SINGLE LUMEN EMBOLECTOMY CATHETER

K972572 · American Biomed, Inc. · DXE · Jan 13, 1998 · Cardiovascular

Device Facts

• Record ID: K972572
• Device Name: SINGLE LUMEN EMBOLECTOMY CATHETER
• Applicant: American Biomed, Inc.
• Product Code: DXE · Cardiovascular
• Decision Date: Jan 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Removing arterial emboli.

Device Story

Single lumen embolectomy catheter; used for removing arterial emboli. Features three silicone balloons: two at distal end for embolus removal; one at proximal end as safety balloon to prevent over-injection of fluid. Sizes 2 to 7 French; lengths 40-100 cm. Operated by clinicians in surgical settings. Device functions by inflating balloons to capture and extract emboli from arteries. Safety balloon design provides additional control over fluid volume compared to single-balloon predicates. Benefits include effective embolus removal with enhanced safety mechanism.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single lumen catheter; 100% silicone compound construction. Three-balloon configuration (two distal, one proximal). Sizes 2-7 French. Inflation via liquid volume (0.05 ml to 2.00 ml depending on size). Non-bonded, dip-molded silicone construction. No electronic components or software.

Indications for Use

Indicated for the removal of arterial emboli in patients requiring embolectomy procedures.

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

• Catheter Embolectomy (K881455)
• Catheter Embolectomy (K905139)
• Baxter Fogarty Arterial Embolectomy Catheter

Submission Summary (Full Text)

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## 1972572

JAN 1 3 1998

# Section 2

510(k) Summary

Single Lumen Embolectorny Catheter American BioMed, Inc. The Woodlands, Texas 77380

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#### Section 2 510(k) Premarket Notification Summary

#### July 1997

Steven Rash President and CEO American BioMed, Inc P. O. Box 8429 The Woodlands, Texas 77387-8429 [phone] [phone] Fax

| CLASSIFICATION NAME: | Catheter, Embolectomy |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| COMMON/USUAL NAME: | Single Lumen Embolectomy Catheter |
| PROPRIETARY NAME: | Single Lumen Embolectomy Catheter |
| CLASSIFICATION: | 21 CFR Part 870.5150 Catheter, Embolectomy |
| PERFORMANCE STANDARDS: | No Performance Standards for the Catheter,<br>Embolectomy are effective as of this date. |
| PREDICATED DEVICE | Catheter Embolectomy K881455 and K905139,<br>American BioMed, (CathLab Corp.) and Baxter<br>Fogarty® Arterial Embolectomy Catheter. |
| DEVICE DESCRIPTION | Single Lumen Embolectomy catheter with three<br>100% silicone balloons. Catheter intended for use<br>in removing arterial emboli. Sizes 2 to 7 French. |
| INDICATIONS | Removing arterial emboli. |
| TECHNOLOGICAL CHARACTERISTICS | This modification of K881455 and K905139,<br>changes the number of balloons, two balloons are<br>located at the distal end for embolus removal<br>purpose, the third balloon is located at the proximal<br>end as a safety balloon to prevent over injection of<br>fluid. |
| SUBSTANTIAL EQUIVALENCE | The Single Lumen Embolectomy Catheter is<br>equivalent to K881455, K905139, and Baxter |

Section 2 page 1

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Fogarty Arterial Embolectomy Catheter, same intended use, with change in number of balloons.

| Parameter | American<br>BioMed Single<br>Lumen<br>Embolectomy<br>Catheter | American<br>BioMed Single<br>Lumen<br>Catheter<br>K881455 &<br>K905139 | Baxter Fogarty<br>Arterial<br>Embolectomy<br>Catheter<br>K No. Not Found<br>in FDA 510(k)<br>Data Base |
|------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Body Material | Silicone<br>Compound | Silicone<br>Compound | Polyvinylchloride |
| Balloon Material | Silicone<br>Compound | Silicone<br>Compound | Latex |
| Balloon to Body Bonding | No. All Silicone.<br>Formed through<br>dipping process | No. All Silicone.<br>Formed through<br>dipping process | Yes |
| Number of Balloons | Three. Two at<br>distal end and<br>one at proximal<br>end. | One. At distal<br>end. | One. At distal<br>end. |
| Catheter French Sizes | 2, 3, 4, 5, 6,<br>and 7 | 2, 3, 4, 5, 6,<br>and 7 | 2, 3, 4, 5, 6, and<br>7 |
| Catheter Length | 40, 60, 80, 100<br>cm. | 40, 60, 80, 100<br>cm. | 40, 60, 80, 100<br>cm. |
| Inflated Balloon<br>Diameter | 2 Fr. - 4 mm<br>3 Fr. - 5 mm<br>4 Fr. - 9 mm<br>5 Fr. - 11 mm<br>6 Fr. - 13 mm<br>7 Fr. - 14 mm | 2 Fr. - 4 mm<br>3 Fr. - 5 mm<br>4 Fr. - 9 mm<br>5 Fr. - 11 mm<br>6 Fr. - 13 mm<br>7 Fr. - 14 mm | 2 Fr. - 4 mm<br>3 Fr. - 5 mm<br>4 Fr. - 9 mm<br>5 Fr. - 11 mm<br>6 Fr. - 13 mm<br>7 Fr. - 14 mm |
| Maximum Liquid Volume | 2 Fr. - 0.05 ml<br>3 Fr. - 0.10 ml<br>4 Fr. - 0.50 ml<br>5 Fr. - 0.75 ml<br>6 Fr. - 1.25 ml<br>7 Fr. - 2.00 ml | 2 Fr. - 0.05 ml<br>3 Fr. - 0.10 ml<br>4 Fr. - 0.50 ml<br>5 Fr. - 0.75 ml<br>6 Fr. - 1.25 ml<br>7 Fr. - 2.00 ml | 2 Fr. - N/A<br>3 Fr. - 0.20 ml<br>4 Fr. - 0.75 ml<br>5 Fr. - 1.50 ml<br>6 Fr. - 2.00 ml<br>7 Fr. - 2.50 ml |
| Intended Use | Removing<br>arterial emboli | Removing<br>arterial emboli | Removing<br>arterial emboli |

### Statement of Similarities and Differences

#### CONCLUSIONS

The conclusion drawn from the above is that the modified American BioMed Single lumen Embolectomy Catheters are equivalent in safety and efficacy to their predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 1998

American Biomed, Inc c/o J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071

Re: K972572 Single Lumen Embolectomy Catheter Requlatory Class: II (two) Product Code: DXE Dated: October 17, 1997 Received: October 21, 1997

Dear Mr. Knauss:

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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.

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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" (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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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510(k) Number (if Known)

Device Name: Single Lumen Embolectomy Catheter

Indications for use: Removing arterial emboli.

(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)

1

OR

Over-The-Counter Use

.

R-h

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K972572