(28 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a guidewire, with no mention of AI or ML.
No
The device is a guidewire used to introduce and position other interventional devices; it does not in itself treat a condition.
No
Explanation: The device, a guidewire, is explicitly described as being "intended for use in percutaneous procedures to introduce and position catheters and other interventional devices." This indicates a tool used for delivery and placement, not for diagnosing a condition or disease.
No
The device description clearly describes a physical guidewire made of stainless steel with various coatings and a radiopaque coil, indicating it is a hardware device, not software.
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 Bandit guidewire is for "percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature." This describes a device used within the body for interventional procedures, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a physical guidewire designed to be inserted into blood vessels. This aligns with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Bandit guidewire's function is purely mechanical and procedural within the body.
N/A
Intended Use / Indications for Use
The Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
Product codes
DOX
Device Description
The Bandit guidewire is a 0.014" diameter stainless steel core guidewire with a 0.008" diameter tapered distal tip. It is available in 200 cm and 300 cm lengths. The 200 cm length is compatible with a guidewire extension. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
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)
Performance Testing - Bench:
The technological differences between the subject and predicate device have been evaluated through bench tests to provide evidence that the Bandit guidewire is substantially equivalent to the predicate device. The device design was verified through the following tests:
- Tensile Strength
- Torque Strength
- Torqueability
- Tip Flexibility
- Coating Adherence/Integrity
- Catheter Compatibility
- Dimensional Analysis
- Radiopacity
- Coating Adherence/Integrity
- Corrosion
The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety and effectiveness.
Biocompatibility Testing:
The biocompatibility evaluation for the Bandit guidewire was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The Bandit guidewire is considered an externally communicating device in contact with circulating blood and tissue for a limited period of time (
§ 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.
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July 20, 2018
Vascular Solutions, Inc. Ms. Becky Astrup Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369
Re: K181647
Trade/Device Name: Bandit Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: June 21, 2018 Received: June 22, 2018
Dear Ms. Astrup:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lydia S. Glaw -S 2018.07.20 15:51:10 -04'00'
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Bandit guidewire
Indications for Use (Describe)
The Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
| 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]
510(k) Number: _K181647
SUBMITTER AND DEVICE
| Submitter: | Vascular Solutions, Inc.
6464 Sycamore Court North
Minneapolis, MN 55369 USA |
| ------------ | ------------------------------------------------------------------------------------ |
|---|
| Date Prepared: | June 21st, 2018 |
|---|---|
| ---------------- | ----------------- |
| Name of Device: | Bandit guidewire |
|---|---|
| ----------------- | ------------------ |
| Establishment Registration: | 2134812 |
|---|---|
| ----------------------------- | --------- |
| Common or Usual Name: | Guidewire |
|---|---|
| ----------------------- | ----------- |
| Phone: | 763-656-4300 |
|---|---|
| -------- | -------------- |
| Classification Name: | Catheter Guidewire
(21 CFR 870.1330) |
| ---------------------- | ----------------------------------------- |
|---|
| Fax: | 763-656-4253 |
|---|---|
| ------ | -------------- |
| Regulatory Class: | II |
|---|---|
| ------------------- | ---- |
| Contact Person: | Becky Astrup,
Regulatory Product Specialist |
| ----------------- | ------------------------------------------------ |
|---|
| Product Code: | DQX |
|---|---|
| --------------- | ----- |
PREDICATE DEVICE
The legally marketed device to which substantial equivalence is claimed is:
Vascular Solutions Inc., Raider guidewire, K173532 cleared December 15, 2017.
The Asahi Intecc Co., LTD Fielder XT guidewire, K072431 cleared September 26, 2007 is included as a reference device for this submission.
DEVICE DESCRIPTION
The Bandit guidewire is a 0.014" diameter stainless steel core guidewire with a 0.008" diameter tapered distal tip. It is available in 200 cm and 300 cm lengths. The 200 cm length is compatible with a guidewire extension. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating.
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INDICATIONS FOR USE
The Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The table below compares the technological characteristics of the Bandit guidewire and the Raider guidewire predicate device.
| Characteristic | Subject Device:
Bandit | Predicate Device:
Raider |
|---------------------|-----------------------------------------------|-----------------------------|
| Maximum Diameter | 0.014" | Identical |
| Lengths | 200 cm, 300 cm | Similar
190cm, 300cm |
| Core Wire Material | Stainless Steel with Distal
Polymer Jacket | Identical |
| Distal Tip | Radiopaque Coil | Identical |
| Lubricious Coatings | Distal: Hydrophilic
Proximal: PTFE | Identical |
PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Performance Testing - Bench
The technological differences between the subject and predicate device have been evaluated through bench tests to provide evidence that the Bandit guidewire is substantially equivalent to the predicate device. The device design was verified through the following tests:
- Tensile Strength ●
- Torque Strength ●
- Torqueability
- Tip Flexibility ●
- Coating Adherence/Integrity ●
- Catheter Compatibility ●
- Dimensional Analysis
- Radiopacity
- Coating Adherence/Integrity ●
- Corrosion
The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety and effectiveness.
5
Biocompatibility Testing
The biocompatibility evaluation for the Bandit guidewire was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The Bandit guidewire is considered an externally communicating device in contact with circulating blood and tissue for a limited period of time (