TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815

K022357 · Boston Scientific, Target · DQX · Oct 16, 2002 · Cardiovascular

Device Facts

• Record ID: K022357
• Device Name: TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
• Applicant: Boston Scientific, Target
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Transend 300 ES Guidewire and Transend 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included with the guidewires to facilitate directional manipulation of the guidewires.

Device Story

Transend 300 ES and 300 Floppy are 0.014" diameter, 300cm length intravascular guidewires; designed for exchange of therapeutic devices without extension wires. Operated by physicians in clinical settings; used to navigate neuro and peripheral vasculature. Manual torque device (pin vise) included for directional manipulation. Facilitates selective placement of diagnostic or therapeutic catheters. Benefits include procedural efficiency by enabling device exchange without additional hardware.

Clinical Evidence

Bench testing only. In vitro performance testing included particle analysis, friction testing, angular rotation, tip buckling, and tip stiffness. Biocompatibility testing performed per ISO-10993.

Technological Characteristics

Materials: stainless steel, platinum, PTFE, polyurethane, lubricious coating. Diameter: 0.014". Length: 300cm. Principle: manual torque-controlled intravascular navigation. Sterilization: not specified. Software: none.

Indications for Use

Indicated for general intravascular use in neuro and peripheral vasculature to facilitate selective placement of diagnostic or therapeutic catheters. 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

• FasDasher-14 Guidewire (K950069)
• ChoICE Extra Support Guidewire (K950113)
• ChoICE Floppy Guidewire (K950113)

Submission Summary (Full Text)

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# SECTION 2 – 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### July 17, 2002 a. Date Prepared:

#### b. Contact Person

George J. Prendergast Regulatory Affairs Specialist II Boston Scientific Target 47900 Bayside Parkway Fremont, CA 94538

#### c. Trade Name

Transend™ 300 ES Guidewire Transend™ 300 Floppy Guidewire

#### d. Common Name

Catheter Guidewire

#### e. Classification Name

Catheter Guidewire (21 CFR Section 870.1330)

#### f. Identification of Predicate Devices

| Number | Description | Clearance Date |
|---------|------------------------------------------------------------------|----------------|
| K950069 | DasherTM - 14 Guidewire | 12 April 1995 |
| K950113 | ChoICETM Extra Support<br>Guidewire<br>ChoICETM Floppy Guidewire | 31 March 1995 |

Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission

OCT 1 6 2002

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#### g. Device Description

The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The 300cm length allows exchange of therapeutic devices without the use of other exchange devices, i.e. extension wires. The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire have a nominal diameter of 0.014".

All device materials, manufacturing processes and product dimensions are identical to the Boston Scientific Scimed ChoICE™ ES 300cm exchange guidewire and the ChoICE™ 300cm Floppy exchange guidewire.

#### h. Intended Use

The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire Indications For Use are as follows:

The Transend 300 ES Guidewire and Transend 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included with the guidewires to facilitate directional manipulation of the guidewires.

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## i. Product Feature Comparison

| Feature | FasDasher™ – 14<br>Guidewire<br>Predicate device | Transend™ 300 ES<br>Guidewire<br>Transend™ 300 Floppy<br>Guidewire<br>Subject devices | ChoICETM PTCA Exchange<br>Guidewire<br>ChoICETM PTCA Exchange<br>Guidewire<br>Predicate devices |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | FasDasher-14 Guidewire is<br>intended to assist delivery<br>of catheters to selected<br>vascular sites (neuro<br>peripheral and coronary<br>vasculature). | The Transend 300 ES<br>Guidewire and<br>Transend 300 Floppy<br>Guidewire are intended<br>for general intravascular<br>use, including the neuro<br>and peripheral<br>vasculature. These devices<br>are not intended for use in<br>coronary arteries. | The ChoICE ES 300cm<br>Exchange Guidewire<br>ChoICE Floppy 300cm<br>Exchange Guidewire are<br>intended to facilitate the<br>placement of balloon<br>dilatation catheters or<br>other therapeutic devices<br>during PTCA. The ChoICE<br>guidewires are not<br>intended for use in the<br>cerebral vasculature. |
| Design: | | | |
| Length | 195cm | 300cm | 300cm |
| Distal<br>Outside<br>Diameter | 0.014" minimum | 0.014" minimum | 0.014" minimum |
| Materials | Predominately stainless<br>steel, platinum,<br>polytetrafluoroethylene,<br>polyurethane, lubricious<br>coating | Predominately stainless<br>steel, platinum,<br>polytetrafluoroethylene,<br>polyurethane, lubricious<br>coating | Predominately stainless<br>steel, platinum,<br>polytetrafluoroethylene,<br>polyurethane, lubricious<br>coating |

Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission

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#### i. Comparison of Technological Characteristics

The Transend™300 ES Guidewire and Transend™ 300 Floppy Guidewire are substantially equivalent to the predicate devices in terms of functionality, intended use, design, materials, method of operation, size, length, sterilization methods, packaging, biocompatibility, and labeling.

#### k. Testing

In vitro performance testing of the Transend 300 ES Guidewire and the Transend 300 Floppy Guidewire included particle analysis, friction testing, angular rotation, tip buckling, and tip stiffness to gain clearance for a neurovascular and peripheral indications.

Biocompatibility testing was verified according to ISO-10993, Biological Evaluation of Medical Devices. Test results confirm biocompatibility of the Transend 300 ES Guidewire and the Transend 300 Floppy Guidewire.

All testing indicates that the devices are safe and perform according to their intended use.

### 1. Summary of Substantial Equivalence

Boston Scientific Target's determination of substantial equivalence to Boston Scientific Scimed's ChoICE™ Extra Support Guidewire and ChoICE™ Floppy Guidewire and Boston Scientific Target's FasDasher™- 14 Guidewire as predicate devices is based on the following.

The subject guidewires are substantially equivalent to the FasDasher-14 Guidewire with respect to the following:

- size
- intended use ●
- labeling ●
- . biocompatibility
- packaging
- functionality
- method of operation

Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission

Boston Scientific Target

July 2002

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The subject guidewires are substantially equivalent to the Scimed's ChoICE™ Extra Support Guidewire and ChoICE™ Floppy Guidewire with respect to the following:

- materials .
- . size
- . length
- . labeling
- packaging ●
- sterilization methods .
- . functionality
- design
- method of operation ●
- biocompatibility ●

Based on the above information provided in this submission, Boston Scientific Target's Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire are substantially equivalent to Boston Scientific Target's FasDasher ™-14 Guidewire and Boston Scientific Scimed's ChoICE Extra Support Guidewire and ChoICE Floppy Guidewire.

Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2002

Boston Scientific Target c/o Mr. George J. Prendergast 47900 Bayside Parkway Fremont, CA 94538

K022357 Re:

> Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire Regulation Number: 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II (two) Product Code: DQX Dated: July 17, 2002 Received: July 19, 2002

Dear Mr. Prendergast:

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. George J. Prendergast ·

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Dalatium

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 STATEMENT

510(k) Number: _ K022.357

Device Name: Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire

Indications for Use:

The Transend™ 300 ES Guidewire and Transend™ 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included to facilitate directional manipulation of the guidewires.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use
(Per 21 CFR 801.109)

Over The Counter Use

Division of Cardiovascular & Respiratory Devices
510(k) Number K022357

Transend™ 300 ES Guidewire, Transend™ 300 Floppy Guidewire 510(k) Submission