(149 days)
No
The device description and performance studies focus on the physical characteristics and biological compatibility of the cannulae and introducers, with no mention of AI or ML capabilities.
Yes
The device is used to cannulate and perfuse vessels for cardiopulmonary bypass, which is a therapeutic intervention.
No
The device description and intended use indicate that these are cannulae and introducers used for infusing or withdrawing fluids from vessels, primarily for cardiopulmonary bypass. There is no mention of diagnostic capabilities such as generating images, analyzing biological samples for disease detection, or providing diagnostic information. The performance studies focus on physical and biological compatibility, not diagnostic accuracy.
No
The device description clearly outlines physical components made of polyurethane and PVC, indicating it is a hardware device, not software-only.
Based on the provided information, 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 directly on or within the patient's body for therapeutic or procedural purposes.
- Device Description: The description details physical components like cannulae, introducers, and connectors, which are used for accessing and manipulating blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or compatibility testing. IVDs typically involve reagents, analyzers, or test kits used in a laboratory setting or at the point of care for analyzing biological samples.
This device is clearly an invasive medical device used in a surgical or procedural setting, not an in vitro diagnostic device.
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. These products are intended for use up to 6 hours.
Product codes
DWF
Device Description
The pediatric venous cannulae consist of a polyurethane wirewound body with a multi-port distal tip. All pediatric venous cannulae come with a non-vented 1/4-in connector. The one-piece nonphthalate PVC blunt and guidewire style introducers and included with these cannulae have an elongated taper for dilation over a longer distance.
The pediatric arterial cannulae consist of a polyurethane wirewound body and distal tip. All of the pediatric arterial cannulae come with a non-vented 1/4-in connector. The one-piece nonphthalate PVC blunt and guidewire introducers included with these cannulae have an elongated taper for dilation over a longer distance.
Sterile, nonpyrogenic disposable, single use only
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels
Indicated Patient Age Range
Pediatric
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)
Pre-clinical bench testing was used to verify the performance characteristics of this device. Animal testing was also completed to establish substantial equivalence with the predicate devices.
The following performance tests were conducted and passed:
- Blood Trauma Testing
- . Sterilization Testing
- Packaging Testing ●
- . Pressure Drop Testing
- Cannula Shelf Life Testing ●
- Cannula and Introducer Performance Testing .
- Cannula Testing ●
- Introducer Testing .
- Securement Clip Testing with Cannula and Introducer ●
- . Biocompatibility Testing (all blood contacting surfaces)
- Cytotoxicity l
- Sensitization -
- Intracutaneous Toxicity -
- Pyrogenicity -
- Genotoxicity -
- Hemocompibility -
- Subacute Toxicity -
Biocompatibility testing was performed in accordance with ISO 10993-1 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process. Performance and biological tests confirm that the Medtronic Bio-Medicus Pediatric Arterial and Venous Cannulae product met pre-determined acceptance criteria and is substantially equivalent to the predicate device.
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
§ 870.4210 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol resembles an abstract human figure embracing the world, representing the department's mission to protect and enhance the health and well-being of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MAR 2 7 2015
Medtronic, Inc Bruce Backlund Principal Regulatory Affairs Specialist 8200 Coral St Ne Mounds View, Minnesota 55112
Re: K143083
Trade/Device Name: Bio-Medicus Pediatric Cannulae and Introducers Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: February 9, 2015 Received: February 11, 2015
Dear Mr. Backlund,
This letter corrects our substantially equivalent letter of March 25, 2015.
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
1
Page 2 - Bruce Backlund
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 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. Lillehammer
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) K143083
Device Name
Bio-Medicus Pediatric Cannulae and Introducers
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. These products are intended for use up to 6 hours.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary of Safety and Effectiveness
| Date Prepared: | October 23, 2014 |
|---|---|
| Applicant: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establish Registration Number: 2184009 | |
| Contact Person: | Bruce Backlund |
| Principal Regulatory Affairs Specialist | |
| Phone: (763) 526-2357 | |
| Fax: (763) 367-8361 | |
| E-mail:bruce.j.backlund@medtronic.com | |
| Trade Name: | Bio-Medicus™ Pediatric Cannulae and Introducers |
| 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 Devices: | Bio-Medicus™ Cannula-Tubing |
| (K872033) | |
| DLP Pediatric™ One-Piece Arterial Cannulae | |
| (K024069) |
Device Description:
The pediatric venous cannulae consist of a polyurethane wirewound body with a multi-port distal tip. All pediatric venous cannulae come with a non-vented 1/4-in connector. The one-piece nonphthalate PVC blunt and guidewire style introducers and included with these cannulae have an elongated taper for dilation over a longer distance.
The pediatric arterial cannulae consist of a polyurethane wirewound body and distal tip. All of the pediatric arterial cannulae come with a non-vented 1/4-in connector. The one-piece non
4
phthalate PVC blunt and guidewire introducers included with these cannulae have an elongated taper for dilation over a longer distance.
Sterile, nonpyrogenic disposable, single use only
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. These products are intended for use up to 6 hours.
Contraindications:
Alone, the cannula and introducer are not medical treatment devices. The introducer is to be used only with the appropriately-sized Bio-Medicus™ cannula. These devices are not intended for use except as indicated above.
Comparison to Predicate Devices:
A comparison of the Medtronic Bio-Medicus Pediatric Arterial and Venous Cannulae to the predicate devices indicates the following similarities:
- . Same intended use
- . Same technological characteristics
- Same operating principle .
- . Similar design features, exceptions include improved transition between the introducer body and cannula tip to increase ease of cannula insertion, and an added radiopaque suture ring.
- Similar materials, exceptions include the introducer material which has changed from ● Polyethylene to Polyvinyl Chloride (PVC), connector material from Polycarbonate to PVC and hemostasis cap material from Styrene to Silicone.
- Same shelf life .
5
Summary of Performance Data
Pre-clinical bench testing was used to verify the performance characteristics of this device. Animal testing was also completed to establish substantial equivalence with the predicate devices.
The following performance tests were conducted and passed:
- Blood Trauma Testing
- . Sterilization Testing
- Packaging Testing ●
- . Pressure Drop Testing
- Cannula Shelf Life Testing ●
- Cannula and Introducer Performance Testing .
- Cannula Testing ●
- Introducer Testing .
- Securement Clip Testing with Cannula and Introducer ●
- . Biocompatibility Testing (all blood contacting surfaces)
- Cytotoxicity l
- Sensitization -
- Intracutaneous Toxicity -
- Pyrogenicity -
- Genotoxicity -
- Hemocompibility -
- Subacute Toxicity -
Biocompatibility testing was performed in accordance with ISO 10993-1 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process. Performance and biological tests confirm that the Medtronic Bio-Medicus Pediatric Arterial and Venous Cannulae product met pre-determined acceptance criteria and is substantially equivalent to the predicate device.
Conclusion:
The primary predicate device, Bio-Medicus™ Cannula-Tubing was used to compare the fundamental technological characteristics of the proposed Bio-Medicus Pediatric Arterial and Venous Cannula and Introducer. When comparative testing was completed, the proposed Bio-Medicus Pediatric Cannulae and Introducer performed as well or better than the legally marketed devices.
6
The data included in this submission is sufficient to provide reasonable assurance that the Bio-Medicus Pediatric Arterial and Venous Cannulae and Introducers are substantially equivalent to the legally marketed predicate Bio-Medicus Cannula-Tubing (K872033) device.
: