(29 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and material properties of a cannula, with no mention of AI or ML.
No
This device is a cannula used for perfusion during cardiopulmonary bypass, which is a supportive function during surgery, not a therapeutic treatment itself.
No
The device is described as an "Arterial Cannula" intended for "perfusion of the ascending aorta during short term (...) cardiopulmonary bypass," which indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines a physical, hardware-based medical device (cannula) with components like a flexible body, tip, suture ring, connector, and obturator. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is an arterial cannula intended for use in perfusion of the ascending aorta during cardiopulmonary bypass. This is a device used within the body during a surgical procedure, not for testing samples outside the body.
The information provided focuses on the physical characteristics, materials, and performance testing related to its function as a surgical tool for delivering fluid to the aorta. There is no mention of analyzing biological samples.
N/A
Intended Use / Indications for Use
These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
Product codes
DWF
Device Description
The EOPA 3D® Arterial Cannula consists of a flexible, thin wall, wirewound body with a tapered distal tip. The tip features depth markings and an adjustable radiopaque suture ring to indicate insertion depth. The proximal end of the cannula terminates in a vented or non-vented connector. An obturator is provided to facilitate cannula insertion and priming. Multiple depth markings, catalog code, and French size are printed on the cannula body. The EOPA 3D® Arterial Cannula is sterile, nonpyrogenic, and single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ascending aorta
Indicated Patient Age Range
Not Found
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
Testing has demonstrated that the EOPA 3D Arterial Cannula is substantially equivalent to the predicate.
The following tests were conducted to demonstrate substantial equivalence of the proposed cap (with alternate material formulation) to the current cap:
- Liquid Leakage: Pass
- Separation Force: Pass
- Unscrewing Torque: Pass
- Resistance to Overriding: Pass
- Stress Cracking: Pass
- Cytotoxicity: Pass
- Sensitization: Pass
- Irritation/Intracutaneous: Pass
- Acute Systemic Toxicity: Pass
- Hemocompatibility: Pass
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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2015
Medtronic, Inc. Chelsea L. Pioske Regulatory Affairs Specialist 7611 Northland Dr. Minneapolis, MN 55428
Re: K150422
Trade/Device Name: EOPA 3D Arterial Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: February 18, 2015 Received: February 19, 2015
Dear Ms. Chelsea Pioske,
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Bram D. Zuckerman -S
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) K150422
Device Name EOPA 3D Arterial Cannula
Indications for Use (Describe)
These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
Page 1 of 1
Image /page/2/Picture/20 description: The image shows the text 'KXXXXXX' on the first line and '1-26' on the second line. The first line is underlined. The text is black on a white background.
3
510(k) Summary
| Date Prepared: | February 18, 2015 |
|---|---|
| Applicant: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establish Registration Number: 2184009 | |
| Contact Person: | Chelsea Pioske |
| Regulatory Affairs Specialist | |
| Phone: (763) 514-9838 | |
| Fax: (763) 367-8361 | |
| E-mail:chelsea.pioske@medtronic.com | |
| Alternate Contact: | Sue Fidler |
| Senior Regulatory Affairs Manager | |
| Medtronic Perfusion Systems | |
| Phone: 763.514.9839 | |
| Fax: | |
| 763.367.8360 | |
| Email: susan.c.fidler@medtronic.com | |
| Trade Name: | |
| Classification Name: | |
| Regulation Number: | |
| Product Classification: | |
| Product Code: | EOPA 3D® Arterial Cannula |
| Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass | |
| 21 CFR 870.4210 | |
| Class II | |
| DWF |
Name of Predicate Device: EOPA 3D Arterial Cannula, Models 78220,78222,78320,78322
Device Description:
The EOPA 3D® Arterial Cannula consists of a flexible, thin wall, wirewound body with a tapered distal tip. The tip features depth markings and an adjustable radiopaque suture ring to indicate insertion depth. The proximal end of the cannula terminates in a vented or non-vented connector. An obturator is provided to facilitate cannula insertion and priming. Multiple depth markings, catalog code, and French size are printed on the cannula body. The EOPA 3D® Arterial Cannula is sterile, nonpyrogenic, and single use.
Indications for Use:
These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
4
Contraindications:
The device is not intended for use except as indicated above.
Comparison to Predicate Devices:
A comparison of the EOPA 3D® Arterial Cannula to the predicate device (the EOPA 3D® Arterial Cannula) indicates the following similarities:
- Intended Use: The intended use is the same as predicate devices.
- Design: The overall design is the same as the predicate.
- Materials: The base material types used are the same as the predicate. The proposed material formulation change of the cap remains polypropylene.
- o Principles of Operation and Technology: The principles of operation are the same as the predicate device.
- Performance: The performance is substantially equivalent to the predicate device. ●
Summarv of Testing
Testing has demonstrated that the EOPA 3D Arterial Cannula is substantially equivalent to the predicate.
The following tests were conducted to demonstrate substantial equivalence of the proposed cap (with alternate material formulation) to the current cap:
| Component | Base Material Changes | Verification/Validation | Results |
|---|---|---|---|
| Luer Cap | Current: Polypropylene | ||
| Proposed: Polypropylene | Liquid Leakage | Pass | |
| Separation Force | Pass | ||
| Unscrewing Torque | Pass | ||
| Resistance to Overriding | Pass | ||
| Stress Cracking | Pass | ||
| Cytotoxicity | Pass | ||
| Sensitization | Pass | ||
| Irritation/Intracutaneous | Pass | ||
| Acute Systemic Toxicity | Pass | ||
| Hemocompatibility | Pass |
Conclusion:
The data included in this submission is sufficient to provide reasonable assurance of the safety and effectiveness of the device and the EOPA 3D® Arterial Cannula is substantially equivalent to the legally marketed predicate device, the EOPA 3D® Arterial Cannula (K061254).