Magic Torque DLVR Guidewire

K182315 · Boston Scientific Corporation · DQX · Sep 26, 2018 · Cardiovascular

Device Facts

• Record ID: K182315
• Device Name: Magic Torque DLVR Guidewire
• Applicant: Boston Scientific Corporation
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 26, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Magic Torque™ Guidewires facilitate placement of devices during peripheral intravascular diagnostic or interventional procedures.

Device Story

The Magic Torque DLVR Guidewire is a 315 cm peripheral intravascular guidewire used by physicians during diagnostic or interventional procedures. It features a stainless steel core wire with a distal stainless steel coil. The distal 10 cm of the coil has a hydrophilic coating for lubricity in difficult anatomy; the proximal 40 cm of the coil is PTFE-coated. A PTFE polymer sleeve jackets the proximal core wire. The device is fluoroscopically visible. It is operated manually by a physician to navigate tortuous peripheral arteries and position catheters. The device provides mechanical support and steerability to facilitate device delivery, aiding in successful diagnostic or interventional outcomes.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical performance data, including biocompatibility, microbial assessments (bioburden, endotoxin, pyrogenicity), sterility assurance, and bench testing.

Technological Characteristics

Materials: Stainless steel core and coil, PTFE coating, hydrophilic coating, PTFE polymer sleeve. Dimensions: 315 cm length. Connectivity: None. Sterilization: Not specified. Sensing/Actuation: Mechanical torque transmission for navigation. Software: None.

Indications for Use

Indicated for patients undergoing peripheral intravascular diagnostic or interventional procedures requiring catheter placement. Facilitates navigation through tortuous arteries and avoidance of side branches. Contraindicated for use in coronary arteries.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Magic Torque™ Guidewires (K933334)

Submission Summary (Full Text)

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September 26, 2018

Boston Scientific Corporation Andrea Dance Regulatory Affairs Specialist 3 Scimed Place Maple Grove, Minnesota 55311

Re: K182315

Trade/Device Name: Magic Torque DLVR Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: August 23, 2018 Received: August 27, 2018

Dear Ms. Dance:

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Michael John -S 2018.09.26 16:39:04 -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)

K182315

Device Name Magic Torque™ DLVR Guidewire

Indications for Use (Describe)

The Magic Torque™ Guidewires facilitate placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. Not intended for use in coronary arteries.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### SECTION 3. 510(K) Summary Per CFR 807.92

| Submitter's Name<br>and Address | Boston Scientific Corporation<br>Three Scimed Place<br>Maple Grove, MN 55311<br>USA |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and<br>Information | Andrea Dance<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | August 23, 2018 |
| Trade Name | Magic Torque™ DLVR Guidewires |
| Common Name | Wire, Guide, Catheter |
| Product Code | DQX |
| Classification<br>Name | Class 2 according to 21 CFR 870.1330 |
| Predicate Device | Magic Torque™ Guidewires (K933334) 26 Jan 1994 |
| Description of<br>Device | The 315 cm Magic Torque™ DLVR Guidewire facilitates placement of<br>a catheter during diagnostic or interventional procedures. The<br>guidewire contains a stainless steel (SS) core wire. A SS coil is wound<br>over the distal 50 cm of the core wire. The most distal 10 cm of the SS<br>coil is coated with a proprietary hydrophilic coating from Boston<br>Scientific that provides a slippery surface to facilitate negotiation of<br>difficult anatomy and tight lesions. The proximal 40 cm of the coil is<br>coated with polytetrafluoroethylene (PTFE) for lubricity. A PTFE<br>polymer sleeve jackets the proximal end of the core wire. The<br>guidewire is clearly visible under fluoroscopy. |
| Intended Use | The Magic Torque™ Guidewires facilitate placement of devices during<br>peripheral intravascular diagnostic or interventional procedures. |
| Indications for Use | The Magic Torque™ Guidewires facilitate placement of a catheter<br>during diagnostic or interventional procedures. The wire can be<br>torqued to facilitate navigation through tortuous arteries and/or avoid<br>unwanted side branches. Not intended for use in coronary arteries. |
| Device Technology<br>Characteristics<br>and Comparison to<br>Predicate Device | Magic Torque DLVR Guidewire incorporates substantially equivalent<br>design, materials, packaging, fundamental technology, manufacturing<br>processes, sterilization method, and intended use as those featured in<br>the predicate Magic Torque Guidewire. |
| Non-Clinical<br>Performance Data | Determination of substantial equivalence is based on an assessment<br>of non-clinical performance data.<br><b>Biological Safety Testing:</b><br>A biocompatibility assessment in accordance with ISO 10993-1,<br>microbial assessments including bioburden, endotoxin, and<br>pyrogenicity, and sterility assurance testing were conducted. The<br>assessments show the device to be biocompatible for its intended use.<br><b>Bench Testing:</b><br>The following tests were performed to demonstrate substantial<br>equivalence to the predicate device.<br>• Overall Length Measurement<br>• Guidewire Withdrawal from the Carrier Tube<br>The Magic Torque DLVR Guidewire met the predetermined<br>acceptance criteria, thereby demonstrating substantial equivalence to<br>the predicate device. No new safety or performance issues were<br>raised during testing. |
| Clinical<br>Performance Data | Not applicable; determination of substantial equivalence is based on<br>an assessment of non-clinical performance data. |
| Conclusion | Based on the indications for use, technological characteristics and<br>non-clinical testing, the proposed Magic Torque DLVR Guidewire is<br>substantially equivalent to the predicate Magic Torque Guidewire<br>(K933334) and it is at least as safe and effective for its intended use. |

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