(115 days)
No
The device description focuses on the physical properties and materials of a guide wire, and there is no mention of AI, ML, or any computational processing of data for decision-making or analysis.
No
The device is described as a guide wire intended to facilitate the placement and exchange of other diagnostic and therapeutic devices, rather than being therapeutic itself.
No
This device is a guidewire intended to facilitate the placement and exchange of other diagnostic and therapeutic devices, which is a therapeutic rather than diagnostic function. While it is radiopaque to help with positioning (a form of imaging assistance), its primary intended use is not to diagnose a medical condition.
No
The device description clearly details a physical guide wire made of NiTi alloy and stainless steel, with various coatings and a coil assembly. It also mentions a detachable extension wire and a torque device, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the product is for "facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures." This describes a device used within the body to aid in medical procedures, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a physical guide wire with coatings and a radiopaque coil, designed for insertion into blood vessels. This is consistent with an interventional device, not an IVD.
- Anatomical Site: The device is intended for "Peripheral vascular," which is an anatomical location within the body. IVDs typically analyze samples like blood, urine, or tissue outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
In summary, the VASSALLO GT 018 Hybrid is a medical device used in interventional procedures within the body, not an in vitro diagnostic device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
DQX
Device Description
The VASSALLO GT 018 Hybrid consists of a hybrid NiTi alloy and stainlesssteel core wire and a coil assembly on the distal end of the device. The coil assembly is soldered to the NiTi alloy 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 018 Hybrid. The proximal portion is coated with PTFE. The distal section is coated with a hydrophilic coating and polyurethane coating. When wet, the hydrophilic coating increases the lubricity of the quidewire surface. The middle portion of the device is coated with PFA and silicone coatings. The VASSALLO GT 018 Hybrid has an outer diameter of 0.018 inches (0.45 mm) 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 quide wire with a length of less than 300 cm. A Torque device is included in the same package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical laboratory testing was performed on the VASSALLO® GT 018 following Hvbrid to determine substantial equivalence. The testing/assessments were performed:
- Dimensional Verification
- Visual Inspection
- Tensile Strength / Tip Pull
- Torque Strength
- Torqueability
- Coating Adhesion
- Catheter Compatibility / Lubricity
- Corrosion Resistance .
- Kink Resistance
- Tip Flexibility
- Radiopacity
The in vitro bench tests demonstrated that the VASSALLO GT 018 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.
Testing was performed to assess biocompatibility of the VASSALLO GT 018 Hybrid. The following tests were performed:
- Cytotoxicity
- . Sensitization
- Intracutaneous Irritation
- Systemic Toxicity
- Hemolvsis
- Partial Thromboplastin Time
- In Vivo Thromboresistance
- SC5b-9 Complement Activation
- Material Mediated Pyrogenicity
The results from the testing performed showed the VASSALLO GT 018 Hybrid to be biocompatible.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
March 9, 2023
Filmecc CO., LTD % Candace Cederman Principal Consultant CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401
Re: K223432
Trade/Device Name: Vassallo GT 018 Hybrid Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 10, 2022 Received: November 14, 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
1
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 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 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, -vdia S Digitally signed by Lydia S. Glaw -S Date: 2023.03.09 Glaw -14:38:28 -05'00'
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
Enclosure
2
Indications for Use
510(k) Number (if known) K223432
Device Name VASSALLO® GT 018 Hybrid
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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3
510(k) Summary
(as required by 21 CFR 807.92)
Image /page/3/Picture/2 description: The image shows the logo for Filmecc, an Asahi Intecc Group company. The logo features a stylized red "A" shape on the left, followed by the word "Filmecc" in bold, black letters. Below "Filmecc" is the text "ASAHI INTECC Group" in a smaller, sans-serif font.
