BIOSENSORS EMBOLECTOMY CATHETER

K973477 · Sunscope Intl., Inc. · DXE · Sep 4, 1998 · Cardiovascular

Device Facts

• Record ID: K973477
• Device Name: BIOSENSORS EMBOLECTOMY CATHETER
• Applicant: Sunscope Intl., Inc.
• Product Code: DXE · Cardiovascular
• Decision Date: Sep 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biosensors Embolectomy Catheter is indicated for use in the removal of emboli and thrombi from the arterial system. The catheter should be used only by a physician with surgical skill in the vascular system.

Device Story

Single-lumen, balloon-tipped catheter used for embolectomy procedures. Device inserted into arterial system to reach thrombotic obstructions; balloon inflated with sterile isotonic saline to capture and remove emboli/thrombi. Available in 3-7 French diameters with corresponding 6-14 mm balloon sizes. Includes stainless steel stylet for insertion rigidity; color-coded with distance markings for positioning. Used by vascular surgeons in clinical settings. Benefits include mechanical removal of arterial blockages to restore blood flow.

Clinical Evidence

Bench testing only. Data includes balloon burst and pull strength, inflation volume accuracy, catheter tensile strength, and leak testing. Biocompatibility established via identical materials to other company devices with similar blood-contact duration.

Technological Characteristics

Single-lumen catheter; latex-coated tip and inflatable latex balloon; stainless steel stylet; rigid winged adapter with female luer lock; color-coded; 3-7 French diameters; 6-14 mm balloon diameters. Non-electronic, mechanical device.

Indications for Use

Indicated for removal of emboli and thrombi from the arterial system. For use by physicians with vascular surgical skills.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• Baxter Healthcare's Fogarty® Arterial Embolectomy Catheter

Submission Summary (Full Text)

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K973477

# BIOSENSORS EMBOLECTOMY CATHETER PREMARKET NOTIFICATION

# 510K SUMMARY Prepared: August 11, 1997

## 1. Submitted by:

John Shulze Sunscope International, Inc. 20250 Acacia St., Suite 115 Newport Beach, CA 92660 Tel: [phone] Fax: [phone]

## 2. Contact Person:

John Shulze

## 3. Device Identification:

Trade Name: Biosensors Embolectomy Catheter Common Name: Embolectomy Catheter Classification Name: Catheter, Embolectomy

## 4. Predicate Device(s):

Baxter Healthcare's Fogarty® Arterial Embolectomy Catheter

## 5. Device Description:

Biosensors International (BI) has developed an embolectomy catheter that is equivalent in design and performance to embolectomy catheters currently marketed by Baxter. BSI's embolectorny catheters are configured as single lumen, balloon-tipped catheters.

The catheters vary in length and diameter to accommodate various thrombotic obstruction and vessel lumen sizes. They are supplied in 3, 4, 5, 6, and 7 French diameters, with inflated balloon diameters of 6, 9, 11, 13, and 14 mm, respectively.

The catheters are color coded, and have black distance markings at 10 cm intervals (with "0" cm located at the distal catheter tip.)

The proximal end of the flexible catheters terminate in a rigid, winged adapter with female luer lock port to permit attachment to a stylet for stiffening the catheter during insertion, or sterile syringe during balloon inflation. The distal end of the catheters terminate in a latex-coated tip immediately distal to the latex balloons. The latex balloons lie flat against the catheters during insertion through the vasculature and lesion, and are inflated with sterile isotonic saline or other appropriate sterile solution during embolectomy procedures.

The catheters are supplied with a stainless steel stylet inserted in their lumens. The stylets terminate proximally in a rigid male luer adapter that mates with the female luer

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# BIOSENSORS EMBOLECTOMY CATHETER PREMARKET NOTIFICATION

of the catheters. The stylets can be used, when appropriate, to add rigidity to the catheters to aid in their insertion.

## 6. Intended Use:

The Biosensors Embolectomy Catheter is indicated for use in the removal of emboli and thrombi from the arterial system. The catheter should be used only by a physician with surgical skill in the vascular system.

# 7. Summary of Technological Characteristics of Device in relation to Predicate Device(s):

The design of the Biosensors 3 through 7 Fr. embolectomy catheters is identical to that of the predicate devices. All of the catheter tips (3-7 Fr.) are latex-coated to minimize the potential for vessel trauma during catheter insertion. Both the Biosensors and Baxter 3 French embolectomy catheters terminate in a latex-coated spring tip.

Inflatable latex balloons are affixed at the distal tips of the Biosensors and Baxter catheters, which are inflated with an appropriate sterile liquid during embolectomy procedures. Placement of distance markings on the catheters are identical. The proximal ends of the flexible catheters terminate in rigid, winged adapters with female luer ports to provide for attachment to an inflation syringe.

## 8. Assessment of Performance Data used to justify Substantial Equivalence Claim

Biosensors International has developed an embolectomy catheter that is substantially equivalent in function to the predicate Baxter embolectomy catheters. The materials used in the fabrication of Biosensors embolectomy catheters are identical to those used for other Biosensors catheters which also are exposed to circulating blood for a short period of time, and, therefore have identical biocompatibility requirements as the embolectomy catheters.

Further, test data collected on the burst and pull strength of the balloon, balloon inflation volume accuracy, tensile strength of the catheter, and leak test data demonstrate that Biosensors International Embolectomy Catheters' performance is substantially equivalent to that of the predicate devices, and no new questions concerning safety and efficacy are raised.

## 9. Conclusion:

Based on the test data gathered, Biosensors International Embolectomy Catheters are substantially equivalent to Baxter Healthcare's embolectomy catheters.

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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 depiction of a human figure, represented by three curved lines forming a profile. The figure is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the upper portion of the circle. The text is in all capital letters and is evenly spaced around the curve.

ದಿದ್ದಾರೆ.
ವಿದ್ಯಾರಿ ಮಾರ್ಥಿಕಾರಿ ಮಾಡಿ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಕಾರಿ ಮಾರ್ಕಾರಿ 4 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John E. Shulze Directing Manager Sunscope International Inc. 20250 Acacia Street, Suite 115 Newport Beach, CA 92660

K973477 Re : Trade Name: Biosensors Embolectomy Catheter Requlatory Class: II Product Code: DXE Dated: June 8, 1998 Received: June 9, 1998

Dear Mr. Shulze:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, 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

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Page 2 - Mr. John E. Shulze

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 our 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Radiological Health

Enclosure

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of Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name: BIOSENSORS EMBOLECTOMY CATHETER

Indications For Use:

The Biosensors Embolectomy Catheter is indicated for use in the removal of emboli and thrombi from the arterial system. The catheter should be used only by a physician with surgical skill in the vascular system.

Proscription Use .. Proscription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------

Judith Danielson for Doyle Gantt

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_ K 973477

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)