(70 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a cannula, with no mention of AI or ML technologies. Performance studies are based on physical tests, not algorithmic performance.
No
The device is described as a cannula used to deliver blood or fluids, which serves a supportive function during surgery rather than directly treating a disease or condition to restore health.
No
The device is described as a cannula for delivering blood/fluids during cardiopulmonary bypass surgery, and the performance studies focus on physical integrity (bonding, air flow, leak), not diagnostic capabilities.
No
The device description clearly details a physical cannula with a silicone tip, flexible tube, and clamps, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for delivering blood or fluids during cardiopulmonary bypass surgery. This is a surgical procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a cannula and tubing designed for surgical insertion and fluid delivery. This aligns with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely in vivo (within the body) during surgery.
N/A
Intended Use / Indications for Use
This cannula is intended for use in conjunction with cardiopulmonary bypass surgery for up to 6 hours. When properly placed, it can be used to deliver blood (or fluids) to the proximal end of a vein graft.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The cannula has a graduated, soft silicone, rubber tip to accommodate vessels of various sizes. The attached 50.8 cm (20 in) flexible tube has a clamp to stop flow through the cannula. Model 10011 has an additional clamp on the antegrade outlet line to stop the flow of fluid into the antegrade cannula. The antegrade cannula connector is a male luer adapter. The cardioplegia inlet fitting is a female luer port. Sterile, nonpyrogenic, single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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® Vein Graft Cannula is substantially equivalent to the predicate. The following performance tests were conducted:
For Model 10010, Bonding to male luer: Air Flow Test, Leak Test, Bond Strength Test - Results: Pass, Pass, Pass.
For Model 10010, Y-Connector changed to in-house manufacturing: Air flow test - Result: 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 Department of Health & Human Services - USA. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 7, 2015
Medtronic, Inc. Kevin Lam Senior Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, MN 55428
Re: K143107
Trade/Device Name: DLP Vein Graft Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF Dated: December 4, 2014 Received: December 8, 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 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 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. 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 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. Hilleman
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Device Name
DLP® Vein Graft Cannula
Indications for Use (Describe)
This cannula is intended for use in conjunction with cardiopulmonary bypass surgery for up to 6 hours. When properly placed, it can be used to deliver blood (or fluids) to the proximal end of a vein graft.
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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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary
| Date Prepared: | December 4, 2014 |
|---|---|
| Applicant: | 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, Inc. | |
| Phone: (763) 526-2360 | |
| Fax: (763) 367-8360 | |
| Email: kevin.t.lam@medtronic.com | |
| Alternate Contacts: | |
| Susan C. Fidler | |
| Senior Regulatory Affairs Manager | |
| Medtronic, Inc. | |
| Phone: (763) 514-9839 | |
| Fax: (763) 367-8360 | |
| Email: susan.c.fidler@medtronic.com | |
| Device Name and Classification | |
| Trade Name: | DLP® Vein Graft Cannula |
Common Name:
Product Code:
Regulation Number:
Product Classification:
Models: 10010 and 10011
Cardiopulmonary bypass vascular catheter, cannula, or tubing
DWF
21 CFR 870.4210
Class II
Classification:
Predicate Device
DLP® Vein Graft Cannula K791832
4
Indications for Use
This cannula is intended for use in conjunction with cardiopulmonary bypass surgery for up to 6 hours. When properly placed, it can be used to deliver blood (or fluids) to the proximal end of a vein graft.
Device Description
The cannula has a graduated, soft silicone, rubber tip to accommodate vessels of various sizes. The attached 50.8 cm (20 in) flexible tube has a clamp to stop flow through the cannula. Model 10011 has an additional clamp on the antegrade outlet line to stop the flow of fluid into the antegrade cannula. The antegrade cannula connector is a male luer adapter. The cardioplegia inlet fitting is a female luer port. Sterile, nonpyrogenic, single use.
Comparison to Predicate Devices
- Same intended use
- Same technological characteristics
- . Same operating principle
- . Same design features
- Same base materials Acrylic, Polypropylene, Polyvinyl chloride (PVC), Silicone ●
- Same shelf life ●
Summary of Performance Data
Testing has demonstrated that the DLP® Vein Graft Cannula is substantially equivalent to the predicate.
The following performance tests were conducted:
| Change | Verification/Validation | Results |
|---|---|---|
| For Model 10010 | ||
| Bonding to male luer | Air Flow Test | |
| Leak Test | ||
| Bond Strength Test | Pass | |
| Pass | ||
| Pass | ||
| For Model 10010 | ||
| Y-Connector changed to in-house manufacturing | Air flow test | Pass |
5
Conclusion
Medtronic has demonstrated that the modifications made to the DLP® Vein Graft Cannulae products described in this submission resulted in a substantially equivalent device because the fundamental scientific principle, operating principle, design features, and intended use are unchanged from the predicate device.