(90 days)
No
The document describes a physical guidewire and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.
No
Explanation: The device is described as facilitating the placement of other therapeutic devices, not as a therapeutic device itself.
No
Explanation: The device description and intended use clearly state that the guidewires are for facilitating the placement of interventional therapeutic devices and are not involved in diagnosing conditions.
No
The device description clearly states the device is a physical guidewire made of metal and coated materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the guidewires are "intended to facilitate the placement of balloon dilaters or other interventional therapeutic devices during PTCA, PTA, or other intravascular interventional procedures." This describes a device used within the body to assist in a medical procedure.
- Device Description: The description details the physical characteristics of the guidewires (material, size, coating, etc.) and how they function mechanically to guide other devices.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. This device does not interact with specimens in this way.
The information provided describes a medical device used for interventional procedures, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The Savion DLVR and Savion FLX Guidewires are intended to facilitate the placement of balloon dilaters or other interventional therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.
Product codes
DOX, DQX
Device Description
The Boston Scientific Savion DLVR and Savion FLX Guidewires with ICE® Hydrophilic Coating are available with a nominal diameter of 0.014 in (0.37 mm) and in nominal lengths of 182 cm, 185 cm, or 300 cm. These guidewires contain a metal core wire. Varying tapers along the core wire and differing tip materials (spring coil or polymer) provide combinations of rail support and tip flexibility to address user requirements. The proximal core wire section of all models is coated with polytetrafluoroethylene (PTFE) for lubricity.
The 182 cm and 185 cm guidewires are designed with an extension section for exchange of Over-the-Wire systems by using the AddWire™ Extension Wire (K030617). The 300 cm guidewires allow exchange of therapeutic devices without the use of an exchange system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Nonclinical testing per FDA Guidance for Coronary and Cerebrovascular Guide Wires (1995) supports a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed devices have been designed and tested to assure conformance to the requirements for their intended use. No new safety or performance issues were raised during the device testing. Biocompatibility tests included: Cytotoxicity, Sensitization, Materials Mediated Rabbit Pyrogenicity, Acute Systemic Toxicity, Direct Contact Hemolysis, In Vitro Hemocompatibility, Partial Thromboplastin Time, Intracutaneous Reactivity, Complement Activation. Performance tests included: Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence/Integrity, Catheter Compatibility, Pushability, Radiopacity, J-Tip Retention, Surface, Polymer Sleeve Shear, Adhesive/Potting Adherence, Bends, Exchange System Coupling Strength, Exchange System Connectability.
Key Metrics
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/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 18, 2018
Boston Scientific Inc. Jake Baldauf Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311
Re: K180726
Trade/Device Name: Savion DLVR Guidewire, Savion FLX Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: March 16, 2018 Received: March 20, 2018
Dear Jake Baldauf:
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 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);
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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 2018.06.18 15:37:11 -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 Savion DLVR Guidewire Savion FLX Guidewire
Indications for Use (Describe)
The Savion DLVR and Savion FLX Guidewires are intended to facilitate the placement of balloon dilaters or other interventional therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K180726
510(k) Summary per 21 CFR §807.92
| Date Prepared | March 16, 2018 | ||
|---|---|---|---|
| Submitter's Name and | |||
| Address | Boston Scientific Corporation | ||
| Three Scimed Place | |||
| Maple Grove, MN 55311 | |||
| Contact Name and | |||
| Information | Jake Baldauf | ||
| Regulatory Affairs Specialist II | |||
| Phone: 763-494-2591 | |||
| Fax: 763-494-2222 | |||
| Email: jake.baldauf@bsci.com | |||
| Trade Name(s) | Savion DLVR™ Guidewires and Savion FLX™ Guidewires | ||
| Common or Usual Name | Catheter Guide Wire | ||
| Product Code | DQX | ||
| Classification of Device | Class 2 according to 21 870.1330 | ||
| Predicate Device(s) | PT2 Guidewire | K030617 | 21 May 2003 |
| Mailman Guidewire | K143587 | 15 Jan 2015 |
Device Description
The Boston Scientific Savion DLVR and Savion FLX Guidewires with ICE® Hydrophilic Coating are available with a nominal diameter of 0.014 in (0.37 mm) and in nominal lengths of 182 cm, 185 cm, or 300 cm. These guidewires contain a metal core wire. Varying tapers along the core wire and differing tip materials (spring coil or polymer) provide combinations of rail support and tip flexibility to address user requirements. The proximal core wire section of all models is coated with polytetrafluoroethylene (PTFE) for lubricity.
The 182 cm and 185 cm guidewires are designed with an extension section for exchange of Over-the-Wire systems by using the AddWire™ Extension Wire (K030617). The 300 cm guidewires allow exchange of therapeutic devices without the use of an exchange system.
Intended Use/ Indications for Use
The Savion DLVR and Savion FLX Guidewires are intended to facilitate the placement and exchange of balloon dilatation catheters or other interventional therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.
Comparison of Required Technological Characteristics
The Savion FLX Guidewire and Savion DLVR Guidewire incorporate substantially equivalent design, fundamental technology, packaging, sterilization method and intended use as the predicates PT2 Guidewire (K030617), Mailman Guidewire (K143587), respectively.
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Summary of Nonclinical Tests
Nonclinical testing per FDA Guidance for Coronary and Cerebrovascular Guide Wires (1995) supports a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed devices have been designed and tested to assure conformance to the requirements for their intended use. No new safety or performance issues were raised during the device testing.
Biocompatibility tests included:
| Cytotoxicity | Acute Systemic Toxicity | Partial Thromboplastin Time |
|---|---|---|
| Sensitization | Direct Contact Hemolysis | Intracutaneous Reactivity |
| Materials Mediated Rabbit | ||
| Pyrogenicity | In Vitro Hemocompatibility | Complement Activation |
Performance tests included:
| Tensile Strength | J-Tip Retention |
|---|---|
| Torque Strength | Surface |
| Torqueability | Polymer Sleeve Shear |
| Tip Flexibility | Adhesive/Potting Adherence |
| Coating Adherence/Integrity | Bends |
| Catheter Compatibility | Exchange System Coupling Strength |
| Pushability | Exchange System Connectability |
| Radiopacity |
Animal Studies
Not required.
Clinical Studies
Not required.
Conclusion
Based on the indications for use, technological characteristics, safety and performance testing, the Savion DLVR and Savion FLX are appropriate for the intended use and are considered to be substantially equivalent to the Mailman Guidewire (K143587) and PT2 Guidewire (K030617), respectively.