AngioVac Circuit

K142607 · Angiodynamics · DWE · Dec 11, 2014 · Cardiovascular

Device Facts

• Record ID: K142607
• Device Name: AngioVac Circuit
• Applicant: Angiodynamics
• Product Code: DWE · Cardiovascular
• Decision Date: Dec 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.

Device Story

Extracorporeal perfusion set; includes main perfusion circuit (non-DEHP PVC tubing, Y-connector, quick-connects, priming line), waste line, tuohy adapter, and reinfusion cannula connector. Used in clinical procedures requiring extracorporeal circulatory support. Operates by facilitating blood drainage and reinfusion; connects to AngioVac Cannula via specific male/female quick connectors. Used by clinicians in surgical or interventional settings. Provides circulatory support; enables extracorporeal blood management.

Clinical Evidence

Bench testing only. Physical integrity and performance testing conducted. Biocompatibility testing performed per ISO 10993 for externally communicating, circulating blood path devices (≤ 24 hours), including cytotoxicity, intracutaneous reactivity, acute systemic toxicity, guinea pig sensitization, and hemocompatibility. No adverse effects noted.

Technological Characteristics

Extracorporeal perfusion circuit; 0.375" non-DEHP PVC coextruded tubing. Includes Y-connector, quick-connects, priming line, waste line, tuohy adapter, and reinfusion cannula connector. Designed for use with AngioVac Cannula. Biocompatibility per ISO 10993. No electronic components or software.

Indications for Use

Indicated for patients requiring extracorporeal circulatory support for up to six hours.

Regulatory Classification

Identification

A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.

Predicate Devices

• Vortex Medical, Inc. AngioVac Cardiopulmonary Bypass Circuit (K092486)

Reference Devices

• AngioVac Cannula (K133445)

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

December 11, 2014

AngioDynamics Inc. Wanda Carpinella 26 Forest Street Marlborough, MA 01752

Re: K142607

Trade/Device Name: AngioVac Circuit Regulation Number: 21 CFR 870.4390 Regulation Name: Cardiopulmonary bypass pump tubing Regulatory Class: II Product Code: DWE Dated: September 11, 2014 Received: September 15, 2014

Dear Ms. Carpinella:

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. Isting 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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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. Hillebrenner

for

for
Bram Zuckerman, MD Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | |
| K142607 | |
| Device Name | |
| AngioVac Circuit | |
| Indications for Use (Describe)<br>The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to<br>six hours. | |
| Type of Use (Select one or both, as applicable) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| FOR FDA USE ONLY | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the<br>time to review instructions, search existing data sources, gather and maintain the data needed and complete<br>and review the collection of information. Send comments regarding this burden estimate or any other aspect<br>of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff | |
| PRAStaff(@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of<br>information unless it displays a currently valid OMB number." | |

FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Sarvices [phone]

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## 510(k) SUMMARY (page 1 of 2)

Device Name: AngioVac Circuit

Date Prepared: September 11, 2014

#### A. Submitter/Sponsor

AngioDynamics Inc. 26 Forest Street Marlborough, MA 01752 Telephone Number/Fax: [phone] Contact Person: Wanda Carpinella

#### Device Name B.

| Trade Name: | AngioVac Circuit |
|-----------------------|-------------------------------------------------------------------|
| Common/Usual names: | Cardiopulmonary Bypass Circuit |
| Classification Names: | Cardiopulmonary bypass pump tubing<br>21 CFR§870.4390 ProCode DWE |
| Classification: | Class II |

#### Predicate Device(s) ﻥ

| Trade Name | 510(k) | Company |
|-----------------------------------------------------------------|---------|---------------------------------------------------------|
| Vortex Medical, Inc. AngioVac<br>Cardiopulmonary Bypass Circuit | K092486 | Vortex Medical Inc.<br>(acquired by AngioDynamics Inc.) |

#### Device Description D.

The AngioVac Circuit is an extracorporeal perfusion set that includes four subassemblies including a main perfusion circuit (manufactured of 0.375" non-DEHP PVC coextruded tubing with Y-connector, tubing quick-connects and priming line), waste line, tuohy adapter and reinfusion cannula connector. An extra reinfusion cannula connector and tuohy adapter are provided in a sealed pouch with the circuit.

#### Indications For Use E.

The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.

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### Technology Characteristics F.

Within this current premarket notification, AngioDynamics is proposing to implement design modifications to the AngioVac Circuit. The changes proposed are designed to facilitate extracorporeal circuit set-up including improved connectors, longer tubing lengths and enhanced packaging presentation. There has been no change to the indications for use, nor do the proposed changes significantly affect the technological characteristics or principle of operation for the device as described in K092486. Included among the changes proposed, is that a male quick connector has been added to the blood drainage line of the circuit assembly. The male quick connector has been designed to specifically interface with a female quick connector to be provided on AngioDynamic's venous drainage cannula: i.e., the AngioVac Cannula (reference K133445). Due to this change, the circuit has been labeled with the statement that it is intended to be used solely with the AngioVac Cannula as the venous drainage cannula.

### G. Performance Data

Bench testing, including physical integrity and performance testing, was performed to support substantial equivalence of the AngioVac Circuit The AngioVac Circuit met all specified design and performance requirements. Additionally, the AngioVac Circuit has fulfilled the biocompatibility testing requirements identified in ISO 10993: Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process. The product was evaluated as an externally communicating device, circulating blood path with a limited contact duration (≤ 24 hours). Testing performed included: Cytotoxicity, Intracutaneous Reactivity, Acute Systemic Toxicity, Guinea Pig Sensitization and Hemocompatibility. No adverse effects were noted in any tests performed.

# H. Clinical Testing

Not applicable

#### I. Conclusion

Based on responses to questions posed in the FDA's Decision Making Flow Chart, the proposed device is substantially equivalent to the predicate device.