PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES

K032146 · Precision Vascular Systems, Inc. · DQX · Aug 12, 2003 · Cardiovascular

Device Facts

• Record ID: K032146
• Device Name: PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES
• Applicant: Precision Vascular Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 12, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The PVS 1300 Synchro® 0.014" & 1600 Synchro® 0.010" Neuro Guidewire series of products are intended for general intravascular use, which includes peripheral and neurovascular use. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral & neurovasculature. The device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Device Story

PVS 1300 Synchro (0.014") and PVS 1600 Synchro (0.010") are sterile, single-use guidewires designed for navigating small, tortuous peripheral and neurovascular anatomy. The device features a shapeable distal tip, a Nitinol core, and a platinum marker coil for fluoroscopic visualization. A lubricious coating is applied to the distal segment to facilitate navigation. The wire is manually operated by a physician during interventional procedures to guide catheters or other devices. A torque device and guidewire introducer are provided to assist in deployment and positioning; these accessories do not enter the body. The device provides steerability and torque transmission to reach distal vasculature. By facilitating the placement of interventional tools, the guidewire enables diagnostic and therapeutic procedures in complex vascular environments.

Clinical Evidence

Bench testing only. Verification testing included dimensional inspection, fatigue assessment, tip flexibility, tip shaping, tensile strength, guidewire compatibility, torsional strength, torqueability, and corrosion resistance. Testing was conducted in accordance with ISO 11070:1998. Biocompatibility was verified per ISO 10993-1 for external communicating, blood contact, short duration (<24 hours) devices. All tests yielded acceptable safety and performance outcomes.

Technological Characteristics

Materials: Nitinol core, platinum marker coil, lubricious coating. Dimensions: 0.014" and 0.010" OD; 180-300cm length. Sensing/Actuation: Manual torque transmission and steerability. Connectivity: None. Sterilization: Sterile, single-use. Standards: ISO 10993-1 (biocompatibility), ISO 11070:1998 (catheter introducers).

Indications for Use

Indicated for general intravascular use in peripheral and neurovasculature to selectively introduce and position catheters and 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" (K002907)
• Synchro™ .010" (K023700)
• Transend-14 (K964611)
• Agility-14 (K001033)
• MTI Silverspeed (K001454)
• Transend-10 (K964611)
• Agility-10 (K991646)
• Mirage .008" (K002212)

Reference Devices

• Merit Medical Systems torque device (K936032)
• B. Braun guidewire introducer (K760389)

Submission Summary (Full Text)

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AUG 1 2 2003

510K SUMMARY

K 032146

## Summary of Safety and Effectiveness

| Prepared July 11, 2003 | | | | |
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| General<br>Provisions | Submitter of 510(k)<br>Premarket Notification: | | Precision Vascular<br>2405 West Orton Circle<br>West Valley City, UT 84119<br>Phone: [phone]<br>Fax: [phone] | |
| | Contact Person: | | Rick Gaykowski<br>Vice President, Regulatory/Clinical Affairs<br>& Quality Systems | |
| | Device Trade Name: | | PVS 1300 Synchro® 0.014" & PVS 1600 Synchro®<br>0.010" Guidewires | |
| | Device Generic Name: | | Guide Wire | |
| The predicate devices are listed in the table below. | | | | |
| | Device | Manufacturer | 510(k) Number,<br>Concurrence Date | Product<br>Code |
| Predicate<br>Devices | Synchro™ .014" | Precision Vascular | K002907, 08 Mar 2001 | DQX |
| | Synchro™ .010" | Precision Vascular | K023700, 04 Dec 2002 | DQX |
| | Transend-14 | Target Therapeutics | K964611, 28 Jan 1997 | DQX |
| | Agility-14 | Cordis | K001033, 14 Apr 2000 | DQX |
| | MTI Silverspeed | Micro Therapeutics | K001454, 07 Jun 2000 | DQX |
| | Transend-10 | Target Therapeutics | K964611, 02 May 1996* | DQX |
| | Agility-10 | Cordis | K991646, 20 Jul 2000 | DQX |
| | Mirage .008" | Micro Therapeutics | K002212, 03 Aug 2000 | DQX |
| * This information is assumed based on our best, current 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 PVS 1300 Synchro® 0.014" & 1600 Synchro® 0.010" Neuro Guidewire series of<br>products are intended for general intravascular use, which includes peripheral and<br>neurovascular use. The device can be used to selectively introduce and position<br>catheters and other interventional devices within the peripheral & neurovasculature.<br>The device should be used only by physicians trained in percutaneous, intravascular<br>techniques and procedures. | | | |

Description products having a 0.014" & 0.010" outside diameter respectively, being sterile, single use/disposable products, with shapeable tip which is used to gain intravascular access

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to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral, neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical Systems (K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer (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 or the torque device are intended to enter the body. The products are projected to be provided in a 180cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 25cm - 65cm range, with 35-45cm being nominal. 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 segment 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 PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" guidewires and the cited Synchro™ predicates remain identical. This is also true for competitive predicate device 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" & PVS 1600 Synchro®0.010" guidewires.

Biocompatibility of the PVS 1300 Synchro® 0.014" 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 PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" guidewires was conducted in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers. Verification testing for the subject device included dimensional inspection, fatigue assessment, tip flexibility, tip shaping, tensile strength, guide wire compatibility testing and performance under simulated conditions. Subject product testing has yielded acceptable safety & performance outcomes.

In addition, torsional strength, torqueability, and corrosion resistance tests also yielded acceptable results. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" 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 PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" guidewires meet the minimum requirements that are considered adequate for their intended use and are substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available guidewires/cited predicates.

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## Class III Certification

This section is not applicable to the subject PVS 1300 Synchro™ 0.014" & PVS 1600 Synchro® 0.010" devices, nor the cited predicates, since these products have been classified under Class II.

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Public Health Service

Image /page/3/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem consists of three stylized, overlapping wave-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

AUG 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Precision Vascular, Inc. c/o Mr. Rick Gaykowski Vice President, Regulatory/Clinical Affairs and Quality Systems 2405 West Orton Circle West Valley City, UT 84119

Re: K032146

Trade Name: PVS 1300 Synchro®0.014" & PVS 1600 Synchro® 0.010" Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II (two) Product Code: DQX Dated: July 11, 2003 Received: July 14, 2003

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

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## Page 2 – Mr. Rick Gaykowski

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/dsma/dsmamain.html

Sincerely yours,

Bran 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):

Device Name: PVS 1300 Synchro®0.014" & PVS 1600 Synchro®0.010" Guidewire

Indications for Use:

The PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" 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.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
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| (Division Sign-Off) | | | |
| Division of Cardiovascular Devices | | | |
| 510(k) Number | K032146 | | |
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use | |