(120 days)
The MECC Set with Bioline Coating is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
The modified MECC SET with Bioline Coating follows the same concept of a minimized extracorporeal circuit as the Jostra MECC System (K023132) that is, the same operational principles and clinical application, benefits for the patient and risks during clinical application are comparable. The MECC SET with Bioline Coating corresponds to the HLM Tubing Set with Bioline Coating (K080592) with regards to the Bioline Coating of the components and with regards to the aspect that the MECC SET may be customized for the convenience of the customer.
The provided text is a 510(k) summary for the MECC Set with Bioline Coating. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting standalone performance data against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance evaluation is not explicitly available in the provided document.
Here's a breakdown of what can and cannot be answered based on the text:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission aims to show "substantial equivalence" to existing predicate devices, implying that its performance is expected to be similar or at least not worse than those devices, but it does not list specific quantitative acceptance criteria or corresponding performance metrics for the MECC Set with Bioline Coating.
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 document. The text does not describe a test set or clinical study conducted specifically to prove the MECC Set's performance. The "evaluation on safety and effectiveness" is mentioned as demonstrating substantial equivalence, but details of this evaluation (like sample size, type of study, or data provenance) are absent.
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 as there is no mention of a test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no mention of a test set requiring adjudication.
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
This information is not provided. The device is a medical device for cardiopulmonary bypass, not an AI-assisted diagnostic tool, so an MRMC study is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable to this type of medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as no specific "ground truth" for a performance study is described. The "evaluation on safety and effectiveness" for substantial equivalence would likely rely on a comparison of device characteristics, materials, and intended use with the predicate devices, potentially referencing existing clinical literature or non-clinical tests for the predicate devices.
8. The sample size for the training set
This information is not provided. This device is not an AI/ML device that would typically have a "training set."
9. How the ground truth for the training set was established
This information is not provided as it's not applicable to this type of medical device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2016
Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirrlingen, Germany
Re: K083794
Trade/Device Name: MECC Set with Bioline Coating Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-Type Cardiopulmonary Bypass Blood Pump Regulatory Class: Class II Product Code: KFM Dated: April 3, 2009 Received: April 7, 2009
Dear Ms. Schwenkglenks:
This letter corrects our substantially equivalent letter of April 21, 2009.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your 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 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 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric E. Richardson -S
Bram D. Zuckerman, M.D. for 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) K083794
Device Name
MECC Set with Bioline Coating
Indications for Use (Describe)
The MECC Set with Bioline Coating is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory necessary for open surgical procedures on the aorta or vena cava.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Special 510(k): Device Modification MECC SET with Bioline 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: | December 18, 2008 |
| DEVICE TRADE NAME: | MECC SET with Bioline·Coating |
| COMMON/USUAL NAME | Minimized Extracorporeal CirculationSystem |
| CLASSIFICATION NAMES | CardiopulmonaryBypassVascularCatheter, Cannula, or Tubing;Cardiopulmonary Bypass Adaptor,Stopcock, Manifold, or Fitting;Pump, Blood, Cardiopulmonary Bypass,Non-Roller Type. |
Maquet Cardiopulmonary AG, Hirrlingen, Germany
510(k) Summary – Page 1 of 3
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PREDICATE DEVICES OR LEGALLY MARKETED DEVICES
HLM Tubing Sets with Bioline Coating (K080592) Jostra MECC System (K023132)
INDICATONS FOR USE STATEMENT
The MECC SET with Bioline Coating is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The modified MECC SET with Bioline Coating follows. the same concept of a minimized extracorporeal circuit as the Jostra MECC System (K023132) that is, the same operational principles and clinical application, benefits for the patient and risks during clinical application are comparable.
Maquet Cardiopulmonary AG, Hirrlingen, Germany
510(k) Summary - Page 2 of 3
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The MECC SET with Bioline Coating corresponds to the HLM Tubing Set with Bioline Coating (K080592) with regards to the Bioline Coating of the components and with regards to the aspect that the MECC SET may be customized for the convenience of the customer.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Evaluation on safety and effectiveness was executed to demonstrate that the MECC SET with Bioline Coating described in this submission is substantially equivalent to the HLM-Tubing Set with Bioline Coating with regards to the Bioline Coating and customization and to the Jostra MECC System with regards to the principles of a minimal extracorporeal circuit and its application.
CONCLUSION
The data given demonstrate that the MECC Set with Bioline Coating is substantially equivalent to the named predicate devices which hold currently market clearance.
Maquet Cardiopulmonary AG, Hirrlingen, Germany
510(k) Summary - Page 3 of 3
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.