PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE

{0}------------------------------------------------ DEC 0 4 2002 K023700 page 1 of 2 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ # Summary of Safety and Effectiveness | | Submitter of 510(k)<br>Premarket Notification: | | Precision Vascular<br>2405 West Orton Circle<br>West Valley City, UT 84119<br>Phone: 801.974.1700<br>Fax: 801.974.1740 | | | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------| | General<br>Provisions | Contact Person: | | Rick Gaykowski<br>Vice President, Regulatory/Clinical Affairs<br>& Quality Systems | | | | | Device Trade Name:<br>Device Generic Name: | | PVS 1600 Synchro® 0.010" NGW<br>Guide Wire | | | | | The predicate devices are listed in the table below. | | | | | | Predicate<br>Devices | Device | Manufacturer | | 510(k) Number,<br>Concurrence Date | Product<br>Code | | | Synchro™ .014" | Precision Vascular | | K002907, 08 March 2001 | 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 1600 Synchro® 0.010" Neuro Guidewire series of products is intended for<br>neurovascular use. It can be used to selectively introduce and position catheters and<br>other interventional devices within the neurovasculature. This device should be used<br>only by physicians trained in percutaneous, intravascular techniques and procedures. | | | | | | Device<br>Description | The PVS 1600 is a member of the Synchro® Neuro Guidewire family of products<br>having a 0.010" 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>neuro diagnostic and interventional procedures. The guidewire can be torqued to<br>facilitate navigation through the vasculature. A torque device, (Merit Medical Systems<br>(K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire<br>introducer (B. Braun (K760389)) is also supplied and may be used to aid introduction of<br>the guidewire into the catheter hub and/or hemostasis valve and to gently shape the<br>guidewire's distal flexible tip, if desired, according to standard practice. Neither the<br>guidewire introducer or the torque device are intended to enter the body. The product | | | | | Prepared November 1, 2002 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows handwritten text. The text at the top reads "K025700". Below that, the text reads "page 2 of 2". The handwriting is cursive and slightly faded. is 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 35cm - 65cm range, with 55cm being nominal. A traditional range of flexibility profiles shall also be provided, ranging from standard (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 similarities between the PVS 1600 Synchro® 0.010" Neuro Guidewire and the PVS 1300 Synchro™ predicate remain identical. This is also comparatively true for competitive predicate device features including the basal design and dimensions, generic materials & construction, and hydrophilic coating. In instances where the technological characteristics may differ, it has been demonstrated that there are no new questions raised regarding safety or efficacy of the PVS 1600 Synchro® 0.010" Neuro Guidewire. Biocompatibility of the PVS 1600 Synchro® 0.010" Neuro 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 Technological Characteristics Performance testing of materials comprising the PVS 1600 Synchro® 0.010" Neuro Guidewire 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, quide 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 1600 Synchro® 0.010" Neuro Guidewires' substantial equivalence to the cited predicate devices. Based on the indications for use, technological characteristics, and safety and Summary of performance testing, the subject PVS 1600 Synchro® 0.010" Neuro Guidewire meets Substantial the minimum requirements that are considered adequate for its intended use and is Equivalence substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available quidewires/cited predicates. {2}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, arranged in a stacked formation. The profiles are depicted in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 0 4 2002 Mr. Rick Gaykowski Corporate Vice President, Regulatory/Clinical Affairs and Quality Systems Precision Vascular Systems, Inc. 2405 West Orton Circle West Valley City, Utah 84119 Re: K023700 Trade/Device Name: PVS 1600 Synchro® 0.010" Neuro Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: DQX Dated: November 1, 2002 Received: November 4, 2002 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 incan 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 {3}------------------------------------------------ #### Page 2 - Mr. Rick Gaykowski 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, L. Mark N. Mullinson Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### 510(k) Number (if known): J ## Device Name: PVS 1600 Synchro®0.010" Neuro Guidewire #### Indications for Use: The PVS 1600 Synchro® 0.010" Neuro Guidewire series of products is intended for neurovascular use. It can be used to selectively introduce and position catheters and other interventional devices within the neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures. #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | | OR | | Over-the-Counter Use | | |----------------------|--|----|--|----------------------|--| | (Per 21 CFR 801.109) | | | | | | *Mah n Milliken* (Division Sign-Off) Division of General, Restorative and Neurological Devices | 510(k) Number | K023700 | |---------------|---------| |---------------|---------|