(30 days)
No
The device description and intended use focus on physical components and their function in cannulation, with no mention of AI or ML capabilities.
Yes.
The device is used to cannulate and perfuse vessels or organs, and connect with extracorporeal equipment for cardiopulmonary bypass, which are therapeutic medical procedures.
No
Explanation: The device is used to cannulate vessels, perfuse organs, and connect with extracorporeal equipment, which are therapeutic and interventional actions, not diagnostic.
No
The device description clearly states it is a kit containing physical medical devices (cannulae, introducer, Seldinger needle, guidewire, scalpel blade, dilators, syringe) used for surgical procedures. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the device as being used to "cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment." This involves direct interaction with the patient's circulatory system for therapeutic or supportive purposes (like cardiopulmonary bypass).
- Device Description: The device is a cannula and insertion kit, designed for physically accessing and manipulating blood vessels.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening.
IVDs are typically used to perform tests on samples taken from the body, not to directly interact with the body's systems in the way this cannula does.
N/A
Intended Use / Indications for Use
These devices are to be used by a trained physician only. Cannulae are used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately-sized cannula within the vessel for cardiopulmonary bypass. The Bio-Medicus™ cannulae (18-cm [7.09-in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as a venous return cannula. This product is intended for use up to 6 hours.
Product codes
DWF
Device Description
This kit is a combination of the following two sets of devices:
- Bio-Medicus Adult Cannula and Introducer, cleared on November 18, 2014 (K142673) ●
- Bio-Medicus Insertion Kit, cleared on April 9, 2015 (K150567) ●
The Bio-Medicus Adult Cannula and Introducer is designed to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment and is designed for periods of up to six hours of use.
The Bio-Medicus cannula (18 cm [7.09 in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as a venous return cannula.
Bio-Medicus™ Insertion Kits contains the necessary components to achieve insertion of a Bio-Medicus™ cannula and introducer. The included items are: a Seldinger needle, a guidewire, a scalpel blade, stepped dilators, and a catheter tip syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, femoral position, jugular position
Indicated Patient Age Range
Adult
Intended User / Care Setting
trained physician
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)
Medtronic Bio-Medicus™ Insertion Kit (K150567), Medtronic Bio-Medicus™ Cannula Adult Cannula and Introducer (K142673)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
0
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2016
Medtronic, Inc. Jennifer Tang Principal Regulatory Affairs Specialist 8200 Coral Sea Street Ne Mounds View, Minnesota 55112
Re: K153598
Trade/Device Name: Bio-Medicus™ Adult Cannula Kit Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: December 15, 2015 Received: December 16, 2015
Dear Jennifer Tang:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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" (21 CFR 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,
M.A. Hillebrenner
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
1. Indications for Use Statement
510(k) Number (if known): K153598
Device Name: Bio-Medicus™ Adult Cannula Kit
Indications for Use:
These devices are to be used by a trained physician only. Cannulae are used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately-sized cannula within the vessel for cardiopulmonary bypass. The Bio-Medicus™ cannulae (18-cm [7.09-in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as a venous return cannula. This product is intended for use up to 6 hours.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
3
2.510(k) Summary
| Date Prepared: | December 15, 2015 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration Number: 2184009 | |
| Contact Person: | Jennifer Tang |
| Principal Regulatory Affairs Specialist | |
| Medtronic Perfusion Systems | |
| Phone: (763) 526-6758 | |
| Fax: (763) 367-8360 | |
| Email: Jennifer.tang@medtronic.com | |
| Alternate Contact: | |
| Susan C. Fidler | |
| Sr. Regulatory Affairs Manager | |
| Medtronic Perfusion Systems | |
| Phone: (763) 514-9839 | |
| Fax: (763) 367-8360 | |
| Email: susan.c.fidler@medtronic.com | |
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
| Proprietary Name: | Bio-Medicus™ Adult Cannula Kit |
| Classification: | Classification: Class II |
| Panel: Cardiovascular | |
| Regulation: 21 CFR 870.4210 | |
| Product Code: DWF |
Medtronic Bio-Medicus™ Insertion Kit (K150567) and Medtronic Bio-Predicate Device: Medicus™ Cannula Adult Cannula and Introducer (K142673)
Device Description
This kit is a combination of the following two sets of devices:
- Bio-Medicus Adult Cannula and Introducer, cleared on November 18, 2014 (K142673) ●
- Bio-Medicus Insertion Kit, cleared on April 9, 2015 (K150567) ●
4
The Bio-Medicus Adult Cannula and Introducer is designed to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment and is designed for periods of up to six hours of use.
The Bio-Medicus cannula (18 cm [7.09 in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as a venous return cannula.
Bio-Medicus™ Insertion Kits contains the necessary components to achieve insertion of a Bio-Medicus™ cannula and introducer. The included items are: a Seldinger needle, a guidewire, a scalpel blade, stepped dilators, and a catheter tip syringe.
Indications for Use
These devices are to be used by a trained physician only. Cannulae are used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately-sized cannula within the vessel for cardiopulmonary bypass. The Bio-Medicus™ cannulae (18-cm [7.09-in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as a venous return cannula. This product is intended for use up to 6 hours.
Comparison to Predicate Device
A comparison of the proposed product to the currently marketed Medtronic Bio-Medicus Adult Cannula and Introducer (K142673) and Medtronic Bio-Medicus™ Cannula Adult Cannula and Introducer (K142673) indicates the following similarities:
- Same intended use
- Same operating principle
- Same fundamental technological characteristics
- . Same materials
- Same sterilization requirements ●
- . Same shelf life
A detailed, technological characteristics comparison is provided in section 12 of this submission.
Conclusion
Compared to the predicate devices, the fundamental scientific technology, operating principles, design features, intended use, and shelf life are unchanged. As such, it has been demonstrated that Bio-Medicus Adult Cannula Kit described in this substantially equivalent to the predicate devices.