(30 days)
The Quart Arterial Filter is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flowrates, the Quart Arterial Filter removes particulate and gaseous micro-embolisms from the extracorporeal circulation system. The eliminated gas can be removed via the purge line. The max. flow rate of the Quart Arterial Filter is 7 1/min.
The decision regarding the method in which the arterial filter is to be employed rests solely with the treating physician.
The unit may not be continuously employed for more than 6 hours. We do not recommend longer contact with the blood.
The Quart Arterial Filter with Bioline Coating is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flow rates, the arterial filter removes particulate and gaseous micro-embolisms from the extracorporeal circulation system. The eliminated gas can be removed via the purge line. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.
Acceptance Criteria and Device Performance for Quart Arterial Filter with Bioline Coating
The provided document describes a Special 510(k) submission for a modified device, the Quart Arterial Filter with Bioline Coating. This submission aims to demonstrate substantial equivalence to a predicate device, the Quart Arterial Filter (uncoated), by adding a Bioline coating. The Bioline coating itself is previously cleared for use with the Quadrox D Diffusion Membrane Oxygenator (K071774).
The acceptance criteria and device performance are not explicitly detailed with specific numerical targets in this summary, but the document states that "Evaluation and testing on safety and effectiveness was executed to demonstrate that the Quart Arterial Filter with Bioline Coating described in this submission is substantially equivalent to the Quart Arterial Filter as an arterial filter and to the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating the Bioline coating."
The areas tested and/or evaluated are listed below, which serve as the broad acceptance criteria categories the device had to meet to demonstrate substantial equivalence.
1. Table of Acceptance Criteria (Categories) and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Integrity | Demonstrated through evaluation and testing. |
| Performance | Demonstrated through evaluation and testing. |
| Biocompatibility | Demonstrated through evaluation and testing. |
| Sterility | Demonstrated through evaluation and testing. |
Note: The document only mentions "demonstrated through evaluation and testing" for each category without providing specific metrics or results achieved. It implicitly means the device successfully met the established criteria within each category for demonstrating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "evaluation and testing."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications. The evaluation appears to be based on laboratory testing and comparison to predicate devices, rather than expert-based ground truth for clinical outcomes or diagnostic accuracy.
4. Adjudication Method
The document does not mention any adjudication method. This type of device (an arterial filter) is not typically evaluated using adjudication methods relevant to diagnostic imaging or clinical decision-making.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or mentioned. This type of study is typically relevant for diagnostic devices where human interpretation is involved. For an arterial filter, the focus is on physical and biological performance characteristics.
6. Standalone Performance
A standalone performance evaluation (algorithm only, without human-in-the-loop) was effectively done in the sense that the device's performance characteristics (integrity, performance, biocompatibility, sterility) were evaluated intrinsically. The device is a medical device, not an algorithm. The evaluation focused on the device itself meeting the criteria.
7. Type of Ground Truth Used
The ground truth used for this evaluation was primarily established through laboratory testing and established standards for medical devices, specifically related to:
- Integrity: Structural soundness, absence of leaks, etc.
- Performance: Efficiency of particle and gas removal as per expected function (within cited flow rates), pressure drop, etc. This would be based on validated test methods for arterial filters.
- Biocompatibility: In vitro and/or in vivo tests to confirm the material's compatibility with blood and tissues, as per ISO 10993 series.
- Sterility: Validation of the sterilization process to ensure the device is sterile when packaged.
The ultimate ground truth for this 510(k) submission is the demonstration of substantial equivalence to existing legally marketed predicate devices in terms of safety and effectiveness, based on these technical characteristics.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this type of device modification submission. This is not an AI/ML powered device, so there is no algorithm that requires training data. The Bioline coating itself has a previous clearance (K071774), indicating its properties were validated as part of that submission.
9. How Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, this question is not applicable.
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Ko 82544
MAQUET
OCT 3 - 2008
Special 510(k): Device Modification: Quart Arterial Filter with Bioline Coating
510(k) SUMMARY
SUBMITTER:
Maquet Cardiopulmonary AG Hechinger Strasse 38
CONTACT PERSON: Katrin Schwenkalenks Phone: (011) 49 7478 921- 151 Fax: (011) 49 7478 921- 400 DATE PREPARED: August 27, 2008 DEVICE TRADE NAME: Quart Arterial Filter with Bioline Coating COMMON/USUAL NAME Arterial Filter, coated CLASSIFICATION NAME Filter, Blood, Cardiopulmonary Bypass, Arterial
Line
PREDICATE DEVICES OR LEGALLY MARKETED DEVICES
Quart Arterial Filter (K001787)
72145 Hirrlingen, Germany
Quadrox D Diffusion Membrane Oxygenator with Bioline Coating (K071774)
:
DEVICE DESCRIPTION / INDICATONS FOR USE STATEMENT
The Quart Arterial Filter with Bioline Coating is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flow rates, the arterial filter removes particulate and gaseous micro-embolisms from the extracorporeal circulation system. The eliminated gas can be removed via the purge line.
The decision regarding the method in which the arterial filter is to be employed rests solely with the treating physician.
The unit may not be continuously employed for more than 6 hours. We do not recommend longer contact with the blood.
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MAOI
The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The Quart Arterial Filter with Bioline Coating is identical to the Quart Arterial Filter, uncoated with the only exception that the Quart Arterial Filter with Bioline Coating has been coated with Bioline. The Bioline Coating is the same as with the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating. Besides this difference the both Quart Arterial Filters are the same in design, indications for use, method of operation, components, packaging, and fundamental scientific technology.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Evaluation and testing on safety and effectiveness was executed to demonstrate that the Quart Arterial Filter with Bioline Coating described in this submission is substantially equivalent to the Quart Arterial Filter as an arterial filter and to the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating the Bioline coating.
The following areas have been tested and / or evaluated:
- ・ Integrity
- ı Performance
- Biocompatibility® -
- Sterility -
Conclusion
The data given demonstrate that the Quart Arterial Filter with Bioline Coating is substantially equivalent to the named predicate devices which hold currently market clearance.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.
OCT 3 - 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Maquet Cardiopulmonary AG Ms. Katrin Schwenkglonks Regulatory Affairs Manager llechinger Strasse 38 72145 Hirrlingen, Germany
Re: K082544
Trade/Device Name: Quart Arterial Filter with Bioline Coating Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II (two) Product Code: DTM Dated: August 27, 2008 Received: September 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 intestate 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, Dr to 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 Ac1 . 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 devins, 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. Please e advised that FDA's issuance of a substantial equivalence determination does not mean fDA has made a determination that your device complies with other requirements of the Act 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 CFF) Part
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Page 2 -- Ms. Katrin Schwenkglenks
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 dcsire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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Indications for Use
510(k) Number (if known): _ K082544
Device Name: Quart Arterial Filter with Bioline Coating___
Indications for Use:
The Quart Arterial Filter is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flowrates, the Quart Arterial Filter removes particulate and gaseous micro-embolisms from the extracorporeal circulation system. The eliminated gas can be removed via the purge line. The max. flow rate of the Quart Arterial Filter is 7 1/min.
The decision regarding the method in which the arterial filter is to be employed rests solely with the treating physician.
The unit may not be continuously employed for more than 6 hours. We do not recommend longer contact with the blood.
Prescription Use Over-The-Counter Use × AND/OR (Part 21 CFR 801 Subpart D) (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)
Page 1 of ]
(Posted November 13, 2003)
Duna 2-10
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko82544
§ 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.”