(9 days)
No
The device description focuses on the physical characteristics and function of arterial cannulae, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used for perfusion during cardiopulmonary bypass, which is a medical treatment.
No
The device is an arterial cannula used for perfusion during cardiopulmonary bypass. While one model (Select CAP™) has a pressure monitoring port for "accurately measuring central arterial pressure within the aorta," its primary function is for a therapeutic procedure (perfusion), not solely for diagnosis. The pressure monitoring is a supplementary feature to aid in the therapeutic application, not to diagnose a condition.
No
The device description clearly details physical components like PVC bodies, connectors, tips, and a pressure monitoring port, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass." This describes a device used in vivo (within the body) for a surgical procedure.
- Device Description: The description details a physical cannula designed to be inserted into the aorta. This is a surgical instrument, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information. IVDs are typically used in laboratories or point-of-care settings to detect or measure substances in these samples.
Therefore, this device is a surgical/medical device used for a therapeutic procedure, not an in vitro diagnostic device.
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
74 DWF
Device Description
The Select 3D™ and Select CAP™ Arterial Cannulae both have clear flexible, thin w.ill wire-wound PVC bodies with angled, beveled tips. The proximal end of each cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line.
The Select 3D™ Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicate direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). It is available in 22 and 24 Fr sizes.
The Select CAP™ Arterial Cannula tips have an integrated pressure monitoring port. The pressure monitoring port on the tip of the cannulae provides the real time capability of accurately measuring central arterial pressure within the aorta. Overall cannula length is 12" (30.5 cm). It is available in 18, 20, 22, and 24 Fr. sizes.
The devices may include a Carmeda® BioActive Surface.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro visual and functional testing was used to establish the performance characteristic of the materials of these devices after Carmeda® coating. In addition coverage, bioactivity, and leach testing was performed on Carmeda® coated devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K840002, K000776, K013013, K010737, K891687
Reference Device(s)
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
NOV = 5 2003
K033416
f1/2
:
510(k) Summary
| Date Prepared: | October 24, 2003 |
|---|---|
| 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: | Select 3D™ Arterial Cannula
22, 24 Fr. with Carmeda® BioActive Surface
Select CAP™ Arterial Cannula
18, 20, 22, 24 Fr. with Carmeda® BioActive Surface |
| ------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or
tubing |
|-----------------|------------------------------------------------------------------------------|
| Classification: | Class II |
| | Predicate Devices:
Arterial Cannula
K840002, K000776, K013013, K010737 |
| | Extracorporeal Circuit with BioActive Surface |
Extracorporeal Cir
K891687
1
Device Description:
The Select 3D™ and Select CAP™ Arterial Cannulae both have clear flexible, thin w.ill wire-wound PVC bodies with angled, beveled tips. The proximal end of each cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line.
The Select 3D™ Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicate direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). It is available in 22 and 24 Fr sizes.
The Select CAP™ Arterial Cannula tips have an integrated pressure monitoring port. The pressure monitoring port on the tip of the cannulae provides the real time capability of accurately measuring central arterial pressure within the aorta. Overall cannula length is 12" (30.5 cm). It is available in 18, 20, 22, and 24 Fr. sizes.
The devices may include a Carmeda® BioActive Surface.
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 3DTM and Select CAP™ Arterial Cannulae with the same design characteristics. The predicate cannulae were uncoated. The predicate cannulae have the same indications for use, with the addition of the clarification "(6 hours or less)" for the Select CAPTM.
Summary of Performance Data
In vitro visual and functional testing was used to establish the performance characteristic of the materials of these devices after Carmeda® coating. In addition coverage, bioactivity, and leach testing was performed on Carmeda® coated devices.
Conclusion
Medtronic Perfusion Systems has demonstrated that the modified Select 3D™ and Select CAP™ Arterial Cannulae are substantially equivalent to the predicate devices based upon design, test results, and indications for use.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes.
Public Health Service
NOV - 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Perfusion Systems c/o Mr. Ronald W. Bennett Director, Regulatory/Clinical Affairs 7611 Northland Drive N Brooklyn Park, MN 55428-1088
Re: K033416
Select 3D™ Arterial Cannula and Select CAP™ Arterial Cannula with Carmeda® BioActive Surface Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: 74 DWF Dated: October 24, 2003 Received: October 27, 2003
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 W. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1_
510(k) Number (if known): KD3341 b
Device Name:
Select 3D™ Arterial Cannula and Select CAP™ Arterial Cannula with Carmeda® BioActive Surface
Indications for Use:
These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Q. M. C.
of Cardiovascular Devices
510(k) Number K033416
(Optional Format 3-10-98)