RUNTHROUGH NS EXTENSION WIRE

K080563 · Terumo Medical Corp. · DQX · Mar 20, 2008 · Cardiovascular

Device Facts

• Record ID: K080563
• Device Name: RUNTHROUGH NS EXTENSION WIRE
• Applicant: Terumo Medical Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 20, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

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

Device Story

Runthrough NS Extension Wire is a coil-type guide wire accessory; connects to proximal end of 180cm Runthrough NS guide wire to convert monorail catheter systems to over-the-wire systems. Device consists of core wire (Ni/Ti alloy and stainless steel), tip coil, and surface coatings (silicone/PTFE). Operated manually by physicians in clinical settings (e.g., cath lab) during PTCA/PTA procedures. Facilitates balloon catheter placement by extending reach of primary guide wire. Benefits include procedural flexibility for clinicians transitioning between catheter systems.

Clinical Evidence

Bench testing only. Verification tests included dimensional inspection, tip tensile strength, and extension wire connection strength. Biocompatibility testing performed per ISO-10993. Sterilization validated per ANSI/AAMI/ISO 11135-1994.

Technological Characteristics

Coil-type guide wire; 0.014" diameter. Materials: Ni/Ti alloy and stainless steel core, Pt/Ni alloy radiopaque marker, silicone/PTFE surface coatings. Manual operation. Sterilized via ethylene oxide (SAL 10^-6). Complies with ISO-10993 for biocompatibility.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) requiring balloon dilatation catheter placement.

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

• Runthrough NS (K063695)

Submission Summary (Full Text)

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## SECTION II. 510(K) SUMMARY

### A. Device Name

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

### B. Intended Use

The Runthrouh NS Extension Wire are used to facilitate the 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 - Runthrough NS K063695

### 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. An extension wire is available to connect to the proximal end of the 180cm wire when the physician wants to convert from a monorail catheter system to an over the wire system.

## D. Principle Of Operation / Technology

The Runthrough NS and Runthrough NS Extension wire are operated manually or by a manual process.

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# Terumo Corporation

Special 510k – Runthrough NS Extension Wire Section II. 510(k) Summary

## E. Design / Materials

Differences in materials between the modified device and the predicate device the Runthrough NS cleared under K063695 raise no new issues of safety and effectiveness.

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## F. Specifications

| Feature | Runthrough NS | Runthrough NS<br>Extension Wire |
|--------------------|------------------------------------|--------------------------------------------------------------|
| Available diameter | 0.014" ( 0.36mm ) | 0.014" ( 0.36mm ) |
| Available length | 180cm, 300cm | 120-165cm which docs<br>into the 180cm<br>Runthrough NS wire |
| Tip marker length | 30mm | none |
| Accessory Devices | Torque Device, Inserter,<br>Stylet | Torque Device, Inserter |
| Shelf life | 36 months | 36 months |

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## G. Performance

The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Runthrough NS Extension Wire) to the unmodified device (Runthrough NS K063695).

- Dimensional Inspection .
- . Tensile strength of tip
- . Extension wire connection strength

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 Extension Wire is substantially equivalent to the performance of the predicate device the unmondified Runthrough NS K063695.

## 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.

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 106.

#### H. Substantial Equivalence

The modified Runthrough NS Extension Wire is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device the Runthrough NS K063695. Differences between the two devices do not raise any significant issues of safety or effectiveness.

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## 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: | February 26, 2008 |

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Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, depicted in a minimalist, abstract design.

MAR 2 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K080563

Runthrough NS Extension Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide Catheter Regulatory Class: II Product Code: DQX Dated: February 26, 2008 Received: February 28, 2008

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Bhimnma 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

Koros63 510(k) Number (if known): ___

Runthrough NS Extension Wire Device Name:

Indications For Use:

The Runthrough NS Extension Wire are used to facilitate the 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)

Bhummer

Division of Cardiovascular Devices
510(k) Number K08056