(45 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a venous cannula, with no mention of AI or ML capabilities.
Yes.
The device is a cannula intended for use in venous drainage during cardiopulmonary bypass surgery, which is a medical procedure aimed at treating a health condition.
No
This device is a cannula used for venous drainage during cardiopulmonary bypass surgery, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical, wire-wound cannula with side ports, insertion depth marks, and optional coating. It is a hardware device used in surgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery." This is a surgical procedure performed directly on a patient's body.
- Device Description: The description details a physical cannula designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health status. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
This device is a surgical instrument used in vivo (within the body) during a medical procedure.
N/A
Intended Use / Indications for Use
This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The MC2 family of cannula, including the new MC2X™ Multi-Stage Venous Cannula, are one piece, wire wound bodies with side ports in the distal tip, with ported atrial basket drainage and with an overall length of 15 ¼". Insertion depth marks aid in positioning the cannula. All are supplied sterile, are non-pyrogenic and are single use. The devices may include a Carmeda® coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Right atrium and inferior vena cava
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)
Collapse, flow, kink and tensile testing were conducted to ensure proper performance. In addition coverage, bio-activity, leaching and functional testing was performed on Carmeda® coated devices.
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
JUL 25 2003
510(k) Summary
| Date Prepared: | July 14, 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: | MC2X TM Multi-Stage Venous Cannula |
|---|---|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or |
| tubing | |
| Classification: | Class II |
| Predicate Devices: | Two Stage Venous Cannula |
| K915268 |
Extracorporeal Circuit with Bio-Active Surface
K891687 |
:
1
K031776
PG 2 of 2
Device Description:
The MC2 family of cannula, including the new MC2X™ Multi-Stage Venous Cannula, are one piece, wire wound bodies with side ports in the distal tip, with ported atrial basket drainage and with an overall length of 15 ¼". Insertion depth marks aid in positioning the cannula. All are supplied sterile, are non-pyrogenic and are single use. The devices may include a Carmeda® coating.
Indication for Use
This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.
Comparison to Predicate Device
The predicate devices are cannulae are Two Stage Venous Cannulae with the same general design characteristics. The predicate 510(k) devices currently marketed have the same indications for use. The predicate devices also provide drainage of the vena cava at the tip and provide atrial drainage. The currently marketed predicate devices include the same French size devices.
Summary of Performance Data
Collapse, flow, kink and tensile testing were conducted to ensure proper performance. In addition coverage, bio-activity, leaching and functional testing was performed on Carmeda® coated devices.
Conclusion
Medtronic Perfusion Systems has demonstrated that the modified MC2X Multi-Stage Venous Cannulae are substantially equivalent to the predicate devices based upon design. test results, and indications for use.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the snakes intertwined around a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 25 2003
Medtronic Perfusion Systems c/o Mr. Ronald W. Bennett Principal Regulatory Affairs Specialist 7611 Northland Boulevard Brooklyn Park, MN 55428
Re: K031776
Trade Name: MC2XTM Multi-Stage Venous Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter cannula Regulatory Class: Class II (two) Product Code: DWF Dated: July 14, 2003 Received: July 15, 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.
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
3
Page 2 - Mr. Ronald W. Bennett
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
h. Qer Q. TUL
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): K031776
Device Name:
MC2XTM Multi-Stage Venous Cannula
Indications for Use:
This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) N
Prescription Use Only
(Optional Format 3-10-98)