These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.

Device Description

The Malleable Single Stage Venous Cannula with Carmeda® BioActive Surface, is designed for use with cardiopulmonary bypass as a venous drainage cannula. The malleability feature allows the cannulae to be shaped and positioned to meet each customer's specific needs. The Carmeda® BioActive Surface adds a heparin based coating to the cannulae surface.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study details for the Malleable Single Stage Venous Cannula with Carmeda® BioActive Surface:

Overview:

This 510(k) submission (K033264) is for a Malleable Single Stage Venous Cannula with a Carmeda® BioActive Surface, intended for use in cardiopulmonary bypass surgery. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices. The study described is primarily in vitro testing to establish the performance characteristics of the modifications (the Carmeda® BioActive Surface) compared to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a quantitative or formal manner typically seen for clinical endpoints or diagnostic accuracy. Instead, the "performance" is demonstrated through various in vitro tests establishing that the modified device performs comparably to or within acceptable limits for a device of its kind.

Acceptance Criteria (Implied)	Reported Device Performance
Visual Integrity	"In vitro visual... testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications." (Implies the device maintains visual integrity when coated.)
Coating Coverage	"Coverage... testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications." (Implies adequate and consistent coating coverage was achieved.)
Bioactivity (Heparin function)	"Bioactivity... testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications." (Implies the heparin-based coating maintains its intended biological activity, likely related to anticoagulation properties.)
Leaching (Coating stability)	"Leaching... testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications." (Implies the heparin coating does not leach off at an unacceptable rate, which would compromise its effectiveness or safety.)
Functional Performance	"Functional... testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications." (This is a broad category, but likely refers to mechanical integrity, flow characteristics, or other physical performance measures relevant to venous cannulae, ensuring the added coating does not negatively impact the primary function of the cannula.)
Biocompatibility	"Biocompatibility testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications." (Implies the device, with its coating, meets established standards for biological safety, such as cytotoxicity, sensitization, irritation, etc., and does not elicit undesirable biological responses when in contact with blood/tissue.)
Substantial Equivalence	"Medtronic Perfusion Systems has demonstrated that the Malleable Venous Cannulae with Carmeda® BioActive Surface are substantially equivalent to the predicate devices based upon design, test results, and indications for use." (Overall conclusion, based on all the above tests, that the device is as safe and effective as the predicate.)

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: The document does not specify the exact number of cannulae or test samples used for each of the "in vitro visual, coverage, bioactivity, leaching, functional and biocompatibility testing."
Data Provenance: The studies were "in vitro" testing, meaning they were conducted in a laboratory setting, not on human subjects. No country of origin is explicitly mentioned, but the submitter is based in the USA (Brooklyn Park, MN). The data is by nature retrospective in the sense that it's generated for regulatory submission, rather than a prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to the provided study description. The evaluations were "in vitro" tests, relying on scientific methodologies and established standards rather than expert clinical consensus for "ground truth."

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

This information is not applicable. The study involves in vitro laboratory tests, not human assessments requiring adjudication.

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

This information is not applicable. The device described is a medical cannula, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This information is not applicable. The device is a physical medical device, not an algorithm, so the concept of standalone performance does not apply.

7. The Type of Ground Truth Used (Expert Concensus, Pathology, Outcomes Data, Etc.)

The "ground truth" for the in vitro tests would be established by:

Standardized test methods and protocols: For aspects like visual inspection, flow rates, coating thickness.
Chemical/Biological assays: For bioactivity (e.g., anti-Xa activity for heparin), leaching assays (measuring leached heparin concentration), and biocompatibility (e.g., ISO 10993 series standards for cytotoxicity, hemolysis, etc.).
Engineering specifications: For functional performance, comparing against design requirements and predicate device performance.

8. The Sample Size for the Training Set

This information is not applicable. The device is not an AI/machine learning algorithm, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this type of device.

Summary

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K033264

510(k) Summary

Date Prepared:	September 26, 2003
Submitter:	Medtronic Perfusion Systems7611 Northland BoulevardBrooklyn Park, MN 55428
Contact Person:	Preeti JainDirector, Regulatory/Clinical Affairs
	Phone: (763) 391-9533Fax: (763) 391-9603

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Device Name and Classification:

Trade Name:	Malleable Single Stage Venous Cannula with Carmeda®BioActive Surface12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40 Fr.
Common Name:	Cardiopulmonary bypass vascular catheter, cannula ortubing
Classification:	Class II
Predicate Devices:	Malleable Single Stage Venous CannulaK022272
	Extracorporeal Circuit with Bio-Active SurfaceK8918687

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Device Description:

Indication for Use

These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.

Comparison to Predicate Devices

The predicate devices are cannulae with the same design characteristics. The predicate Malleable Single Stage Venous Cannula has the same indications for use.

Summary of Performance Data

In vitro visual, coverage, bioactivity, leaching, functional and biocompatibility testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications of this device from previously marketed devices.

Conclusion

Medtronic Perfusion Systems has demonstrated that the Malleable Venous Cannulae with Carmeda® BioActive Surface are substantially equivalent to the predicate devices based upon design, test results, and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 2003

Medtronic Perfusion Systems c/o Ms. Preeti Jain Director, Regulatory/Clinical Affairs 7611 Northland Drive N Brooklyn Park, MN 55428-1088

Re: K033264

Malleable Single Stage Venous Cannula with Carmeda® BioActive Suface Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: 74 DWF Dated: October 2, 2003 Received: October 9, 2003

Dear Ms. Jain:

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.

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Page 2 - Ms. Preeti Jain

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

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Page _ 1 _ of _ 1 _

510(k) Number (if known):

Device Name:

Malleable Single Stage Venous Cannula with Carmeda® BioActive Surface

Indications for Use:

These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava 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)

(Optional Format 3-10-98)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number K033264

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).