(30 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the cannula and introducer, with no mention of AI or ML technologies.
No
The device is a cannula and introducer used for cannulating vessels and perfusing organs during cardiopulmonary bypass. While it facilitates a medical procedure, it does not directly treat a disease or condition itself.
No
This device is a cannula and introducer set used for cardiopulmonary bypass to perfuse vessels or organs, not for diagnosing medical conditions.
No
The device description clearly outlines physical components such as polyurethane cannulae, stainless steel wire, connectors, suture rings, PVC introducers, and securement clips. 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 IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used by a trained physician to "Cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment." This involves direct interaction with the patient's body for therapeutic or supportive purposes (cardiopulmonary bypass).
- Device Description: The device is a cannula and introducer set, which are physical instruments used to access and manage blood flow within the body.
- Lack of Diagnostic Purpose: The description does not mention any function related to analyzing samples (blood, tissue, etc.) to diagnose a condition, monitor a disease, or determine compatibility. IVDs are specifically designed for these types of in vitro (outside the body) analyses.
The device is clearly intended for use in vivo (within the body) for medical procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
These devices are to be used by a trained physician only. 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™ 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 venous return cannula. This product is intended for use up to 6 hours.
Product codes
DWF
Device Description
The Bio-Medicus™ Adult Cannulae and Introducer is intended 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 appropriate sized cannula within the vessel for cardiopulmonary bypass.
The Bio-Medicus™ Adult Cannulae and Introducer set consists of adult arterial and venous cannulae and introducer. This submission will focus on the adult venous cannulae only. The adult venous cannulae are all supplied sterile, and non-pyrogenic and are for single use only.
The adult venous cannula consists of:
- o Polyurethane cannula with stainless steel wire-wound multi-port body
- o Non-vented 3/8-in connector
- The overall length of the cannulae is 25.6-in and 30-in o
- Insertion marks that aid in positioning the cannula ●
- o Repositionable suture ring that is radiopaque
The one-piece non-phthalate PVC introducers included with these cannulae have an elongated taper for dilation over a longer distance.
The Bio-Medicus™ Adult Cannulae and Introducer package contains a securement clip which can be used near the insertion site for securement of the cannula body which aides in securement as well as an aide for physician organization. The large venous models (23-25 Fr) also contain a 3/8-in x ½-in tubing adapter with an attached length of 3/8-in tubing to allow connection to a ½in cardio pulmonary bypass circuit.
This new Bio-Medicus™ Adult Cannulae and Introducer set consists of increased number of drainage side holes along the insertable length and the increase of depth markings from every 10cm to every 5cm to further aid in positioning of the cannula. The change is taking place on the 15 French (F) through 25 F adult venous Bio-Medicus cannulae.
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
Bench testing was used to verify the performance characteristics of these devices. Clinical testing was not required to establish substantial equivalence.
The following tests were conducted:
- Blood Trauma Testing ●
- Bioburden Testing
- Pressure Drop Testing ●
- Cannula Testing-Kink During Perfusion ●
- Depth Marking Presence ●
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 22, 2018
Medtronic Inc Huda Yusuf Sr. Regulatory Affairs Specialist 8200 Coral Street NE Mounds View, Minnesota 55112
Re: K180453
Trade/Device Name: Bio-Medicus Adult Cannulae and Introducer Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: February 16, 2018 Received: February 20, 2018
Dear Huda Yusuf:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K180453
Device Name Bio-Medicus Adult Cannulae and Introducer
Indications for Use (Describe)
These devices are to be used by a trained physician only. 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™ 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 venous return cannula. This product is intended for use up to 6 hours.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
510(k) Summary of Safety and Effectiveness
| Date Prepared | February 16, 2018 |
|---|---|
| Applicant | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration No. 2184009 | |
| Contact Person | Ms. Huda Yusuf, M.Sc., RAC |
| Sr. Regulatory Affairs Specialist | |
| Phone: (763) 514-9805 | |
| Fax: (763) 367-8147 | |
| Email: huda.yusuf@medtronic.com | |
| Mike Green, MBA | |
| Regulatory Affairs Manager | |
| Phone: (763) 514-9774 | |
| Fax: (763) 367-8147 | |
| Email: mike.green@medtronic.com | |
| Trade Name | Bio-Medicus™ Adult Cannulae and Introducer |
| Common Name | Cardiopulmonary bypass vascular catheter, cannula, |
| or tubing | |
| Classification Name | Catheter, Cannula and Tubing, Vascular, |
| Cardiopulmonary Bypass | |
| Classification | Class II, 21 CFR 870.4210 |
| Product Code | DWF |
| Name of Predicate Device | Bio-Medicus™ Adult Cannulae and Introducer |
| (K142673) |
4
Device Description
The Bio-Medicus™ Adult Cannulae and Introducer is intended 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 appropriate sized cannula within the vessel for cardiopulmonary bypass.
The Bio-Medicus™ Adult Cannulae and Introducer set consists of adult arterial and venous cannulae and introducer. This submission will focus on the adult venous cannulae only. The adult venous cannulae are all supplied sterile, and non-pyrogenic and are for single use only.
The adult venous cannula consists of:
- o Polyurethane cannula with stainless steel wire-wound multi-port body
- o Non-vented 3/8-in connector
- The overall length of the cannulae is 25.6-in and 30-in o
- Insertion marks that aid in positioning the cannula ●
- o Repositionable suture ring that is radiopaque
The one-piece non-phthalate PVC introducers included with these cannulae have an elongated taper for dilation over a longer distance.
The Bio-Medicus™ Adult Cannulae and Introducer package contains a securement clip which can be used near the insertion site for securement of the cannula body which aides in securement as well as an aide for physician organization. The large venous models (23-25 Fr) also contain a 3/8-in x ½-in tubing adapter with an attached length of 3/8-in tubing to allow connection to a ½in cardio pulmonary bypass circuit.
This new Bio-Medicus™ Adult Cannulae and Introducer set consists of increased number of drainage side holes along the insertable length and the increase of depth markings from every 10cm to every 5cm to further aid in positioning of the cannula. The change is taking place on the 15 French (F) through 25 F adult venous Bio-Medicus cannulae.
Intended 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™ 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 venous return cannula. This product is intended for use up to 6 hours.
5
Contraindications
Alone, the cannula and introducer are not medical treatment devices. The cannula introducer is only to be used with the appropriately-sized Bio-Medicus cannula. These devices are not intended for use, except as indicated above. Do not use if the patient has severe peripheral atherosclerosis or severe arterial dissection.
Comparison to Predicate Devices
A comparison of the Medtronic Bio-Medicus™ Adult Cannulae and Introducer to the predicate device indicates the subject devices are substantially equivalent with the following similarities:
- Same intended use
- Same technological characteristics
- Same operating principle
- Same design features ●
- except for increased number of drainage side holes along the insertable length | and
- । the increase of depth markings from every 10cm to every 5cm to further aid in positioning of the cannula
- the addition of a single marking which is 5cm from the proximal set of holes | to further aid the positioning of the cannula
- Same device and packaging materials ●
- Same sterilization requirements
- Same shelf life
Summary of Performance Data
Bench testing was used to verify the performance characteristics of these devices. Clinical testing was not required to establish substantial equivalence.
The following tests were conducted:
- Blood Trauma Testing ●
- Bioburden Testing
- Pressure Drop Testing ●
- Cannula Testing-Kink During Perfusion ●
- Depth Marking Presence ●
Conclusion
In conclusion, the information included in this submission demonstrates that the Bio-Medious™ Adult Cannulae and Introducer, with the changes made to them, are substantially equivalent to the legally marketed predicate devices.