Medline Vessel Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery or in vascular surgery to perfuse a vein graft or to help check for leaks in a harvested vein which will be used for a graft.

Device Description

Medline's Vessel Cannula are to be supplied as sterile, non-pyrogenic, single use, disposable devices. They are visually transparent and consist of a flexible, kink resistant body with a one way valve. This vessel cannula is 2 inches in length and terminates with a female luer and a soft blunt tip.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Medline Vessel Cannula, focusing on its substantial equivalence to a predicate device and its compliance with non-clinical testing standards. It does not contain information about a study proving the device meets acceptance criteria in the context of typical clinical or diagnostic device performance metrics such as sensitivity, specificity, or reader studies for AI-powered devices.

The document primarily outlines:

Substantial Equivalence: The Medline Vessel Cannula is deemed substantially equivalent to the DLP Vessel Cannulae (Medtronic, K810820). This means its technological characteristics and performance are comparable, and it's intended for the same use.
Non-Clinical Testing: The submission includes results from biocompatibility and functional performance testing. These are primarily engineering and safety tests rather than clinical performance studies.

Therefore, many of the requested categories for a diagnostic or AI-driven device's performance study cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Test	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Sensitization	Meets ISO 10993 requirements	Meets ISO 10993 requirements
	Irritation	Meets ISO 10993 requirements	Meets ISO 10993 requirements
	Cytotoxicity	Meets ISO 10993 requirements	Meets ISO 10993 requirements
	Intramuscular Implant	Meets ISO 10993 requirements	Meets ISO 10993 requirements
	Acute Systemic Toxicity	Meets ISO 10993 requirements	Meets ISO 10993 requirements
	Subchronic Systemic Toxicity	Meets ISO 10993 requirements	Meets ISO 10993 requirements
	Pyrogen	Meets ISO 10993 requirements	Meets ISO 10993 requirements
	Hemolysis (direct contact)	Meets ISO 10993 requirements	Meets ISO 10993 requirements
	Hemolysis (extract method)	Meets ISO 10993 requirements	Meets ISO 10993 requirements
	Complement Activation	Meets ISO 10993 requirements	Meets ISO 10993 requirements
Functional Performance	Appearance	Device effectiveness	Demonstrated device effectiveness
	Dimensions	Device effectiveness	Demonstrated device effectiveness
	Direction of Flow	Device effectiveness	Demonstrated device effectiveness
	Tensile Strength	Device effectiveness	Demonstrated device effectiveness
	Leakage	Device effectiveness	Demonstrated device effectiveness

2. Sample size used for the test set and the data provenance: Not applicable. These were non-clinical, laboratory/benchtop tests, not a clinical study on a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance was not established as no clinical performance study was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 device is a physical medical instrument (cannula), not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for these tests would be the established scientific methods and standards defined in ISO/ASTM guidelines for biocompatibility and functional testing (e.g., passing specific thresholds for toxicity, tensile strength, or leakage).

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable.

Summary

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510(k) Summary

K 11147 JUL 1 9 2011

Summary Preparation Date

July 1, 2011

Submitter / 510(k) Sponsor

Medline Industries, Inc. One Medline Place Mundelein, IL 60060

Contact Person

Matt Clausen Regulatory Affairs Specialist Phone: 847-643-4785 Fax: 847-643-4466

Device Name / Classification

Device Name: Vessel Cannula Proprietary Name: Medline Vessel Cannula Common Name: Vessel Cannulae Classification Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass under 21 CFR 870.4210

Predicate Device

DLP Vessel Cannulae (Medtronic), K810820

Device Description

Indications for Use

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Summary of Technological Characteristics

Information included in this submission demonstrates that there are no significant differences in technological characteristics between Medline's Vessel Cannula and the cited predicate device.

Summary of Non-Clinical Testing

Biocompatibility testing of the Medline Vessel Cannula demonstrated that it meets the requirements of guidelines presented in the ISO 10993 Testing Standard. Below is a listing of the specific testing performed.

1. Sensitization
1. Irritation
1. Cytotoxicity
1. Intramuscular Implant
న్. Acute Systemic Toxicity
1. Subchronic Systemic Toxicity
1. Pyrogen
1. Hemolysis (direct contact method)
1. Hemolysis (extract method)
1. Complement Activation

Functional performance testing of the Medline Vessel Cannula demonstrated device effectiveness in accordance with relevant ISO/ASTM test methods. Below is a listing of the specific testing performed.

Appearance 1.
1. Dimensions
1. Direction of Flow
Tensile Strength 4.
1. Leakage

Conclusion

In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Vessel Cannula is safe, effective and substantially equivalent as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

Medline Industries, Inc. c/o Mr. Matt Clausen Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060

JUL 19 2011

Re: K11147 Medline Vessel Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheters, cannula, or tubing Regulatory Class: Class II (two) Product Code: DWF Dated: April 21, 2011 Received: April 25, 2011

Dear Mr. Clausen:

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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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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

R. D. Zuckerman, M.D.

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): K11147

Device Name:

Medline Vessel Cannula

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Division of Cardiovascular Devices

510(k) Number K111147

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).