(41 days)
Not Found
No
The summary describes a mechanical extracorporeal blood oxygenation system with sensors and a control module, but there is no mention of AI or ML in the device description, intended use, or performance studies. The modification is a simple component exchange.
Yes
Explanation: The device is an extracorporeal blood oxygenation system intended for cardiac and/or pulmonary support, which directly treats a medical condition.
No
The device is an extracorporeal blood oxygenation system for cardiac and/or pulmonary support, which is a therapeutic function, not a diagnostic one. It includes sensors to read system parameters, but these are for monitoring the system's operation, not for diagnosing a patient's condition.
No
The device description clearly outlines multiple hardware components including a patient module with an extracorporeal circuit, sensors, a control module, and a base module with a touch screen. The modification described is the exchange of a hardware component (oxygenator).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "extracorporeal blood oxygenation system for patients needing short term... cardiac and/or pulmonary support." This describes a device that directly interacts with the patient's blood outside the body for therapeutic purposes (oxygenation and support), not for diagnosing a condition.
- Device Description: The description details components like a pump, oxygenator, filters, and sensors that are all involved in the process of circulating and oxygenating blood, not in analyzing biological samples for diagnostic information.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information about a patient's condition.
Therefore, the LIFEBRIDGE SYSTEM, as described, falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LIFEBRIDGE SYSTEM is indicated for use as an extracorporeal blood oxygenation system for patients needing short term, 6 hours or less, cardiac and/or pulmonary support.
Product codes
KFM
Device Description
The LIFE.BRIDGE SYSTEM is a compact, pre-assembled, modular system consisting of:
-
Patient module housing an extracorporeal circuit comprised of several previously 510k-cleared devices. The circuit includes a rigid reservoir bag, a centrifugal pump, oxygenator, arterial filter, active air management system, tubing and connectors.
-
Sensors, including flow, pressure, level and bubble to read system parameters.
-
Control module that contains the electronics and user interface.
-
Base module that contains a touch screen, the main power connection and acts as a stable frame for the system.
The modification to the current Lifebridge System is to exchange the current oxygenator, BioCor 200, used in the patient module, for the Medtronic Affinity® NT oxygenator. The Affinity NTC Oxygenator is available with either a Carmeda® BioActive surface coating or a Trillium Biopassive surface coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance testing has been carried out to validate the mitigations and to ensure that the change to the patient module is safe, does not create any new risks and that performance of the modified module is equivalent to that of the original.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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/0 description: The image shows the word "LIFEBRIDGE" in a bold, sans-serif font. Above the word, there are two curved lines that resemble an arch. The word "LIFEBRIDGE" is in all caps, and there is a small symbol to the right of the word.
K10335.7
LIFEBRIDGF Special 5100k1 Additional Information
Special 510(k) Summary
| SUBMITTER: | LIFEBRIDGE® Medizintechnik AG
Simon-Ohm-Str 1
84539 Ampfing Germany | DEC 27 2010 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON: | Kathleen Johnson
Medical Device Approvals, Inc.
Phone: (610) 527-0585
Fax: (610) 527-0584
Mobile: (302) 521-9496. | |
| DATE PREPARED: | November 26, 2010 | |
| DEVICE TRADE NAME: | LIFEBRIDGE SYSTEM | |
| COMMON/USUAL NAME: | Cardiopulmonary Support System | |
| CLASSIFICATION: | Class III per 21 CFR 870.4360 | |
| PRODUCT CODE: | KFM | |
CLASSIFICATION NAMES:
Cardiopulmonary bypass heart/lung machine console (21 CFR 870.4220) Non-roller type cardiopulmonary bypass blood pump (21 CFR 870.4360) Cardiopulmonary bypass vascular catheter, cannulae, or tubing (21 CFR 870.4210) Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting (21 CFR 870.4290) Cardiopulmonary bypass blood reservoir (21 CFR 870.4400) Cardiopulmonary bypass pump speed control (21 CFR 870.4380) Cardiopulmonary bypass oxygenator (21 CFR 870.4350) Cardiopulmonary bypass heat exchanger (21 CFR 870.4240) Cardiopulmonary bypass arterial line blood filter (21 CFR 870.4260) Cardiopulmonary bypass level sensing monitor and/or control (21 CFR 870.4340) Cardiopulmonary bypass bubble detector (21 CFR 870.4205)
PREDICATE DEVICES:
Lifebridge B2T System K090006 Medtronic Affinity NT oxygenator with Carmeda Bioactive Surface K000430 Avecor Affinity Hollow Fiber oxygenator with Trillium Biopassive Surface K973760
DEVICE DESCRIPTION:
The LIFE.BRIDGE SYSTEM is a compact, pre-assembled, modular system consisting of:
-
Patient module housing an extracorporeal circuit comprised of several previously 510k-cleared devices. The circuit includes a rigid reservoir bag, a centrifugal pump, oxygenator, arterial filter, active air management system, tubing and connectors.
-
Sensors, including flow, pressure, level and bubble to read system parameters.
1
Image /page/1/Picture/0 description: The image shows the word "LIFEBRIDGE" in bold, sans-serif font. Above the word is a curved line that resembles a bridge. To the right of the word is a registered trademark symbol.
-
Control module that contains the electronics and user interface.
-
Base module that contains a touch screen, the main power connection and acts as a stable frame for the system.
The modification to the current Lifebridge System is to exchange the current oxygenator, BioCor 200, used in the patient module, for the Medtronic Affinity® NT oxygenator. The Affinity NTC Oxygenator is available with either a Carmeda® BioActive surface coating or a Trillium Biopassive surface coating.
INDICATIONS FOR USE:
The LIFEBRIDGE SYSTEM is indicated for use as an extracorporeal blood oxygenation system for patients needing short term, 6 hours or less, cardiac and/or pulmonary support.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON:
This "Special 510(k)" is being submitted for a modification to the patient module of the Lifebridge System. The modification is to exchange one 510(k) cleared oxygenator for another. Both are hollow fiber membrane oxygenators cleared for short-term cardio-pulmonary support up to 6 hrs.
The major differences between the oxygenators are availability and a surface coating.
The Medtronic Affinity® NT oxygenator provides a surface coating to the large surface area of the oxygenator and the BioCor oxygenator does not. The coating can be nither Carmeda® Bioactive Surface coating or Trillium Biopassive Surface coating.
The modification has been implemented through adherence to Design Controls. Risks posed by the change have been identified and analyzed. Measures to reduce any possible risks hovod been identified. Performance testing has been carried out to validate the mitigations and to ensure that the change to the patient module is safe, does not create any new risks and that performance of the modified module is equivalent to that of the original.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 7 2010
Lifebridge Medizintechnik AG c/o Ms. Kathleen Johnson Medical Device Approvals, Inc. 1282 Round Hill Rd. Bryn Mawr, PA 19010
K103357 Re:
LIFEBRIDGE System Regulation Number: 21 CFR 870.4360 Regulation Name: Non-roller type CPB Pump Regulatory Class: Class III (three) Product Code: KFM Dated: December 13, 2010 Received: December 14, 2010
Dear Ms. Kathleen Johnson:
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.
3
Page 2 - Ms. Kathleen Johnson
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Bram D. Zuckerman, M Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
DEC 2 7 2010
510(k) Number (if known): Device Name:
LIFEBRIDGE
.
Indications For Use: The LIFEBRIDGE is indicated for use as an extracorporcal blood ox ygenation system for patients needing short term, 6 hours or less, cardiac and / or pulmonary support.
AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.
rdiovascular Devices
510(k) Number K083557
Page I of I
11/26/2010
Confidential