(153 days)
No
The device description focuses on the physical components, materials, and mechanical properties of a guide wire. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are based on bench testing, not algorithmic performance metrics.
No.
The device is intended to facilitate the placement and exchange of diagnostic devices, acting as a guide wire for procedures, not to provide therapy itself.
No
Explanation: The device description clearly states its intended use is to "facilitate the placement and exchange of diagnostic devices" and it is a "guide wire". A guide wire is a tool used to navigate within the body to assist in the delivery or placement of other devices, not to diagnose a condition itself.
No
The device description clearly details physical components like a core wire, coil assembly, coatings, and a torque device, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the placement and exchange of diagnostic devices during intravascular procedures." This describes a tool used during a medical procedure, not a device used to perform a diagnostic test on a sample taken from the body (which is the definition of an IVD).
- Device Description: The description details a guide wire used for navigation within blood vessels. This is a surgical/interventional tool, not a diagnostic reagent or instrument that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is clearly intended for use in vivo (within the body) to assist with procedures, not in vitro (in glass/outside the body) for diagnostic testing.
N/A
Intended Use / Indications for Use
Intended to facilitate the placement and exchange of diagnostic devices during intravascular procedures. This device is intended for peripheral vascular use only.
Product codes
DQX
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.
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 Hybrid 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 / . 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.
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.
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
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
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 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
2
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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3
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-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 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 and |
| K163426 | |
| 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:
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
4
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 of
Devices | FILMECC Peripheral
Guidewire
VASSALLO GT®
Hybrid
Subject | ASAHI Peripheral Guide
Wires
ASAHI Gladius, ASAHI
Halberd, ASAHI Gaia PV
Predicate | MINAMO
Reference |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | TBD | K150445 and K163426 | K190176 |
| 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. | PCI Guide Wires are intended
to facilitate the placement of
balloon dilatation catheters
during percutaneous coronary
intervention (PCI) and
percutaneous transluminal
angioplasty (PTA).
The PCI Guide Wires are not
intended for use in the
neurovasculature. |
| Nominal OD | 0.36mm
(0.014in) | 0.36mm and 0.45mm
(0.014in and 0.018in) | 0.36mm
(0.014in) |
| Overall Length | 190cm
300cm | 200cm to
300cm | 190cm
300cm |
| Outer Coil | Platinum-Nickel | Platinum-Nickel and
Stainless Steel | Platinum-Nickel and
Stainless Steel |
| Tapered Core
Wire | Hybrid
Nitinol and Stainless Steel | Stainless Steel | Hybrid
Nitinol and Stainless Steel |
| Inner Structure | Stainless Steel Coil | Stainless Steel Coil | Stainless Steel Coil |
| Tip Shape | Straight (shapeable) | Straight (shapeable)
Preshape | Straight (shapeable)
Preshape
J-tip |
| Coating | Hydrophilic
Hydrophobic | Hydrophilic
Hydrophobic | Hydrophilic
Hydrophobic |
| 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:
5
- 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.