Uncoated Tubing and Connector Components

K151523 · Medtronic, Inc. · DWF · Jul 16, 2015 · Cardiovascular

Device Facts

• Record ID: K151523
• Device Name: Uncoated Tubing and Connector Components
• Applicant: Medtronic, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Jul 16, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.

Device Story

Uncoated tubing and connector components facilitate fluid flow within extracorporeal circuits during cardiopulmonary bypass surgery. Components interconnect primary bypass circuit devices, providing a continuous, smooth-surfaced pathway for blood and other fluids. Tubing is manufactured from polyvinyl chloride (PVC); connectors are manufactured from polycarbonate and Plastisol. Connectors are available in Y-type, straight, and reducer configurations with 1/2 inch connection sites. Used in clinical settings by perfusionists or surgical staff during bypass procedures to maintain circulation. Device provides a passive conduit for blood flow; no active processing or electronic output. Benefits include reliable fluid transport within the bypass circuit.

Clinical Evidence

Bench testing only. Testing included shelf life, pressure integrity, kink resistance, pressure decay, spallation, pull force, sterilization validation, and blood trauma assessment. Biocompatibility testing was conducted per EN ISO 10993-1:2009. All tests met pre-determined acceptance criteria.

Technological Characteristics

Materials: Polyvinyl chloride (PVC) tubing; polycarbonate and Plastisol connectors. Configuration: Y-type, straight, and reducer, 1/2 inch connection sites. Principle: Passive fluid conduit. Sterilization: Not specified. Connectivity: None (mechanical component).

Indications for Use

Indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.

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

• Tubing, Connectors and Accessories with Balance Biosurface (K113845)
• Connector Components with Balance Biosurface (K122811)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 15, 2015

Medtronic, Inc. Jacqueline A. Hauge Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112

Re: K151523

Trade/Device Name: Uncoated Tubing and Connector Components Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF, DTL Dated: June 18, 2015 Received: June 22, 2015

Dear Jacqueline Hauge:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

M.A. Hillebrand

for 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) K151523

#### Device Name

Uncoated Tubing and Connector Components

Indications for Use (Describe)

This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

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| Date Prepared: | June 4, 2015 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Medtronic, Inc.<br>Medtronic Perfusion Systems<br>7611 Northland Drive<br>Minneapolis, MN 55428<br>Establishment Registration Number: 2184009 |
| Contact Person: | Jacqueline A. Hauge<br>Senior Regulatory Affairs Specialist<br>Medtronic Perfusion Systems<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Alternate Contact: | Susan Fidler<br>Senior Regulatory Affairs Manager<br>Medtronic Perfusion Systems<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

## Device Name and Classification

| Trade Name : | Uncoated Tubing and Connector Components |
|----------------------|--------------------------------------------------------------|
| Regulation Name : | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
| Regulation Number: | 21 CFR 870.4210 |
| Product Code: | DWF, DTL |
| Regulatory Class : | Class II |
| 510(k) Review Panel: | Cardiovascular |

## Predicate Devices

| K113845 | Tubing, Connectors and Accessories with Balance Biosurface |
|---------|------------------------------------------------------------|
| K122811 | Connector Components with Balance Biosurface |

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#### De vice Description

Medtronic uncoated Tubing and Connector Components are intended for use in the extracorporeal circuit during cardiopulmonary bypass surgery. These components are primarily used to interconnect the primary devices of the bypass circuit. The lumen of the uncoated Tubing and Connector Components consist of smooth blood-contacting surfaces which provide a continuous pathway for the flow of blood and/or other fluids during cardiopulmonary bypass surgical procedures. The uncoated Tubing Components are comprised of polyvinyl chloride (PVC) and the uncoated Connector Components are comprised of polycarbonate and Plastisol. The uncoated Connectors are provided in Y-type, straight, and reducer configurations with ½ inch to ½ inch connection sites.

### Indications for Use

This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.

### Comparison to Predicate

When compared to the predicate devices, the uncoated Tubing and Connector Components have the same:

Base materials

Packaging materials and configurations

- Intended Use
- Technological characteristics ●
- Operating principle - - -●
- Design features ●
- Performance ●

### Summary of Performance and Biological Testing

Medtronic conducted the following performance testing for the uncoated Tubing and Connector Components:

Shelf life

- . Pressure Integrity Kink Resistance
- Pressure Decay ●

Spallation

.

●

.

.

●

- Pull Force
Method of sterilization and sterility assurance level

- Blood Trauma ●
Additionally, biocompatibility testing was performed in accordance with EN ISO 10993-1:2009 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process.

Performance and biological tests confirm that the uncoated Tubing and Connector Components met pre-determined acceptance criteria and are substantially equivalent to the predicate device.

### Conclusion

●

Medtronic has demonstrated that uncoated Tubing and Connector Components for use in extracorporeal cardiopulmonary bypass perfusion systems (tubing sets/packs) are substantially equivalent to the predicate devices based upon design, test results, and indications for use. The fundamental scientific principle, labeling and intended use are unchanged from the predicate devices.