PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER

K033726 · Precision Vascular · KRA · Jan 16, 2004 · Cardiovascular

Device Facts

• Record ID: K033726
• Device Name: PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER
• Applicant: Precision Vascular
• Product Code: KRA · Cardiovascular
• Decision Date: Jan 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2

Intended Use

The PVS "Pivot™" Steerable Delivery System® Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic or interventional procedures.

Device Story

PVS Pivot™ Steerable Delivery System® Microcatheter is a 1.9F/2.4F tubular device (~150 cm length) designed for navigation through tortuous vasculature. Device features a polymeric lumen (0.0165" ID) for delivery of contrast, drugs, or embolics; distal radiopaque markers for fluoroscopic visualization; and a proximal luer adapter. Operated by physicians in clinical settings, the device is tracked over a guidewire to reach target sites. Steerability allows navigation through complex anatomy. Output is the delivery of therapeutic/diagnostic agents at the distal tip. Benefits include improved access to distal vasculature for minimally invasive interventions.

Clinical Evidence

Bench testing only. Testing included dimensional inspection, hub integrity, flow rate, burst strength, tensile strength, guidewire compatibility, torsional strength, torqueability, and corrosion resistance per ISO 10555-1. Biocompatibility verified per ISO 10993-1 for external communicating, blood contact, short duration (<24 hours) devices.

Technological Characteristics

Tubular microcatheter, 1.9F/2.4F, ~150 cm length. Polymeric construction with hydrophilic coating on distal segment. Two radiopaque markers at distal tip. Standard luer adapter. Biocompatibility per ISO 10993-1; performance per ISO 10555-1. Manual operation; no software or energy source.

Indications for Use

Indicated for patients requiring sub-selective access to distal, peripheral, coronary, or neurovasculature for the delivery of diagnostic, embolic, or therapeutic agents, or for guidewire exchange/support during diagnostic or interventional procedures.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• SDS 0.018" (K020733)
• SDS 0.010" (K032494)

Submission Summary (Full Text)

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K03776

## JAN 1 6 2004

## Summary of Safety and Effectiveness

| Prepared 26 November 2003 | | | | | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------|--|
| | 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] | | | |
| General<br>Provisions | Contact Person: | Rick Gaykowski<br>Vice President, Regulatory/Clinical<br>Affairs & Quality Systems | | | |
| | Device Trade Name: | | PVS "Pivot™" Steerable Delivery System®<br>Microcatheter | | |
| | Device Generic Name: | | Infusion Catheter | | |
| | The predicate devices are listed in the table below. | | | | |
| Predicate<br>Devices | Device | Manufacturer | 510(k) Number,<br>Concurrence Date | Product<br>Code | |
| | SDS 0.018" | PVS, Inc. | K020733, 21 March 2002 | KRA | |
| | SDS 0.010" | PVS, Inc. | K032494, 05 Sep 2003 | KRA | |
| Classification | Class II, 21 CFR 870.1210, Continuous Flush Catheter, KRA | | | | |
| 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 "Pivot™" Steerable Delivery System® Microcatheter is intended to be used<br>to access tortuous vasculature for sub-selective controlled infusion or delivery of<br>diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and<br>neurovasculature, and for guide wire exchange/support during diagnostic or<br>interventional procedures. | | | | |
| Device<br>Description | The PVS "Pivot™" Steerable Delivery System® Microcatheter is a 1.9F/2.4F (nominal<br>distal/proximal) tubular device, ~150 cm in length, with a lumen to be used for delivery<br>of contrast, drugs, or embolics. The lumen is constructed from a polymeric material<br>and has an inside diameter of 0.0165". The device is coated on the outer diameter with<br>a lubricious coating over the distal segment of the device. Two radiopaque markers<br>are positioned at the distal tip of the device to aid visualization under fluoroscopy. The<br>proximal end of the device has a standard luer adapter for attachment of accessories<br>and can be used to flush the lumen. The subject device has the ability to access distal,<br>tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability<br>to be steered like a guide wire as needed. | | | | |

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| Technological<br>Characteristics | Technological similarities between the PVS "Pivot™" Steerable Delivery System®<br>Microcatheter and predicate devices include the basal tubular design and dimensions,<br>polymeric materials and construction, and hydrophilic coating. In instances where the<br>technological characteristics may differ slightly, it has been demonstrated that there<br>are no new questions raised regarding safety and efficacy of the PVS "Pivot™"<br>Steerable Delivery System® Microcatheter. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Biocompatibility of the PVS "Pivot™" Steerable Delivery System® Microcatheter has<br>been verified in accordance with ISO 10993-1, Biocompatibility of Medical Devices –<br>Part 1. Test results confirmed biocompatibility of the subject device when tested as an<br>external communicating, blood contact, short duration (<24 hours) devices. |
| Safety and<br>Performance<br>Tests | Performance testing of the PVS "Pivot™" Steerable Delivery System® Microcatheter<br>was conducted in accordance with ISO 10555-1, Sterile, Single-Use Intravascular<br>Catheters - Part 1. Verification testing for the subject device included dimensional<br>inspection, hub integrity, flow rate measurements, burst strength, tensile strength,<br>guidewire compatibility testing and performance under simulated conditions. Subject<br>product testing is believed to have yielded acceptable results. |
| | In addition, torsional strength, torqueability, and corrosion resistance tests also yielded<br>acceptable results. The results of these tests, in conjunction with the substantial<br>equivalence claims as outlined in the premarket notification, effectively demonstrate<br>the PVS "Pivot™" Steerable Delivery System® Microcatheter is substantial<br>equivalence to the cited predicate devices. |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the subject PVS "Pivot™" Steerable Delivery System®<br>Microcatheter meets the minimum requirements that are considered adequate for its<br>intended use and is substantially equivalent in design, materials, sterilization,<br>principles of operation and indications for use to current commercially available<br>catheters/cited predicates. |
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2004

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

Re: K033726

> PVS "Pivot™" Steerable Delivery System® Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II Product Code: KRA Dated: November 26, 2003 Received: November 28, 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. Ilsting 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 fisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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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 [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,

Ilise D. Haryfor

Bram D. Zuckerman, M Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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9

510(k) Number (if known): _ << 033726

Device Name: PVS "Pivot™" Steerable Delivery System® Microcatheter

Indications for Use:

The PVS "Pivot™" Steerable Delivery System® Microcatheter is intended to be used to access thereoutin agants into the distributed infusion or delivery of diagnostic, embolic, and therapedition and distal, peripheral, coronary, and neurovasculature, and for guidewire exchange/support during diagnostic or interventional procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---------------------------------------|---|
|---------------------------------------|---|

OR
Over-the-Counter Use

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(Division Sign-off)
Division of Cardiovascular Devices

| 510(K) Number | K033726 (SM. K) |
|---------------|-----------------|
|---------------|-----------------|