PVS 1500 SDS

K020733 · Precision Vascular Systems, Inc. · KRA · Mar 21, 2002 · Cardiovascular

Device Facts

• Record ID: K020733
• Device Name: PVS 1500 SDS
• Applicant: Precision Vascular Systems, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Mar 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

The PVS 1500 SDS is intended to be used to access tortuous vasculature for infusion 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 1500 SDS is a 2.4 F, 155 cm long tubular infusion catheter; used to access tortuous vasculature; facilitates delivery of contrast, drugs, or embolics; supports guide wire exchange. Device features: polymeric lumen (0.021" ID); lubricious distal coating; two radiopaque markers for fluoroscopic visualization; proximal luer adapter. Operated by physicians in clinical settings. Steerable like a guide wire. Output is visual confirmation via fluoroscopy and delivery of therapeutic agents. Benefits include access to distal, tortuous vessels for targeted therapy.

Clinical Evidence

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

Technological Characteristics

2.4 F, 155 cm length, 0.021" ID lumen. Polymeric construction. Lubricious distal coating. Two radiopaque markers (31 mm apart). Proximal luer adapter. Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for accessing distal peripheral, coronary, and neurovasculature for controlled, regional delivery of diagnostic, embolic, and therapeutic agents into selected vessels.

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

• FasTracker-18 (K960806)
• Rebar-18 (K001966)

Submission Summary (Full Text)

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MAR 2 1 2002

## Summary of Safety and Effectiveness

K020733

Prepared January 25, 2002

| 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: | 801.974.1740 | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------------------------------------------------------------------------------------|-----------------------|---------|
| | Contact Person: | | Rick Gaykowski<br>Vice President, Quality Assurance,<br>Regulatory and Clinical Affairs | | |
| | Device Trade Name:<br>Device Generic Name: | | Not Yet Determined<br>Infusion Catheter | | |
| Predicate<br>Devices | The predicate devices are listed in the table below. | | | | |
| | | | | 510(k) Number, | Product |
| | Device | | Manufacturer | Concurrence Date | Code |
| | FasTracker-18 | | Target Therapeutics | K960806, 02 May 1996* | DQO |
| | Rebar-18 | | Micro Therapeutics | K001966, 20 Jul 2000 | KRA |
| | This information is assumed based on our best, current knowledge. | | | | |
| Classification | Class II, 21 CFR 870.1210, Continuous Flush Catheter | | | | |
| 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 1500 SDS is intended to be used to access tortuous vasculature for infusion<br>of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and<br>neurovasculature, and for guide wire exchange/support during diagnostic<br>Or<br>interventional procedures. | | | | |
| Device<br>Description | The PVS 1500 SDS is a 2.4 F tubular device, 155 cm in length, with a lumen to be used<br>for delivery of contrast, drugs, or embolics. The lumen is constructed from a polyment<br>material and has an inside diameter of 0.021". The device is coated on the outer<br>diameter with a lubricious coating over the distal segment of the device. Two<br>radiopaque markers are positioned 31 mm apart at the distal tip of the device to aid<br>visualization under fluoroscopy. The proximal end of the device has a standard luer<br>adapter for attachment of accessories and can be used to flush the 1500 SDS. The<br>subject device has the ability to access distal, tortuous vasculature over a guide wire,<br>deliver embolics and agents, and has the ability to be steered like a guide wire as<br>needed. | | | | |
| | | | | | |

Precision Vascular Systems, Inc. PVS 1500 SDS Device
Premarket Notification

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Technological Characteristics

Technological similarities between the PVS 1500 SDS and predicate devices include the basal tubular design and dimensions, polymeric materials and construction, and hydrophilic coating. In instances where the technological characteristics are different, it has been demonstrated that there are no new questions raised regarding safety or efficacy of the PVS 1500 SDS.

Biocompatibility of the PVS 1500 SDS has been verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices - Part 1. Test results confirmed bjocompatibility of the subject device when tested as an external communicating, blood contact, short duration (<24 hours) device.

Safety and Performance Tests

Performance testing of the PVS 1500 SDS was conducted in accordance with ISO 10555-1, Sterile, Single-Use Intravascular Catheters - Part 1. Verification testing for the sublect device included dimensional inspection, hub integrity, flow rate measurements, burst strength, tensile strength, guide wire compatibility testing and performance under simulated conditions. Subject product testing is believed to have vielded acceptable results.

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 1500 SDS' 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 1500 SDS 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 catheters/cited predicates.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three heads, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 2 1 2002

Mr. Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548

K020733 Re:

> PVS 1500 SDS Regulation Number: 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: II (two) Product Code: KRA Dated: January 25, 2002 Received: March 6, 2002

Dear Mr. Devine:

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

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Page 2 - Mr. Ned Devine

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualis (Systems (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) This letter wif anow you to organizations of substantial equivalence of your device to a legally premarket notincation. The PDF minuting of cation 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 and If you desire specific aurroo for you invitro diagnostic devices), please contact the Office of additionally 21 CHT Furt 007.10 10 11:10 PM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Compliance at [phone]. I fine of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entralion on your responsibilities under the Act may be obtained from the Other general informational 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,

N. Dea. Meller

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

Enclosure

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Page 1 of 1

510(k) Number (if known): K020733

Device Name: PVS 1500 SDS

## Indications for Use:

The PVS 1500 SDS is intended for use in accessing distal peripheral, coronary, and THE TVS TOOD CDO To Incondotive, controlled, regional delivery of diagnostic, embolic, and therapeutic agents into selected vessels.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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