PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER

K032494 · Precision Vascular Systems, Inc. · KRA · Sep 5, 2003 · Cardiovascular

Device Facts

• Record ID: K032494
• Device Name: PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER
• Applicant: Precision Vascular Systems, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Sep 5, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2

Intended Use

The PVS 1700 Steerable Delivery System®-10 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 1700 Steerable Delivery System-10 is a 1.9F/2.4F tubular microcatheter (155 cm length) designed for accessing tortuous vasculature. Device features a polymeric lumen (0.0165" ID) for delivering contrast, drugs, or embolics; lubricious outer coating; and two distal radiopaque markers for fluoroscopic visualization. Proximal end includes a standard luer adapter for flushing and accessory attachment. Operated by clinicians in interventional settings; device is tracked over a guide wire and can be steered to navigate distal anatomy. Output is the delivery of therapeutic/diagnostic agents to target sites. Benefits include improved access to distal, tortuous vessels for minimally invasive procedures.

Clinical Evidence

Bench testing only. Biocompatibility verified per ISO 10993-1 for external communicating, blood contact, short duration (<24 hours) devices. Performance testing conducted per ISO 10555-1, including dimensional inspection, hub integrity, flow rate, burst strength, tensile strength, guide wire compatibility, torsional strength, torqueability, and corrosion resistance. All results were acceptable.

Technological Characteristics

1.9F/2.4F tubular microcatheter; 155 cm length; polymeric lumen (0.0165" ID); lubricious distal coating; two distal radiopaque markers; standard luer adapter. Materials and construction consistent with predicate catheters. Biocompatibility per ISO 10993-1; performance per ISO 10555-1.

Indications for Use

Indicated for patients requiring access to tortuous distal, peripheral, coronary, or neurovasculature for sub-selective infusion of diagnostic, embolic, or therapeutic agents, or for guide wire 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)
• Excelsior SL-10 (K013789)
• Rebar-14 (K993672)

Submission Summary (Full Text)

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K032494/

## Summary of Safety and Effectiveness

| Prepared 11 August 2003 | | | | | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|------------------------------------------------------------------------------------------------------------------------|-----------------|--|
| 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<br>Affairs & Quality Systems | | |
| | Device Trade Name:<br>Device Generic Name: | | PVS 1700 Steerable Delivery System®-10<br>Infusion Catheter | | |
| | The predicate devices are listed in the table below. | | | | |
| | Device | Manufacturer | 510(k) Number,<br>Concurrence Date | Product<br>Code | |
| Predicate<br>Devices | SDS 0.018" | PVS, Inc. | K020733, 21 March 2002 | KRA | |
| | Excelsior SL-10 | BSC/Target | K013789, 06 Dec 2001 | DQY | |
| | Rebar-14 | Micro Therapeutics | K993672, 04 Jan 2000 | 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 1700 Steerable Delivery System®-10 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 1700 Steerable Delivery System®-10 is a 1.9F/2.4F (nominal<br>distal/proximal) tubular device, 155 cm in length, with a lumen to be used for delivery of<br>contrast, drugs, or embolics. The lumen is constructed from a polymeric material and<br>has an inside diameter of 0.0165". The device is coated on the outer diameter with a<br>lubricious coating over the distal segment of the device. Two radiopaque markers are<br>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 1700 Steerable Delivery System®-10<br>and predicate devices include the basal tubular design and dimensions, polymeric<br>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 1700 Steerable<br>Delivery System®-10. |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and<br>Performance<br>Tests | Biocompatibility of the PVS 1700 Steerable Delivery System®-10 has been verified in<br>accordance with ISO 10993-1, Biocompatibility of Medical Devices - Part 1. Test<br>results confirmed biocompatibility of the subject device when tested as an external<br>communicating, blood contact, short duration (<24 hours) devices.<br><br>Performance testing of the PVS 1700 Steerable Delivery System®-10 was conducted<br>in accordance with ISO 10555-1, Sterile, Single-Use Intravascular Catheters - Part 1.<br>Verification testing for the subject device included dimensional inspection, hub<br>integrity, flow rate measurements, burst strength, tensile strength, guidewire<br>compatibility testing and performance under simulated conditions. Subject product<br>testing is believed to have yielded acceptable results.<br><br>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 1700 Steerable Delivery System®-10 substantial equivalence to the cited<br>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 1700 Steerable Delivery System®-10 meets<br>the minimum requirements that are considered adequate for its intended use and is<br>substantially equivalent in design, materials, sterilization, principles of operation and<br>indications for use to current commercially available catheters/cited predicates. |

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## 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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2003

Precision Vascular Systems, Inc. c/o Mr. Rick Gaykowski 2405 West Orton Circle West Valley City, UT 84119

Re: K032494 PVS 1700 Steerable Delivery System®-10 Microcatheter Regulation Number: 870.1210/1330 Regulation Name: Continous Flush Catheter/Catheter Guide Wire Regulatory Class: Class II Product Code: KRA Dated: August 11, 2003 Received: August 13, 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. Iisting 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. Rick Gaykowski

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 (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]. 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) you may obtain. 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,

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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Page 1 of 1

KO32494 510(k) Number (if known): _

Device Name: PVS 1700 Steerable Delivery System®-10 Microcatheter

Indications for Use:

The PVS 1700 Steerable Delivery System®-10 Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery of dlagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guldewire exchangelsupport 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 __

N. Leartus