PEDIATRIC AORTIC ROOT CANNULA

K040173 · Medtronic Perfusion Systems · DWF · Mar 19, 2004 · Cardiovascular

Device Facts

• Record ID: K040173
• Device Name: PEDIATRIC AORTIC ROOT CANNULA
• Applicant: Medtronic Perfusion Systems
• Product Code: DWF · Cardiovascular
• Decision Date: Mar 19, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

This cannula is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.

Device Story

Pediatric Aortic Root Cannula (18 Gauge) facilitates cardioplegia delivery and aortic air aspiration during cardiopulmonary bypass surgery. Device consists of a cannula with a flange, two side holes, and a flexible tapered tube terminating in a female luer fitting. Includes a stainless steel 18-gauge introducer needle with a locking male luer fitting and an over-molded ABS introducer needle sheath. Used in clinical settings by surgical teams. Provides a conduit for cardioplegic solutions and air removal; supports myocardial protection and air management during bypass procedures.

Clinical Evidence

Bench testing only. Performance established through in vitro dimensional and functional testing, biocompatibility evaluation, sterilization validation, packaging integrity, and accelerated aging studies. All testing passed.

Technological Characteristics

18-gauge cannula featuring a flange, two side holes, and flexible tapered tube. Includes stainless steel introducer needle and over-molded ABS needle sheath. Connectivity via female luer fitting. Sterilization and biocompatibility standards applied.

Indications for Use

Indicated for pediatric patients undergoing cardiopulmonary bypass surgery requiring cardioplegia delivery or aortic air aspiration. Intended for short-term use (≤6 hours).

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

• Aortic Root Cannulae (K790565)
• Aortic Root Cannulae (K810548)
• Aortic Root Cannulae (K831591)

Submission Summary (Full Text)

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MAR 1 9 2004

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# 510(k) Summary

| Date Prepared: | March 2, 2004 |
|-----------------|--------------------------------------------------------------------------------------------------------------|
| Submitter: | Medtronic Perfusion Systems<br>7611 Northland Boulevard<br>Brooklyn Park, MN 55428 |
| Contact Person: | Ronald W. Bennett<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |

# Device Name and Classification:

| Trade Name: | Pediatric Aortic Root Cannula<br>(18 Gauge) |
|-----------------|----------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or<br>tubing |
| Classification: | Class II |
| | Predicate Devices: |

Predicate Devices:
Aortic Root Cannulae K790565, K810548, K831591

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#### Device Description:

Dorice Decliption. a flange and two side holes. The tip is attached to a flexible tapered tube that terminates in a female luer fitting. A stainless steel 18 gauge introducer with needle tip and locking male luer fitting is supplied inside the cannula.

### Indication for Use

This cannula is intended for short term use (six hours or less) in conjunction with I mo cannala is may bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.

#### Comparison to Predicate Device

The predicate devices are Aortic Root Cannulae with the same design characteristics and indications for use. The predicate cannulae had similar design and materials. The new cannula varies from the predicates in tip length and color, in having a ribbed body, in overall length and in featuring an over-molded ABS introducer needle sheath.

#### Summary of Performance Data

In vitro dimensional and functional testing was used to establish the performance characteristic of the new device. The biocompatibility, sterilization, and packaging were evaluated. Accelerated aged dimensional and functional testing was also performed. All testing passed.

## Conclusion

Medtronic Perfusion Systems has demonstrated that the modified Pediatric Aortic Root Cannula (18 Gauge) is substantially equivalent to the predicate devices based upon design, test results, and indications for use.

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Public Health Service

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MAR 1 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040173

Pediatric Aortic Root Cannula (18 Gauge) Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula or Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: March 3, 2004 Received: March 4, 2004

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 W. 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/dsmamain.html

Sincerely yours,

Ashley B. Beam

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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# Indications for Use

510(k) Number (if known): K040173 Device Name: Pediatric Aortic Root Cannula

Indications for Use:

This cannula is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.

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 THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashley B. Baan

510(k) Number K040173 (SM. K)