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 Description

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.

AI/ML Overview

This looks like a submission for a medical device (IBC FloGard) seeking 510(k) clearance, which means the manufacturer is trying to demonstrate that their new device is "substantially equivalent" to a legally marketed predicate device (Quest RetroGuard). The analysis primarily involves comparing performance characteristics rather than establishing de novo clinical efficacy through large-scale trials.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly substantial equivalence to the predicate device, Quest RetroGuard, particularly in key performance metrics relevant to its intended use in cardiopulmonary bypass. The document provides comparison results directly.

Performance Metric	Acceptance Criteria (Implicit: Substantially equivalent to Quest RetroGuard)	IBC FloGard Performance (Reported)	Quest RetroGuard Performance (Reported - for comparison)
Pressure Drop (at 4 L.P.M. flow with blood at 45% hematocrit)	No substantial increase compared to predicate	(Measured - specific value not given, implied to be comparable to predicate)	(Measured - specific value not given)
Hemolysis (at 7 L.P.M. for 6 hours with fresh bovine blood at 45% hematocrit)	No substantial increase compared to predicate; "substantially lowered hemolysis" compared to predicate	Substantially lowered hemolysis	(Baseline for comparison)
Reverse-flow (at 100 mm Hg back-pressure)	Comparable to predicate	(Measured - specific value not given, implied to be comparable to predicate)	(Measured - specific value not given)
Pressure required to close valves in reverse direction	Comparable to predicate	(Measured - specific value not given, implied to be comparable to predicate)	(Measured - specific value not given)
Prime Volume	"Substantially lowered prime volume" compared to predicate	Substantially lowered prime volume	(Baseline for comparison)
Biocompatibility	Nontoxic, meeting ISO standards and FDA modified matrix of 1995	Nontoxic	(Implicitly also met by predicate materials)
Bioburden (prior to sterilization)	"Extremely low and comparable to other 510(k) listed products manufactured by IBC"	Extremely low	(Comparable to other IBC 510(k) listed products)

Note: For many metrics, the specific numerical values for current and predicate devices are not provided in the executive summary, only qualitative comparisons. The implicit acceptance criterion is that the IBC FloGard performs as well as or better than the Quest RetroGuard in these critical areas, demonstrating substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- The study involved comparing "the IBC FloGard (sterile, 6 month aged, environmentally conditioned)" against the "Quest RetroGuard." It's not explicitly stated how many units of each device were tested for each metric (e.g., how many FloGard valves for pressure drop, how many RetroGuard valves for hemolysis). It refers to "the IBC FloGard Valve" and "the Quest RetroGuard valve" implying a representative sample, but specific numbers are absent.
Data Provenance: The study was conducted by IBC, the manufacturer, as part of their 510(k) submission. This is retrospective in the context of device development (i.e., tests were run on finished devices to support the submission). The data is generated internally by the company for regulatory purposes. Country of origin for data generation is not specified but assumed to be the US given the submission to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This type of device clearance (510(k) for a physical medical device like a check valve) primarily relies on engineering and laboratory performance testing, not expert-established "ground truth" on diagnostic images or clinical outcomes.
Therefore, no experts were explicitly described as establishing ground truth in the way a radiologist might for an AI diagnostic algorithm. The "ground truth" for this device's performance is derived from standardized laboratory measurements (e.g., flow rates, pressure, hemolysis assays). The "experts" involved would be the biomedical engineers and lab technicians conducting the tests, whose qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 reconciliation are typically used for establishing ground truth in clinical data (e.g., imaging studies where multiple readers interpret cases to reach a consensus).
For this device, the "adjudication" is inherent in the reproducibility and standardization of the laboratory tests and comparison against established physical principles and the predicate device's measured performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is not relevant for this type of device (a mechanical check valve). MRMC studies evaluate the diagnostic performance of human readers, often with and without AI assistance, especially in radiology or pathology. This device is a component in a cardiopulmonary bypass circuit, not a diagnostic tool requiring human interpretation.

6. If a Standalone Performance Study was done

Yes, a standalone performance characterization was done for the IBC FloGard, and importantly, it was conducted side-by-side with the predicate device (Quest RetroGuard). This is crucial for demonstrating substantial equivalence.
The description details various tests:
- Pressure drop measured at 4 L.P.M.
- Hemolysis measured at 7 L.P.M. for 6 hours.
- Reverse-flow measured at 100 mm Hg back-pressure.
- Pressure required to close the valves.
- Biocompatibility, bioburden, and sterilization.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established through:
- Direct physical measurements and laboratory assays: Pressure, flow rate, hemolysis, reverse flow, prime volume measurements.
- Compliance with recognized standards: Biocompatibility tested against "tripartite biocompatible ISO standards and the FDA modified matrix of 1995."
- Comparison to a legally marketed predicate device: The performance metrics are held against the measured performance of the Quest RetroGuard.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical component, not an AI/ML algorithm that requires a "training set." The engineering design and material selection process are not "trained" on data in the same way an algorithm is.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for a mechanical device. The design and validation are based on engineering principles, material science, and performance testing against specified requirements and predicate device characteristics.

Summary

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K992785

EXECUTIVE SUMMARY

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 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).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use(Per 21 CFR 801.109)	X
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or Over-The-Counter-Use__________________________
1

Regulation Number and Section

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
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.(b)
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.