PVS 2000 SYNCHRO2 GUIDEWIRE

K053268 · Boston Scientific - Precision Vascular · DQX · Mar 13, 2006 · Cardiovascular

Device Facts

• Record ID: K053268
• Device Name: PVS 2000 SYNCHRO2 GUIDEWIRE
• Applicant: Boston Scientific - Precision Vascular
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The PV 2000 Synchro®2 Guidewire series of products is intended for peripheral and neurovascular use. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Device Story

PV 2000 Synchro®2 Guidewire is a sterile, single-use, 0.014" diameter guidewire designed for navigating small, tortuous peripheral and neurovasculature. It features a shapeable distal tip, Nitinol construction, and a lubricious coating. A platinum marker coil at the distal tip enables fluoroscopic visualization. The device is manually operated by physicians during percutaneous, intravascular procedures to facilitate catheter exchange and positioning. It is supplied with a torque device and an introducer/shaping mandrel to assist in navigation and insertion. The guidewire provides steerability and torque transmission, allowing clinicians to reach distal vascular sites. By enabling precise catheter placement, the device facilitates diagnostic and interventional procedures, potentially improving patient outcomes in complex vascular anatomy.

Clinical Evidence

Bench testing only. Testing conducted in accordance with ISO 11070:1998. Performance evaluations included dimensional inspection, fatigue assessment, tip flexibility, tip shaping, tensile strength, guidewire compatibility, torsional strength, torqueability, and EO sterilization validation. Biocompatibility verified per ISO 10993-1 for external communicating, blood contact, short duration (<24 hours) devices. All results were acceptable.

Technological Characteristics

0.014" diameter guidewire; Nitinol distal tip; platinum marker coil for fluoroscopic visualization; lubricious coating on distal portion. Materials verified per ISO 10993-1. Performance tested per ISO 11070:1998. Supplied with torque device and introducer/shaping mandrel. Sterilized via Ethylene Oxide (EO).

Indications for Use

Indicated for general intravascular use, including neuro and peripheral vasculature, to selectively introduce and position catheters and other interventional devices. For use by physicians trained in percutaneous, intravascular techniques.

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

• Synchro™ .014" (K032146)
• Synchro™ .010" (K032146)
• Synchro™ .016" (K050964)
• Transend (K971254)

Reference Devices

• Merit Medical torque device (K936032)
• B. Braun guidewire introducer/shaping mandrel (K760389)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

| Prepared November 22, 2005<br>Revised March 2, 2006 | | | | | |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------|
| General<br>Provisions | Submitter of 510(k)<br>Premarket Notification: | | Boston Scientific - Precision Vascular<br>2405 West Orton Circle<br>West Valley City, UT 84119<br>Phone: [phone]<br>Fax: [phone] | | |
| | Contact Person: | | Rick Gaykowski<br>VP, Regulatory/Clinical Affairs<br>Quality Systems & Operations | | |
| | Device Trade Name:<br>Device Generic Name: | | PV 2000 Synchro®2 Guidewire<br>Guidewire | | |
| | The predicate devices are listed in the table below. | | | | |
| Predicate<br>Devices | Device | Manufacturer | | 510(k) Number/Date | Pro Code |
| | Synchro™ .014" | Precision Vascular | | K032146, 12 August 2003 | DQX |
| | Synchro™ .010"<br>Synchro™ .016"<br>Transend | Precision Vascular<br>Precision Vascular<br>Target Therapeutics | | K032146, 12 August 2003<br>K050964, 13 June 2005<br>K971254, 01 July 1997* | DQX<br>DQX<br>DQX |
| * This information is assumed based upon our best knowledge. | | | | | |
| Classification | Class II, 21 CFR 870.1330, Wire, Guide, Catheter 74DQX | | | | |
| Performance<br>Standards | Performance standards have not been established by FDA under section 514 of the<br>Federal Food, Drug and Cosmetic Act. | | | | |
| Intended Use | The PV 2000 Synchro®2 Guidewire series of products is intended for peripheral and<br>neurovascular use. The device can be used to selectively introduce and position<br>catheters and other interventional devices within the peripheral and neurovasculature.<br>This device should be used only by physicians trained in percutaneous, intravascular<br>techniques and procedures. | | | | |
| Device<br>Description | The PV 2000 is a member of the Synchro® Guidewire family of products having a<br>0.014" outside diameter, being a sterile, single use/disposable product, with a<br>shapeable tip which is used to gain intravascular access to and facilitate the positioning<br>and exchange of interventional devices in small diameter, tortuous vasculature for<br>peripheral and neuro diagnostic and interventional procedures. The guidewire can be<br>torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical<br>(K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire | | | | |

