RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE)

K030696 · Medtronic Perfusion Systems · DWF · Apr 11, 2003 · Cardiovascular

Device Facts

• Record ID: K030696
• Device Name: RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE)
• Applicant: Medtronic Perfusion Systems
• Product Code: DWF · Cardiovascular
• Decision Date: Apr 11, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Retrograde Coronary Sinus Perfusion (RCSP) cannula; used during cardiopulmonary bypass surgery; delivers cardioplegia retrograde through coronary sinus. Device body: kink-resistant silicone or extruded PVC; silicone models wire-wound. Tip: bevel with side holes or bullet nose with multi-ports for flow. Features inflatable balloon near tip for positioning/occlusion. Manual models include inflation assembly with female slip luer and one-way valve; auto-inflate models available. Includes guidewire or solid stylet for placement. Operated by surgical team in OR. Removes pressure monitoring line compared to previous versions; otherwise identical design/function.

Clinical Evidence

No clinical data. Bench testing only; modification (removal of pressure monitoring line) determined to have no effect on design or functionality, requiring no additional performance testing.

Technological Characteristics

Materials: kink-resistant silicone or extruded PVC; wire-wound silicone. Components: inflatable balloon, female luer, one-way valve (manual models), guidewire/solid stylet. Form factor: cannula/tubing. Energy source: none (mechanical). Sterilization: not specified.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring retrograde delivery of cardioplegia through the coronary sinus for a duration of six hours or less.

Regulatory Classification

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.

Predicate Devices

• Venous Perfusion Return Cannula with cuff (14 French, Manual Inflate) Model 94015 (K860149)
• Retrograde Coronary Sinus Perfusion Cannula (15 French, Auto Inflate) (K901074)

Submission Summary (Full Text)

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APR 1 1 2003

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# 510(k) Summary

| Date Prepared: | March 4, 2003 |
|---------------------------------|------------------------------------------------------------------------------------------------------------|
| Submitter: | Medtronic Perfusion Systems<br>7611 Northland Boulevard<br>Brooklyn Park, MN 55428 |
| Contact Person: | Preeti Jain<br>Senior Manager, Regulatory/Clinical Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Device Name and Classification: | |
| Trade Name: | Retrograde Coronary Sinus Perfusion Cannula with no<br>Pressure Line |
| | Models 94115NPL, 94725NPL - Manual Inflate<br>Models 94535 NPL - Auto Inflate |
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or<br>tubing |
| Classification: | Class II |
| Predicate Devices: | K860149: Venous Perfusion Return Cannula with cuff<br>(14 French, Manual Inflate)<br>Model 94015 |
| | And |
| | K901074: Retrograde Coronary Sinus Perfusion Cannula<br>(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 [phone]. 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 [phone] or [phone] 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): _|<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)