(87 days)
No
The summary describes a physical extracorporeal perfusion circuit and its components, with no mention of software, algorithms, or any AI/ML related terms. The performance studies focus on physical integrity, biocompatibility, and bench testing.
No
The device is an extracorporeal perfusion set used for circulatory support, which is a supportive function rather than a therapeutic one designed to treat a disease or condition. The indicated use is to support the body during procedures, not to directly treat a medical condition.
No
Explanation: The device is described as an "extracorporeal perfusion set" used for "extracorporeal circulatory support." Its primary function is to support physiological processes outside the body, not to diagnose a medical condition or disease.
No
The device description clearly states it is an "extracorporeal perfusion set" made of physical components like tubing and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, the AngioVac Circuit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "procedures requiring extracorporeal circulatory support for periods of up to six hours." This describes a device used on a patient to support their circulation, not a device used to test samples from a patient outside the body.
- Device Description: The description details an "extracorporeal perfusion set" with components like tubing, connectors, and cannulas. These are all components used in a system that circulates blood outside the body during a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical support of circulation.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AngioVac Circuit does not fit this definition.
N/A
Intended Use / Indications for Use
The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.
Product codes (comma separated list FDA assigned to the subject device)
DWE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical Testing: Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4390 Cardiopulmonary bypass pump tubing.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, connected by flowing lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
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)
The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to
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
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
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
information unless it displays a currently valid OMB number." | |
FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Sarvices (301) 443-6740
3
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: 508-658-7929/508-658-7976 Contact Person: Wanda Carpinella
Device Name B.
| Trade Name: | AngioVac Circuit |
|---|---|
| Common/Usual names: | Cardiopulmonary Bypass Circuit |
| Classification Names: | Cardiopulmonary bypass pump tubing |
| 21 CFR§870.4390 ProCode DWE | |
| Classification: | Class II |
Predicate Device(s) ﻥ
| Trade Name | 510(k) | Company |
|---|---|---|
| Vortex Medical, Inc. AngioVac | ||
| Cardiopulmonary Bypass Circuit | K092486 | Vortex Medical Inc. |
| (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.
4
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.