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 DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff is used during cardiopulmonary bypass surgical procedures for collecting and directing blood from the right side of the heart via the superior and inferior vena cava into the bypass circuit. These cannulae are comprised of a wire-wound, kink-resistant silicone cannula body with a nominal tip outer diameter of 37Fr and an overall length of 15 inches. The DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff model features a manually inflatable silicone inflatable cuff near the distal tip of the device which, once inflated, assists in maintaining the position of the device throughout the cardiopulmonary bypass procedure.

AI/ML Overview

This 510(k) summary (K120987) describes a medical device, the DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff, but does not contain information about acceptance criteria or a study proving the device meets said criteria.

The submission focuses entirely on demonstrating substantial equivalence to a predicate device (K854487), rather than providing performance data against specific acceptance criteria. This is a common characteristic of 510(k) submissions where the device is not significantly different from an already legally marketed device.

Therefore, I cannot provide the requested information from the provided text. The document explicitly states:

"Medtronic has demonstrated that the modifications to the DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff described in this submission result in a substantially equivalent device because the fundamental scientific technology, the intended use, operating principle and design features are unchanged since the predicate device. Any noted differences do not raise new issues of safety and effectiveness."

This indicates that the argument for clearance is based on similarity to an existing device, not on new performance studies with acceptance criteria.

To answer your request, here's what's missing:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned as a performance study wasn't conducted or reported in this submission for the modified device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no performance study described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable, as there's no algorithm or AI involved.
How the ground truth for the training set was established: Not applicable.

Summary

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K120987

JUN - 6 2012

510(k) Summary

Date Prepared

March 30, 2012

Submitter

Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establishment Registration Number: 2184009

Contact Person

Emily Blus Regulatory Affairs Operations Specialist 8200 Coral Sea Street NE Mounds View, MN 55433 Phone: (763) 514-9853 Fax: (763) 367-836 Email: emily.blus@medtronic.com

Alternate Contact:

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

Device Name and Classification

Trade Name:	DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff
Common Name:	Cardiopulmonary bypass vascular catheter, cannula, or tubing
Regulation Number:	21 CFR 870.4210
Product Code:	DWF
Classification:	Class II

Predicate Device

K854487

Venous Return Cannula with Cuff

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Device Description

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.

Contraindications

This device is contraindicated for long-term use. Do not use for extended terms such as Ventricular Assist procedures.

Comparison to Predicate Device

A comparison of the modified device to the currently marketed DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff notes the following similarities:

. Same intended use
. Same operating principle
. Same technological characteristics
. Same design features
Same shelf life .

Conclusion

Medtronic has demonstrated that the modifications to the DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff described in this submission result in a substantially equivalent device because the fundamental scientific technology, the intended use, operating principle and design features are unchanged since the predicate device. Any noted differences do not raise new issues of safety and effectiveness.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

JUN - 6 2012

Medtronic. Inc. c/o Ms. Jacqueline A. Hauge Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112

Re: K120987

Trade/Device Name: DLP Silicone Single Stage Venous Cannula with Inflatable Cuff Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: May 10, 2012 Received: May 11, 2012

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

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Page 2 - Ms. Jacqueline A. Hauge

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 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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M.A. Hillen

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): K120987

DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff Device Name:

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.

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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.A. Hilliber

Page 1 of 1

(Division Sign-Off) Division of Čardiovascular Devices

510(k) Number_k (20987

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).