(53 days)
Not Found
No
The summary describes a physical medical device (catheter and introducer) used in extracorporeal support procedures. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes
The device is used in extracorporeal cardiopulmonary bypass (CPB), Extracorporeal Membrane Oxygenation (ECMO), and Extracorporeal Life Support (ECLS) procedures to perfuse vessels or organs in patients with acute respiratory or acute cardiopulmonary failure, which are all therapeutic interventions aimed at supporting or replacing organ function.
No
The device is described as a "peripheral-access catheter" used in procedures like CPB, ECMO, and ECLS to perfuse vessels or organs, or to drain/reinfuse blood. Its purpose is to facilitate treatment by providing access for extracorporeal support, not to diagnose a condition.
No
The device description clearly describes a physical catheter and introducer, which are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a catheter used to drain or reinfuse blood directly into vessels or organs during extracorporeal procedures like CPB, ECMO, and ECLS. It is a device that interacts directly with the patient's circulatory system, not a test performed on a sample outside the body.
- Intended Use: The intended use is to support the patient's cardiopulmonary function by managing blood flow during these procedures, not to diagnose a condition based on a sample analysis.
Therefore, this device falls under the category of a medical device used for treatment and support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Cardiopulmonary Bypass (CPB): Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours.
Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS): The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory or acute cardiopulmonary failure. where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
Product codes
QHW, DWF
Device Description
The Bio-Medicus Life Support™ catheter is a single-lumen catheter used to drain or reinfuse blood. The introducer facilitates proper insertion and placement of the appropriately sized catheter over a guidewire within the vessel. These devices are intended to perfuse vessels or organs in conjunction with extracorporeal support, including cardiopulmonary bypass (CPB), Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS). Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in), with and without additional side holes may be used as either drainage or reinfusion catheters.
These devices are sterile, nonpyrogenic, disposable, intended for single use only. Do not store the product above 25℃ (77°F).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels or organs
Indicated Patient Age Range
adult and pediatric patients
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)
Bench studies were performed after device preconditioning including exposure (21 days) to simulated in vivo use conditions to demonstrate safety and reliability. Risk-based testing and evaluations to qualify this change included product functional testing and biocompatibility assessment. Results: Pass
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
Not Found
§ 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
(a)
Identification. An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).(b)
Classification —Class II (special controls). The special controls for this device are:(1) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible;
(2) The devices and accessories in the circuit must be demonstrated to be biocompatible;
(3) Sterility and shelf-life testing must demonstrate the sterility of any patient-contacting devices and accessories in the circuit and the shelf life of these devices and accessories;
(4) Non-clinical performance evaluation of the devices and accessories in the circuit must demonstrate substantial equivalence of the performance characteristics on the bench, mechanical integrity, electromagnetic compatibility (where applicable), software, durability, and reliability;
(5) In vivo evaluation of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the clinical evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness if a specific indication (patient population and/or condition) is identified; and
(6) Labeling must include a detailed summary of the non-clinical and in vivo evaluations pertinent to use of the devices and accessories in the circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 19, 2024
Medtronic Inc. Kimberly Peterson Regulatory Affairs Director 8200 Coral Sea St. NE Mounds View, Minnesota 55112
Re: K240534
Trade/Device Name: Bio-Medicus Life Support Catheter and Introducer Regulation Number: 21 CFR 870.4100 Regulation Name: Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure Regulatory Class: Class II Product Code: QHW, DWF Dated: February 23, 2024 Received: February 26, 2024
Dear Kimberly Peterson:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Nicole M. Gillette -S
Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
K24053
Device Name
Bio-Medicus Life Support Catheter and Introducer
Indications for Use (Describe)
Cardiopulmonary Bypass (CPB):
Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours.
Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS): The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory or acute cardiopulmonary failure. where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
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
510(k) Summary
| Date Prepared: | February 23, 2024 |
|---|---|
| Applicant: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration Number: 2184009 | |
| Contact Person: | Anna Wetherille |
| Sr. Regulatory Affairs Specialist | |
| Medtronic Perfusion Systems | |
| Phone: (612) 810-9450 | |
| Email: anna.wetherille@medtronic.com | |
| Alternate Contact: | Kimberly Peterson |
| Regulatory Affairs Manager | |
| Medtronic Perfusion Systems | |
| Phone: (763) 526-6751 | |
| Email: kimberly.m.peterson@medtronic.com | |
| Device Name and Classification | |
| Trade Name: | Bio-Medicus Life Support™ Catheter and Introducer |
| Common Name: | |
| Classification Name: | Extracorporeal Life Support Single Lumen Catheter |
| Extracorporeal circuit and accessories for long-term | |
| respiratory/cardiopulmonary failure | |
| Regulation Number: | 21 CFR 870.4100 |
| Product Code: | |
| Classification: | QHW |
| II (with special controls) | |
| Common Name: | Extracorporeal Life Support Single Lumen Catheter |
| Cardiopulmonary bypass vascular catheter, cannula, or tubing | |
| Classification Name: | |
| Regulation Number: | |
| Product Code: | |
| Classification: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass |
| 21 CFR 870.4210 | |
| DWF | |
| II | |
| Predicate Device: | Bio-Medicus Life Support™ Catheter and Introducer (K201057, |
| K201100) |
4
Device Description
The Bio-Medicus Life Support™ catheter is a single-lumen catheter used to drain or reinfuse blood. The introducer facilitates proper insertion and placement of the appropriately sized catheter over a guidewire within the vessel. These devices are intended to perfuse vessels or organs in conjunction with extracorporeal support, including cardiopulmonary bypass (CPB), Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS). Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in), with and without additional side holes may be used as either drainage or reinfusion catheters.
These devices are sterile, nonpyrogenic, disposable, intended for single use only. Do not store the product above 25℃ (77°F).
Extracorporeal membrane oxygenation (ECMO): Bench studies were performed after device preconditioning including exposure (21 days) to simulated in vivo use conditions to demonstrate safety and reliability.
Indications for Use
Cardiopulmonary Bypass (CPB):
Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7
in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours.
Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS):
The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
Contraindications
Alone, the catheter and introducer are not medical treatment devices. The introducer is to be used only with the appropriately sized Bio-Medicus Life Support catheter. These devices are intended for use only as indicated in these instructions for use. Do not insert the catheter in a vessel that has arterial dissection or severe peripheral atherosclerosis.
Comparison to Predicate Device
A comparison of the of the modified devices to the currently marketed predicate device (K201057, K201100) indicates the subject devices are substantially equivalent with the following similarities:
5
- Same intended use and labeling ●
- Same technological characteristics
- Same operating principle ●
- Same design features
- Same sterilization requirements, methods, and parameters ●
- Same shelf life
- Same packaging materials and configuration ●
The following device modification was made to the predicate device:
-
Luer cap material formulation change (vented connector models) ●
The Bio-Medicus Life Support™ Catheter and Introducer device meets all special controls identified in 21 CFR 870.4100, as follows: -
Technological Characteristics: The geometry and design parameters of the subject ● device are consistent with the device's intended use in extracorporeal support procedures, and the device is compatible with the other devices and accessories in the extracorporeal circuit.
-
Biocompatibility: The subject device is demonstrated to be biocompatible as a ● prolonged use device in accordance with ISO 10993-1:2018 and with FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (8 September 2023).
-
Sterility and Shelf-life: Sterilization adoption evaluation and shelf-life testing demonstrate that the subject device maintains its sterility, integrity, durability, and reliability over the stated shelf life of the device.
-
Non-clinical Performance: Substantial equivalence of the performance characteristics ● is demonstrated on bench, mechanical integrity, durability, and reliability testing.
-
In vivo Evaluation: In vivo evaluation demonstrates the subject device's performance ● over a 7-day duration of use.
-
Labeling: The Instructions for Use include a detailed summary of the non-clinical and . in vivo evaluations pertinent to use of the device in an extracorporeal circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure.
Summary of Performance Testing
Testing has demonstrated the Bio-Medicus Life-Support Catheter and Introducers are substantially equivalent to the predicate device. The tests summarized in Table 7-1 were conducted to demonstrate substantial equivalence of the proposed alternate luer cap (with alternate material formulation) to the predicate device.
6
| Component | Material Change | Design Verification and
Validation | Results |
|-----------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------|
| Luer cap | The luer cap used on vented connector
models has undergone a supplier and
material formulation change. | Risk-based testing and evaluations to
qualify this change included product
functional testing and
biocompatibility assessment. | Pass |
Table 1: Summary of Changes from Predicate Device
Conclusion
The information included in this submission demonstrates that the modified Medtronic Bio-Medicus Life Support Catheter and Introducer is substantially equivalent to the legally marketed predicate device, Bio-Medicus Life Support Catheter and Introducer (K201057, K201100).