Compatibility / Lubricity	Not specified in document	Met acceptance criteria
Corrosion Resistance	Not specified in document	Met acceptance criteria
Kink Resistance	Not specified in document	Met acceptance criteria
Tip Flexibility	Not specified in document	Met acceptance criteria
Radiopacity	Not specified in document	Met acceptance criteria

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for each non-clinical test.
The data provenance is from non-clinical laboratory testing performed on the VASSALLO® GT. The country of origin for the manufacturing company (Filmecc Co., Ltd.) is Japan. The type of study is bench testing (in vitro), not human subject testing (prospective or retrospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable as the study described is non-clinical bench testing, not a clinical study involving expert interpretation of data or images. Ground truth for non-clinical tests is established by adhering to testing standards and specifications.

4. Adjudication Method for the Test Set

This question is not applicable as the study described is non-clinical bench testing. Adjudication methods are typically relevant for clinical studies where human interpretation or consensus is required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document focuses on non-clinical bench testing of a guide wire, not an AI-assisted diagnostic device. Therefore, there is no discussion of human readers, AI assistance, or effect sizes in that context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a medical guide wire, not an algorithm or software requiring standalone performance evaluation.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" or reference for evaluating performance would be predefined engineering specifications, international standards, and performance characteristics of predicate devices. The document states that the device "met all acceptance criteria" and "performed similarly to the predicate and reference devices," implying comparison against these types of benchmarks.

8. The Sample Size for the Training Set

This question is not applicable. There is no mention of a "training set" as this is a physical medical device undergoing bench testing, not an AI/machine learning model.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for a guide wire.

Summary

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April 21, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Filmecc Co., Ltd % Candace Cederman Principal Consultant CardioMed Device Consultants, LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401

Re: K203533

Trade/Device Name: Vassallo Gt Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 26, 2021 Received: March 29, 2021

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

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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 mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medical-devices/ device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-andcontinuing-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-regulatory-assistance/contact-usdivision-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

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Indications for Use

510(k) Number (if known) K203533

Device Name VASSALLO® GT Guide Wire

Indications for Use (Describe)

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)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

(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 abstract shape on the left, followed by the word "Filmecc" in black letters, with a red square above the "i". Below the word "Filmecc" is the text "PERIPHERAL GUIDE WIRES".

PERIPHERAL GUIDE W VASSALLO® GT

510(k) K203533

Date Prepared:	1 December 2020
Applicant:	FILMECC CO., LTD.
	1703 Wakita-cho, Moriyama-ku
	Nagoya-shi, Aichi 489-0071
	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 489-0071
	Japan
	TEL : +81-52-768-1212, FAX : +81-52-768-1222
	e-mail: takahiro.kuroiwa@filmecc.com
Trade Name:	VASSALLO® GT
Device Classification:	Class 2 per 21 CFR §870.1330
Classification Name:	Catheter, Guide, Wire
Product Code:	DQX - Catheter Guide Wire
Predicate Devices:	ASAHI Peripheral Guide Wire, K150445 and K163426
Reference Devices:	ASAHI Astato XS 40, K153443
	ASAHI Regalia XS 1.0, K083146
	ASAHI PROWATER, K022762 and K070945

INTENDED USE/INDICATIONS FOR USE:

VASSALLO® GT

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 Peripheral Guide Wires in this submission are steerable guide wires with a maximum diameter of 0.014 inches (0.36mm) and available in 190cm and 300cm lengths.

FILMECC CO., LTD.

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These devices have a solid core with a hydrophilic coil-type distal end. When wet, the hydrophilic coating increases the lubricity of the quidewire surface. Some models also include silicone coating on the distal tip. 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:

Comparisons of the VASSALLO GT® and predicate / reference 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 to the currently marketed predicate and reference devices. The intended use of the subject device and its predicates are the same.

Name of Devices	VASSALLO GTⓇ	ASAHI Peripheral Guide WiresASAHI Gladius, ASAHI HalberdASAHI Gaia PV
	Subject	Primary Predicate
510(k)	TBD	K150445 and K163426
Intended Use andIndications	This product is intended to facilitatethe placement and exchange ofdiagnostic and therapeutic devicesduring intravascular procedures. Thisdevice is intended for peripheralvascular use only.	This product is intended to facilitatethe placement and exchange ofdiagnostic and therapeutic devicesduring intravascular procedures. Thisdevice is intended for peripheralvascular use only.
Nominal OD	0.36mm(0.014in)	0.36mm and 0.45mm(0.014in and 0.018in)
Overall Length	190, 300cm	200cm to 300cm
Outer Coil	Platinum orPlatinum-Nickel and StainlessSteel	Platinum-Nickel and StainlessSteel
Tapered Core Wire	Stainless Steel	Stainless Steel
Inner Structure	--	Stainless Steel Coil
Tip Shape	Straight	StraightPreshape
Coating	Hydrophilic, Hydrophobic	Hydrophilic, Hydrophobic
Sterilization	Ethylene Oxide	Ethylene Oxide

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NON-CLINICAL TESTING/PERFORMANCE DATA:

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

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

The in vitro bench tests demonstrated that the VASSALLO GT 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 devices.

BIOCOMPATIBILITY:

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

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

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

CONCLUSION:

The VASSALLO GT 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 and reference devices. Performance data demonstrates that the device functions as intended. The conclusions drawn from the nonclinical and clinical tests demonstrate that the VASSALLO GT is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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

FILMECC CO., LTD.

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.