ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106

K024069 · Medtronic Vascular · DWF · Jan 8, 2003 · Cardiovascular

Device Facts

• Record ID: K024069
• Device Name: ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106
• Applicant: Medtronic Vascular
• Product Code: DWF · Cardiovascular
• Decision Date: Jan 8, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

These cannulae are intended for use in perfusion of the ascending aorta during cardiopulmonary bypass, up to six hours or less.

Device Story

One Piece Pediatric Arterial Cannula (Models 77006, 77106) is a 6 Fr. flexible, thin-walled, wire-wound PVC cannula; 9" length. Features include beveled tip, 1 cm depth markings, and tip orientation line. Proximal end has molded 1/4" barbed connector; Model 77006 is vented, 77106 is non-vented. Used in clinical settings during cardiopulmonary bypass; operated by perfusionists or surgeons. Device facilitates blood flow to ascending aorta. Benefits include secure perfusion access during pediatric cardiac procedures.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including in vitro visual inspection, dimensional analysis, simulated use, and functional testing (water/air leak tests and bend tests).

Technological Characteristics

Materials: PVC body, wire-wound. Dimensions: 6 Fr. diameter, 9" length. Features: Beveled tip, 1 cm depth markings, tip orientation line, 1/4" barbed connector (vented or non-vented). Sterilization: Not specified.

Indications for Use

Indicated for perfusion of the ascending aorta during cardiopulmonary bypass procedures 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

• Arterial Cannula 7000 Series (K840001)

Submission Summary (Full Text)

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K∅24∅69

# JAN 0 8 2003

# 510(k) Summary

| Date Prepared: | December 6, 2002 |
|-----------------|------------------------------------------------------------------------------------------------------------------|
| Submitter: | Medtronic Perfusion Systems<br>7611 Northland Boulevard<br>Brooklyn Park, MN 55428 |
| Contact Person: | Ronald W. Bennett<br>Principal Regulatory Affairs Specialist<br><br>Phone: [phone]<br>Fax: [phone] |

# Device Name and Classification:

| Trade Name: | One Piece Pediatric Arterial Cannula<br>Models 77006 and 77106 |
|--------------------|----------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or<br>tubing |
| Classification: | Class II |
| Predicate Devices: | K840001<br>Arterial Cannula<br>7000 Series<br>8, 10, 12, 14, 16, 18, 20, 22, 24, 26 Fr.<br>Pediatric and Adult Sizes |

#### Device Description:

The One Piece Pediatric Arterial Cannula Models 77006 and 77106 are 6 Fr., flexible, thin-walled cannula with wire wound bodies and a 9" overall length. They have a beveled tip that is made as part of the PVC body. There are depth markings located at 1 cm increments. A tip orientation line indicates the direction of the bevel for location once the cannula is inside the body. The proximal end of the cannula terminates in a 1/4" barbed connector that can be either vented or non-vented. The model 77006 is vented and the model 77106 is non-vented. The proximal end connector on these models is also molded as part of the body.

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## Indication for Use

These cannulae are intended for use in perfusion of the ascending aorta during cardiopulmonary bypass, up to six hours or less.

# Comparison to Predicate Device

The predicate devices are cannulae with a thin walled tip attached to a flexible PVC body and having both 1/4 " and 3/8" connectors. There was an indexing line for determining tip orientation when the cannula is in the aorta. There was a molded plastic vent plug to allow venting before connection to the perfusion line. The overall length of the cannula was 7". The predicate devices had the same indication for use.

## Summary of Performance Data

In vitro visual, dimensional, simulated use and functional testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices. Visual inspection for defects, dimensional testing of the cannula and markings, water and air leak testing, and various bend tests were performed and the results found acceptable.

#### Conclusion

Medtronic Perfusion Systems has demonstrated that the Arterial One Piece Pediatric Cannula Models 77006 and 77106 are substantially equivalent to predicate devices based upon design, test results, and indications for use.

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three overlapping profiles, suggesting a sense of community or interconnectedness.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 8 2003

Medtronic Perfusion Systems c/o Mr. Ronald W. Bennett Principal Regulatory Affairs Specialist 7611 Northland Drive N. Minneapolis, MN 55428-1088

Re: K024069

Trade Name: One Piece Pediatric Arterial Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular cannula Regulatory Class: Class II (two) Product Code: DWF Dated: December 6, 2002 Received: December 10, 2002

Dear Mr. Bennett:

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.

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Page 2 - Mr. Ronald Bennett

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); 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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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.

K. Oa. Till

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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K024069

Page _1_ of _1__

510(k) Number (if known):

One Piece Pediatric Arterial Cannula Device Name:

Models 77006 and 77106

Indications for Use:

These cannulae are intended for use in perfusion of the ascending aorta during cardiopulmonary bypass, 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 Only

(Optional Format 3-10-98)

V. Oettel

iovascular Devices

510(k) Number K024069