PERIPHERAL GUIDE WIRES VASSALLO® GT 018 Hybrid
510(k) K223432
| Date Prepared: | January 30, 2023 |
|---|---|
| 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 Hybrid |
| Device Classification: | Class 2 per 21 CFR §870.1330 |
| Classification Name: | Catheter, Guide, Wire |
| Product Code: | DQX - Catheter Guide Wire |
| Predicate Devices: | VASSALLO GT Hybrid Guide Wire, K203529 |
| Reference Devices: | VASSALLO GT, K203533 |
| VASSALLO GT 018 Floppy, K213949 |
INTENDED USE/INDICATIONS FOR USE:
VASSALLO® GT 018 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:
The VASSALLO GT 018 Hybrid consists of a hybrid NiTi alloy and stainlesssteel core wire and a coil assembly on the distal end of the device. The coil assembly is soldered to the NiTi alloy 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
4
on the surface of the VASSALLO GT 018 Hybrid. The proximal portion is coated with PTFE. The distal section is coated with a hydrophilic coating and polyurethane coating. When wet, the hydrophilic coating increases the lubricity of the quidewire surface. The middle portion of the device is coated with PFA and silicone coatings. The VASSALLO GT 018 Hybrid has an outer diameter of 0.018 inches (0.45 mm) 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 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 018 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 of
Devices | FILMECC Peripheral
Guidewire
VASSALLO GT 018
Hybrid | FILMECC
Peripheral
Guidewire
VASSALLO GT
Hybrid | FILMECC Peripheral
Guidewire
VASSALLO GT | FILMECC
Peripheral
Guidewire
VASSALLO GT 018
Floppy |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Subject
K223432 | Predicate
K203529 | Reference
K203533 | Reference
K213949 |
| Intended
Use and
Indications | 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. | 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. | 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. | 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. |
| Nominal OD | 0.45 mm
(0.018 in) | 0.36 mm
(0.014 in) | 0.36 mm
(0.014 in) | 0.45 mm
(0.018 in) |
| Overall
Length | 190cm
300cm | 190cm
300cm | 190cm
300cm | 190cm
300cm |
| Outer Coil | Platinum-Nickel | Platinum-Nickel | Platinum-Nickel or
Platinum-Nickel and
Stainless Steel | Platinum-Nickel |
| Tapered
Core Wire | Hybrid
Nitinol and Stainless
Steel | Hybrid
Nitinol and Stainless
Steel | Stainless Steel | Stainless Steel |
| Inner
Structure | Stainless Steel Coil | Stainless Steel Coil | - | Stainless Steel |
| Tip Shape | Straight (shapeable) | Straight (shapeable) | Straight (shapeable) | Straight (shapeable) |
| Coating | Hydrophilic
Hydrophobic | Hydrophilic
Hydrophobic | Hydrophilic
Hydrophobic | Hydrophilic
Hydrophobic |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
5
NON-CLINICAL TESTING/PERFORMANCE DATA:
Non-clinical laboratory testing was performed on the VASSALLO® GT 018 following Hvbrid to determine substantial equivalence. The testing/assessments were performed:
- Dimensional Verification ●
- Visual Inspection ●
- Tensile Strength / Tip Pull ●
- Torque Strength
- Torqueability
- Coating Adhesion
- Catheter Compatibility / Lubricity ●
- Corrosion Resistance .
- Kink Resistance ●
- Tip Flexibility ●
- Radiopacity ●
The in vitro bench tests demonstrated that the VASSALLO GT 018 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 018 Hybrid. The following tests were performed:
- Cytotoxicity ●
- . Sensitization
- Intracutaneous Irritation
- Systemic Toxicity ●
- Hemolvsis ●
- Partial Thromboplastin Time ●
- In Vivo Thromboresistance ●
- SC5b-9 Complement Activation ●
- Material Mediated Pyrogenicity ●
The results from the testing performed showed the VASSALLO GT 018 Hybrid to be biocompatible.
6
CONCLUSION:
The VASSALLO GT 018 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 018 Hybrid is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
Therefore, the VASSALLO GT 018 Hybrid is substantially equivalent to the predicate devices.