(30 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the cannula and introducer kit. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is used to cannulate and perfuse vessels/organs and connect with extracorporeal equipment for cardiopulmonary bypass, but it does not directly provide therapy. It facilitates a medical procedure rather than administering a therapeutic substance or action itself.
No
The device is a cannula kit intended for procedures like cannulating vessels, perfusing organs, and connecting to extracorporeal equipment for cardiopulmonary bypass. Its function is to facilitate physical access and fluid transfer, not to diagnose a condition.
No
The device description clearly outlines physical components such as cannulae, needles, guidewires, scalpels, dilators, and syringes. These are all hardware components, indicating the device is not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment." This describes a device used in vivo (within the body) for surgical and circulatory support procedures.
- Device Description: The device is a cannula kit containing components for inserting a cannula into a blood vessel. This is a surgical/medical device, not a device used to examine specimens in vitro (outside the body).
- No mention of analyzing biological samples: The text does not describe the device being used to analyze blood, tissue, or any other biological sample for diagnostic purposes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on facilitating a medical procedure within the body.
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 (comma separated list FDA assigned to the subject device)
DWF
Device Description
Bio-Medicus Cannula Kits contains the necessary components to achieve insertion of a Bio-Medicus cannula and introducer. The included items are: Adult Cannula and Introducer (in various sizes), a Seldinger needle, a guidewire, a scalpel blade, stepped dilators, and or a catheter tip syringe.
The Bio-Medicus Cannula Kit is intended to be 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 appropriate sized cannula within the vessel for cardiopulmonary bypass.
The Bio-Medicus Cannula Kit set consists of adult arterial and venous cannulae and introducer:
All kits are provided sterile and nonpyrogenic, disposable, and for single use only and comprised of:
- Adult Arterial and Venous Cannulae (in numerous sizes)
- Seldinger Needle
- Scalpel Blade
- Catheter Tipped Syringe ●
- Appropriately Sized Dilators and Guidewires ●
This submission will focus on the adult venous cannulae only and there are no other changes to the remaining kit components. The adult venous cannulae are all supplied sterile, and nonpyrogenic and are for single use only.
The adult venous cannula consists of:
- 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 ●
- 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 adult venous cannula 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 ½-in cardio pulmonary bypass circuit.
This new adult venous cannulae consists of increased number of drainage side holes along the insertable length and the increase of depth markings from 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 cannulae.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels
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)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 870.4210 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
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March 22, 2018
Medtronic Inc. Huda Yusuf Sr. Regulatory Affairs Specialist 8200 Coral Street NE Mounds View, Minnesota 55112
Re: K180456
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: 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) K180456
Device Name
Bio-Medicus Adult Cannula Kit
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 Cannula Kit | |
| 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 | Medtronic Bio-Medicus Adult Cannula Kit
(K153598) | |
4
Device Description
Bio-Medicus Cannula Kits contains the necessary components to achieve insertion of a Bio-Medicus cannula and introducer. The included items are: Adult Cannula and Introducer (in various sizes), a Seldinger needle, a guidewire, a scalpel blade, stepped dilators, and or a catheter tip syringe.
The Bio-Medicus Cannula Kit is intended to be 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 appropriate sized cannula within the vessel for cardiopulmonary bypass.
The Bio-Medicus Cannula Kit set consists of adult arterial and venous cannulae and introducer:
All kits are provided sterile and nonpyrogenic, disposable, and for single use only and comprised of:
- Adult Arterial and Venous Cannulae (in numerous sizes)
- Seldinger Needle
- Scalpel Blade
- Catheter Tipped Syringe ●
- Appropriately Sized Dilators and Guidewires ●
This submission will focus on the adult venous cannulae only and there are no other changes to the remaining kit components. The adult venous cannulae are all supplied sterile, and nonpyrogenic and are for single use only.
The adult venous cannula consists of:
- 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 ●
- 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 adult venous cannula 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 ½-in cardio pulmonary bypass circuit.
This new adult venous cannulae consists of increased number of drainage side holes along the insertable length and the increase of depth markings from 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 cannulae.
5
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.
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 Kit to the predicate device indicates the subject devices are substantially equivalent with the following similarities:
- Same intended use
- o 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
6
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-Medicus Adult Cannula Kits, with the changes made to them, are substantially equivalent to the legally marketed predicate devices.