(36 days)
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, or any data processing that would suggest the use of such technologies.
Yes, this device is a therapeutic device.
Explanation: The device is used to deliver cardioplegia (a therapeutic agent) retrograde through the coronary sinus to stop the heart during cardiopulmonary bypass surgery. This direct involvement in a medical treatment procedure, altering physiological function for a clinical purpose, classifies it as therapeutic.
No
This device is a therapeutic device used for delivering cardioplegia during cardiopulmonary bypass surgery, not a diagnostic device for identifying medical conditions.
No
The device description clearly details physical components like a cannula body, tip, balloon, and inflation assembly, indicating it is 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 cardioplegia retrograde through the coronary sinus during cardiopulmonary bypass surgery. This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is a cannula designed to be inserted into the coronary sinus. This is a physical medical device used for direct intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, etc.) outside of the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used in vitro (in glass, or outside the body) to analyze samples. This device is used in vivo (in the body) for a therapeutic purpose (delivering cardioplegia).
N/A
Intended Use / Indications for Use
These cannula are intended for use during cardiopulmonary bypass surgery for the delivery of Cardioplegia retrograde through the coronary sinus.
The Retrograde Coronary Sinus Perfusion cannula is intended for use during cardiopulmonary bypass surgery for the delivery of cardioplegia retrograde through the coronary sinus up to six hours or less.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The RCSP cannula consists of kink resistant , silicone or extruded PVC body. The silicone cannula are wire wound. The tip of the cannula has a bevel with side holes or bullet nose with multi ports to allow the free flow in the coronary sinus. The back of the cannula terminates in a locking female luer. An inflatable balloon is located at the closer to the tip. The inflation assembly for the manual models is located at the back of the cannula body and contains a female slip luer and a one-way valve assembly. These devices are offered with either a guidewire stylet or a solid stylet to help position the cannula.
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
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)
This modification of the device involved removal of a pressure monitoring line that had no effect on the design of the product and its functionality. No product performance testing was necessary for the product.
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
APR 1 1 2003
·
510(k) Summary
| Date Prepared: | March 4, 2003 |
|---|---|
| Submitter: | Medtronic Perfusion Systems |
| 7611 Northland Boulevard | |
| Brooklyn Park, MN 55428 | |
| Contact Person: | Preeti Jain |
| Senior Manager, Regulatory/Clinical Affairs | |
| Phone: (763)-391-9533 | |
| Fax: (763) 391-9603 | |
| Device Name and Classification: | |
| Trade Name: | Retrograde Coronary Sinus Perfusion Cannula with no |
| Pressure Line | |
| Models 94115NPL, 94725NPL - Manual Inflate | |
| Models 94535 NPL - Auto Inflate | |
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or |
| tubing | |
| Classification: | Class II |
| Predicate Devices: | K860149: Venous Perfusion Return Cannula with cuff |
| (14 French, Manual Inflate) | |
| Model 94015 | |
| And | |
| K901074: Retrograde Coronary Sinus Perfusion Cannula | |
| (15 French, Auto Inflate) |
Device Description:
The RCSP cannula consists of kink resistant , silicone or extruded PVC body. The silicone cannula are wire wound. The tip of the cannula has a bevel with side holes or
Model 94315
1
bullet nose with multi ports to allow the free flow in the coronary sinus. The back of the cannula terminates in a locking female luer. An inflatable balloon is located at the closer to the tip. The inflation assembly for the manual models is located at the back of the cannula body and contains a female slip luer and a one-way valve assembly. These devices are offered with either a guidewire stylet or a solid stylet to help position the cannula.
Indication for Use
These cannula are intended for use during cardiopulmonary bypass surgery for the delivery of Cardioplegia retrograde through the coronary sinus. 0000 100 105 .
Comparison to Predicate Device
The predicate devices are existing models of manual and auto inflate RCSP cannula that are identical to the modified device with the exception of the pressure monitoring line. The predicate models also have kink resistant , silicone or extruded PVC body. The silicone cannula are wire wound. The tip of the cannula has a bevel with side holes or bullet nose with multi ports to allow the free flow in the coronary sinus. The back of the cannula terminates in a locking female luer. An inflatable balloon is located at the closer to the tip. The predicate devices have the same indications for use.
Summary of Performance Data
This modification of the device involved removal of a pressure monitoring line that had no effect on the design of the product and its functionality. No product performance testing was necessary for the product.
Conclusion
Medtronic Perfusion Systems has demonstrated that the Retrograde Coronary Sinus Perfusion Cannula with No Pressure Line , Models 94115NPL, 94725NPL and 94535NPL are substantially equivalent to predicate devices based upon design, and indications for use.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and features the department's name around the edge. In the center of the seal is an abstract image of an eagle with three human profiles within the eagle's body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2003
Medtronic Perfusion Systems c/o Mr. Preeti Jain Senior Manager, Regulatory/Clinical Affairs 7611 Northland Drive N Minneapolis, MN 55428-1088
Re: K030696
Retrograde Coronary Sinus Perfusion Cannula without Pressure Monitoring Lumen Models 94115NPL, 94725NPL - Manual Inflate Models 94535NPL - Auto Inflate Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: April 3, 2003 Received: April 4, 2003
Dear Mr. Jain:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Mr. Preeti Jain
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Elias Mollio
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _|