(50 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and in vitro testing of a cannula, with no mention of AI or ML technologies.
No
The device is a cannula used for perfusion during cardiopulmonary bypass, which assists in a medical procedure but does not directly treat or cure a disease or condition itself.
No
The device is described as a cannula intended for perfusion of the ascending aorta during cardiopulmonary bypass, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly describes a physical medical device (cannulae) made of PVC with specific dimensions and features, not a software-only product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that this device is a cannula intended for use in the perfusion of the ascending aorta during cardiopulmonary bypass. This is a device used within the body during a surgical procedure.
- Lack of IVD Characteristics: The description does not mention any testing of specimens, analysis of biological samples, or providing diagnostic information based on laboratory results.
Therefore, based on the provided information, this device is a surgical instrument used for direct intervention within the body, not an IVD.
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™ Cannulae have clear flexible, thin wall wire-wound PVC bodies with a tapered distal tip. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The EOPA 3D™ Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body has multiple depth markings, catalog code, and French size marked. Overall cannula length is 12.5" (31.8 cm). It will be available in 20 and 22 Fr sizes and either uncoated or with a Carmeda coating.
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
In vitro visual and functional testing was used to establish the performance characteristic of the changes from the predicate devices This includes visual, functional, and blood trauma testing.
Key Metrics
Not Found
Predicate Device(s)
Select 3D Arterial Cannula K033416, K043179
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
510(k) Summary
| Date Prepared: | May 3, 2006 | JUN 2 3 2006 |
|---|---|---|
| Submitter: | Medtronic Perfusion Systems | |
| 7611 Northland Boulevard | ||
| Brooklyn Park, MN 55428 | ||
| Contact Person: | Ronald W. Bennett | |
| Principal Regulatory Affairs Specialist | ||
| Phone: (763)-391-9086 | ||
| Fax: (763) 391-9603 |
Device Name and Classification:
Trade Name: EOPA 3D™ Arterial Cannula Models 78220, 78222, 78320, 783222
Cardiopulmonary bypass vascular catheter, cannula or tubing
· .
Classification:
Predicate Devices: Select 3D Arterial Cannula K033416, K043179
Class II
1
Device Description:
The EOPA 3D™ Cannulae have clear flexible, thin wall wire-wound PVC bodies with a tapered distal tip. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The EOPA 3D™ Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body has multiple depth markings, catalog code, and French size marked. Overall cannula length is 12.5" (31.8 cm). It will be available in 20 and 22 Fr sizes and either uncoated or with a Carmeda coating.
Indication for Use
These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
Comparison to Predicate Device
The predicate devices are Select 3D™ Arterial Cannulae with the same design characteristics. The modified devices use a straight body with the Select 3D Arterial Cannula diffuse flow tip.
Summary of Performance Data
In vitro visual and functional testing was used to establish the performance characteristic of the changes from the predicate devices This includes visual, functional, and blood trauma testing.
Conclusion
Medtronic Perfusion Systems has demonstrated that the modified EOPA 3D™ and Arterial Cannulae are substantially equivalent to the predicate devices based upon design, test results, and indications for use.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2006
Medtronic Perfusion Systems Ronald W. Bennett Principal Regulatory Affairs Specialist 7611 Northland Drive N. Brooklyn Park, MN 55428
Re: K061254
Trade Name: EOPA 3D Arterial Cannula, Models 78220,78222,78320.78322 Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula or tubing Regulatory Class: II (two) Product Code: DWF Dated: May 3. 2006 Received: May 4, 2006
Dear Mr. Bennett:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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.
3
Page 2 - Mr. Ronald Bennett
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
vuna R. Vahner
Bram D. Zuckerman, M. D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 06 (254
Device Name: EOPA 3D™ Arterial Cannula
Indications for Use:
These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
Prescription Use X ______ (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 - 1 - 1 - 1 -
una be line
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(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Kole) 254