The cannula is intended for use during cardiopulmonary bypass surgery for the delivery of cardioplegia retrogradely through the coronary sinus up to six hours or less.

Device Description

The DLP® Retrograde Coronary Sinus Perfusion Cannulae Without Pressure Monitoring Line devices consist of a silicone or extruded PVC body. The silicone cannulae consist of a kink resistant wirewound body and a beveled tip with two side holes. A smooth manual inflating balloon is located at the distal end of the wirewound body and has an inflation assembly at the proximal end of the cannula that contains a female luer and a one-way valve. The PVC cannula consists of an extruded body with a multi-port tip and a smooth pre-formed auto-inflating balloon. Both silicone and PVC cannulae terminate with a female luer on the proximal end. These devices are offered with either a guidewire stylet or a solid stylet to help position the cannula. The cannula are sterile, non-pyrogenic, disposable, and for single use only.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study to prove novel efficacy or safety against acceptance criteria in the manner usually associated with AI/ML devices. Therefore, many of your requested criteria are not applicable or cannot be found in this type of submission.

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

1. Table of acceptance criteria and the reported device performance:

The acceptance criteria and performance reported here are for biocompatibility and functional pressure integrity, not for a diagnostic or AI-driven performance metric like sensitivity or specificity.

Test	Acceptance Criteria	Reported Device Performance
Cytotoxicity	PASS	PASS (for both Luer Material Change and Manufacturing Process Material Change)
Sensitization assay	PASS	PASS (for both Luer Material Change and Manufacturing Process Material Change)
Intracutaneous reactivity study	PASS	PASS (for both Luer Material Change and Manufacturing Process Material Change)
Systemic toxicity (acute) - Acute systemic toxicity study	PASS	PASS (for both Luer Material Change and Manufacturing Process Material Change)
Systemic toxicity (acute) - Pyrogen	PASS	PASS (for both Luer Material Change and Manufacturing Process Material Change)
Genotoxicity	PASS	PASS (for both Luer Material Change and Manufacturing Process Material Change)
Hemocompatibility	PASS	PASS (for both Luer Material Change and Manufacturing Process Material Change)
Functional (pressure integrity) testing (for check valve)	Met specified criteria	Test results met the specified criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Biocompatibility Tests: Not explicitly stated in this summary. These tests are typically conducted on a limited number of samples according to ISO standards.
Sample Size for Functional Testing: Not explicitly stated.
Data Provenance: Not specified, but likely from laboratory testing conducted by the manufacturer or a contracted lab. This is not clinical data in the sense of patient 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. This device is not an AI/ML diagnostic tool, and its "ground truth" is established through standardized laboratory test methods and engineering specifications, not expert consensus on medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As above, this is not a diagnostic device requiring expert adjudication of results.

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 is not an AI-assisted device.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on:

Established Biocompatibility Standards: Meeting the "PASS" criteria for various toxicology and material interaction tests (e.g., ISO 10993 series).
Engineering Specifications: The device's functional performance (e.g., pressure integrity) is judged against pre-defined engineering requirements for its components.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary of what the document does convey:

This 510(k) submission demonstrates that a modified version of the DLP® Retrograde Coronary Sinus Perfusion Cannulae is substantially equivalent to a previously cleared predicate device. The changes were to non-blood-contacting components (luers, check valve material, ink) and a manufacturing process aid. The proof of substantial equivalence relies on:

Same Intended Use, Technological Characteristics, Operating Principle, Design Features, and Base Materials as the predicate.
Successful Biocompatibility Testing: All tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Pyrogen, Genotoxicity, Hemocompatibility) for the material changes passed, demonstrating the materials remain safe for their intended use.
Successful Bench Testing: Functional pressure integrity testing for the changed check valve components met specified criteria, confirming no degradation in performance.

In essence, this document is a regulatory submission for a minor modification to an existing device, focusing on a robust comparison to a predicate device and demonstrating that the changes do not introduce new safety or efficacy concerns through targeted testing. It is not an evaluation of a novel AI/ML device.

