OASIS THROMBECTOMY CATHETER SYSTEM

K982363 · Boston Scientific Corp · MCW · Feb 23, 1999 · Cardiovascular

Device Facts

• Record ID: K982363
• Device Name: OASIS THROMBECTOMY CATHETER SYSTEM
• Applicant: Boston Scientific Corp
• Product Code: MCW · Cardiovascular
• Decision Date: Feb 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oasis Thrombectomy System is a percutaneous, hydrodynamic, mechanical thrombectomy device designed for use with standard angiographic injectors. The catheter uses a high velocity saline stream to microfragment and remove thrombus from hemodialysis access grafts.

Device Story

Oasis Thrombectomy System is a percutaneous, hydrodynamic, mechanical thrombectomy catheter. Device utilizes high-velocity saline stream delivered via angiographic injector to microfragment and aspirate thrombus from hemodialysis access grafts. Catheter features three lumens: inflow for saline, outflow for thrombus removal, and guidewire lumen for 0.018-inch guidewire. Used by clinicians in clinical settings to restore patency in thrombosed hemodialysis access grafts. Output is physical removal of thrombotic material, facilitating improved graft function and patient outcomes.

Clinical Evidence

Randomized, prospective clinical trial conducted to evaluate safety and effectiveness for treatment of thrombosed hemodialysis grafts compared to pulsed spray thrombolytic therapy. Results established the device is safe and effective for its intended use.

Technological Characteristics

6F diameter catheter; available in soft and braided configurations. Features three-lumen design (inflow, outflow, guidewire). Sterilized via ethylene oxide gas. Packaged in heat-sealed Tyvek/mylar pouch.

Indications for Use

Indicated for percutaneous, hydrodynamic, mechanical removal of thrombus from hemodialysis access grafts in patients requiring thrombectomy.

Regulatory Classification

Identification

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

Predicate Devices

• Fogarty Embolectomy Balloon Catheter
• Microvena's 8F Clot Buster Amplatz Thrombectomy Catheter

Submission Summary (Full Text)

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2/23/99

#### SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.

## A. GENERAL INFORMATION

| | Owner Operator Submitting Boston Scientific Corporation |
|------------------------|----------------------------------------------------------|
| | this Premarket Notification: One Boston Scientific Place |
| | Natick, MA 01757 |
| | [phone] |
| Contact Person: | Wanda M. Carpinella |
| | Regulatory Affairs Department |
| Device Generic Name: | Thrombectomy Catheter |
| Device Classification: | 74 DXE, Catheter Embolectomy |

### B. INDICATIONS FOR USE

The Oasis Thrombectomy System is a percutaneous, hydrodynamic, mechanical thrombectomy device designed for use with standard angiographic injectors. The catheter uses a high velocity saline stream to microfragment and remove thrombus from hemodialysis access grafts.

## C. DESCRIPTIVE CHARACTERISTICS

The catheter features an outer shaft and is comprised of three: an inflow lumen to supply saline to the catheter tip, an outflow lumen for removal of thrombotic material and a guidewire lumen to accommodate an 0.018 inch guidewire. The catheter is 6F in diameter and is available in soft and braided configurations.

# D. SUBSTANTIAL EQUIVALENCE

The subject thrombectomy catheter has been shown to be substantially equivalent to the Fogarty Embolectomy Balloon Catheter and Microvena's 8F Clot Buster Amplatz Thrombectomy Catheter. Results from a randomized, prospective clinical trial established that the proposed thrombectomy catheter is safe and effective for treatment of thrombosed hemodialysis grafts when compared to pulsed spray thrombolytic therapy.

#### E. PACKAGING, STERILIZATION, AND PYROGENICITY

The catheter is packaged in a heat-sealed Tyvek/mylar pouch. The product is sterilized using ethylene oxide gas. Boston Scientific monitors bacterial endotoxins on product on a monthly basis.

### F. CONCLUSION

Based on the information presented, Boston Scientific Corporation believes that the thrombectomy catheter meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently thrombectomy catheters.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 1999

Ms. Laura Mondano Manager Requlatory Affairs Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

Re: K982363

> Oasis™ Thrombectomy Catheter System Trade Name: Regulatory Class: II Product Code: MCW Dated: November 23, 1998 Received: November 25, 1998

Dear Ms. Mondano:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listinq of devices, qood manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such

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Page 2 - Ms. Laura Mondano

Existing major requlations affecting your device additional controls. can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

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510(k) Number (if known): New Application

Oasis™ Thrombectomy System Device Name:

Indications for Use: The Oasis Thrombectomy System is a percutaneous, hydrodynamic, mechanical thrombectomy device designed for use with standard angiographic injectors. The catheter uses a high velocity saline stream to microfragment and remove thrombus from hemodialysis access grafts.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Christopher for TJC

Division of Cardiovascular, Respiratory, and Neurological Devic 510(k) Number

Prescription Use (Per 21 CRF 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)