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.

Device Description

The Multi-Stage Venous Cannula product family includes the MC2" Two-Stage Venous Cannula, OVAL MC2™ Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, and MC2X " Three-Stage Venous Cannula configurations. All Multi-Stage Venous Cannula configurations feature a wire wound polyvinyl chloride (PVC) body with side ports in the distal tip, a ported atrial basket, and a % inch (0.95cm) - ½ inch (1.27cm) connection site. The overall length of each cannula is approximately 15% inch (38.7cm). Insertion depth marks are provided to aid in positioning of the cannula during the surgical procedure. These cannulae are sterile, non-pyrogenic, disposable medical devices.

AI/ML Overview

The provided text describes a medical device, the Medtronic Multi-Stage Venous Cannula, and summarizes performance and biological testing to demonstrate its substantial equivalence to predicate devices. However, the document does not contain the detailed acceptance criteria or a study proving the device meets specific performance targets in the format requested.

The document states: "Performance and biological tests confirm that the modified Multi-Stage Venous Cannula product met pre-determined acceptance criteria and is substantially equivalent to the predicate device." While this confirms tests were done and criteria were met, the specific quantitative acceptance criteria and the results are not provided in the summary.

Therefore, for section 1 (Table of acceptance criteria and reported device performance), I can only list the types of tests performed, as the actual quantitative criteria and results are absent.

Here's the information based on the provided text, with limitations noted where data is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Not Detailed in Document)	Reported Device Performance (Not Detailed in Document)
Kink / Bend	Met pre-determined criteria	Confirmed to meet criteria
Collapse under negative pressure	Met pre-determined criteria	Confirmed to meet criteria
Tensile strength / Pull	Met pre-determined criteria	Confirmed to meet criteria
Biocompatibility	In accordance with EN ISO 10993-1	Confirmed to meet EN ISO 10993-1

Note: The document states that "Performance and biological tests confirm that the modified Multi-Stage Venous Cannula product met pre-determined acceptance criteria and is substantially equivalent to the predicate device." However, the specific quantitative values for these acceptance criteria and the detailed results of the device's performance against them are not provided in this summary.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is generally relevant for AI/software-based medical devices or diagnostic tools. The Medtronic Multi-Stage Venous Cannula is a physical medical device. Therefore, no experts were used to establish ground truth in this context, as the "ground truth" would be the physical properties and performance of the device under testing conditions.

4. Adjudication method for the test set

Not applicable, as this is a physical device subject to engineering and biological performance testing, not diagnostic performance evaluation involving human observers.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

The "ground truth" in this context would be the objective measurements and standards defined for the physical and biological performance of the cannula. For example, a "kink/bend" test would have a defined failure threshold (ground truth for failure), and the device is tested against it. Similarly, biocompatibility is evaluated against established ISO standards.

8. The sample size for the training set

Not applicable. This is a physical device undergoing performance testing, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical device undergoing performance testing, not a machine learning model.

Summary

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Image /page/0/Picture/0 description: The image shows the Medtronic logo. The logo consists of a stylized human figure inside a circle to the left of the word "Medtronic". The text is in a bold, sans-serif font.

510(k) Summary

K140165

MAY 2 0 2014

Date Prepared:

Submitter:

Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428

January 17, 2014

Establishment Registration Number: 2184009

Contact Person:

Jacqueline A. Hauge Senior Regulatory Affairs Specialist Medtronic Perfusion Systems Phone: 763.514.9967 763.367.8360 Fax: Email: jacqueline.a.hauge@medtronic.com

Alternate Contact: Susan C. Fidler Senior Regulatory Affairs Manager Medtronic Perfusion Systems Phone: 763.514.9839 Fax: 763.367.8360 Email: susan.c.fidler@medtronic.com

Device Name and Classification

Trade Name:	MC2™ Two-Stage Venous CannulaOVAL MC2™ Two-Stage Venous CannulaThin Wall Two-Stage Venous CannulaMC2X™ Three-Stage Venous Cannula
Common Name:	Cardiopulmonary bypass vascular catheter, cannula, or tubing
Regulation Number:	870.4210
Product Code:	DWF
Product Classification:	Class II

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Image /page/1/Picture/0 description: The image shows the Medtronic logo. The logo consists of a symbol on the left and the word "Medtronic" on the right. The symbol appears to be a stylized representation of a person or figure within a circular shape. The word "Medtronic" is written in a bold, sans-serif font.

Predicate Devices

MC2XTM Multi-Stage Venous Cannula K052372 DLPTM Single Stage Venous Cannula K120988

Device Description

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.

Comparison to Predicate Devices

A comparison of the modified Multi-Stage Venous Cannula product to the currently marketed predicate products (K052372 and K120988) indicates the following similarities:

Same intended use .
. Same technological characteristics
에 Same operating principle
l Same design features
. Same base materials (Polyvinyl Chloride (PVC), Stainless Steel)
I Same shelf life

Summary of Performance and Biological Testing

Medtronic conducted the following performance testing for the modified Multi-Stage Venous Cannula product:

. Kink / Bend . Collapse under negative pressure · Tensile strength / Pull Additionally, biocompatibility testing was performed in accordance with EN ISO 10993-1 Biological evaluation of medical devices –Part 1: Evaluation and testing within a risk management process. Performance and biological tests confirm that the modified Multi-Stage Venous Cannula product met pre-determined acceptance criteria and is substantially equivalent to the predicate device.

Conclusion

Medtronic has demonstrated that the modifications made to the Multi-Stage Venous Cannula product family described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three swooping lines representing its wings or body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2014

Medtronic, Inc. Medtronic Perfusion Systems Jacqueline A. Hauge Senior Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, MN 55428

Re: K140165

Trade/Device Name: MC2TM Two-Stage Venous Cannula OVAL MC2™ Two-Stage Venous Cannula Thin Wall Two-Stage Venous Cannula MC2XTM Three-Stage Venous Cannula

Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: February 17, 2014 Received: February 19, 2014

Dear Ms. Hauge:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any Federal statutes and regulations administered by other Federal agencies. You must

.. . .

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Page 2 - Jacqueline A. Hauge

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

.ポイ

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use	Form Appro
	Expiration C
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510(k) Number (if known).

K140165

Device Name MC27M Two-Stage Venous Cannula

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Indications for Use (Describe)

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2008 11:20 11 12 12 12 12 11 11 This cannula is intended for use in venous drains and inferior vena cava similaneously during cardlopulnonary bypass surgery up to six hours or less.

2017 11:12:12

Type of Use (Select one or both, as applicable) 1 80 - 60 [2] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (1/14)

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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).