TORQUE DEVICE

K123024 · Boston Scientific Corporation · DQX · Oct 26, 2012 · Cardiovascular

Device Facts

• Record ID: K123024
• Device Name: TORQUE DEVICE
• Applicant: Boston Scientific Corporation
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 26, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Torque Device is used for guidewire manipulation during general intravascular procedures.

Device Story

Torque Device is a manual accessory for guidewires (0.010 to 0.018 inches diameter) used during intravascular procedures. Device consists of a tubular body, cap, and internal collet. Operator inserts guidewire through device, positions it at desired location, and rotates cap to secure collet onto wire. Once secured, operator applies manual torsional and axial force to manipulate guidewire distal end within vasculature. Used in clinical settings by physicians. Device facilitates precise guidewire navigation, aiding in successful catheter placement and procedure completion.

Clinical Evidence

No clinical data. Bench testing only, including design verification (torque/pull slip force, guidewire deformation, collet release) and biocompatibility testing.

Technological Characteristics

Manual mechanical device; three-component assembly (tubular body, cap, collet). Accommodates 0.010-0.018 inch diameter guidewires. Non-powered. Biocompatible materials used. Sterilized.

Indications for Use

Indicated for guidewire manipulation during general intravascular procedures. No specific patient population, age, or gender restrictions defined.

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

• SCIMED® Sideliner™ Torque Device (K922706)
• Encore 26 Advantage Kit (K120694)

Submission Summary (Full Text)

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K123624 Page 1 of 1

# 510(k) Summary per 21 CFR §807.92

| | 510(k) Summary<br>per 21 CFR §807.92 | OCT 26 2012 |
|-------------------|-------------------------------------------------------------------------------------------------------------------|-------------|
| Sponsor: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick MA 01760 | |
| Contact Person: | Rachel Owens | |
| Phone Number: | 763-494-1491 | |
| Fax Number: | 763-494-2222 | |
| Prepared: | 27 September 2012 | |
| Trade Name: | Torque Device | |
| Common Name: | wire, guide, catheter | |
| Classification: | II | |
| Product Code: | DQX<br>21 CFR 870.1330 | |
| Predicate Device: | SCIMED® Sideliner™ Torque Device (K922706; 10 December 1992)<br>Encore 26 Advantage Kit (K120694, 03 April 2012). | |

# Device Description:

The Torque Device is an accessory device used to apply torsional and/or axial force to the guidewire to manipulate its distal end in the vasculature. It is designed to accommodate guidewires with diameters from 0.010 to 0.018 inches and is composed of three main components: 1.) a tubular collet contained within the body and cap assembly; 2.) a cap and 3.) a tubular body.

A guidewire is inserted through the Torque Device from the distal (cap) end. The Torque Device is positioned optimally on the guidewire at the desired location, and then secured by rotation of the cap. Once tightened, the torque device is used to apply torsional and axial force to the guidewire to manipulate its distal end in the vasculature.

# Intended Use

The Torque Device is used for guidewire manipulation during general intravascular procedures.

#### Substantial Equivalence

The Torque Device design, materials, manufacturing process and intended use are substantially equivalent to the Sideliner Torque Device (K922706) and Encore 26 Advantage Kit (K120694).

## Summary of Non-Clinical Testing

Design verification was performed to verify the performance and usability of the Torque Device remains substantially equivalent to the predicate device. Biocompatibility and sterility testing were also performed to verify the overall substantial equivalence to the predicates.

Specifically the following design verification testing was performed:

- � Torque Slip Force
- � Pull Slip Force
- Guidewire Deformation �
- � Collet Release
- ◆ . Biocompatibility Testing: Latex

### Summary of Clinical Testing

Clinical Evaluation was not required for this device.

Boston Scientific Corporation Premarket Notification - Special 510(k)

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue White Oak Building 66 Silver Spring, MD 20993

OCT 2 6 2012

Boston Scientific Corporation c/o Rachel Owens Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311

Re: K123024

Trade Name: Torque Device Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: September 27, 2012 Received: September 28, 2012

Dear Ms. Owens:

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 adviseration. 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

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Page 2 - Ms. Rachel Owens

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ht

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devises 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: Torque Device

Indications For Use:

The Torque Device is used for guidewire manipulation during general intravascular procedures.

Over-The-Counter Use _ Prescription Use _ X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Dhicion Sigh-Off)

Brocardiovascular Devk

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f Cardiovascular Device:
510(k) Number 4123024