The percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less

Device Description

The Biomedicus Femoral Cannula and Introducer Set include the new Bio-Medicus Femoral Venous Cannula and Introducer. The Cannula are one piece, wire wound bodies with basket type holes. Insertion depth marks aid in positioning the Cannula. All are supplied sterile, and non-pyrogenic and are single use. This new Biomedicus Femoral Venous Cannula and Introducer Set consists of a longer flexible cannula with multiple side holes, a longer introducer, an improved introducer to cannula tip transition and 3/8" barbed connector. The cannulae are available in 19 Fr, 21 Fr and 25 Fr sizes. The Cannula are intended to be used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The Cannula Introducer is intended to facilitate proper insertion and placement of the appropriate sized Cannula within the vessel for cardiopulmonary bypass. The overall product length is approximately 30.125 inches. The device is sterile, nonpvrogenic and disposable, and is intended for short-term single use. The product will be available in both Carmeda coated and uncoated versions.

AI/ML Overview

The provided 510(k) summary (K052524) describes a venous cannula and introducer set, which is a Class II medical device. The submission focuses on demonstrating substantial equivalence to a predicate device (K884129) rather than establishing new performance criteria through a standalone clinical study for a novel algorithm or AI.

Therefore, the following information cannot be extracted from the provided text as it typically applies to AI/ML-driven devices or devices requiring extensive clinical trials for efficacy claims beyond substantial equivalence:

Acceptance Criteria and Reported Device Performance Table: The document states "Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device." However, it does not provide specific quantitative acceptance criteria or their corresponding reported performance values in a table. The assessment is qualitative, asserting "substantial equivalence" based on "design, test results, and indications for use."
Sample size used for the test set and the data provenance: Not applicable. No test set for AI/ML performance is described. The "test results" refer to engineering validation, not clinical data for AI performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for AI/ML is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No adjudication for AI/ML is described.
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 device is a physical medical instrument, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No explicit "ground truth" as understood in AI/ML validation is mentioned. "Test results" likely refer to bench testing or in-vitro performance.
The sample size for the training set: Not applicable. No AI/ML training set is described.
How the ground truth for the training set was established: Not applicable. No AI/ML training set is described.

Summary of Acceptance Criteria and Study (based on available information):

The primary acceptance criterion for this 510(k) submission was to demonstrate substantial equivalence to the predicate device (Bio-Medicus Femoral Cannula and Introducer, K884129) in terms of:

Design: The device description details modifications such as a longer flexible cannula with multiple side holes, a longer introducer, an improved introducer to cannula tip transition, and a 3/8" barbed connector. These design changes were compared to the predicate.
Test Results: While specific tests and their outcomes are not detailed, the submission states that "Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device." This implicitly means the device met performance standards (e.g., flow rates, material compatibility, strength, patency, etc.) comparable to or better than the predicate, considering the intended use.
Indications for Use: The indications for use for the new device were compared directly to those of the predicate. Both devices are intended "to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment" for cardiopulmonary bypass. The new device specifies "for use by trained physicians only" and "up to six hours or less."

Study Proving Acceptance Criteria:

The study proving the acceptance criteria was a non-clinical validation testing described as "Validation testing" to establish "performance characteristic of the modifications." This type of study demonstrates that the new device's engineering and functional parameters are acceptable and do not raise new questions of safety or effectiveness compared to the predicate. The FDA's clearance letter confirms that based on the submitted information, the device was found to be "substantially equivalent."

In conclusion, for this specific 510(k) summary, the core "study" was the engineering and performance validation comparing the new device's characteristics to those of the legally marketed predicate device, demonstrating that its design and performance were substantially equivalent and supported the same indications for use.

Summary

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NOV 2 2 2005

K052524

510(k) Summary

Date Prepared:	September 7, 2005
----------------	-------------------

Submitter:

Medtronic Perfusion Systems 7611 Northland Boulevard Brooklyn Park, MN 55428

Contact Person:

Bruce Backlund Senior Regulatory Affairs Specialist

Phone: (763)-391-9183 (763) 391-9603 Fax:

Device Name and Classification:

Trade Name:	Bio-Medicus Multi-Stage Venous Femoral PercutaneousKit
Common Name:	Percutaneous Cannula and Introducer Set
Classification:	Class II
Predicate Devices:	Bio-Medicus Femoral Cannula and IntroducerK884129

And Children Children Children

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Device Description

This new Biomedicus Femoral Venous Cannula and Introducer Set consists of a longer flexible cannula with multiple side holes, a longer introducer, an improved introducer to cannula tip transition and 3/8" barbed connector.

The cannulae are available in 19 Fr, 21 Fr and 25 Fr sizes.

The Cannula are intended to be used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The Cannula Introducer is intended to facilitate proper insertion and placement of the appropriate sized Cannula within the vessel for cardiopulmonary bypass.

The overall product length is approximately 30.125 inches. The device is sterile, nonpvrogenic and disposable, and is intended for short-term single use.

The product will be available in both Carmeda coated and uncoated versions.

Indications for Use

This product is intended for use up to six hours or less.

Comparison to Predicate Device

The predicate device 510(k) K884129 was cleared on December 21, 1988. This 510(k) was for various sizes and shapes of Cannula.

This Cannula was indicated as intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory Extracorporeal equipment.

The Cannula Introducer is intended to facilitate proper insertion and placement of the appropriate sized Cannula within the vessel for cardiopulmonary bypass.

A copy of the original IFU as provided in the 510(k) is included in Appendix A.

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Summary of Performance Data

Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device.

Conclusion

Medtronic Perfusion Systems has demonstrated that the Bio-Medicus Femoral Venous Cannula and Introducer is substantially equivalent to the predicate devices based upon design, test results, and indications for use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around it. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with flowing lines above them.

Public Health Service

NOV 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Perfusion Systems c/o Mr. Bruce Backlund Senior Regulatory Affairs Specialist 7611 Northland Drive N Brooklyn Park, MN 55428

Re: K052524

Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (Two) Product Code: DWF Dated: October 28, 2005 Received: October 31, 2005

Dear Mr. Backlund:

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 - Mr. Bruce Backlund

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), please contact the Office of Compliance at (240) 276-0120. 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/industry/support/index.html.

Sincerely yours.

Dmne R. Wagner

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): Koss252A

Device Name: Bio-Medicus Multistage Venous Femoral Percutaneous Kit

Indications for Use:

This product is intended for use up to six hours or less

Prescription Use X (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)

R. Vorhuer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K c52524

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(Posted November 13, 2003)

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).