(78 days)
The Cardiotomy Vent Valve is indicated for use to maintain a low level of vacuum in cardiotomy reservoirs.
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.
This looks like a 510(k) summary for a medical device called the "IBC Vent Valve." The document states that the IBC Vent Valve is "basically identical" to a predicate device, the American Omni Vent Valve, and that 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." This strongly suggests that the acceptance criteria for the IBC Vent Valve are tied to its functional equivalence to the American Omni Vent Valve.
However, the provided text does not contain a detailed study with specific acceptance criteria, sample sizes, expert ground truth, or statistical analysis typical of a study proving a device meets acceptance criteria. The 510(k) process often relies on demonstrating substantial equivalence to a predicate device rather than de novo clinical trials with detailed performance metrics.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence to the American Omni Vent Valve | "perfusionist ... will be unable to distinguish between the two valves functionally." |
| Operates to maintain a low level of vacuum in reservoirs | "intended for use to maintain a low level of vacuum in reservoirs" |
| Functions best when the pump runs at a very slow rate | "operates best when the pump runs at a very slow rate" |
| Closed until vacuum reaches a pre-determined value | "The valve is closed until the vacuum reaches a pre-determined value" |
| Materials are non-toxic and meet ISO biocompatible tripartite standards | "materials used ... are non-toxic and meet current ISO biocompatible tripartite standards" |
The document does not provide specific numerical acceptance criteria (e.g., vacuum level ranges, specific trigger pressures) or quantitative reported device performance measurements.
Regarding the study proving the device meets acceptance criteria, the document does not describe a formal study with the details requested. Instead, it relies on a claim of "substantial equivalence" to a predicate device.
Here's an analysis of the requested information based on the provided text:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
* Not provided. The document does not describe a specific "test set" or data collection for performance evaluation beyond the general statement of functional equivalence.
* The statement "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" suggests a subjective assessment, but no details on who performed this, how many, or under what conditions are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not provided. No explicit "ground truth" establishment process or experts are detailed for device performance in the provided text. The "perfusionist" mentioned is not quantified or qualified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable/Not provided. There is no described test set or adjudication process in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not applicable. This device is a mechanical vacuum relief valve, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reading performance with or without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is a mechanical component. The concept of "algorithm only" performance does not apply. Its function is standalone in the sense that it operates independently once installed, but it's not a computational algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Implied functional equivalence to a predicate device. The "ground truth" seems to be the established performance and functional characteristics of the American Omni Vent Valve, which the IBC Vent Valve claims to replicate. No independent "expert consensus, pathology, or outcomes data" is described for the IBC Vent Valve's performance.
8. The sample size for the training set:
* Not applicable/Not provided. This is a mechanical device, not a machine learning algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
* Not applicable. As above, no training set or its ground truth establishment is relevant to this device.
In summary: The provided document is a 510(k) summary focusing on demonstrating "substantial equivalence" to a predicate device. It primarily relies on the claim that the new device is functionally identical to the previously cleared predicate. It does not detail specific, quantitative performance studies with controls, sample sizes, or expert assessments as would be typically found for novel device performance claims.
{0}------------------------------------------------
NOV 1 9 1999
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.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter.
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.
{2}------------------------------------------------
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{3}------------------------------------------------
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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 | |
|---|---|---|---|
| --------------------------------------- | --- | ------------------------- | -- |
§ 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.