(36 days)
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.
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.
The provided text is a 510(k) summary for a medical device. It describes a Retrograde Coronary Sinus Perfusion Cannula and states that no performance testing was necessary because the modification (removal of a pressure monitoring line) had no effect on the design or functionality of the product.
Therefore, the document does not contain information related to acceptance criteria or a study proving the device meets said criteria in the context of typical performance metrics such as accuracy, sensitivity, or specificity. The submission relies on substantial equivalence to predicate devices for which performance would have been established previously.
Specifically, the following information is not present in the provided text:
- A table of acceptance criteria and the reported device performance: No performance criteria or metrics are listed as no new performance testing was conducted.
- Sample sized used for the test set and the data provenance: No test set was used for performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no test set for performance.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance study: The document explicitly states "No product performance testing was necessary for the product."
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable as there's no mention of an algorithm or AI model requiring training.
- How the ground truth for the training set was established: Not applicable.
The conclusion drawn by Medtronic Perfusion Systems is that the modified device is "substantially equivalent to predicate devices based upon design and indications for use." This implies that the regulatory acceptance criteria for this specific submission were met by demonstrating that the modification did not alter the fundamental safety and effectiveness previously established for the predicate devices.
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APR 1 1 2003
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510(k) Summary
| Date Prepared: | March 4, 2003 |
|---|---|
| Submitter: | Medtronic Perfusion Systems7611 Northland BoulevardBrooklyn Park, MN 55428 |
| Contact Person: | Preeti JainSenior Manager, Regulatory/Clinical AffairsPhone: (763)-391-9533Fax: (763) 391-9603 |
| Device Name and Classification: | |
| Trade Name: | Retrograde Coronary Sinus Perfusion Cannula with noPressure Line |
| Models 94115NPL, 94725NPL - Manual InflateModels 94535 NPL - Auto Inflate | |
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula ortubing |
| 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
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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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Page 1 of 1
510(k) Number (if known): _|<Ø30696
Retrograde Coronary Sinus Perfusion Cannula without Device Name: Pressure Monitoring Lumen
Models 94115NPL, 94725NPL - Manual Inflate
Models 94535NPL - Auto Inflate
Indications for Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
§ 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).