(30 days)
Not Found
No
The description focuses on the physical components and function of a blood reservoir for cardiopulmonary bypass, with no mention of AI or ML.
No
This device is a component of an extracorporeal perfusion circuit used to collect and store blood during cardiopulmonary bypass procedures; it does not directly treat a disease or medical condition.
No
The device description and intended use indicate it's for collecting and storing blood during cardiopulmonary bypass procedures, which is a supportive function, not a diagnostic one.
No
The device description clearly indicates it is a physical, single-use device designed to collect and store blood, coated with specific surfaces, and intended for use in an extracorporeal perfusion circuit. It is not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device's function within an extracorporeal perfusion circuit to collect and store blood during cardiopulmonary bypass procedures. This is a direct interaction with the patient's blood outside the body for the purpose of supporting circulation, not for diagnostic testing.
- Device Description: The description reinforces its role in collecting, filtering, and defoaming blood within the bypass circuit.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood, detect markers, or provide any information for diagnosing a condition.
- Performance Studies: The performance studies focus on the physical and biological compatibility of the device itself (biocompatibility, cap removal force, particulate generation), not on the accuracy or reliability of any diagnostic measurements.
IVDs are devices intended to be used in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The Affinity Pixie Cardiotomy/Venous Reservoir with Carmeda BioActive Surface or Balance Biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie Cardiotomy/Venous Reservoir is intended to be used in jan extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during toutine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
Product codes (comma separated list FDA assigned to the subject device)
DTN, JOD, DTP
Device Description
The Medtronic Affinity Pixie Cardiotomy Venous Reservoir (CVR) is a single use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the filtered venous blood. The reservoir can also be used for vacuum-assisted venous drainage.
The Affinity Pixie Cardiotomy Venous Reservoir is coated with either Carmeda BioActive Surface or Balance Biosurface. The device is single-use, nontoxic, nonpyrogenic, and supplied sterile for clinical use.
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
neonate, infant, and small pediatric patients
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 was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence.
The following performance tests were conducted:
- . Biocompatibility
- Cap removal force .
- Cap particulate generation .
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.
Not Found
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.
0
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JUN 1 2 2014
| 510(k) Summary | ||
|---|---|---|
| Date Prepared: | May 9, 2014 | |
| Submitter: | Medtronic, Inc. | |
| Medtronic Perfusion Systems | ||
| 7611 Northland Drive | ||
| Minneapolis, MN 55428 | ||
| Establish Registration Number: 2184009 | ||
| Contact Person: | Jessica Sixberry | |
| Principle Regulatory Affairs Specialist | ||
| Phone: (763) 514-9849 | ||
| Fax: (763) 367-8360 | ||
| Email: jessica.m.sixberry@medtronic.com |
Device Name and Classification:
| Trade Name: | Affinity Pixie® Cardiotomy Venous Reservoir with Carmeda®
BioActive Surface or with Balance® Biosurface |
|-----------------------|------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiotomy Venous Reservoir |
| Classification Name: | Blood Reservoir, cardiopulmonary bypass |
| Classification Panel: | Cardiovascular |
| Regulation Number: | 21 CFR 870.4400, 21 CFR 870.4270, 21 CFR 870.4230 |
| Product Code: | DTN, JOD, DTP |
| Classification: | Class II |
Predicate Devices
Medtronic Affinity Pixie® Cardiotomy Venous Reservoir with Carmeda® BioActive Surface or with Balance® Biosurface (K100645)
Device Description
The Medtronic Affinity Pixie Cardiotomy Venous Reservoir (CVR) is a single use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the filtered venous blood. The reservoir can also be used for vacuum-assisted venous drainage.
The Affinity Pixie Cardiotomy Venous Reservoir is coated with either Carmeda BioActive Surface or Balance Biosurface. The device is single-use, nontoxic, nonpyrogenic, and supplied sterile for clinical use.
| Models | Description | |
|---|---|---|
| BBP241 | Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir Balance | |
| Biosurface |
Alleviating Pain · Restoring Health · Extending Life
1
| Models | Description |
|---|---|
| CBP241 | Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir Carmeda |
| BioActive Surface |
Indications for Use
The Affinity Pixie Cardiotomy/Venous Reservoir with Carmeda BioActive Surface or Balance Biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie Cardiotomy/Venous Reservoir is intended to be used in jan extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during toutine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
Comparison to Predicate Devices
The Affinity Pixie CVR has the same intended use, design and materials, and principles of operation and technology when compared to the predicate Affinity Pixie CVR.
- Intended Use: The intended use is the same as the predicate device. .
- Design: The design is the same as the predicate device. .
- Materials: The materials of the Affinity Pixie CVR are the same with the exception . of the protective port caps which have undergone a minor formulation change.
- Principles of Operation and Technology: The principles of operation are the same as ● the predicate device.
- Performance: The performance of the device is the same as the predicate device. .
Summary of Performance Data
Bench testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence.
The following performance tests were conducted:
- . Biocompatibility
- Cap removal force .
- Cap particulate generation .
Conclusion
Medtronic has demonstrated that the Affinity Pixie CVR is substantially equivalent to the predicate devices based upon design, test results, and indications for use.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract caduceus or a symbol representing health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2014
Medtronic, Inc. Ms. Jessica Sixberry Principal Regulatory Affairs Specialist 7611 Northland Dr. Minneapolis, MN 55428
Re: K141233
Trade/Device Name: Affinity Pixie Oxygenation System with Carmeda BioActive Surface or Balance BioSurface Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary bypass blood reservoir Regulatory Class: Class II Product Code: DTN, JOD, DTP Dated: May 9, 2014 Received: May 13, 2014
Dear Ms. Sixberry:
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
.. .
3
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 Industry and Consumer Education 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. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
MDA
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K141233
Device Name: Affinity Pixie Oxygenator System with Carmeda Bioactive Surface or with Balance Biosurface
Indications for Use:
ModelBBP241:
The Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Carmeda BioActive Surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie Hollow Fiber Oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The Affinity Pixie Cardiotomy/Venous Reservoir 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.
See next page for Model CBP241.
Prescription Use X OR Over-The-Counter Use
Per 21 CFR 801.109
(PLEASEDONOTWRITEBELOWTHISLINE-CONTINUEONANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
MDA
5
Model CBP241:
The Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie Hollow Fiber Oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The Affinity Pixie Cardiotomy/Venous Reservoir 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.