FLO-THRU

K981624 · Bio-Vascular, Inc. · DXC · Aug 4, 1998 · Cardiovascular

Device Facts

• Record ID: K981624
• Device Name: FLO-THRU
• Applicant: Bio-Vascular, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Aug 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Flo-Thru is indicated for use in coronary artery or peripheral vascular procedures. The device shunts blood at the anastomotic site which provides a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis. The device is removed just prior to the final suturing of the vessel.

Device Story

Flo-Thru Intraluminal Shunt (FTIS) is a sterile, single-use, radiopaque silicone tube with atraumatic bulbs at each end. Used in coronary artery or peripheral vascular surgery; operated by surgeons in an OR setting. Device inserted into vessel at anastomotic site; bulbs allow blood flow distal to site while providing blood-free field for suturing. Radiopaque tab with tether facilitates positioning and removal. Removed prior to final vessel suturing. Benefits include maintained distal perfusion and improved visualization during anastomosis.

Clinical Evidence

Bench testing only. No clinical data provided. Testing confirmed substantial equivalence in strength, flow rate, handling, flexibility, and radiopacity.

Technological Characteristics

Radiopaque silicone tube; one-piece construction; atraumatic bulbs at ends; radiopaque tab with tether for positioning. Single-use. Non-kinking material properties.

Indications for Use

Indicated for patients undergoing coronary artery or peripheral vascular procedures requiring temporary blood flow shunting at an anastomotic site to maintain distal perfusion while creating a blood-free operative field.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• BVI Flo-Rester vessel occluder
• CTS MIDCAB Coronary Shunt (CTS FloCoil Shunt)
• AnastaFLO Intravascular Shunt
• DLP Intravascular Arteriotomy Cannula
• Rivetti-Levinson Intraluminal Shunt
• Chase Blood Vessel Shunt

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant Name & Address: | Bio-Vascular, Inc.<br>2575 University Ave.<br>St. Paul, MN 55114-1024 |
|-----------------------------|-----------------------------------------------------------------------|
| Contact: | D. E. Gardner, Ph.D.<br>VP, Regulatory Affairs / Quality Assurance |
| Date Prepared: | May 4, 1998 |
| Common or Usual Name: | Intraluminal shunt |
| Device Classification Name: | Clamp, vascular; 870.4450; Class II |

### Substantial Equivalence:

The device is substantially equivalent to the BVI Flo-Rester vessel occluder, the CTS MIDCAB Coronary Shunt (CTS FloCoil Shunt), the AnastaFLO Intravascular Shunt, DLP Intravascular Arteriotomy Cannula, the Rivetti-Levinson Intraluminal Shunt, and the Chase Blood Vessel Shunt.

### Device Description:

The sterile, single-use Flo-Thru Intraluminal Shunt (FTIS) is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the bulbs allow blood to flow through the shunt and distal to the anastomotic site. A radiopaque tab, which identifies the outer diameter of the bulbs, is attached to the shunt by a tether to facilitate positioning and removal of the shunt.

### Statement of Intended Use:

The Flo-Thru is indicated for use in coronary artery or peripheral vascular procedures. The device shunts blood at the anastomotic site which provides a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis. The device is removed just prior to the final suturing of the vessel.

### Summary/Comparison of Technological Characteristics:

Functional testing conducted on the Flo-Thru intraluminal shunt and predicate samples show the Flo-Thru performs in a manner substantially equivalent with regard to strength, and flow rate. Handling characteristics, flexibility, and radiopacity of the Flo-Thru device meet design requirements. Also, the Flo-Thru has no memory of kinking or manipulation.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 1998

D.E. Gardner, Ph.D. VP, Regulatory Affairs / Quality Assurance Bio-Vascular, Inc. 2575 University Avenue St. Paul, MN 55114-1024

Re : K981624 Trade Name: Flo-Thru™ Requlatory Class: II Product Code: DXC Dated: May 4, 1998 Received: May 7, 1998

Dear Dr. Gardner:

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 leqally 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, Druq, 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, qood 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 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 regulation may result in regulatory 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 obligation you might have under sections 531 through 542 of the Act

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Page 2 - Dr. Gardner

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 regulation 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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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510(k) Number (if known):

## K98 1624

Device Name: Flo-Thru™

Indications for Use:

The Flo-Thru is indicated for use in coronary artery or peripheral vascular procedures. The device shunts blood at the anastomotic site which provides a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis. The device is removed just prior to the final suturing of the vessel.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Tu A.R.

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

Prescription Use
Per 21 CFR 801.109

OR

Over-The-Counter Use