(140 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of AI or ML capabilities.
No
The device is described as a steerable guide wire intended to facilitate the placement and exchange of diagnostic and therapeutic devices, rather than being a therapeutic device itself.
No
This device is a guide wire, which is a therapeutic device intended to facilitate the placement and exchange of other diagnostic and therapeutic devices. It does not perform a diagnostic function itself.
No
The device description clearly outlines physical components such as guide wires, coatings, and a torque device, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is "intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures." This describes a device used in vivo (within the body) to aid in medical procedures, not a device used in vitro (outside the body) to examine specimens like blood or tissue for diagnostic purposes.
- Device Description: The description details a physical guide wire used for navigation within blood vessels. This is consistent with an in vivo procedural device.
- Anatomical Site: The specified anatomical site is "Peripheral vascular," which is within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the VASSALLO® GT Peripheral Guide Wire is a medical device used for interventional procedures, not an in vitro diagnostic device.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K153443, K083146, K022762, K070945
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
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
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 (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
2
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)
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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. 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.
4
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 Wires
ASAHI Gladius, ASAHI Halberd
ASAHI Gaia PV |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject | Primary Predicate |
| 510(k) | TBD | K150445 and K163426 |
| 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. |
| 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 or
Platinum-Nickel and Stainless
Steel | Platinum-Nickel and Stainless
Steel |
| Tapered Core Wire | Stainless Steel | Stainless Steel |
| Inner Structure | -- | Stainless Steel Coil |
| Tip Shape | Straight | Straight
Preshape |
| Coating | Hydrophilic, Hydrophobic | Hydrophilic, Hydrophobic |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
5
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.
6
Therefore, the VASSALLO GT is substantially equivalent to the predicate devices.
FILMECC CO., LTD.