IBC VENT VALVE, MODEL 1400

K992964 · International Biophysics Corp. · MNJ · Nov 19, 1999 · Cardiovascular

Device Facts

• Record ID: K992964
• Device Name: IBC VENT VALVE, MODEL 1400
• Applicant: International Biophysics Corp.
• Product Code: MNJ · Cardiovascular
• Decision Date: Nov 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4400
• Device Class: Class 2

Intended Use

The Cardiotomy Vent Valve is indicated for use to maintain a low level of vacuum in cardiotomy reservoirs.

Device Story

IBC Cardiotomy Vent Valve is a single-use, disposable vacuum relief valve; maintains low vacuum levels in cardiotomy reservoirs. Valve remains closed until vacuum reaches pre-determined threshold; operates optimally at slow pump rates. Used in clinical settings by perfusionists during cardiopulmonary bypass procedures. Device is functionally identical to American Omni Vent Valve; provides equivalent performance. Available as sterile, single-use unit or bulk non-sterile for custom perfusion packs. Benefits include reliable vacuum regulation within cardiotomy reservoirs, ensuring consistent system performance during perfusion.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, functional, and material similarity to the predicate device.

Technological Characteristics

Single-use, disposable vacuum relief valve. Manufactured in Class 100,000 clean room. Materials are non-toxic and compliant with ISO biocompatible tripartite standards. Mechanical operation based on vacuum-threshold activation.

Indications for Use

Indicated for use in cardiotomy reservoirs to maintain a low level of vacuum. No specific patient population, age, or gender restrictions provided.

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

• American Omni Vent Valve

Submission Summary (Full Text)

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NOV 1 9 1999

K992964

## 510(k) SUMMARY

The IBC Vent Valve is a single use, disposable, vacuum relief valve that is intended for use to maintain a low level of vacuum in reservoirs. The valve is closed until the vacuum reaches a pre-determined value in the reservoir and operates best when the pump runs at a very slow rate. The fully assembled IBC Vent Valve is basically identical to the American Omni Vent Valve, which is the predicate device for purposes of this 510(k) submission. The operating principles, performance and indications for use of the two devices are the same.

The IBC Vent Valve is manufactured in a Class 100,000 clean room. The device will be packaged and sterilized for single use. Additionally, the IBC Vent Valve will be packaged in bulk form and non-sterile for the Custom Perfusion Pack market. The materials used to manufacture the IBC Vent Valve are non-toxic and meet current ISO biocompatible tripartite standards using the FDA matrix.

A perfusionist substituting an IBC Vent Valve for an American Omni Vent Valve with his or her cardiotomy reservoir will be unable to distinguish between the two valves functionally.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 1 9 1999

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

K992964 Re : IBC Cardiotomy Vent Valve Requlatory Class: II (two) Product Code: MNJ August 31, 1999 Dated: Received: September 2, 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 Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further regulatory action. 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 requlations.

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Page 2 - Mr. David Shockley, Jr.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Maria Maddalena

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

Enclosure

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## INDICATIONS FOR USE

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: IBC Cardiotomy Vent Valve

Indications for use:

The Cardiotomy Vent Valve is indicated for use to maintain a low level of vacuum in cardiotomy reservoirs.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | Bette L. Temperell |
|-------------------------------------------------------------------|--------------------|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| (Division Sign-Off) | |
| 510(k) Number | K992964 |

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