PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101

K023548 · Velocimed · DQY · Aug 4, 2003 · Cardiovascular

Device Facts

• Record ID: K023548
• Device Name: PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101
• Applicant: Velocimed
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Proxis Flow-Control device controls the flow of fluids in the coronary and periphery vasculature. This is achieved by the temporary occlusion of vessels and holding the 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 device is not indicated for use for embolic protection.

Device Story

Dual balloon catheter system comprising evacuation sheath, inflation system, infusion catheter, and evacuation syringe. Proximal balloon resides in guide catheter; distal balloon in arterial vessel. Radiopaque markers facilitate placement. Physician inflates balloons to occlude vessel, creating stagnant fluid column. Enables roadmap visualization via contrast dye infusion or local delivery of anticoagulants/thrombolytics/cardioplegia. Therapeutic devices deployed through 0.058-inch inner diameter sheath. Evacuation syringe removes fluids; infusion catheter provides distal perfusion if needed. Used in clinical settings by physicians to manage local vessel environment during interventional procedures.

Clinical Evidence

Bench testing included dimensional verification, balloon compliance/integrity, tensile/torque strength, flexibility, and trackability. Compliance with ISO 10555, ISO 10993-1, ASTM D-4169, ISO 11607, and ISO 11135. Animal study data included 9 acute and 8 chronic models to validate performance and safety.

Technological Characteristics

Dual balloon catheter with low-pressure compliant balloons. Evacuation sheath inner diameter 0.058 inches. Radiopaque markers for visualization. Sterilized via ETO (ISO 11135). Mechanical operation; no software or electronic components.

Indications for Use

Indicated for temporary occlusion of coronary and peripheral vasculature to control fluid flow, aid lesion visualization, or deliver local 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

• Equinox Occlusion Balloon Catheter (K990487)
• 4.5F ImageCath Coronary Angioscope (K952638)
• Dispatch Coronary Infusion Catheter (K932616)
• Isolate Infusion Catheter (K913517)
• Parodi Catheter for Angiography (K001917)

Submission Summary (Full Text)

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AUG - 4 2003

### KO23548 2. 510(K) SUMMARY

#### 2.1 Administrative Information

## 2.1.1 Name and address

| Submitted by: | Velocimed Inc<br>11400 73rd Avenue North, Suite 134<br>Minneapolis, MN 55369 |
|---------------|------------------------------------------------------------------------------|
|---------------|------------------------------------------------------------------------------|

| Contact Person: | John Carline |
|-----------------|--------------|
| Telephone No.: | 763-463-4742 |
| Facsimile No.: | 763-488-9780 |

October 21, 2002 Date Prepared:

## 2.1.2 Device Name

| Trade Name | Proxis Flow-Control Device |
|---------------------|-----------------------------------------------------------------------------|
| Common Name | Occlusion Balloon Catheter,<br>Infusion Catheter |
| Classification Name | Catheter, Intravascular<br>Occluding, Temporary<br>Intravascular Diagnostic |
| Classification | Class II<br>MJN, DQY |

## 2.1.3 Applicant

- Applicant's Name: Velocimed Inc 11400 73rd Avenue North, Suite 134 Minneapolis, MN 55369
#### 2.2 Predicate Devices

The Proxis Flow-Control Device is substantially equivalent to the Equinox Occlusion Balloon Catheter (K 990487), 4.5F ImageCath Coronary Angioscope (K952638), Dispatch Coronary Infusion Catheter (K932616), and the Isolate Infusion Catheter (K913517).

#### 2.3 Indication for use

The Proxis Flow-Control device controls the flow of fluids in the coronary and periphery vasculature. This is achieved by the temporary occlusion of vessels and

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holding the 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 device is not indicated for use for embolic protection.

#### 2.4 Device Description

The Proxis Flow-Control device is a dual balloon catheter. It has four major components: The Evacuation Sheath Catheter, the Inflation System, Infusion Catheter System, and an Evacuation syringe.

The Evacuation Sheath also has two low-pressure compliant balloons that are inflated simultaneously. The proximal balloon stays within the guide catheter while the distal balloon resides in the arterial vessel. Radiopaque markers at the two balloon sites facilitate visualization and intravascular placement of the catheter prior to inflation. The Evacuation Sheath has an inner diameter of 0.058 inches and can accommodate standard therapeutic devices that have profiles of 0.058 inches or lower. The balloons are inflated using the Inflation System.

Devices can be deployed through the Evacuation sheath to the target site before, during or after the Proxis balloons are inflated, and the vessel occluded. Infusing less than 0.5cc of contrast dye through the guide catheter will produce a "roadmap" of the lesion as an aid for the physician in guiding the therapeutic device to the lesion site.

Alternatively, less than 0.5cc of therapeutic solutions like anticoagulant, cardioplegia and thrombolytics may be infused through the guide catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device while the vessel is occluded.

The Evacuation syringe is provided in the event that removal of contrast, or therapeutic solution is desired. If distal perfusion of fluid is needed during evacuation, the Infusion Catheter System may be used.

#### 2.5 Substantial Equivalence

The Proxis Flow-Control device covered by this submission is substantially equivalent to other legally marketed Occlusion Balloon Catheters. Specifically, the Proxis Flow-Control device is substantially equivalent to the Parodi Catheter for Angiography (K 001917), the Equinox Occlusion Balloon Catheter (K 990487), the 4.5F ImageCath Coronary Angioscope (K952638), Dispatch Coronary Infusion Catheter (K932616) and the Isolate Infusion Catheter (K913517). The Proxis has the same general indication for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices. The differences between this device and its predicate devices do not raise new questions of safety or efficacy.

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#### 2.6 Performance Data

The performance test data is provided in the 510(k) submission. The performance data demonstrates that the device complies with the applicable sections of:

- o ISO 10555 (Part 1 and Part 4),
- o ISO 10993-1,
- o Product specification
- O ASTM D-4169 (Packaging Integrity Testing)
- ISO 11607 (Packaging for terminally sterilized medical devices) o
- ISO 11135: 1994(E) (Validation and routine control of ETO o sterilization)

Performance testing included dimensional verification, balloon compliance and integrity, catheter tensile strength, torque strength, flexibility and trackability. Nine acute and eight chronic animals were used to test and validate the performance and safety of the device. Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three overlapping wings, suggesting movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

AUG - 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Velocimed, Inc. c/o John Carline Sr. RA Associate 11400 73td Avenue North Suite 134 Maple Grove, MN 55369

Re: K023548

> Trade/Device Name: Proxis Flow-Control Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: May 13, 2003 Received: May 14, 2003

Dear Mr. Carline:

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. John Carline

forth in the quality systems (OS) 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/dsmaldsmamain.html

Sincerely yours,

V.A. DeLeon, M.D.

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

Enclosure

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# 14. INDICATION FOR USE

K023548 510(k) Number;

Device Name: Proxis™ Flow-Control

## Indication for Use

The Proxis Flow-Control device controls the flow of fluids in the coronary and periphery vasculature. This is achieved by the temporary occlusion of vessels and holding the 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 device is not indicated for use for embolic protection.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

| 510(k) Number | K023548 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div style="display:inline-block; vertical-align:middle;"> <img alt="Checkmark" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAUAAAAFCAYAAACNbyblAAAAHElEQVQI12P4//8/w+r8+v9/AwPDwMDQwMDAwMDAwMAAAw0A8smkc9AAAAAASUVORK5CYII=" style="width:10px; height:10px;"/> </div> |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (Per 21 CFR 801.109) | |

OR Over-The Counter Use _______