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K05 3268

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introducer/shaping mandrel (B. Braun (K760389)) is also supplied and may be used to aid introduction of the guidewire into the catheter hub and/or hemostasis valve and to gently shape the guidewire's distal flexible tip, if desired, according to standard practice. Neither the guidewire introducer nor the torque device are intended to enter the body. The product is projected to be provided in a 100cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 35cm length. A traditional range of flexibility profiles shall also be provided, ranging from support (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal portion of the device. The marker coil is platinum wire at the distal tip of the device to aid visualization under fluoroscopy. The subject device has the ability to access distal, tortuous vasculature, with steerability and torque transmission properties.

Technological Characteristics Technological similarities between the subject PV 2000 Synchro®2 Guidewire and the PVS 1300 Synchro™ predicate remain identical. This is also true for competitive predicate device features including the basal design and dimensions, generic materials & construction, and hydrophilic coating. There are no new questions raised regarding safety or efficacy of the PVS 1300 Synchro® 0.014" Guidewire.

Biocompatibility of the PV 2000 Synchro®2 Guidewire materials have been verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices - Part 1. Materials test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (<24 hours) device.

Safety and Performance Tests

Performance testing of materials comprising the PV 2000 Synchro®2 Guidewire was conducted in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers. Ventication testing for the subject device included dimensional inspection, fatique assessment, tip flexibility, tip shaping, tensile strength, guidewire compatibility testing and performance under simulated conditions. Subject product testing has yielded acceptable safety & performance outcomes.

In addition, torsional strength, torqueability, and EO sterilization adoption tests also The results of these tests, in conjunction with the vielded acceptable results. substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the PV 2000 Synchro®2 Guidewires' substantial equivalence to the cited predicate devices.

Summary of Substantial Equivalence

Based on the indications for use, technological characteristics, and safety and performance testing, the subject PV 2000 Synchro@2 Guidewire meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available quidewires/cited predicates.

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Food and Drug Administration

Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

9200 Corporate Boulevard Rockville MD 20850 MAR 1 3 2006

Boston Scientific - Precision Vascular c/o Mr. Rick Gaykowski V.P. Regulatory/Clinical Affairs Quality Systems and Operations 2405 West Orton Circle West Valley City, UT 84119

Re: K053268

PVS 2000 Synchro®2 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II Product Code: DQX Dated: February 15, 2006 Received: February 16, 2006

Dear Mr. Gaykowski:

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.

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

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Page 2 - Mr. Rick Gaykowski

systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 335this (Q) 70g visions 531-542 of the Act); 21 CFR 1000-1050. Control provisions (Soctions 551 - 12 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 This letter with anow you're ough maning of substantial equivalence of your device to a legally premarket notification: "The PDF maing sification 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 If you desire specific at notiance at [phone]. Also, please note the regulation entitled, Connate the Office of Central of Centralion" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general intermational 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,

Blymmman 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

510(k) Number (if known): K053268

Device Name: PV 2000 Synchro®2 Guidewire

Indications For Use: The PV 2000 Synchro®2 Guidewire series of products are intended for general intravascular use, including the neuro and peripheral vasculature. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Prescription Use ﮯ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

ivision Sigh-O ivision of Clardiova

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**510(k) Number** k053268