(28 days)
These Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.
The DLP® Silicone Coronary Artery Ostial Cannulae feature a soft bulb beveled tip with a silicone body. The Cannulae terminate with a locking female luer fitting. The Cannulae are nonpyrogenic, single use, and sterile.
This document is a 510(k) Pre-Market Notification from the FDA regarding Medtronic's DLP® Silicone Coronary Artery Ostial Cannulae. It confirms the device's substantial equivalence to previously marketed predicate devices. The information provided heavily focuses on regulatory approval and comparisons to a predicate device, rather than a clinical study evaluating its performance against specific acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI device studies is not applicable or present in this document.
However, I can extract the information that is present concerning the device itself and the testing performed for its regulatory approval.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present "acceptance criteria" in the traditional sense of a clinical trial's primary endpoints for a new AI device or a software's performance metrics (e.g., sensitivity, specificity). Instead, for this medical device (cannulae), the "acceptance criteria" are implied by the performance tests conducted to ensure substantial equivalence to a predicate device after a material change. The "reported device performance" reflects the successful completion of these tests.
| Acceptance Criteria (Implied by Test Type) | Reported Device Performance (Result) |
|---|---|
| Material Strength/Integrity: | |
| Hub Tensile Pull-Off Force (Barbed Female Luer) | Pass |
| Dimensional Conformance: | |
| Dimensional Analysis (Barbed Female Luer) | Pass |
| Biocompatibility: | |
| Biocompatibility (Barbed Female Luer) | Pass |
| Biocompatibility (Silicone adhesive for ink printing) | Pass |
| Ink Adhesion: | |
| Rub Off Test (Silicone adhesive for ink printing) | Pass |
Note: The document states "The following performance tests were conducted:", but then only lists the results of those tests under the "Verification/Validation" column for the specific component changes.
2. Sample Size for Test Set and Data Provenance
This document does not describe a "test set" in the context of clinical data for an AI/software device. The performance tests mentioned (Tensile Pull-Off Force, Dimensional analysis, Biocompatibility, Rub off test) are engineering/material tests performed on the device components. The sample size for these specific tests is not explicitly stated in this document.
Given that this is a 510(k) submission for a physical medical device (cannulae) and not a software/AI device, the concept of "data provenance (e.g. country of origin of the data, retrospective or prospective)" as it relates to patient data is not applicable here. The "data" refers to engineering test results.
3. Number of Experts and their Qualifications for Ground Truth
This information is not applicable and not provided in the document. The regulatory filing is for a physical medical device (cannulae) based on demonstrating substantial equivalence through engineering tests, not an AI/software device requiring human expert ground truth for clinical performance.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in AI datasets, which is not the subject of this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and not provided in the document. MRMC studies are used for evaluating the performance of imaging devices or AI algorithms interpreted by human readers, which is not relevant to this physical device submission.
6. Standalone Performance Study (Algorithm Only)
This information is not applicable and not provided in the document. This device is a physical medical instrument, not an algorithm, so a "standalone algorithm only" performance study is not relevant.
7. Type of Ground Truth Used
For the engineering tests conducted, the "ground truth" would be established by established engineering standards, material specifications, and validated test methods. For example, the "Pass" result for tensile pull-off force indicates that the component met pre-defined strength requirements, which serve as the "ground truth" for its mechanical integrity. This is not "expert consensus," "pathology," or "outcomes data" in a clinical sense.
8. Sample Size for the Training Set
This information is not applicable and not provided in the document. A "training set" refers to data used to train an AI algorithm, which is not relevant to this physical device submission.
9. How Ground Truth for the Training Set was Established
This information is not applicable and not provided in the document, as there is no training set for an AI algorithm.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black, and the text is in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2014
Kevin T. Lam Senior Regulatory Affairs Specialist Medtronic. Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428
Re: K141951
Trade/Device Name: DLP® Silicone Coronary Artery Ostial Cannulae: Model Numbers 30315, 30317, and 30320 Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: II Product Code: DWF Dated: July 17, 2014 Received: July 18, 2014
Dear Mr. Lam:
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
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
M.A. Hillebrand
for Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141951
Device Name
DLP Silicone Coronary Artery Ostial Cannulae
Indications for Use (Describe)
These Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Date Prepared: | July 17, 2014 |
|---|---|
| Submitter: | Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establishment Registration Number: 2184009 |
| Contact Person: | Kevin T. LamSenior Regulatory Affairs SpecialistMedtronic Perfusion SystemsPhone: 763.526.2360Fax: 763.367.8360Email: kevin.t.lam@medtronic.com |
| Alternate Contact: | Susan FidlerSenior Regulatory Affairs ManagerMedtronic Perfusion SystemsPhone: 763.514.9839Fax: 763.367.8360 |
Email: susan.c.fidler@medtronic.com
Device Name and Classification
| Trade Name: | DLP® Silicone Coronary Artery Ostial CannulaeModels: 30315, 30317, and 30320 |
|---|---|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
| Regulation Number: | 21 CFR 870.4210 |
| Product Code: | DWF |
| Product Classification: | Class II |
Predicate Devices
DLP® Silicone Coronary Artery Ostial Cannulae
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Device Description
The DLP® Silicone Coronary Artery Ostial Cannulae feature a soft bulb beveled tip with a silicone body. The Cannulae terminate with a locking female luer fitting. The Cannulae are nonpyrogenic, single use, and sterile.
Indications for Use
These Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.
Comparison to Predicate Devices
A comparison of the modified product to the currently marketed predicate products (K131269) indicates the following similarities:
- Same intended use ■
- ' Same technological characteristics
- Same operating principle 트
- 트 Same design features
- 트 Same base materials (Silicone and Polypropylene)
- 트 Same shelf life
- ' Same manufacturing process
Summary of Performance Data
Testing has demonstrated that the DLP® Silicone Coronary Artery Ostial Cannulae are substantially equivalent to the predicate.
| Component | Base Material Changes | Verification/Validation | Results |
|---|---|---|---|
| Barbed Female Luer | Current: PolypropyleneProposed: Polypropylene | Hub tested for Tensile Pull-Off ForceDimensional analysisBiocompatibility | PassPassPass |
| Silicone adhesive for ink printing | From: SiliconeTo: Silicone | Rub off testBiocompatibility | PassPass |
The following performance tests were conducted:
Conclusion
Medtronic has demonstrated that the material changes made to the DLP® Silicone Coronary Artery Ostial Cannulae presented in this submission resulted in a substantially equivalent device
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because the base material types, fundamental scientific principle, operating principle, design features, and intended use are unchanged from the predicate devices.
§ 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).