(23 days)
Not Found
No
The document describes a physical medical device (cannula) and its intended use and testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
This device is a cannula used in cardiopulmonary bypass surgery for venous drainage, which is a therapeutic intervention.
No
The device is described as a cannula intended for venous drainage during surgery, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical cannula with specific dimensions, materials (implied by "cannula"), and physical features like side ports and insertion depth marks. The performance studies also involve physical testing (visual inspection, collapse, flow, kink, tensile testing). This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for venous drainage during cardiopulmonary bypass surgery. This is a surgical procedure performed directly on a patient's body.
- Device Description: The description details a cannula designed for insertion into the body for fluid drainage.
- 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, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a surgical 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.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The MC2X™ Multi-Stage Venous Cannulae are cannula with with with an approximate The MC2X™ Multi-Stage Vehous Calimitat are camage and with an appoximate side ports in the distal tip, with ported arrial basket drainage and with an any side ports in the distal tip, with ported annor ousset online the cannula. All are overall length of 15 ¼". Insertion depth marks and in positioning the cannula. All are a overall length of 15 % . Insertion depth mains are single use. The devices may include a supplied sterile, are non-pyrogenic and are single use. The devices may include atte supplied sterile, are non-pyrogenc and are smgre ass. The artistion with tubing attached with a quick disconnect.
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)
Qualification including visual inspection, collapse, flow, kink and tensile testing were Qualification including Visual inspection, conapos, as is, "Are and to qualify the 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
K 052372
SEP 2 2 2005
510(k) Summary
| Date Prepared: | August 24, 2005 |
|---|---|
| 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™ Multi-Stage Venous Cannula |
|---|---|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or |
| tubing | |
| Classification: | Class II |
| Predicate Devices: | MC2X™ Multi-Stage Venous Cannula |
| K031776 |
.
1
Device Description:
Device Description:
The MC2X™ Multi-Stage Venous Cannulae are cannula with with with an approximate The MC2X™ Multi-Stage Vehous Calimitat are camage and with an appoximate
side ports in the distal tip, with ported arrial basket drainage and with an any side ports in the distal tip, with ported annor ousset online the cannula. All are
overall length of 15 ¼". Insertion depth marks and in positioning the cannula. All are
a overall length of 15 % . Insertion depth mains are single use. The devices may include a
supplied sterile, are non-pyrogenic and are single use. The devices may include atte supplied sterile, are non-pyrogenc and are smgre ass. The artistion with tubing attached with a quick disconnect.
Indication for Use
Indication for Use
This cannula is intended for use in venous drainage via the right atrium and inferior vena
nd in intended for use in the change colores surgery I his cannula is intended for assessionulmonary bypass surgery.
Comparison to Predicate Device
Comparison to Predicate Device
The predicate devices are Two Stage Venous Cannulae with the same The predicate devices are Two Stage Venous Currently marketed have the same
characteristics. The predicate 510(k) devices currently marketed have cav characteristics. The predicate devices also provide drainsee of the vena cava at the vena cava at the draina indications for use. The predicale devices and provee a change to the size of the size of the drainage tip and provide atrial drainage. The new models have a thing
basket, a slight change to the shape of the tip, and a three piece rather than one piece construction.
Summary of Performance Data
Summary of Performance Data
Qualification including visual inspection, collapse, flow, kink and tensile testing were Qualification including Visual inspection, conapos, as is, "Are and to qualify the devices.
Conclusion
Conclusion
Medtronic Perfusion Systems has demonstrated that the modified MC2X Multi-Stage Meditonic Perfusion Systems itas demonstrated that the mount .
Venous Cannulae are substantially equivalent to the predicate devices based upon design, test results, and indications for use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
SEP 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Perfusion Systems c/o Mr. Ronald W. Bennett Principal Regulatory Affairs Specialist 7611 Northland Drive N Brooklyn Park, MN 55428
K052372 Re:
MC2XTM Multi-Stage Venous Cannula MC2X
Regulation Number: 21 CFR 870.4210 Regulation Number: 21 CFR 870.4210
Regulation Name: Cardiopulmonary Bypass Catheter, Cannula, Tubing
Cannula, Name: Cardiopulmonary Bypass Catheter, Cannula, Tubing Regulatory Class: II Product Code: DWF Dated: August 26, 2005 Received: August 30, 2005
Dear Mr. Bennett:
We have reviewed your Section 510(k) premarket notification of intent to market the device
ty the indication in the county of the device is substantially equivalent (for the We have reviewed your Section 5 I ((L) premium in the invision in the indications
referenced above and have described is substantially equivalent (for the indications referenced above and have deemined the useved is subscate devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device (Device Amendme for use stated in the enclosure) to legally market production Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medice Americe America commerce prior to May 28, 1976, the enactinent with the provisions of the Federal Food, Drug, devices that have been reclassities in accordance while the one over and application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. T and Cosmetic Act (Act) that do not require approval or the general controls of the Act. The Act. The Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the general connect projection, listing of
general controls provisions of the Act include requirements for annual registrati general controls provisions of the Act include requirements for allering and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
in the can and the collection in the Frighting major regulations aff If your device is classified (see above) into entire) in the major regulations affecting your device can
may be subject to such additional controls. Existing major regulatio may be subject to such additional controls: Exismig major regalato 898. In addion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addi be found in the Code of Federal Regulations, True 20, 2017
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
ts of the Actively and and the see device complies with other requirements of t Please be advised that FDA's issuance of a substantial complies with other requirements of the Act
that FDA has made a determination that your device onmilies . You must that FDA has made a determination in anyon division other Federal agencies. You must
or any Federal statutes and regulations administered by other for registration and list or any Federal statutes and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but not mornies teaminents as set comply with all the Act s requirements, including, out not minount as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (2) CFR Part 801); good manufacturing platf applicable, the electronic
forth in the quality systems (QS) regulation (2) CFR Part 820); and 1f applica forth in the quality systems (QS) regulation (21 CFR 1600), and 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action 5 product radiation control provisions (Sections 55 cm device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a This letter will allow you to begin marketing your acvice of your device of your device to a legally
premarket notification. The FDA inding of substantial equiralevice and t premarket notification. The FDA finding of substantial equice 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
r the are and the many of the case one ... Algo, mlesse note the regulation If you desire specific advice for your device on our acoming the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please not the regulation of contact the Office of Compliance at (240) 270-01-01. The Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obta "Misbranding by reference to premarket nouthcapor " (216) x f x f x f x r x r x = Division of Small
other general information on your responsibilities under the Act from the other general information on your responsionities uner the fires musices and of the many of index. In the Manufacturers, International and Consumer Assistance at 10 for noo and 2011 - 10:10 pm
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/inde
Sincerely yours,
Donna R. Lochner
Image /page/3/Picture/5 description: The image contains a handwritten symbol or signature. It appears to be a stylized combination of curved lines and a diagonal stroke. The symbol is compact and has a slightly abstract quality, making it difficult to discern a specific letter or shape.
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): Ko 593 3 3
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.
Prescription Use __ × (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)
DANA R. Vichner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Ko 523 7 2
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