Summary

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OCT 3 1 2013

510(k) Summary

Date Prepared: Submitter:

September 20, 2013

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

Contact Person:

Chelsea L. Pioske Associate Regulatory Affairs Specialist Medtronic Perfusion Systems Phone: 763.514.9838 Fax: 763.367.8360 Email: chelsea.pioske@medtronic.com

Alternate Contact:

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

Device Name and Classification

Trade Name:	DLP® Retrograde Coronary Sinus Perfusion Cannula WithoutPressure Monitoring Line (also known as DLP® RetrogradeCoronary Sinus Perfusion Cannula Without Pressure MonitoringLumen)
Models:	94115NPL, 94535NPL, 94725NPL
Common Name:	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Regulation Number:	21 CFR 870.4210
Product Code:	DWF
Product Classification:	Class II

Predicate Devices

K030696

Retrograde Coronary Sinus Perfusion Cannula with no Pressure Monitoring Line

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Device Description

Indications for Use

The cannula is intended for use during cardiopulmonary bypass surgery for the delivery of cardioplegia retrogradely through the coronary sinus up to six hours or less.

Comparison to Predicate Devices

A comparison of the modified product to the currently marketed predicate products indicates the following similarities:

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

Summary of Biocompatibility Testing for Previously Implemented Changes

The DLP® Retrograde Coronary Sinus Perfusion Cannulae Without Pressure Monitoring Line devices have changed the the luers and the ink material since the predicate was first cleared. Additionally, the concentration of a chemical within a manufacturing process aid was decreased. The change to blue ink was cleared previously in K120988 and K123762. A summary of the biocompatibility tests performed for the changes to the luer material and manufacturing process material are summarized below.

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Test	Luer Material ChangeBiocompatibility Test Result	Manufacturing ProcessMaterial Change (Worst-Case)Biocompatibility Test Result
Cytotoxicity	PASS	PASS
Sensitization assay	PASS	PASS
Intracutaneous reactivity study	PASS	PASS
Systemic toxicity (acute)• Acute systemic toxicity study	PASS	PASS
Systemic toxicity (acute)• Pyrogen	PASS	PASS
Genotoxicity	PASS	PASS
Hemocompatibility	PASS	PASS

Summary of Bench Testing for Previously Implemented Changes

The DLP® Retrograde Coronary Sinus Perfusion Cannulae Without Pressure Monitoring Line devices changed the material of non-blood-contacting components used in the check valve. Function (pressure integrity) testing was completed to show that the component assembly would continue meeting the current specification (thus, demonstrating that the cannula would continue to meet performance specifications). Test results met the specified criteria.

Conclusion

Medtronic has demonstrated that the modifications made to the DLP® Retrograde Coronary Sinus Perfusion Cannulae Without Pressure Monitoring Line devices described in this submission results in a substantially equivalent device because the fundamental scientific principle, operating principle, design features, and overall intended use are unchanged from the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

October 31, 2013

Medtronic Inc. c/o Chelsea Pioske Associate Regulatory Affairs Specialist Medtronic Perfusion Systems 8200 Coral Sea Street NE Mounds View, MN 55112

Re: K132995

Trade/Device Name: DLP® Retrograde Coronary Sinus Perfusion Cannula Without Pressure Monitoring Lumen Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Regulatory Class: Class II Product Code: DWF Dated: September 20, 2013 Received: September 24, 2013

Dear Ms. Pioske:

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 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

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Page 2 - Chelsea Pioske

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Bram D. Zijckerman -S

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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Statement of Indications for Use

510(k) Number (if known): K132995

Device Name: DLP® Retrograde Coronary Sinus Perfusion Cannula Without Pressure Monitoring Lumen

Indications for Use:

The cannula is intended for use during cardiopulmonary bypass surgery for the delivery of cardioplegia retrogradely through the coronary sinus 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)

2013

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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).