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

Device Description

The VASSALLO GT Hybrid consists of a hybrid NiTi and stainless-steel core wire and a coil assembly on the distal end of the device. The coil assembly is soldered to the NiTi portion of the core. 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. Coatings are applied on the surface of the VASSALLO GT Hybrid to increase lubricity and reduce friction. The proximal portion is coated with PTFE. The distal section is coated with a hydrophilic coating and polyurethane coating. The VASSALLO GT Hybrid has an outer diameter of 0.014 inches (0.36mm) and is available in 190cm and 300cm lengths. 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 guide wire with a length of less than 300 cm. A Torque device is included in the same package.

AI/ML Overview

This document describes a 510(k) premarket notification for the VASSALLO GT Hybrid, a catheter guide wire, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance described by specific metrics (e.g., accuracy, sensitivity, specificity), nor details of any study demonstrating this performance. It's a regulatory submission affirming substantial equivalence based on technical characteristics and bench testing against predicate devices, not a clinical performance validation against specific acceptance criteria for a diagnostic AI/ML device.

Therefore, I cannot provide the detailed information requested in the prompt based on the provided text, as it pertains to a different type of medical device submission (a guide wire, not a diagnostic AI/ML device) and does not include the specific performance metrics or study information requested.

Here's a breakdown of what can be inferred from the document regarding the closest analogous information, and what is explicitly missing for your request:

What can be inferred (closest analogies):

"Acceptance criteria" and "reported device performance": The document states, "The in vitro bench tests demonstrated that the VASSALLO GT Hybrid met all acceptance criteria and performed similarly to the predicate and reference devices." and "Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate devices." While this confirms tests were performed and criteria met, the actual criteria (e.g., specific tensile strength in Newtons, specific coating adhesion force) and the numerical performance results against those criteria are not provided. The bench tests listed are:
- 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 study that proves the device meets the acceptance criteria": This refers to "Non-clinical laboratory testing" and "Biocompatibility testing."
"Type of ground truth used": For the guide wire, the "ground truth" is typically defined by engineering specifications, material properties, and established medical standards for guide wire performance (e.g., ISO standards for tensile strength, elongation, etc.), as well as in-vitro performance models that simulate use. These are not explicitly detailed but are inherent in the types of non-clinical tests performed.

What is explicitly missing from the provided text for your request (and why):

A table of acceptance criteria and the reported device performance: While criteria were met, the specific metrics and values are not given.
Sample size used for the test set and the data provenance: Not applicable in the context of bench testing for a guide wire in the way it would be for an AI/ML diagnostic. Bench tests typically use a pre-production sample of devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for engineering bench tests. "Ground truth" is based on objective measurements against engineering specifications.
Adjudication method for the test set: Not applicable. Bench test results are typically objective measurements.
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 a medical instrument, not an AI diagnostic.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used: As mentioned above, it's engineering specifications and in-vitro performance models, not expert consensus, pathology, or outcomes data in the sense of a diagnostic interpretation.
The sample size for the training set: Not applicable. This device does not use a training set as it's not an AI/ML product.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a 510(k) submission for a physical medical device (a guide wire), not an AI/ML diagnostic device. The regulatory pathway involves demonstrating substantial equivalence through comparison of technological characteristics and non-clinical bench testing to predicate devices, rather than establishing clinical performance against human expert ground truth using AI-specific metrics.

Summary

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May 4, 2021

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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

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

Re: K203529

Trade/Device Name: VASSALLO GT Hybrid Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: April 2, 2021 Received: April 5, 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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203529

Device Name VASSALLO® GT Hybrid 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)

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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 Peripheral Guide Wires. The logo consists of a red abstract shape on the left, followed by the word "Filmecc" in black with a red square above the "i". Below the word "Filmecc" is the phrase "PERIPHERAL GUIDE WIRES" in smaller, black letters.

PERIPHERAL GUIDE WIRE VASSALLO® GT Hvbrid

510(k) K203529

Date Prepared:	2 April 2021
Applicant:	FILMECC CO., LTD.1703 Wakita-cho, Moriyama-kuNagoya-shi, Aichi 489-0071JapanTEL : +81-52-768-1212, FAX : +81-52-768-1222
Contact:	Takahiro KuroiwaRegulatory AffairsFILMECC CO., LTD.1703 Wakita-cho, Moriyama-kuNagoya-shi, Aichi 489-0071JapanTEL : +81-52-768-1212, FAX : +81-52-768-1222e-mail: takahiro.kuroiwa@filmecc.com
Trade Name:	VASSALLO® GT Hybrid
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 andK163426
Reference Devices:	MINAMO, K190176

INTENDED USE/INDICATIONS FOR USE:

VASSALLO® GT Hybrid

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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coated with a hydrophilic coating and polyurethane coating. The VASSALLO GT Hybrid has an outer diameter of 0.014 inches (0.36mm) and is available in 190cm and 300cm lengths.

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 guide 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 Hybrid 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 ofDevices	FILMECC PeripheralGuidewireVASSALLO GT®HybridSubject	ASAHI Peripheral GuideWiresASAHI Gladius, ASAHIHalberd, ASAHI Gaia PVPredicate	MINAMOReference
510(k)	TBD	K150445 and K163426	K190176
Intended Useand Indications	This product is intended tofacilitate the placement andexchange of diagnostic andtherapeutic devices duringintravascular procedures.This device is intended forperipheral vascular use only.	This product is intended tofacilitate the placement andexchange of diagnostic andtherapeutic devices duringintravascular procedures.This device is intended forperipheral vascular use only.	PCI Guide Wires are intendedto facilitate the placement ofballoon dilatation cathetersduring percutaneous coronaryintervention (PCI) andpercutaneous transluminalangioplasty (PTA).The PCI Guide Wires are notintended for use in theneurovasculature.
Nominal OD	0.36mm(0.014in)	0.36mm and 0.45mm(0.014in and 0.018in)	0.36mm(0.014in)
Overall Length	190cm300cm	200cm to300cm	190cm300cm
Outer Coil	Platinum-Nickel	Platinum-Nickel andStainless Steel	Platinum-Nickel andStainless Steel
Tapered CoreWire	HybridNitinol and Stainless Steel	Stainless Steel	HybridNitinol and Stainless Steel
Inner Structure	Stainless Steel Coil	Stainless Steel Coil	Stainless Steel Coil
Tip Shape	Straight (shapeable)	Straight (shapeable)Preshape	Straight (shapeable)PreshapeJ-tip
Coating	HydrophilicHydrophobic	HydrophilicHydrophobic	HydrophilicHydrophobic
Sterilization	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide

NON-CLINICAL TESTING/PERFORMANCE DATA:

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

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

The in vitro bench tests demonstrated that the VASSALLO GT Hybrid 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 Hybrid. 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 Hybrid to be biocompatible.

CONCLUSION:

The VASSALLO GT Hybrid 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 Hybrid is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

Therefore, the VASSALLO GT Hybrid 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.