(120 days)
Not Found
No
The document describes a mechanical device for extracorporeal circulation and makes no mention of AI or ML.
Yes
The device is used for cardiopulmonary bypass or temporary circulatory bypass during surgical procedures, which are therapeutic interventions.
No
The device is described as a system for providing cardiopulmonary bypass or temporary circulatory bypass during surgical procedures, which are therapeutic interventions, not diagnostic ones.
No
The device description clearly describes a physical tubing set used in extracorporeal circuits, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used to pump blood through an extracorporeal circuit during surgical procedures on the heart, great vessels, aorta, or vena cava. This is a direct intervention on the patient's circulatory system, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description focuses on the mechanical function of pumping blood and the coating of the components. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood or other biological fluids for diagnostic purposes, no mention of reagents, assays, or any other elements typically associated with IVD devices.
The device is a surgical assist device used during open surgical procedures, not a diagnostic tool.
N/A
Intended Use / Indications for Use
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.
Product codes
KFM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, great vessels, aorta, vena cava
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
HLM Tubing Sets with Bioline Coating (K080592), Jostra MECC System (K023132)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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)
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3
Special 510(k): Device Modification MECC SET with Bioline Coating
510(k) SUMMARY
| SUBMITTER: | Maquet Cardiopulmonary AG
Hechinger Strasse 38
72145 Hirrlingen, Germany |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Katrin Schwenkglenks
Phone: (011) 49 7478 921-151
Fax: (011) 49 7478 921- 400 |
| DATE PREPARED: | December 18, 2008 |
| DEVICE TRADE NAME: | MECC SET with Bioline·Coating |
| COMMON/USUAL NAME | Minimized Extracorporeal Circulation
System |
| CLASSIFICATION NAMES | Cardiopulmonary
Bypass
Vascular
Catheter, 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
4
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