(195 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guide wire, with no mention of AI or ML capabilities.
No
The description states the device is intended to facilitate the placement and exchange of diagnostic and therapeutic devices, but it is not itself described as having a therapeutic effect.
No
The device description clearly states it is a "steerable guide wire" intended to "facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures." While it helps with positioning for diagnostic procedures, it does not itself perform a diagnostic function by providing information about a patient's medical condition. It is a tool for device delivery, not diagnosis.
No
The device description clearly outlines a physical guide wire with specific material properties, dimensions, and included accessories (extension wire, torque device). This 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 clearly states that the product is "intended to facilitate the placement and exchange of diagnostic and therapeutic 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 physical guide wire used for navigation within blood vessels. This is consistent with a surgical or interventional device, not a diagnostic test kit or instrument.
- 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.
Therefore, the VASSALLO GT 018 Peripheral Guide Wire is a medical device used in interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This product is intended to facilitate the placement and exchange of diagnostic devices during intravascular procedures. This device is intended for peripheral vascular use only.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The VASSALLO GT 018 Peripheral Guide Wire in this submission is a steerable guide wire with a maximum diameter of 0.018" (0.45mm) and available in lengths of 190cm and 300cm. The device has a solid core with a hydrophilic coated coil-type distal end. 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory testing was performed on the VASSALLO GT 018 to determine substantial equivalence. The following testing/assessments were performed:
- Dimensional Verification
- Visual Inspection
- Tensile Strength / Tip Pull
- Torque Strength
- Torqueability
- Coating Adhesion/Integrity
- Particulate
- Catheter Compatibility / Lubricity
- Corrosion Resistance
- Kink Resistance
- Tip Flexibility
- Radiopacity
The in vitro bench tests demonstrated that the VASSALLO GT 018 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 and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Filmecc VASSALLO GT (K203533)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
ASAHI Peripheral Guide Wires (K150445 and K163426)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
June 30, 2022
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are displayed side-by-side.
Filmecc Co., Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants, LLC 1783 Forest Drive, Suite 200 Annapolis. Marvland 21401
Re: K213949
Trade/Device Name: VASSALLO GT 018 Floppy Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: June 2, 2022 Received: June 3, 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 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 re gulatory 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) K213949
Device Name VASSALLO GT 018 Floppy Peripheral Guide Wire
Indications for Use (Describe)
This product is 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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summarv (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 curved line on the left, followed by the word "Filmecc" in black, with a red square on top of the "i". The logo is simple and modern, and the use of red and black gives it a bold and professional look.
PERIPHERAL GUIDE WIR VASSALLO GT 018
510(k) K213949
| Date Prepared: | June 29, 2022 |
|---|---|
| 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 Floppy |
| Device Classification: | Class II per 21 CFR §870.1330 |
| Classification Name: | Catheter, Guide, Wire |
| Product Code: | DQX - Catheter Guide Wire |
| Predicate Devices: | Filmecc VASSALLO GT (K203533) |
| Reference Device: | ASAHI Peripheral Guide Wires (K150445 and |
| K163426) |
INTENDED USE/INDICATIONS FOR USE:
VASSALLO GT 018 Floppy
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 Peripheral Guide Wire in this submission is a steerable guide wire with a maximum diameter of 0.018" (0.45mm) and available in lengths of 190cm and 300cm.
FILMECC CO., LTD.
4
The device has a solid core with a hydrophilic coated coil-type distal end. 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:
Comparison of the VASSALLO GT 018 Floppy and predicate 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, if not 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 018
Floppy | VASSALLO GT | ASAHI Peripheral
Guidewires |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------|
| | Subject | Primary Predicate | Reference Device |
| 510(k) | K213949 | K203533 | 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. | | |
| Nominal OD | 0.45mm
(0.018in) | 0.36mm
(0.014in) | 0.36-0.45mm
(0.014 - 0.018in) |
| Overall Length | 190, 300cm | | 180 - 300cm |
| Outer Coil | Platinum | Platinum or
Platinum-Nickel and Stainless Steel | |
| Tapered Core
Wire | Stainless Steel | | |
| Tip Shape | Straight (shapeable) | | Straight (pre-shaped) |
| Coating | Hydrophilic, Hydrophobic | | |
| Sterilization | Ethylene Oxide | | |
NON-CLINICAL TESTING/PERFORMANCE DATA:
Non-clinical laboratory testing was performed on the VASSALLO GT 018 to determine substantial equivalence. The following testing/assessments were performed:
- . Dimensional Verification
- Visual Inspection ●
- Tensile Strength / Tip Pull ●
- . Torque Strength
- Torqueability
- . Coating Adhesion/Integrity
- . Particulate
- Catheter Compatibility / Lubricity
- Corrosion Resistance
- Kink Resistance
- Tip Flexibility
- Radiopacity .
FILMECC CO., LTD.
5
The in vitro bench tests demonstrated that the VASSALLO GT 018 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 and reference devices.
BIOCOMPATIBILITY:
Testing was performed to assess biocompatibility of the VASSALLO GT 018. The following tests were performed:
- . Cytotoxicity
- Sensitization ●
- Intracutaneous Irritation
- Acute Systemic Toxicity
- . Material Mediated Pyrogenicity
- . Hemolysis
- Partial Thromboplastin ● Time
- In Vivo Thromboresistance
- SC5b-9 Complement ● Activation
The results from the testing performed showed the VASSALLO GT 018 Floppy to be biocompatible.
CONCLUSION:
The VASSALLO GT 018 peripheral guidewire 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 conclusions drawn from the nonclinical tests demonstrate that the VASSALLO GT 018 is as safe, as effective, and performs as well as or better than the legally marketed predicate and reference devices.
Therefore, the VASSALLO GT 018 Floppy is substantially equivalent to the predicate devices.