SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX

K061171 · Biosphere Medical, Inc. · DQX · Jun 2, 2006 · Cardiovascular

Device Facts

• Record ID: K061171
• Device Name: SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX
• Applicant: Biosphere Medical, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Jun 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Sequitor™ Steerable Guidewire is intended to facilitate the placement of catheters within the peripheral vasculature for various diagnostic and interventional procedures.

Device Story

Sequitor™ Steerable Guidewire is a stainless steel vascular guidewire; available in .014" or .018" diameters; features polymer distal tip and radiopaque, shapeable distal tip; distal 50 cm includes hydrophilic coating. Used by physicians in clinical settings to navigate peripheral vasculature; provides support for additional tools like microcatheters. Accurate placement achieved via fluoroscopic visualization of radiopaque tip. Single-use, sterile device.

Clinical Evidence

No clinical data. Performance supported by in-vitro and in-vivo design verification and validation testing confirming fulfillment of design and performance specifications.

Technological Characteristics

Stainless steel guidewire; polymer distal tip; radiopaque distal tip; hydrophilic coating on distal 50 cm. Available in .014" and .018" diameters. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for facilitating catheter placement within the peripheral vasculature during diagnostic and interventional procedures.

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

• Radius Medical Cougar Guidewire (K011287 AND K032129)
• Boston Scientific Corporation, Transend Guidewire (K022357)

Submission Summary (Full Text)

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# 510(k) Summary for the BioSphere Medical, Inc. Sequitor™ Steerable Guidewire

### SUBMITTER/510(K) HOLDER 1.

JUN - 2 2006

BioSphere Medical, Inc. 1050 Hingham Street Rockland, MA 02370 USA

Contact Person: Irina Kulinets, Senior Director Regulatory Affairs and Quality Assurance Telephone: [phone]

Date Prepared: April 12, 2006

### 2. DEVICE NAME

Sequitor™ Steerable Guidewire Proprietary Name: Common/Usual Name: Vascular Guidewire Classification Name: Catheter Guidewire

### 3. PREDICATE DEVICES

- . Radius Medical Cougar Guidewire (K011287 AND K032129)
- Boston Scientific Corporation, Transend Guidewire (K022357) .

### 4. DEVICE DESCRIPTION

The Sequitor™ Steerable Guidewire (.014" or .018") is a stainless steel guidewire with a polymer distal tip and a radiopaque distal tip that is shapeable. The distal 50 cm is coated with a hydrophilic coating. The guidewire length is depicted on the product label.

### 5. INTENDED USE

The Sequitor™ Steerable Guidewire is intended to facilitate the placement of catheters within the peripheral vasculature for various diagnostic and interventional procedures.

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#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

BioSphere Medical, Inc. bases its claim of the substantial equivalence of the Sequitor™ Steerable Guidewire with the cited predicate devices based on intended use, indications for use, fundamental technological characteristics, and fundamental operational characteristics. In all cases, the guidewires are used to navigate to target areas of the vascular anatomy and provide support to additional tools, such as microcatheters. Accurate placement is assured through visualization of the radiopaque portions of the guidewire using fluoroscopic imaging. Like predicate devices, the Sequitor™ Steerable Guidewire is available in a range of sizes to permit selection of the most appropriate size for the vasculature and the therapeutic and diagnostic tools. All cited guidewires are intended for singe use and are provided. sterile.

#### 7. PERFORMANCE TESTING

In-vitro and in-vivo design verification and validation testing demonstrates that the Sequitor™ Steerable Guidewire fulfills design and performance specifications.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IIN = 2 2006

BioSphere Medical, Inc. c/o Ms. Rosina Robinson Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K061171 Sequitor™ Steerable Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: May 24, 2006 Received: May 25, 2006

Dear Ms. Robinson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our-labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

R. bochner

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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## 510(k) Number (if known): Ko6117 |

Device Name: BioSphere Sequitor™ Steerable Guidewire

Indications for Use:

The Sequitor™ Steerable Guidewire is intended to facilitate the placement of catheters within the peripheral vasculature for various diagnostic and interventional procedures.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. buchner

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number k061171