(15 days)
The Quart Arterial Filter with Safeline Coating is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flowrates, 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.
The Quart Arterial Filter with Safeline 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 Jostra Quart Arterial Filter with Safeline Coating is identical to the Jostra Quart Arterial Filter uncoated with the only exception that the Quart Arterial Filter with Safeline Coating has been coated with Safeline. The Safeline Coating is the same as with the Jostra RotaFlow Centrifugal Pump with Safeline Coating. Besides this difference the both Quart Arterial Filters are the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology.
The provided text does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study
methodologies in the context of a typical AI/ML device submission. Instead, these documents are part of a 510(k) submission for a
medical device called "Quart Arterial Filter with Safeline Coating," which underwent a review for substantial equivalence to existing
predicate devices.
The document focuses on the mechanical and biocompatibility aspects of the device and its coating, not on an algorithm's
performance against a ground truth dataset. Therefore, I cannot extract the information requested for AI/ML device studies.
The provided text only gives information of two predicate devices, an arterial filter and a centrifugal pump with the same safeline coating.
The new device (Quart Arterial Filter with Safeline Coating) is "substantially equivalent" to these two predicate devices.
The following areas have been tested and / or evaluated: Integrity, Performance, Biocompatibility, Sterility.
No information is provided about:
- Sample size used for the test set and data provenance
- Number of experts and their qualifications
- Adjudication method
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
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JUN 20 2006
Special 510(k): Device Modification: Quart Arterial Filter with Safeline Coating
| 510(k) SUMMARY | |
|---|---|
| SUBMITTER: | Maquet Cardiopulmonary AGHechinger Strasse 3872145 Hirrlingen, Germany |
| CONTACT PERSON: | Katrin SchwenkglenksPhone: (011) 49 7478 921- 151Fax: 011 49 7478 921- 400 |
| DATE PREPARED: | June 02, 2006 |
| DEVICE TRADE NAME: | Jostra Quart Arterial Filter with Safeline Coating |
| COMMON/USUAL NAME | Arterial Filter, coated |
| CLASSIFICATION NAME | Filter, Blood, Cardiopulmonary Bypass, ArterialLine |
| PREDICATE DEVICES OR LEGALLYMARKETED DEVICES | Jostra Quart Arterial Filter |
| Jostra RotaFlow Centrifugal Pump with SafelineCoating |
DEVICE DESCRIPTION/INDICATONS FOR USE STATEMENT
The Quart Arterial Filter with Safeline Coating is designed for use in an extracorporeal rio Quan Antonal Villag 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.
purge into.
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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MAQUET
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The Jostra Quart Arterial Filter with Safeline Coating is identical to the Jostra Quart Arterial Filter uncoated with the only exception that the Quart Arterial Filter with Safeline Coating has been coated with Safeline. The Safeline Coating is the same as with the Jostra nao boom Centrifygal Pump with Safeline Coating. Besides this difference the both Quart Arterial Filters are the same in design, intended 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 Jostra Quart Arterial Filter with Safeline Coating described in this submission is substantially equivalent to the Jostra Quart Arterial Filter as an arterial filter and to the RotaFlow Centrifugal Pump with Safeline Coating regarding the Safeline coating.
The following areas have been tested and / or evaluated:
- Integrity -
- Performance -
- Biocompatibility -
- Sterility ﺳ
Conclusion
The data given demonstrate that the Jostra Quart Arterial Filter with Safeline 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three overlapping human profiles, resembling an abstract representation of people. The logo is black and white.
AUG - 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Hechinger Strasse 38 Hirringen, Germany
Re: K061546
Quart Arterial Filter with Safeline Coating Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II (Two) Product Code: DTM Dated: June 2, 2006 Received: June 6, 2006
Dear Ms. Schwenkglenks:
This letter corrects our substantially equivalent letter of June 20, 2006.
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 C osmetic Act (Act) that do not require approval of a premarket approval (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 vour device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affècting 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
Food and Drug Administration 9200 Corporate Boulevard
Please be advised that FDA's issuance of a substantial equivalence determ frames affermean 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 (OS) 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 continue 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 (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/dsma/dsmamain.html
Sincerely vours,
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): K061546
Device Name: Quart Arterial Filter with Safeline Coating
Indications for Use:
The Quart Arterial Filter with Safeline Coating is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flowrates, 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.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) .
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)
umma R. lochner
(Division Sign-Off) Division of Cardiovascular Devices
Page __ of _
510(k) Number Ko 61546
(Posted November 13, 2003)
§ 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.”