The VASSALLO GT EXT guide wire accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure. This device is intended for peripheral vascular use only.

Device Description

The VASSALLO GT EXT Guide Wire Extension accessory is used to elongate the working length of compatible peripheral extendable wires. The stainless-steel guide wire extension has an outer diameter of 0.014" (0.36 mm) and a length of 165 cm. The distal end consists of a pipe shaped nitinol-titanium connection port (extension tube). The straight stainless steel wire surface is coated with PTFE. The extension wire is intended to connect with a FILMECC peripheral guide wire shorter than 300 cm. The total length of the system after connection will be 300 cm to 400 cm.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the FILMECC VASSALLO GT EXT guide wire extension. This is a medical device, and the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on performance against specific acceptance criteria for an AI/ML-driven diagnostic or prediction system.

Therefore, the information required to populate the fields related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample size, expert ground truth, MRMC study, standalone performance) is not present in the provided document.

The document states:

Non-clinical testing/performance data: "Non-clinical laboratory testing was performed on the VASSALLO GT EXT to determine substantial equivalence. Testing involved evaluating the joint strength of the extension tube and core wire of extension wire in addition to the joint strength of the extension tube and the core extension wire. The in vitro bench tests demonstrated that the VASSALLO GT EXT met all acceptance criteria and that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate device."

This indicates that the acceptance criteria are related to physical performance characteristics (like joint strength) of the guide wire extension and that in vitro bench tests were conducted to demonstrate these. However, the specific quantitative acceptance criteria or the detailed results of these tests (e.g., numerical values for joint strength, performance vs. predicate) are not detailed in this summary.

Given the nature of the device (a guide wire extension, not an AI/ML diagnostic tool), the typical questions about AI/ML device evaluation (like expert readers, MRMC studies, training/test set ground truth for algorithms) are not applicable to this submission.

In summary, based only on the provided text, I cannot complete the requested tables and information fields because:

The device is a physical medical device (guide wire extension), not an AI/ML or diagnostic device that would involve typical "acceptance criteria" in terms of classification performance (e.g., sensitivity, specificity, AUC) or human reader performance.
The "acceptance criteria" mentioned are for engineering/performance bench tests (e.g., joint strength), not diagnostic accuracy.
The document states "in vitro bench tests demonstrated that the VASSALLO GT EXT met all acceptance criteria," but it does not specify what those criteria are or provide the results of those tests.
There is no mention of a test set, expert ground truth, MRMC study, or training set in the context of an AI/ML system.

To provide the requested information, the 510(k) submission's detailed test reports for the physical properties of the guide wire extension would be needed, not just this summary.

Summary

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October 26, 2022

Image /page/0/Picture/1 description: The image shows 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 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.

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

Re: K222631

Trade/Device Name: Vassallo Gt Ext Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: August 30, 2022 Received: August 31, 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) Prem arket 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 w arranties. 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

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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 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 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,

for 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

Enclosure

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Indications for Use

510(k) Number (if known) K222631

Device Name VASSALLO GT EXT

Indications for Use (Describe)

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

(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 on top of the "i". Below the logo, the text "FILMECC Extension Wire" is written in a smaller font size.

FILMECC Extension Wire VASSALLO® GT EXT

510(k) K222631

Date Prepared:	October 14, 2022
Applicant:	FILMECC CO., LTD.1703 Wakita-cho, Moriyama-kuNagoya-shi, Aichi 463-0024JapanTEL : +81-52-768-1212, FAX : +81-52-768-1222
Contact:	Takahiro KuroiwaRegulatory AffairsFILMECC CO., LTD.1703 Wakita-cho, Moriyama-kuNagoya-shi, Aichi 463-0024JapanTEL : +81-52-768-1212, FAX : +81-52-768-1222e-mail: takahiro.kuroiwa@filmecc.com
Trade Name:	VASSALLO GT EXT
Device Classification:	Class 2 per 21 CFR §870.1330
Classification Name:	Catheter, Guide, Wire
Product Code:	DQX - Catheter Guide Wire
Predicate Devices:	ASAHI Guide Wire Extension, K101985

INTENDED USE/INDICATIONS FOR USE:

VASSALLO GT EXT

The VASSALLO GT EXT Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-thewire interventional devices during an angioplasty procedure. This device is intended for peripheral vascular use only.

DEVICE DESCRIPTION:

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The extension wire is intended to connect with a FILMECC peripheral guide wire shorter than 300 cm. The total length of the system after connection will be 300 cm to 400 cm.

COMPARISON WITH PREDICATE DEVICES:

Comparison of the VASSALLO GT EXT and the 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 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 EXT	ASAHI Guide Wire Extension
	Subject	Predicate
510(k)	K222631	K101985
Intended Use andIndications	Intended for extension of the workinglength of an already introduced guidewire when exchanging over-the-wireinterventional devices duringanangioplasty procedure This device isintended for peripheral vascular useonly.	Intended for extension of the workinglength of an already introduced guidewire when exchanging over-the-wireinterventional devices duringanangioplasty procedure
Target location	Peripheral	Coronary and Peripheral
Nominal OD	0.36 mm	0.36 mm
	(0.014 inch)	(0.014 inch)
Overall Length	165 cm	165 cm
Tapered Core Wire	Stainless Steel	Stainless Steel
Extension Tube	Ni-Ti alloy	Ni-Ti alloy
Hydrophobic Coating	PTFE	PTFE
Sterilization	EO	EO
Shelf Life	3 years	3 years

NON-CLINICAL TESTING/PERFORMANCE DATA:

Non-clinical laboratory testing was performed on the VASSALLO GT EXT to determine substantial equivalence. Testing involved evaluating the joint strength of the extension tube and core wire of extension wire in addition to the joint strength of the extension tube and the core extension wire.

The in vitro bench tests demonstrated that the VASSALLO GT EXT met all acceptance criteria and that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate device.

CONCLUSION:

The VASSALLO GT EXT accessory 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 conclusion drawn from the nonclinical tests demonstrate that the VASSALLO GT EXT 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 EXT 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.