RUNTHROUGH NS

K063695 · Terumo Medical Corp. · DQX · Apr 27, 2007 · Cardiovascular

Device Facts

• Record ID: K063695
• Device Name: RUNTHROUGH NS
• Applicant: Terumo Medical Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 27, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Runthrouh NS are used to facilitate placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

Device Story

Runthrough NS is a coil-type guide wire used to facilitate balloon dilatation catheter placement during PTCA or PTA procedures. The device consists of a core wire (Ni/Ti alloy and stainless steel), a radiopaque Pt/Ni alloy tip coil, and a surface coating (silicone and/or hydrophilic). It is operated manually by a physician in a clinical setting. The wire features varying tip flexibilities (Extra Floppy, Floppy, Intermediate) and is available in standard or hyper-coating versions. Accessories include a torque device, inserter, and stylet. The device is used to navigate the vasculature to the target site, allowing the physician to track catheters over the wire to perform angioplasty, potentially benefiting patients by enabling minimally invasive treatment of coronary or peripheral arterial stenoses.

Clinical Evidence

Bench testing only. Verification tests included dimensional inspection, tip sliding resistance, tensile strength (tip and shaft), tip butting load, wire stability, bend strength, seal strength, reshapability, torque strength/ability, tip flexibility, and coating integrity. Biocompatibility testing was conducted per ISO-10993 for externally communicating devices in contact with circulating blood.

Technological Characteristics

Coil-type guide wire; core wire (Ni/Ti alloy and stainless steel); radiopaque Pt/Ni alloy tip coil; surface coating (silicone and PTFE/hydrophilic); 0.014" diameter; 180cm/300cm lengths; manual operation; ethylene oxide sterilization (SAL 10^-6).

Indications for Use

Indicated for facilitating the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) 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

• Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil (K961445)

Submission Summary (Full Text)

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Kd63695

# SECTION II. 510(K) SUMMARY

#### A. Device Name

APR 2 7 2007

| Proprietary Name | Runthrough NS |
|---------------------|-----------------------|
| Classification Name | Wire, Guide, Catheter |
| Common Name | Guide Wire |

#### B. Intended Use

The Runthrouh NS are used to facilitate placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

Note: This is the same intended use as the predicate device - Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445.

#### C. Device Description

The Runthrough NS is a coil-type guide wire. The main components of the wire include a core wire, a tip coil, a tip coil marker, and surface coating. The core wire is constructed of a Ni/Ti alloy wire and a stainless steel wire joined together. The tip coil marker, a Pt/Ni alloy, is radiopaque. The tip coil has lubricous coating (silicone coating) and/or hydrophilic coating on the surface depending on product code. The shaft is surfacecoated with silicone and PTFE. Tip flexibility can be selected among three types, Extra Floppy, Floppy, and Intermediate, flexibility decreasing in the named order. The wire is also available in a hyper-coating type which is more lubricous than the standard wire. The device may be accompanied by a torque device, inserter, and stylet accessories.

## D. Principle Of Operation / Technology

The Runthrough NS is operated manually or by a manual process.

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# E. Design / Materials

Differences in materials between the modified device and the predicate device the Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil cleared under K961445 raise no new issues of safety and effectiveness.

# F. Specifications

| Feature | Modified Runthrough NS | Unmodified Device<br>Radifocus® Glidewire<br>for Coronary Use with<br>Platinum or Gold Coil<br>cleared under K961445 |
|--------------------|------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Available diameter | 0.014" ( 0.36mm ) | 0.014" ( 0.36mm ) |
| Available length | 180cm, 300cm | 180cm, 300cm |
| Tip marker length | 30mm | 20mm |
| Accessory Devices | Torque Device, Inserter,<br>Stylet | Torque Device, Inserter |
| Shelf life | 36 months | 24 months |

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## G. Performance

The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Runthrough NS) to the unmodified device (Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445).

- . Dimensional Inspection
- Tip sliding resistance test
- Tensile strength of tip .
- Tip butting load ●
- Tensile strength of shaft .
- Wire stability in holder loop .
- Bend strength ●
- Seal strength of packaging .
- Reshapability .
- Torque Strength ●
- Torqueability .
- Tip Flexibility .
- Coating Adherence/Integrity .

None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.

Therefore the performance of the modified Runthrough NS is substantially equivalent to the performance of the predicate device the Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445.

#### H. Additional Safety Information

Manufacturing controls include visual, functional, dimensional and sterility tests.

Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".

The guide wire is classified as Externally Communicating Devices, Circulating Blood, Limited Contact (< 24 hrs). Results of the testing demonstrate that the blood contacting materials are biocompatible.

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Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994, Medical Devices – Validation and routine control of ethylene oxide sterilization and EN 550. The device is sterilized to a SAL of 10-6.

#### H. Substantial Equivalence

The modified Runthrough NS is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device the Radifocus® Glidewire for Coronary Use with Platinum or Gold Coil, K961445. Differences between the two devices do not raise any significant issues of safety or effectiveness.

# I. Submitter Information

| Prepared By: | Mr. Mark Unterreiner<br>Sr. Regulatory Affairs Specialist |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared For: | Terumo Medical Corporation<br>950 Elkton Blvd.<br>Elkton, MD 21921<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | December 12, 2006 |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2007

Terumo Medical Corporation c/o Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, MD 21921

Re: K063695 Runthrough NS Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guidewire Regulatory Class: II (two) Product Code: DQX Dated: April 4, 2007 Received: April 5, 2007

Dear Mr. Unterreiner:

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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### Page 2 - Mr. Mark Unterreiner

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,

Donna R. Lachner

Image /page/5/Picture/5 description: The image contains a signature and the words "Brian" and "Director". The signature is a stylized, illegible mark, possibly initials. The text is in a simple, sans-serif font and is positioned to the right of the signature.

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): _ Ko (e 3695

Device Name:__________________________________________________________________________________________________________________________________________________________________ Runthrough NS

Indications For Use:

The Runthrouh NS are used to facilitate placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

and the contraction of the comments of the comments of the contribution of

Duna R. Vechner

Jivision Sign-Off) wision of Cardiovascular Device

10(k) Number_Ko63695

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