MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101

K063638 · St Jude Medical · DQY · May 11, 2007 · Cardiovascular

Device Facts

• Record ID: K063638
• Device Name: MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101
• Applicant: St Jude Medical
• Product Code: DQY · Cardiovascular
• Decision Date: May 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Proxis Flow Control System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control System is not indicated for use for embolic protection.

Device Story

Proxis Flow Control System comprises evacuation sheath catheter, inflation system, infusion catheter, lip seal, and aspiration syringe. Physician uses device in coronary/peripheral vasculature; proximal low-pressure compliant sealing balloon occludes arterial vessel. Radiopaque marker aids placement. System allows infusion of contrast dye for lesion roadmap or delivery of therapeutic solutions (anticoagulants, cardioplegia, thrombolytics) into stagnant vessel column. Aspiration syringe removes stagnated fluid; infusion catheter facilitates saline flushing to augment retrograde flow. Device aids physician in guiding therapeutic tools to lesion site. Benefits include improved visualization and localized drug delivery.

Clinical Evidence

Bench testing only. Verification performed for dimensional, strength, functional, packaging, sterilization, biocompatibility, and shelf life tests. No clinical or animal data required due to scope of modifications.

Technological Characteristics

Percutaneous catheter system; includes sealing balloon, infusion catheter, and aspiration syringe. Features radiopaque marker for placement. Operates via mechanical inflation of balloon to occlude vessel. No software or electronic components.

Indications for Use

Indicated for controlling fluid flow in coronary and peripheral vasculature via temporary vessel occlusion to facilitate lesion visualization or local delivery of therapeutic solutions. Not indicated for embolic protection.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Proxis System (K042117)
• Proxis System (K060651)

Submission Summary (Full Text)

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K063638

# 99 ST. Jude MEDICAL

# 510(k) Summary

# Applicant Information

| Submitted by: | St. Jude Medical |
|---------------|-----------------------|
| | 6550 Wedgwood Rd. N. |
| | Suite 150 |
| | Maple Grove, MN 55311 |

MAY 1 1 2007

| Contact Person: | Shannon Springer |
|-----------------|-------------------|
| Telephone: | 763-383-0900 |
| Fax: | 763-322-8808 |
| Date Prepared: | 06 December, 2006 |

### Device Information

| Trade Name: | |
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| Common Name: | |
| Classification Name: | |
| Classification: | |
| Product Code: | |

Proxis Flow Control System Percutaneous Catheter Catheter, Percutaneous Class II per 21 CFR 870.1250 DQY

### Device Description

The Proxis System has five major components: the Evacuation Sheath Catheter, Inflation System, Infusion Catheter, Lip Seal, and an Aspiration syringe.

The Evacuation Sheath Catheter has one proximal low-pressure compliant sealing balloon that is inflated to occlude the arterial vessel. A radiopaque marker at the balloon site facilitation and intravascular placement of the catheter prior to inflation. The Evacuation Sheath has a sufficiently large inner diameter to accommodate standard therapeutic devices within its size range. The balloon is inflated using the Inflation System.

Devices can be deployed through the Evacuation sheath to the target site before, during or after the sealing balloon is inflated to occlude the vessel. Infusing ~0.5cc of contrast dye through the evacuation sheath catheter will produce a continuous "roadmap" of the lesion as an aid for the physician in guiding the therapeutic device to the lesion site.

Alternatively, while the vessel is occluded, therapeutic solutions like anticoagulant, cardioplegia and thrombolytics may be infused through the evacuation sheath catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device.

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The Aspiration syringe is provided for the removal of stagnated fluid during aspiration. The infusion catheter may be used to infuse saline to augment the retrograde flow of fluid and the removal of stagnated fluid.

# Intended Use

The Proxis Flow Control System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control System is not indicated for use for embolic protection.

## Predicate Device Comparison / Technological Characteristics

The Proxis Flow Control System, a modification of the current over-the-wire Proxis System (K060651), was created by decreasing the diameter of the catheter and sealing balloon. The Proxis Flow Control System device covered by this submission is identical in function, mechanism of action and intended use as the market cleared rapid-exchange Proxis System (K042117). In addition, the technological characteristics and ability to control fluid flow are identical to the over-the-wire Proxis System (K060651). Although the device may be similar in design to the device cleared under K060651, the Proxis Flow Control System is not intended for embolic protection.

### Test Summary

The Proxis Flow Control System passed all verification criteria for dimensional, strength, functional, packaging, sterilization, biocompatibility, and shelf life tests. Test results confirm the device performs as intended without raising additional questions of safety and efficacy. Given the scope of the modifications incorporated to create the Proxis Flow Control System no additional animal or clinical data was deemed necessary.

### Substantial Equivalence

The Proxis Flow Control System has the same indications for use, technical characteristics and principles of operation as the market cleared rapid exchange Proxis System (K042117). In addition, the Proxis Flow Control System has the same technological characteristics and flow control indication as the over-the-wire Proxis System (K06065/). Although the device may be similar in design to the device cleared under K060651, the Proxis Flow Control System is not intended for embolic protection. The differences between this device and its predicate devices do not raise new questions of safety or efficacy. Therefore, the Proxis Flow Control System is substantially equivalent to the predicate devices.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 2007

St. Jude Medical c/o Ms. Shannon Springer Sr. Regulatory Affairs Specialist 6550 Wedgewood Rd. N. Maple Grove, MN 55311

Re: K063638 Proxis Flow Control System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY Dated: April 26, 2007 Received: April 27, 2007

Dear Ms. Springer:

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 - Ms. Shannon Springer

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]. 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/industry/support/index.html.

Sincerely yours,

Duma R. Vochner

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

Enclosure

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#### Indications for Use

510(k) Number (if known): K063638

Device Name: Proxis Flow Control System

Indications for Use:

The Proxis Flow Control system controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control System is not indicated for use for embolic protection.

Prescription Use
(Part 21 CFR 801 Subpart D)

・

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. bechmer
Division Sign-Off

(Division Sign-Off)
(Division of Cardiovascular Devices

**510(k) Number**