(81 days)
The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation, and by doing so supports the perfusionist's obligation to exercise due caution. The product must not be used for more than 6 hours at a time. The physician in charge of treatment must make all decisions concerning use of the venous bubble trap.
The Venous Bubble Trap is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user. The device is sterilized with Ethylene Oxide. The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation. The device is to be used for up to 6 hours.
The provided text describes a 510(k) submission for the "Venous Bubble Trap with and without Bioline Coating." The study described is a non-clinical study focused on demonstrating substantial equivalence to predicate devices, rather than a clinical trial with specific performance metrics against an acceptance criterion in the way modern AI/ML device studies are conducted.
Here's a breakdown based on the provided information, noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from device-specific performance tests) | Reported Device Performance |
|---|---|
| Integrity | Tested, deemed substantially equivalent |
| Performance | Tested, deemed substantially equivalent (separates macroscopic air bubbles from venous line within specified flow rates) |
| Stability of the Coating | Tested, deemed substantially equivalent (same as cleared Quadrox D Diffusion Membrane Oxygenator with Bioline Coating) |
| Biocompatibility | Tested, deemed substantially equivalent |
| Sterility | Tested, deemed substantially equivalent |
Note: The document states that "Testing and evaluation on safety and effectiveness was executed to demonstrate that the Venous Bubble Trap with and without Bioline Coating described in this submission is substantially equivalent to the Capiox Bubble Trap from Terumo Medical Corp. as a bubble trap as well as with the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating with regards to the coating." This indicates that the acceptance criterion was substantial equivalence to the predicate devices across these tested areas. Specific quantitative acceptance values (e.g., "bubble removal efficiency > X%") are not provided in this summary but would have been part of the underlying test protocols that supported the substantial equivalence claim. The reported performance is that it met these criteria, thus supporting the substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified. This was a non-clinical (bench) testing, so there is no patient data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable and not provided for this type of non-clinical device testing. Ground truth for device performance features like integrity, performance (bubble separation), stability of coating, biocompatibility, and sterility would be established through established scientific and engineering test methods and standards, not through expert consensus in the way a diagnostic AI would use medical expert labels.
4. Adjudication Method for the Test Set
- Not applicable for this type of non-clinical device testing. Adjudication is typically relevant for studies involving human interpretation or clinical endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical bubble trap, not an AI or imaging device that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical bubble trap, not an algorithm. The "performance" assessment would have been a standalone test of the physical device's ability to remove bubbles.
7. The Type of Ground Truth Used
- For "Integrity," "Performance," "Stability of the Coating," "Biocompatibility," and "Sterility," the ground truth would have been established through validated laboratory testing methods and engineering specifications. For example, "Performance" (bubble removal) would be measured against a defined standard for air volume or bubble size removed, which would serve as the ground truth. "Biocompatibility" would be assessed according to ISO standards, with the "ground truth" being compliance with those standards.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a physical device.
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KC82412
NOV 10 2008
MAQUET
510 (K) Summary [as required by 21 CFR 807.92(c) ]
August 20, 2008
Submitter:
Maquet Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen Germany
Contact Person:
Katrin Schwenkglenks Phone: +49 7478 921-151 +49 7478 921-400 Fax: E-mail: katrin.schwenkglenks@maquet-cp.com
Date Prepared:
Device Trade Name:
Venous Bubble Trap with and without Bioline Coating
Cardiopulmonary bypass bubble detector
Venous Bubble Trap Common/Usual name:
Classification name:
Predicate Devices:
Quadrox D Diffusion Membrane Oxygenator with Bioline Coating, Maquet Cardiopulmonary AG (K071774). Capiox Bubble Trap, Terumo Medical Corp. (K911632), the Ideal Mimesys Venous Air Removal Device from Dideco S.r.1. as part of the Ideal Mimesys System (K032040) and
the ECC.O System with Integrated Venous Air Removal from Dideco S.r.l. (K050890) which does also contain a venous bubble trap as component.
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MAQUET
Device Description:
The Venous Bubble Trap is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user. The device is sterilized with Ethylene Oxide.
The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation. The device is to be used for up to 6 hours.
Indications for Use:
The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation, and by doing so supports the perfusionist's obligation to exercise due caution. The product must not be used for more than 6 hours at a time. The physician in charge of treatment must make all decisions concerning use of the venous bubble trap.
Statement of Technical Comparison:
The Venous Bubble Trap with and without Bioline Coating has the same design, principals of operation, and performance as the predicate device on the market. The Bioline Coating is the same as cleared with the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating.
Non-clinical Testing:
The following areas have been tested:
- Integrity
- Performance
- Stability of the Coating
- Biocompatibility
- Sterility
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MAQUET
Determination of Substantial Equivalence
Testing and evaluation on safety and effectiveness was executed to demonstrate that the Venous Bubble Trap with and without Bioline Coating described in this submission is substantially equivalent to the Capiox Bubble Trap from Terumo Medical Corp. as a bubble trap as well as with the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating with regards to the coating.
Conclusion
乐
The data given demonstrate that the Venous Bubble Trap with and without Bioline Coating is substantially equivalent to the named predicate devices which currently hold market clearance.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted as a bird-like figure with intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2008
Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Official Correspondent Hechinger Strassue 38 Hirrlingen, Germany 72145
Re: K082412
Venous Bubble Trap with and without Bioline Coating Regulation Number: 21 CFR 870.4230 Regulation Name: Cardiopulmonary bypass defoamer Regulatory Class: Class II Product Code: DTP Dated: October 17, 2008 Received: November 3, 2008
Dear Ms. Schwenkglenks
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.
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Page 2 - Ms. Katrin Schwenkglenks
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to. premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
D. Vachner
ABram D. Zuckerman, M.D. Director Division of Cardiovascular Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Ko82412
Device Name: Venous Bubble Trap with and without Bioline Coating __
Indications for Use:
The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation, and by doing so supports the perfusionist's obligation to exercise due caution.
The product must not be used for more than 6 hours at a time.
The physician in charge of treatment must make all decisions concerning use of the venous bubble trap.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
D/OR Over-In
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
unn R. V. June 1
(Division Sign-Off) Division of Cardiovascular Devices
Page 1 of 1
510(k) Number_Ko&2 412
(Posted November 13, 2003)
……
§ 870.4230 Cardiopulmonary bypass defoamer.
(a)
Identification. A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.”