(68 days)
Not Found
No
The device description and performance studies focus on material properties and mechanical performance, with no mention of AI or ML.
Yes
This device is used for delivery of cardioplegia solutions during cardiopulmonary bypass surgery, which is a medical treatment.
No
The Intended Use / Indications for Use section states that these cannulae are "intended for use in conjunction with cardiopulmonary bypass surgery... for delivery of cardioplegia solutions directly to the coronary arteries," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly describes physical components (basket-style tip, stainless steel tube, silicone body, luer fitting) and the performance studies focus on material properties and mechanical strength, indicating a hardware device.
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 solutions directly to the coronary arteries during cardiopulmonary bypass surgery. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details a physical device (cannulae) designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests in vitro (outside the living body) on biological samples. This device is clearly intended for direct use within the body during surgery.
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
These coronary Cannulae consist of basket-style tip, soft (silicone) tip, or spherical tip which is attached to a malleable stainless steel tube, or a soft bulb beveled tip with an integral silicone body. The Cannulae terminate with a locking female luer fitting. The French diameter is measured at the base of the tip adjacent to the sealing flange or across the diameter for the soft bulb beveled tip style. 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)
Verification and validation testing has demonstrated that the DLP Coronary Ostial Perfusion Cannula are substantially equivalent to the predicates.
Modifications: Silicone to new Silicone due to supplier obsolescence. Verification/Validation: Burst strength relative to predicate material. Results: Pass
Modifications: Organic to synthetic barium sulfate. Verification/Validation: Tip component tested for tensile pull-off force. Results: Pass
Modifications: Organic to synthetic barium sulfate. Verification/Validation: Biocompatibility Assessment. Results: Pass - no impact to biocompatibility
Modifications: Polypropylene to new Polypropylene due to supplier obsolescence. Verification/Validation: Hub tested for Tensile Pull-Off Force and Torsional Twist-Off Force. Results: Pass
Modifications: Polypropylene to new Polypropylene due to supplier obsolescence. Verification/Validation: Biocompatibility Assessment. Results: Pass - no impact to biocompatibility
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
510(k) Summary
| Date Prepared: | May 2, 2013 | JUL 1 0 2013 |
|---|---|---|
| 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® Coronary Ostial Perfusion Cannulae | |
| Trade Name: | DLF Coronary Ostial Perfusion Cannulae | |
| Models: 30010, 30011, 30012, 30014, 30050, 30055, 30315, | ||
| 30317, 30320, 30110, 30112, 30114, 30155, 30212, and 30255. | ||
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing | |
| Regulation Number: | 21 CFR 870.4210 | |
| Product Code: | DWF | |
| Product Classification: | Class II |
Predicate Devices
Spherical Tip Coronary Ostial Cannulae
Device Description
These coronary Cannulae consist of basket-style tip, soft (silicone) tip, or spherical tip which is attached to a malleable stainless steel tube, or a soft bulb beveled tip with an integral silicone body. The Cannulae terminate with a locking female luer fitting. The French diameter is
1
measured at the base of the tip adjacent to the sealing flange or across the diameter for the soft bulb beveled tip style. 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 (K034058) indicates the following similarities:
- Same intended use ■
- Same technological characteristics
- Same operating principle
- 트 Same design features
- 트 Same base materials (Polyviny) Chloride (PVC), Polypropyiene, and Stainless steel)
- P Same shelf life
Summary of Performance Data
Verification and validation testing has demonstrated that the DLP Coronary Ostial Perfusion Cannula are substantially equivalent to the predicates.
| Modifications | Verification/Validation | Results |
|---|---|---|
| Silicone to new Silicone due to | ||
| supplier obsolescence. | Burst strength relative to predicate | |
| material. | Pass | |
| Organic to synthetic barium | ||
| sulfate. | Tip component tested for tensile | |
| pull-off force. | Pass | |
| Organic to synthetic barium | ||
| sulfate. | Biocompatibility Assessment. | Pass - no impact to |
| biocompatibility | ||
| Polypropylene to new | ||
| Polypropylene due to supplier | ||
| obsolescence. | Hub tested for Tensile Pull-Off | |
| Force and Torsional Twist-Off | ||
| Force. | Pass | |
| Polypropylene to new | ||
| Polypropylene due to supplier | ||
| obsolescence. | Biocompatibility Assessment. | Pass - no impact to |
| biocompatibility |
The following performance tests were conducted:
Conclusion
Medtronic has demonstrated that the modifications made to the DLP® Coronary Ostial Perfusion Cannulae product family described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate devices.
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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 features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
July 10, 2013
Medtronic CardioVascular, Inc. c/o Kevin Lam 8200 Coral Street NE Mailstop MVS83 Mounds View, MN 55112
K131269 Re:
Trade/Device Name: DLP Coronary Ostial Perfusion Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF Dated: June 13, 2013 Received: June 14, 2013
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 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
3
Page 2 - Kevin Lam
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M. A. Hillemann
for
Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number: K131269
Device Name: DLP® Coronary Ostial Perfusion Cannulae
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.
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)
M.A. Lillehamm