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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for guidewires, which are physical medical devices, not AI/ML software. Therefore, many of the requested categories related to AI/ML software studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are not applicable.

Here's the information that can be extracted or deduced from the provided text for a medical device that is not AI/ML:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Performed)	Reported Device Performance
Biocompatibility Tests:
Cytotoxicity	Tested. No new safety or performance issues reported.
Sensitization	Tested. No new safety or performance issues reported.
Materials Mediated Rabbit Pyrogenicity	Tested. No new safety or performance issues reported.
Acute Systemic Toxicity	Tested. No new safety or performance issues reported.
Direct Contact Hemolysis	Tested. No new safety or performance issues reported.
In Vitro Hemocompatibility	Tested. No new safety or performance issues reported.
Partial Thromboplastin Time	Tested. No new safety or performance issues reported.
Intracutaneous Reactivity	Tested. No new safety or performance issues reported.
Complement Activation	Tested. No new safety or performance issues reported.
Performance Tests:
Tensile Strength	Tested. No new safety or performance issues reported.
Torque Strength	Tested. No new safety or performance issues reported.
Torqueability	Tested. No new safety or performance issues reported.
Tip Flexibility	Tested. No new safety or performance issues reported.
Coating Adherence/Integrity	Tested. No new safety or performance issues reported.
Catheter Compatibility	Tested. No new safety or performance issues reported.
Pushability	Tested. No new safety or performance issues reported.
Radiopacity	Tested. No new safety or performance issues reported.
J-Tip Retention	Tested. No new safety or performance issues reported.
Surface	Tested. No new safety or performance issues reported.
Polymer Sleeve Shear	Tested. No new safety or performance issues reported.
Adhesive/Potting Adherence	Tested. No new safety or performance issues reported.
Bends	Tested. No new safety or performance issues reported.
Exchange System Coupling Strength	Tested. No new safety or performance issues reported.
Exchange System Connectability	Tested. No new safety or performance issues reported.

Details of the Study:

2. Sample size used for the test set and the data provenance:
- The document states "Nonclinical testing per FDA Guidance for Coronary and Cerebrovascular Guide Wires (1995) supports a determination of substantial equivalence." This refers to laboratory and bench testing, not human patient data sets. The specific sample sizes for each nonclinical test are not provided in this summary.
- Data Provenance: Not applicable in the context of human data. These are laboratory test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for nonclinical performance tests is established by adhering to standardized test methods and measuring physical properties, not by expert consensus on clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for nonclinical, physical performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a physical medical device, not an AI/ML software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI/ML software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from standardized laboratory measurements and physical property evaluations as outlined in the FDA Guidance for Coronary and Cerebrovascular Guide Wires (1995).
8. The sample size for the training set: Not applicable, as this is a physical medical device and does not involve AI/ML training.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary

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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)

K180726

Device Name Savion DLVR Guidewire Savion FLX Guidewire

Indications for Use (Describe)

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 andAddress	Boston Scientific CorporationThree Scimed PlaceMaple Grove, MN 55311
Contact Name andInformation	Jake BaldaufRegulatory Affairs Specialist IIPhone: 763-494-2591Fax: 763-494-2222Email: 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

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 RabbitPyrogenicity	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.

Regulation Number and Section

§ 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.