IBC FLOGUARD, MODEL 6050

K992785 · International Biophysics Corp. · MJJ · Jan 14, 2000 · Cardiovascular

Device Facts

• Record ID: K992785
• Device Name: IBC FLOGUARD, MODEL 6050
• Applicant: International Biophysics Corp.
• Product Code: MJJ · Cardiovascular
• Decision Date: Jan 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4400
• Device Class: Class 2

Intended Use

The IBC FloGard is indicated for use for the prevention of retrograde flow when used with centrifugal pumps during cardiopulmonary bypass surgery (up to six hours).

Device Story

IBC FloGard is a single-use, disposable check valve for arterial lines in cardiopulmonary bypass circuits. It prevents retrograde flow during centrifugal pump operation. Device features a bi-leaflet check valve design housed in a polycarbonate body. Used in clinical perfusion settings; operated by perfusionists. Bi-leaflet design reduces housing size, prime volume, and hemolysis compared to traditional duck-bill valves. Healthcare providers integrate it into the bypass circuit to maintain unidirectional flow and protect the patient from backflow during pump failure or cessation.

Clinical Evidence

Bench testing only. Comparison of IBC FloGard and Quest RetroGuard included pressure drop measurements at 4 L.P.M. flow (45% hematocrit), hemolysis testing in a simulated circuit at 7 L.P.M. for 6 hours (fresh bovine blood, 45% hematocrit), reverse-flow measurement at 100 mm Hg back-pressure, and valve closure pressure testing. Results demonstrate substantial equivalence.

Technological Characteristics

Single-use, disposable check valve. Materials: Polycarbonate body. Bi-leaflet valve mechanism. Dimensions: Reduced housing size compared to predicate. Sterilization: Standard IBC methods. Biocompatibility: ISO standards and FDA 1995 matrix. No software or electronics.

Indications for Use

Indicated for prevention of retrograde flow in patients undergoing cardiopulmonary bypass surgery using centrifugal pumps for up to six hours.

Regulatory Classification

Identification

A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.

Special Controls

*Classification.* Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Quest RetroGuard

Submission Summary (Full Text)

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K992785

### EXECUTIVE SUMMARY

The IBC FloGard is a single-use, disposable, check valve intended for use for the prevention of retrograde flow in the arterial line when used with centrifugal pumps during open-heart surgery. The device is designed for use in the main arterial line when centrifugal pumps are used. The fully assembled IBC FloGard Valve is geometrically similar to the Quest RetroGuard valve, which is the predicate device for purposes of this 510(k) submission. The operating principles of the two devices are identical.

The differences between the IBC VRV and the predicate device are found in the material selection, specific dimensions of the component parts and the type of check valve used. The first of these differences is the choice of polymer for molding the plastic components. The main flow through body of the IBC VRV is made of polycarbonate and the Quest RetroGuard is made of clear ABS. The polycarbonate is clearer, has higher impact resistance, greater tensile and compression strength and superior chemical resistance. Secondly, the straight duck bill check valve in the predicate device, Quest RetroGuard, required an oversized body to accommodate clinical flow rates without a substantial resistance to flow. The bi-leaflet design of the check valve in the IBC FloGard valve substantially reduces the size of the flow through housing without increasing resistance to flow. This geometry substantially lowered prime volume and hemolysis.

The IBC FloGard (sterile, 6 month aged, environmentally conditioned) was subjected to a series of dynamic tests in a side by side comparison with the Quest RetroGuard. The pressure drop of the check valves for both products were measured at 4 L.P.M. flow (average clinical flow rate) with blood at 45% hematocrit. Hemolysis was measured in a simulated clinical circuit at 7 L.P.M. for 6 hours using fresh bovine blood at 45% hematocrit. The reverse-flow was measured at 100 mm Hg back-pressure for both products to simulate reverse flow in a pump failure mode. Pressure required to close both valves in the reverse direction was also measured. Comparison of the IBC FloGard to the Quest RetroGuard demonstrates that the two products are substantially equivalent when used clinically.

The IBC FloGard valve is manufactured in a Class 100,000 clean room. The Bioburden prior to sterilization is extremely low and comparable to other 510(k) listed products manufactured by IBC. The device will be packaged and sterilized for single use using the same packaging and sterilization as other IBC 510(k) listed products. Additionally, the IBC FloGard valve will be packaged in bulk form and non-sterile for the Custom Perfusion Pack market. The materials used to manufacture the IBC FloGard are nontoxic using the tripartite biocompatible ISO standards and the FDA modified matrix of 1995.

A perfusionist substituting an IBC FloGard valve for a Quest RetroGuard in his or her perfusion circuit will be unable to distinguish between the two valves functionally.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

## 'JAN 1 4 2000

Mr. H. David Shockley, Jr. President International Biophysics Corp. 4020 South Industrial Drive Suite 160 Austin, TX 78744

Re: K992785 IBC FloGuard, Model 6050 Regulatory Class: II Product Code: MJJ Dated: November 19, 1999 Received: November 22, 1999

Dear Mr. Shockley:

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 general controls provisions of the Act include the Act. 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 Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation 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 continue marketing your device as described in your 510(k) premarket notification. The FDA finding

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#### Page 2 - Mr. David H. Shockley

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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

for Celia M. Witten, Ph.D., M.D.

Acting Director Division of Cardiovascular Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# INDICATIONS FOR USE

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: IBC FloGard

Indications for use:

The IBC FloGard is indicated for use for the prevention of retrograde flow when used with centrifugal pumps during cardiopulmonary bypass surgery (up to six hours).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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| | Division of Cardiovascular, Respiratory, and Neurological Devices |
| 510(k) Number | __________________________ |

| Prescription Use<br>(Per 21 CFR 801.109) | X |
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or Over-The-Counter-Use__________________________
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