(37 days)
No
The device description and performance studies focus solely on the physical characteristics, materials, and basic functional performance of a mechanical cannula, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is described as being used for the "delivery of cardioplegia retrogradely through the coronary sinus" during cardiopulmonary bypass surgery, which is a medical treatment.
No
The device is described as a cannula intended for delivering cardioplegia, which is a therapeutic function, not a diagnostic one. While it facilitates a medical procedure, its purpose is not to identify or monitor a condition.
No
The device description clearly details physical components made of silicone or PVC, including a body, tip, balloon, and luer. It also mentions stylets. This 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 cardioplegia retrogradely through the coronary sinus during cardiopulmonary bypass surgery. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is a cannula designed for insertion into the body to deliver a substance. This is consistent with a surgical or therapeutic device, not a device used to examine specimens from the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
- Anatomical Site: The coronary sinus is an anatomical location within the body where the device is used in vivo, not a source of a specimen for in vitro analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
DWF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiopulmonary bypass surgery
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)
Summary of Biocompatibility Testing for Previously Implemented Changes:
- Cytotoxicity: PASS
- Sensitization assay: PASS
- Intracutaneous reactivity study: PASS
- Systemic toxicity (acute) • Acute systemic toxicity study: PASS
- Systemic toxicity (acute) • Pyrogen: PASS
- Genotoxicity: PASS
- Hemocompatibility: PASS
Summary of Bench Testing for Previously Implemented Changes:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Without
Pressure Monitoring Line (also known as DLP® Retrograde
Coronary Sinus Perfusion Cannula Without Pressure Monitoring
Lumen) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
Retrograde Coronary Sinus Perfusion Cannula with no Pressure Monitoring Line
1
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.
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.
2
| Test | Luer Material Change
Biocompatibility Test Result | Manufacturing Process
Material 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.
3
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
4
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
5
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
Page 1 of ____________________________________________________________________________________________________________________________________________________________________