SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110

K033997 · Bacchus Vascular, Inc. · MCW · Feb 4, 2004 · Cardiovascular

Device Facts

• Record ID: K033997
• Device Name: SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110
• Applicant: Bacchus Vascular, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Feb 4, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Solera Plus Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts.

Device Story

Solera Plus is a single-use, over-the-wire disposable catheter with an integral Motor Drive Unit (MDU). Device features a central hollow drive shaft connected to an expanding clot maceration and removal system consisting of a Nitinol macerator and a Nitinol outer protective basket. During operation, the macerator rotates within the stationary protective basket, which expands to the graft lumen diameter to protect the vessel wall. Mechanical aspiration is achieved via rotation of the drive shaft combined with an applied vacuum from a locking syringe. The physician controls aspiration (on/off) via a button on the MDU. The system pumps macerated material out of the treatment area. Used in clinical settings by physicians to clear synthetic dialysis grafts; helps restore graft patency by removing obstructive thrombus.

Clinical Evidence

Bench testing only. The device was tested in the same manner as the predicate Solera Magnum Thrombectomy Catheter (K022640). All components and subassemblies met required specifications.

Technological Characteristics

Single-use, over-the-wire catheter with integral Motor Drive Unit. Materials include Nitinol for the macerator and protective basket. Operates via mechanical rotation of a drive shaft and vacuum aspiration. Designed under 21 CFR 820.30 quality system requirements.

Indications for Use

Indicated for mechanical thrombectomy of synthetic dialysis grafts in patients requiring removal of thrombus.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• Solera Thrombectomy Catheter (K003570)
• Solera Magnum Thrombectomy Catheter (K022640)

Submission Summary (Full Text)

{0}------------------------------------------------

| FEB - 4 2004 | 510(k) Summary |
|---------------------|------------------------------------------------------------------------|
| General Information | |
| Classification | Class II |
| Trade Name | Solera™ Plus Thrombectomy Catheter |
| Submitter | Bacchus Vascular, Inc.<br>3110 Coronado Drive<br>Santa Clara, CA 95054 |
| 408-980-8300 | |
| Contact | Gregory J. Mathison<br>Regulatory Affairs Consultant |

### Intended Use

The Solera Plus Thrombectomy Catheter permits mechanical thrombectomy of synthetic dialysis grafts.

### Predicate Devices

| Solera Thrombectomy Catheter<br>Manufactured by Bacchus Vascular, Inc. | K003570 |
|------------------------------------------------------------------------------|---------|
| Solera MagnumThrombectomy Catheter<br>Manufactured by Bacchus Vascular, Inc. | K022640 |

### Device Description

The Solera Plus is a single-use, over-the-wire disposable catheter, with an integral Motor Drive Unit (MDU). The Solera Plus has a central hollow drive shaft connected to an expanding clot maceration and removal system. The clot removal system is comprised of a Nitinol macerator and a Nitinol outer protective basket. The macerator is attached to the drive shaft and rotates within the stationary protective basket. The protective basket expands to the lumen diameter and acts to protect the graft wall from the rotating macerator. Mechanical aspiration is achieved by rotation of the drive shaft and by an applied vacuum (locking syringe). The rotation of this drive shaft in conjunction with the vacuum causes material to be pumped out of the treatment area after maceration. Aspiration is controlled (i.e., on/off) by a button on the motor drive unit, which may be activated by the physician to allow flow out of the Solera Plus. The default position is 'off' to and is designed to minimize blood loss during the procedure.

{1}------------------------------------------------

## Materials

All materials used in the manufacture of the Solera Plus are suitable for this use and have been used in numerous previously cleared products.

## Testing Summary

The Solera Plus Thrombectomy Catheter was tested in the same manner as the Solera The Seriera Thrombectomy Catheter (K022640). All components, subassemblies, and/or full Maginan The required specifications for the completed tests. The Solera Plus was designed under the Bacchus Quality System which is in compliance with 21CFR§820.30.

# Summary of Substantial Equivalence

The Solera Plus Thrombectomy Catheter is equivalent to the predicate product, the Solera Magnum Thrombectomy Catheter. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. Bacchus Vascular, Inc. believes the Solera Plus Thrombectomy Catheter is substantially equivalent to existing legally marketed devices

{2}------------------------------------------------

Image /page/2/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. 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 an eagle or bird in flight. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 4 2004

Bacchus Vascular, Inc c/o Ms. Lisa Caparra 3110 Coronado Drive Santa Clara, CA 95054

Re: K033997

Solcra Vascular Plus Thrombectomy Catheter Regulation Number: 21 CFR 870.4875 Regulation Name: Catheter, Peripheral, Atherectomy Regulatory Class: Class II Product Code: MCW Dated: January 27, 2004 Received: January 28, 2004

Dear Ms. Caparra:

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.

{3}------------------------------------------------

Page 2 - Ms. Lisa Caparra

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/dsma/dsmamain.html

Sincerely yours,

Dmua R. Lochner

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

Enclosure

{4}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | This application-> K033997 |
|---------------------------|--------------------------------------------------------------------------------------------------------|
| Device Name: | Solera Plus Thrombectomy Catheter |
| Indications for Use: | The Solera Plus Thrombectomy Catheter permits<br>mechanical thrombectomy of synthetic dialysis grafts. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V

OR

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Dung R. Vachner

്vision Sign-Off) Vision of Cardiovascular Devices

10(k) Number KO33997

Confidential