(35 days)
No
The summary describes a passive blood collection and return device with a surface coating, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a reservoir that collects blood in an extracorporeal circuit and returns it to the patient; it does not directly treat a disease or condition.
No
The device is a reservoir intended for collecting blood during cardiopulmonary procedures and for blood volume replacement, not for diagnosing conditions.
No
The device description clearly indicates it is a physical reservoir with a biosurface coating, intended for collecting blood in an extracorporeal circuit. It is a single-use, sterile hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in an extracorporeal perfusion circuit to collect and return blood during surgical procedures. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description reinforces the device's role in blood collection and return, highlighting features like the Balance Biosurface for reducing platelet activation. There is no mention of analyzing blood or providing diagnostic information.
- Lack of Diagnostic Elements: The text does not mention any components or processes related to analyzing biological samples (like blood) to diagnose a condition, monitor a disease, or determine compatibility.
- Performance Studies: The performance studies focus on the device's physical and functional performance in handling blood (blood damage, defoaming, filtration, etc.) and its biocompatibility. There are no studies related to diagnostic accuracy or performance metrics typically associated with IVDs (like sensitivity, specificity, etc.).
In summary, the device is designed to manage blood flow and volume during surgery, which is a medical procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.
Product codes (comma separated list FDA assigned to the subject device)
DTN
Device Description
The Affinity Fusion® Cardiotomy/Venous Reservoir (CVR) with Balance® Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement. The inside of the jar is coated with Balance Biosurface to reduce platelet activation and preserve platelet function.
This product is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The Affinity Fusion Cardiotomy/Venous Reservoir is sterilized by ethylene oxide.
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)
The following verification and validation testing has demonstrated that substantially equivalent to the predicate device.
| Test Performed | Result |
|---|---|
| Blood Damage Testing | Pass |
| Defoaming | Pass |
| Filtration Efficiency | Pass |
| Cardiotomy Gaseous Microemboli | Pass |
| Dynamic Holdup | Pass |
| Prime Breakthrough | Pass |
| Static Holdup | Pass |
| Volume Marking Accuracy | Pass |
| Reservoir Capacity | Pass |
| Particulate Count | Pass |
A complete biocompatibility assessment was conducted based on ISO 10993-1. The following biocompatibility testing was performed related to new material and design change to the subject device.
| Test Performed | Result |
|---|---|
| Cytotoxicity | Pass |
| Hemocompatibility | Pass |
Clinical testing was not required to establish substantial equivalence with the predicate devices.
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
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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510(k) Summary of Safety and Effectiveness
Date Prepared: October 25, 2013 Applicant: Medtronic, Inc. OCT 2 8 2013 Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establish Registration Number: 2184009 Contact Person: Julia A. Nelson Principal Regulatory Affairs Specialist Phone: (763) 514-9844 (763) 367-8361 Fax: E-mail:julia.a.nelson@medtronic.com Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Trade Name: Biosurface Common Name: Cardiotomy Venous Reservoir Classification Name: Cardiopulmonary bypass blood reservoir Classification: Class II, 21 870.4400 Product Code: DTN Name of Predicate Device: Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface (K122914) Reference Device: Affinity® NT Cardiotomy/Venous Reservoir with Filter Model 540 (K936003)
Device Description:
The Affinity Fusion® Cardiotomy/Venous Reservoir (CVR) with Balance® Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement. The inside of the jar is coated with Balance Biosurface to reduce platelet activation and preserve platelet function.
1
This product is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The Affinity Fusion Cardiotomy/Venous Reservoir is sterilized by ethylene oxide.
Intended Use:
The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.
Contraindications:
Do not use this device for any purpose other than indicated.
Do not use if air leaks are observed during priming and/or operation; this may result in air embolism to the patient and/or fluid loss.
The Affinity Fusion Cardiotomy/Venous Reservoir is contraindicated for use in postoperative chest drainage and autotransfusion procedures when:
- There is an air leak in the lung or gross perforations to the chest wall exist. .
- o Pericardial, mediastinal, pulmonary or systemic infection or malignancy is present.
- Gross contamination or a lymphatic failure is present or suspected. .
- Suctioned blood is obtained from a site where a topical hemostatic agent has been used. o
- The chest is open and vacuum is applied. ●
- . Protamine has been administered prior to the reservoir being removed from the bypass circuit.
- o The patient is returned to surgery for any reason.
- o Vented chest tubes not incorporating vent flow regulation, such as a stopcock, are used. Caution: An assessment should be made of the quality and suitability of the blood that has been collected before re-infusion begins.
Comparison to Predicate Devices:
A comparison of the Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface to the predicate device (the Affinity Fusion Cardiotomy/Venous Reservoir with Balance® Biosurface) indicates the following similarities:
- . Intended Use: The intended use is the same as predicate and reference devices.
- Design: The basic design is the same as the predicate. Minor enhancements were made . to the cardiotomy filtration, and a valve protector was added.
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- Materials: The materials are the same as the predicate, with the exception of the . cardiotomy filtration media, which is the same as the reference device.
- Principles of Operation and Technology: The principles of operation are the same as the . predicate device.
- Performance: The performance is substantially equivalent to the predicate and/or . reference device.
Summary of Performance Data
The following verification and validation testing has demonstrated that substantially equivalent to the predicate device.
| Test Performed | Result | |
|---|---|---|
| Testing per Special Controls | ||
| Guidance Document | Blood Damage Testing | Pass |
| Defoaming | Pass | |
| Filtration Efficiency | Pass | |
| Additional Testing | Cardiotomy Gaseous Microemboli | Pass |
| Dynamic Holdup | Pass | |
| Prime Breakthrough | Pass | |
| Static Holdup | Pass | |
| Volume Marking Accuracy | Pass | |
| Reservoir Capacity | Pass | |
| Particulate Count | Pass |
A complete biocompatibility assessment was conducted based on ISO 10993-1. The following biocompatibility testing was performed related to new material and design change to the subject device.
| Test Performed | Result |
|---|---|
| Cytotoxicity | Pass |
| Hemocompatibility | Pass |
Clinical testing was not required to establish substantial equivalence with the predicate devices.
Conclusion:
The data included in this submission is sufficient to provide reasonable assurance of the safety and effectiveness of the device and the Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface is substantially equivalent to the legally marketed predicate device, the Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface (K122914).
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird-like figure with three curved lines representing wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
October 28, 2013
Medtronic, Inc. Julia Nelson Principal Regulatory Affairs Specialist Medtronic CardioVascular 8200 Coral Street NE Mailstop MVS83 Mounds View, MN 55112
K132972 Re:
Trade/Device Name: Affinity Fusion® Cardiotomy/Venous Reservoir (CVR) with Balance® Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II Product Code: DTN Dated: September 19, 2013 Received: September 23, 2013
Dear Ms. Nelson:
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
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Page 2 - Julia Nelson
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.
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Resourcesfor You/Industry/default.htm.
Sincerelv vours.
M. Azbillieman
for
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K132972
Device Name
Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface
Indications for Use (Describe)
The Affinity Fusion Cardiotomy/Venous Reservoir with Baiance Biosurface is intended to be used in an extractivered perfusion circuit to collect venous and canioned blood during routine cardiopulmonary procedures up to 6 hours in duntion. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open head surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.
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)
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)
M.A. Zilliox
FORM FDA 3881 (9/13)