(194 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a guidewire, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The guidewire is used to introduce and position other devices, not to provide therapy itself.
No
The device is a guidewire, used to introduce and position other interventional devices, which is a therapeutic/interventional function, not a diagnostic one. It facilitates access for other procedures rather than diagnosing a condition.
No
The device description clearly outlines a physical guidewire made of nitinol alloy, gold-coated tungsten, and PTFE/hydrophilic coatings, indicating it is a hardware 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 "introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature." This describes a device used within the body for a procedural purpose, not a device used outside the body to examine specimens derived from the human body.
- Device Description: The description details a physical guidewire with specific dimensions, materials, and coatings, designed for navigation within blood vessels. This aligns with an interventional medical device, not an IVD.
- Anatomical Site: The anatomical site is the "coronary and/or peripheral vasculature," which are locations within the human body. IVDs typically analyze samples taken from the body (like blood, urine, tissue).
- Input Imaging Modality: Fluoroscopy Visualization is used to guide the device within the body. IVDs do not typically rely on imaging modalities used for in-vivo procedures.
- Performance Studies: The performance studies focus on mechanical properties, biocompatibility, and interaction with other devices during a procedure. IVD performance studies would focus on analytical and clinical performance related to detecting or measuring substances in specimens.
In summary, the R350 guidewire is an interventional medical device used for procedures within the body, not a device used for testing specimens outside the body, which is the definition of an IVD.
N/A
Intended Use / Indications for Use
The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.
Product codes
DOX
Device Description
The R350 guidewire is 350 cm in length with a 0.013" maximum outer diameter (O.D) (0.012″ nominal O.D.). It is composed of a nitinol alloy mandrel with a straight, radiopaque 5 cm gold-coated tungsten coil distal tip. The proximal 150 cm of the R350 guidewire has a PTFE coating, while the distal 200 cm has a hydrophilic coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or 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)
The R350 guidewire design has been verified through the following tests and inspections:
- Hydrophilic Coating Particulate
- Hydrophilic Coating Delamination Inspection (after Fracture Test)
- Fluoroscopy Visualization
- Guidewire O.D.
- Guidewire Length
- Component Alignment
- Interface with Other Devices
- Torqueability
- Torque
- Flex
- Fracture
- Tip Deflection Force
- Tip Load
- Distal Solder Joint Tensile
- Proximal Solder Joint Tensile
- Corrosion
Device samples passed the following biocompatibility tests per ISO 10993-1:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- ASTM Hemolysis
- Complement Activation
- ASTM Platelet and Leukocyte Count Assay
- Partial Thromboplastin Time
- In Vivo Thrombogenicity
The results of the design verification and validation tests met the specified acceptance criteria and did not raise new questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, connected by flowing lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2015
Vascular Solutions, Inc. Beka Vite Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, MN 55639
Re: K151234
Trade/Device Name: R350 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: October 16, 2015 Received: October 19, 2015
Dear Ms. Vite:
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
M.A. Hillebrenner
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) K151234
Device Name R350 Guidewire
Indications for Use (Describe)
The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or 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] Date Prepared: May 06, 2015 510(k) Number: K151234
Submitter's Name / Contact Person
Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person
Beka Vite Regulatory Product Specialist Tel: 763-657-5732 Fax: 763-656-4253
General Information
| Trade Name | R350 guidewire |
|---|---|
| Common / Usual Name | Guidewire |
| Classification Name | 21 CFR 870.1330, DQX – catheter guidewire |
| Predicate Devices | K021990 – R350 guidewire (Galt Medical Corp.) |
| K141339 - Asahi RG3 guidewire (Asahi Intecc Co., Ltd.) |
Device Description
The R350 guidewire is 350 cm in length with a 0.013" maximum outer diameter (O.D) (0.012″ nominal O.D.). It is composed of a nitinol alloy mandrel with a straight, radiopaque 5 cm gold-coated tungsten coil distal tip. The proximal 150 cm of the R350 guidewire has a PTFE coating, while the distal 200 cm has a hydrophilic coating.
Indications for Use
The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.
Technological Characteristics Comparison
The R350 guidewire is similar in design and intended use to the predicate devices as they are all guidewires intended for use in percutaneous procedures. The R350 guidewire and predicate devices are similar in size, and all have a radiopaque tip and lubricous coating.
Substantial Equivalence and Summary of Studies
The technological differences between the R350 guidewire and predicate devices were evaluated through biocompatibility and mechanical tests, and results did not raise new questions of safety or effectiveness.
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The R350 guidewire is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and indications for use. The R350 guidewire design has been verified through the following tests and inspections:
- Hydrophilic Coating Particulate ●
- Hydrophilic Coating Delamination Inspection (after Fracture Test) .
- Fluoroscopy Visualization ●
- Guidewire O.D. ●
- Guidewire Length
- Component Alignment .
- Interface with Other Devices .
- Torqueability
- Torque ●
- Flex .
- . Fracture
- Tip Deflection Force ●
- Tip Load
- Distal Solder Joint Tensile ●
- . Proximal Solder Joint Tensile
- Corrosion
Device samples passed the following biocompatibility tests per ISO 10993-1:
- . Cytotoxicity
- . Sensitization
- Irritation ●
- Acute Systemic Toxicity ●
- Material Mediated Pyrogenicity .
- ASTM Hemolysis
- Complement Activation .
- ASTM Platelet and Leukocyte Count Assay ●
- Partial Thromboplastin Time .
- In Vivo Thrombogenicity
The results of the design verification and validation tests met the specified acceptance criteria and did not raise new questions of safety and effectiveness. Therefore, the R350 guidewire is substantially equivalent to the predicate devices.