The CentriMag Return Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

Device Description

The CentriMag Return Cannula Kit consists of a sterile, single-use, disposable, noncoated, Polyvinyl Chloride (PVC) Cannula and the following accessories:
A) One Obturator (or Introducer)
B) One Hemostasis Seal
C) One Cap
D) One Porous Plug
E) One Needle with Sheath
F) One Guidewire Assembly
G) Two Stabilizer Rings Medium
H) Two Stabilizer Rings Small
I) Two Tip Stabilizers

AI/ML Overview

The provided text describes a medical device, the Levitronix CentriMag Return Cannula Kit, and its 510(k) summary for FDA clearance. However, it does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML performance evaluation. The document focuses on demonstrating substantial equivalence to a predicate device through functional testing, not through AI/ML performance metrics.

Therefore, for aspects related to AI/ML studies, ground truth, sample sizes for training/test sets, expert adjudication, or MRMC studies, the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be extracted based on the provided text, primarily regarding the device's functional performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that functional testing was performed and "All met pre-established acceptance criteria." However, the specific acceptance criteria and the quantified reported device performance values are not provided in the text. It only lists the categories of tests performed.

Acceptance Criteria (Category)	Reported Device Performance (Summary)
Physical Testing	Met pre-established acceptance criteria
Sterilization Validation	Met pre-established acceptance criteria
Biocompatibility	Met pre-established acceptance criteria
Shelf Life Studies	Met pre-established acceptance criteria
Transportation	Met pre-established acceptance criteria
Hemolysis (in vitro)	Met pre-established acceptance criteria
Flow versus Pressure Drop	Met pre-established acceptance criteria

The following questions cannot be answered from the provided text, as they pertain to AI/ML performance studies, which were not conducted for this device clearance.

2. Sample Size Used for the Test Set and the Data Provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The device is a physical medical device (cannula kit), and its clearance relied on functional and bench testing, not an AI/ML model evaluated 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 (e.g., radiologist with 10 years of experience)

Not applicable / Not provided. No ground truth for a test set was established as there was no AI/ML model being evaluated.

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

Not applicable / Not provided. No test set or expert adjudication for an AI/ML model was involved.

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 / Not provided. This is not an AI/ML device.

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

Not applicable / Not provided. This is not an AI/ML device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable / Not provided. Ground truth, in the context of AI/ML, was not established for this device. The "truth" for this device's performance was determined by established engineering specifications and biological safety standards (e.g., for hemolysis, biocompatibility).

8. The Sample Size for the Training Set

Not applicable / Not provided. There was no AI/ML model needing a training set.

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

Not applicable / Not provided. There was no AI/ML model or training set with associated ground truth.

Summary

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K110980

JUN 2 0 2011

510(k) Summary - Levitronix CentriMag Return Cannula Kit

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92.

A. Application Information

Date Prepared: April 6, 2011 Submitter's Name & Address: Levitronix LLC 45 First Avenue Waltham, MA 02451 Contact Person: Lydia Sakakeeny, Ph.D. Regulatory Affairs Specialist Ph: (781) 466-6553 Fax: (781) 622-5090 e-mail: Isakakeeny@levitronix-us.com Device Information Trade or Proprietary Name: CentriMag Return Cannula Kit Common or Usual Name: CentriMag Return Cannula Kit Classification Name: Catheter, cannula and tubing, vascular, cardiopulmonary bypass (DWF, 870.4210), Class II Performance Standard: Performance standards do not currently exist for these devices. None are established under section 514 of the Food, Drug and Cosmetic Act.

். Legally Marketed Predicate Device

Levitronix Device	Predicate	Predicate 510(k)
CentriMag Return Cannula Kit	Medtronic EOPA™ Elongateone-piece Arterial Cannulaand Guidewire (MedtronicEOPA 77722)	K031037

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D. Device Description

CentriMag Return Cannula Kit

The CentriMag Return Cannula Kit consists of a sterile, single-use, disposable, noncoated, Polyvinyl Chloride (PVC) Cannula and the following accessories:

A) One Obturator (or Introducer)
в) One Hemostasis Seal
c) One Cap
D) One Porous Plug
E) One Needle with Sheath
F) One Guidewire Assembly
G) Two Stabilizer Rings Medium
H) Two Stabilizer Rings Small
1. Two Tip Stabilizers

E. Intended Use

The CentriMag Return Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

F. Comparison to Predicate Device

The CentriMag Return Cannula Kit has an indication for use, design features, and functional characteristics which are substantially equivalent to the predicate device. The device raises no new safety or effectiveness issues.

G. Summary of Performance Data

The CentriMag Return Cannula Kit has successfully undergone functional testing demonstrating substantial equivalence to the predicate device. The following functional testing was performed. All met pre-established acceptance criteria.

Physical Testing .
Sterilization Validation .
Biocompatibility .
Shelf Life Studies �
. Transportation
. Hemolysis (in vitro)
. Flow versus Pressure Drop

H. Clinical Performance

Clinical testing was not performed for the CentriMag Return Cannula Kit.

l. Conclusion

The Levitronix CentriMag Return Cannula Kit is substantially equivalent to the Medtronic EOPA™ Elongate one-piece Arterial Cannula and Guidewire (K031037).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract image of an eagle.

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

Levitronix LLC c/o Lydia Sakakeeny, Ph.D. Regulatory Affairs Specialist 45 First Avenue Waltham, MA 02451

JUN 2 0 2011

K110980 Re: CENTRIMAG® Return Cannula Kit 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 6, 2011 Received: April 7, 2011

Dear Dr. Sakakeeny:

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 10 eommer of the ride 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 your 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 - Lydia Sakakeeny, Ph.D.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be davised that I Dri 3 losaanes or our device complies with other requirements of the Act that I DA has made a colorminations administered by other Federal agencies. You must of any I cucral statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sense and CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (22) regions 531-542 of the Act); 21 CFR 1000-1050. production control provisions (Setians (Seting your device as described in your Section 510(k) I mis icher with anow you to begin maniening of substantial equivalence of your device to a legally premarket notification: "The PDF Internation 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 If you desire specific at not to: 700 - 0200 276-0120. Also, please note the regulation entitled, Conact the Office of Compilance in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your respended 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,

Brian 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 Statement

Applicant:

Levitronix LLC

KITO980

510(k) Number (if known):

Device Name:

CentriMag Return Cannula Kit

Indications for Use:

The CentriMag Return Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiov 510(k) Number

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).