(98 days)
The DBT™ is indicated for use in cardiopulmonary bypass procedures for the removal of gaseous microemboli.
The DBT™, Dynamic Bubble Trap is a sterile device with a non-pyrogenic fluid pathway. It is intended for single use only, in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures. It is designed to remove gaseous microemboli from the arterial line of a cardiopulmonary bypass circuit.
The provided text is a 510(k) summary for the DYNAMIC BUBBLE TRAP (DBT™), an arterial filter. It does not contain information about specific acceptance criteria or a study proving that the device meets those criteria in the typical format of a clinical or performance study report with metrics like sensitivity, specificity, or accuracy.
Instead, the document states: "Testing was performed in accordance with the Guidance Performance Data: for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions, dated November 29, 2000. The recommended special controls have been applied to minimize all identified potential risks to health. Bench testing demonstrates that the device has been designed to minimize the identified potential risks to a patient's health. Based upon the performance studies and the proposed Conclusion: device labeling, the DBT™, Dynamic Bubble Trap, is substantially equivalent to the identified predicate devices in terms of intended use, safety, and effectiveness."
This indicates that the assessment was primarily based on bench testing for substantial equivalence to a predicate device (Pall EC Plus Filter (K834380)) and adherence to FDA guidance for arterial line blood filters. This type of submission generally relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device, rather than providing specific performance metrics against pre-defined acceptance criteria in a quantitative table.
Therefore, many of the requested details about a study with specific acceptance criteria, sample sizes, expert ground truth, etc., cannot be extracted from this 510(k) summary. The summary focuses on regulatory approval based on substantial equivalence, not a detailed performance study with quantifiable acceptance criteria.
However, based on the information provided, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list quantitative acceptance criteria in a table format with corresponding device performance metrics. It refers to "bench testing" and compliance with FDA guidance. The "performance studies" mentioned are implicitly comparing the DBT™ to the predicate device in terms of safety and effectiveness, as per the FDA's substantial equivalence pathway.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document mentions "bench testing" but does not detail sample sizes, data provenance, or study design (retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the 510(k) summary as the evaluation appears to be based on bench testing of the physical device's engineering and performance characteristics, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, which is not described here.
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
An MRMC study is not mentioned in the 510(k) summary. This type of study is usually relevant for AI/radiology devices. The DBT™ is a physical medical device (an arterial filter), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the DBT™ is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document refers to "bench testing" to demonstrate that the device is "designed to minimize the identified potential risks to a patient's health." The "ground truth" for such testing would likely involve physical measurements and engineering standards related to the device's ability to remove gaseous microemboli from blood in an in-vitro setup, consistent with the FDA guidance for such devices. Specific details are not provided.
8. The sample size for the training set
This question is not applicable as the DBT™ is a physical medical device, not an AI algorithm that requires a training set. The "bench testing" is a form of validation, not training.
9. How the ground truth for the training set was established
This question is not applicable as the DBT™ is a physical medical device, not an AI algorithm.
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510(k) SUMMARY - DYNAMIC BUBBLE TRAP
| Submitter Name: | Convergenza AG |
|---|---|
| Submitter Address: | St. Markusgasse 16FL 9490 VaduzPrincipality of Liechtenstein |
| Contact Person: | Christie DeWitt |
| Phone/Fax Number: | (239) 992-3163 |
| Date Prepared: | April 25, 2003 |
| Device Trade Name: | DBT™, Dynamic Bubble Trap |
| Device Common Name: | Arterial Filter |
| Classification Name: | Cardiopulmonary Bypass Arterial Line Blood Filter21 CFR §870.4260; Class II |
| Predicate Devices: | Pall EC Plus Filter (K834380) |
| Device Description: | The DBT™, Dynamic Bubble Trap is a sterile device witha non-pyrogenic fluid pathway. It is intended for singleuse only, in the arterial line of an extracorporeal circuitduring cardiopulmonary bypass procedures. It isdesigned to remove gaseous microemboli from thearterial line of a cardiopulmonary bypass circuit. |
| Intended Use: | The DBT™ is indicated for use in cardiopulmonarybypass procedures for the removal of gaseousmicroemboli. |
| Device TechnologicalCharacteristics: | The DBT™ is tubular with 3/8-inch barbed inlet andoutlet ports. Within the tube there is a diffuser chamberand a site for collecting microbubbles, which isconnected to the recirculation line. Inside the diffuserchamber there is a tightly integrated three-channelspiral. As blood passes through the spiral, it isconverted into a rotating stream. The resultingcentripetal forces direct gaseous microemboli to thecenter of the flow line. The collection site, which issituated in the center of the distal end of the tube,diverts the central blood flow line and returns it togetherwith all collected microbubbles to the cardiotomy |
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Testing was performed in accordance with the Guidance Performance Data: for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions, dated November 29, 2000. The recommended special controls have been applied to minimize all identified potential risks to health. Bench testing demonstrates that the device has been designed to minimize the identified potential risks to a patient's health. Based upon the performance studies and the proposed Conclusion:
device labeling, the DBT™, Dynamic Bubble Trap, is substantially equivalent to the identified predicate devices in terms of intended use, safety, and effectiveness.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure, composed of three curved lines. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Convergenza AG c/o Ms. Christine B. DeWitt DeWitt Group International 3625 Woodlake Drive Bonita Springs, FL 34134
Re: K031323
DBT™, Dynamic Bubble Trap Regulation Number: 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II (two) Product Code: DTM Dated: April 24, 2003 Received: April 25, 2003
Dear Ms. DeWitt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
AUG = 1 2003
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Page 2 - Ms. Christine B. DeWitt
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
N. Robertson M.P.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: DBT™, Dynamic Bubble Trap _______________________________________________________________________________________________________________________________________
Indications for Use:
The DBT™ is indicated for use in cardiopulmonary bypass procedures for the removal of gaseous microemboli.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | X OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ------------------------------------------------------------------------------------------------------- | ---------------------- |
(Division Sign-Off)
(Optional Format 1-2-96) Division of Cardiovascular Devices
| 510(k) Number | K031323 |
|---|---|
| --------------- | --------- |
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”