(28 days)
Not Found
No
The summary describes a physical medical device (cannulae) and its intended use and performance testing, with no mention of software, algorithms, or AI/ML technologies.
Yes
The device is used to deliver cardioplegia solutions during cardiopulmonary bypass surgery, which is a therapeutic intervention.
No
The device is described as a cannula for delivering cardioplegia solutions, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical medical device (cannulae) made of silicone with a luer fitting, and the performance studies involve testing physical properties like tensile pull-off force and dimensions. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the cannulae are for "delivery of cardioplegia solutions directly to the coronary arteries" during cardiopulmonary bypass surgery. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical device used for delivering fluids, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the living body) for a therapeutic purpose (delivering cardioplegia).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DWF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has demonstrated that the DLP® Silicone Coronary Artery Ostial Cannulae are substantially equivalent to the predicate.
The following performance tests were conducted:
Hub tested for Tensile Pull-Off Force
Dimensional analysis
Biocompatibility
Rub off test
Results:
Pass
Pass
Pass
Pass
Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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 Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration Number: 2184009 | |
| Contact Person: | Kevin T. Lam |
| Senior Regulatory Affairs Specialist | |
| Medtronic Perfusion Systems | |
| Phone: 763.526.2360 | |
| Fax: 763.367.8360 | |
| Email: kevin.t.lam@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® Silicone Coronary Artery Ostial Cannulae
Models: 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: Polypropylene | ||
| Proposed: Polypropylene | Hub tested for Tensile Pull-Off Force | ||
| Dimensional analysis | |||
| Biocompatibility | Pass | ||
| Pass | |||
| Pass | |||
| Silicone adhesive for ink printing | From: Silicone | ||
| To: Silicone | Rub off test | ||
| Biocompatibility | Pass | ||
| Pass |
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.