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.

AI/ML Overview

This 510(k) summary describes a resubmission for the MC2X™ Multi-Stage Venous Cannula, which is a Class II device used in cardiopulmonary bypass surgery. The resubmission is for a modified version of the previously cleared MC2X™ Multi-Stage Venous Cannula (K031776).

The provided text focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria related to a novel device's clinical performance. Therefore, typical acceptance criteria tables and detailed study results demonstrating clinical efficacy or diagnostic accuracy are not present.

However, based on the provided text, we can infer the acceptance criteria for determining substantial equivalence and describe the study that demonstrates the device meets these criteria.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this resubmission are implicitly defined by the demonstration of substantial equivalence to the predicate device. The "study" conducted is a series of bench tests and a comparison of characteristics to the predicate device.

Acceptance Criteria Category	Specific Criterion (Implicit)	Reported Device Performance
Design Characteristics	The modified device's design characteristics (e.g., presence of side ports, atrial basket drainage, overall length, materials, construction) should be equivalent or demonstrably safe and effective despite changes, compared to the predicate device.	The modified device maintains: - Approximate side ports in the distal tip. - Ported atrial basket drainage. - Overall length of 15 ¼ inches. - Insertion depth marks. - Sterile, non-pyrogenic, single-use status. - Option for tubing attached with a quick disconnect. Changes: 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." These changes are implicitly deemed acceptable based on testing.
Material Composition	The materials used in the modified device should be equivalent or demonstrably safe and effective for the intended use.	Implied to be equivalent or suitable for the intended use, as no specific material changes raising new safety/effectiveness questions are highlighted beyond structural construction.
Functional Performance (Bench Testing)	The device must meet established performance benchmarks for critical functions in a controlled environment, demonstrating no adverse impact from design changes.	Qualification tests included: - Visual inspection - Collapse test - Flow test - Kink test - Tensile testing Conclusion: These tests "were performed to qualify the devices," indicating successful performance and implicitly meeting internal specifications derived from the predicate device's performance.
Intended Use/Indications for Use (IFU)	The fundamental intended use of the device should remain the same as the predicate device.	Predicate IFU: "venous drainage via the right atrium and vena cava..." Modified Device IFU: "venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery." The IFU is stated to be essentially the same: "The predicate devices also provide drainage of the vena cava at the vena cava at the drainage indications for use." The minor rephrasing for "simultaneously" does not indicate a new intended use.
Safety and Effectiveness (Implicit from Substantial Equiv.)	The modified device should be as safe and effective as the legally marketed predicate device.	The conclusion states: "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." This implicitly means that safety and effectiveness are considered maintained.

Study Details

The "study" conducted for this 510(k) submission is a series of bench tests and a direct comparison to the predicate device's characteristics. This is a retrospective comparison to an already cleared device, supplemented by prospective bench testing on the new design.

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as "sample size" in the context of a clinical trial. For bench testing, the sample size would refer to the number of devices or components tested for each specific qualification test (e.g., number of cannulae subjected to flow testing). This number is not provided in the summary.
- Data Provenance: The data is generated internally by Medtronic Perfusion Systems through bench testing ("Qualification including visual inspection, collapse, flow, kink and tensile testing were performed to qualify the devices.") and a direct comparison of specifications to their own previously cleared predicate device (K031776). This is prospective data generation for the physical properties of the new device, but a retrospective comparison to the predicate device's cleared characteristics and performance.
- Country of Origin: Implied to be the USA, where Medtronic Perfusion Systems is located.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This type of information is not applicable to a 510(k) submission based on bench testing and substantial equivalence. Ground truth in this context is established by engineering specifications, validated test methods, and regulatory requirements rather than subjective expert assessment of images or clinical outcomes on a test set.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies where there's a need to resolve discrepancies in expert opinions on clinical endpoints or image interpretations. This submission relies on objective engineering tests.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was NOT done. This type of study investigates diagnostic efficacy or reader performance, typically with AI-assisted interpretation of medical images. The device in question is a physical medical device (cannula), not an AI-driven diagnostic tool.
Standalone (Algorithm Only) Performance Study:
- No, a standalone performance study in the context of an algorithm's performance was NOT done. This submission is for a physical medical device, not an algorithm or AI. The "standalone" performance here refers to the device's functional integrity as demonstrated in bench tests.
Type of Ground Truth Used:
- The "ground truth" for this submission is established through:
  - Engineering specifications and design requirements: These define the target performance and characteristics for the device.
  - Physical measurements and validated bench testing: Objective data from tests like flow, tensile, collapse, and kink provide the "truth" about the device's physical and functional properties.
  - Regulatory standards and predicate device characteristics: The established safety and effectiveness profile of the predicate device (K031776) serves as the benchmark against which the modified device's equivalence is assessed.
Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of an AI/ML algorithm. This device is a physical medical device. The "training" in the engineering sense would be the iterative design and development process, which doesn't involve a distinct "training set" of data for an algorithm.
How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 7.

Summary

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K 052372

SEP 2 2 2005

510(k) Summary

Date Prepared:	August 24, 2005
Submitter:	Medtronic Perfusion Systems7611 Northland BoulevardBrooklyn Park, MN 55428
Contact Person:	Ronald W. BennettPrincipal Regulatory Affairs Specialist
	Phone: (763)-391-9086Fax: (763) 391-9603

Device Name and Classification:

Trade Name:	MC2X™ Multi-Stage Venous Cannula
Common Name:	Cardiopulmonary bypass vascular catheter, cannula ortubing
Classification:	Class II
Predicate Devices:	MC2X™ Multi-Stage Venous CannulaK031776

{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

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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

Page 1 of 1

ﮨﮯ

Regulation Number and Section

§ 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).