(46 days)
No
The document describes a physical medical device (cannula and accessories) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
It is an arterial return cannula used in an extracorporeal bypass circuit for extracorporeal circulatory support. This directly addresses a medical condition by assisting the circulatory system.
No
The device is described as an "arterial return cannula" used with an "extracorporeal bypass circuit" for "extracorporeal circulatory support." Its intended use is for "periods up to six hours" as part of a surgical procedure. This description indicates it is a therapeutic device used to facilitate blood circulation, not to diagnose a condition or disease.
No
The device description clearly lists multiple physical components (cannula, connectors, introducer, etc.) and describes performance testing on these physical components, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support". This describes a device used in vivo (within the body) to facilitate blood circulation during surgery.
- Device Description: The description details a cannula and accessories used in a surgical procedure, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information. The device's function is 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. This device does not fit that description.
N/A
Intended Use / Indications for Use
The CentriMag Return (Arterial) Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
The CentriMag Cannulae are designed to serve as conduits to transport blood between the heart and the extracorporeal blood pump. The Cannulae are intended for use for circulatory support during cardiac surgery for cardiopulmonary surgical procedures for up to six hours.
Product codes
DWF
Device Description
The Thoratec CentriMag Return (Arterial) Cannula Kit consists of the return (arterial) cannula and several accessories used in the surgical placement procedure. The cannula and all kit accessories are sterile, single-use, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System (K020271).
The Cannula Kit includes the following accessories:
QTY Kit Component
1 Return (Arterial) Cannula Body
1 Connector, 3/8-inch, barbed
1 Introducer
1 Hemostasis Seal
1 Cap (with Umbilical tape)
1 Porous Plug
1 Guidewire Assembly
1 Introducer Needle
4 Suture Rings (small)
4 Suture Rings (medium)
4 Tip Rings
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
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
The modified CentriMag Return (Arterial) Cannula Kit has successfully undergone performance testing to demonstrate substantial equivalence to the predicate device.
The following performance and dimensional verification tests have been conducted on the redesigned cannula with successful results:
- . Flex Test
- . Tensile Strength Test
- . Chemical Resistance Test
- . Pressure Test
- Suture and Tip Ring Security and Deformation Test
- . Dimensional Verification Examination
- Cannula Body Material Examination
All testing employed devices that were exposed to 2x sterilized, acceleratedaging to simulate a real-time equivalent of 1-year, and heated saline soak for 30days.
Additional verification involved materials evaluation for chemical characterization and biocompatibility to address raw material supplier changes. Lastly, a reduced confirmatory microbiological performance qualification revalidation) was conducted.
The risk management methods used to assess the design modifications to the CentriMag Return (Arterial) Cannula were a Risk Analysis and a Failure Modes and Effects Analysis (FMEA).
Clinical testing was not performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three overlapping profiles facing right, with flowing lines suggesting movement or connection. The profiles are rendered in black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Thoratec Corporation Lori DonDiego Senior Manager, Regulatory Affairs 6035 Stoneridge Drive Pleasanton, VA 94588
Re: K152161
Trade/Device Name: Thoratec CentriMag Return (Arterial) Cannula Kit Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF Dated: August 31, 2015 Received: September 2, 2015
Dear Ms. DonDiego:
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
1
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/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 (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. Hillebrand
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
4.0 Indications for Use Statement
| Applicant: | Thoratec Corporation |
|---|---|
| 510(k) Number (if known): | K152161 |
| Device Name: | Thoratec CentriMag® Return (Arterial) Cannula Kit |
Indications for Use:
The CentriMag Return (Arterial) Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
5.0 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92.
A. Application Information
| Date Prepared: | July 31, 2015 |
|---|---|
| Submitter's Name & Address: | Thoratec Corporation |
| 6035 Stoneridge Drive | |
| Pleasanton, CA 94588 | |
| Establishment Registration No.: 2916596 | |
| Owner / Operator No.: 9045196 | |
| Contact Person: | Lori DonDiego |
| Sr. Manager, Regulatory Affairs |
Ph: 925-734-6921
Fax: (925) 847-8628 |
B. Device Information
| Trade or Proprietary Name: | CentriMag Return (Arterial) Cannula Kit |
|---|---|
| Common or Usual Name: | Cardiopulmonary bypass cannula |
| Classification Name: | Cardiovascular bypass vascular catheter, |
| cannula, or tubing (DWF, 21 CFR - | |
| 870.4210), Class II | |
| Performance Standard: | Performance standards do not currently |
| exist for these devices. None established | |
| under section 514 of the Food, Drug and | |
| Cosmetic Act. |
C. Legally Marketed Predicate Device
Thoratec CentriMag Return Cannula Kit (K110980)
4
Device Description D.
The Thoratec CentriMag Return (Arterial) Cannula Kit consists of the return (arterial) cannula and several accessories used in the surgical placement procedure. The cannula and all kit accessories are sterile, single-use, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System (K020271).
The Cannula Kit includes the following accessories:
| QTY | Kit Component |
|---|---|
| 1 | Return (Arterial) Cannula Body |
| 1 | Connector, 3/8-inch, barbed |
| 1 | Introducer |
| 1 | Hemostasis Seal |
| 1 | Cap (with Umbilical tape) |
| 1 | Porous Plug |
| 1 | Guidewire Assembly |
| 1 | Introducer Needle |
| 4 | Suture Rings (small) |
| 4 | Suture Rings (medium) |
| 4 | Tip Rings |
E. Intended Use
The CentriMag Cannulae are designed to serve as conduits to transport blood between the heart and the extracorporeal blood pump. The Cannulae are intended for use for circulatory support during cardiac surgery for cardiopulmonary surgical procedures for up to six hours.
ட Technological Characteristics
The technological characteristics of the modified CentriMag Return (Arterial) Cannula Kit are the same as the predicate device.
G. Comparison to Predicate Device
The modified CentriMag Return (Arterial) Cannula Kit has the same indication for use, technological characteristics, and performance attributes which essentially renders the modified device equivalent to the predicate device. Moreover, the new device raises no new questions concerning safety or effectiveness. The modification improves upon the reliability of the connection between the connector and the cannula body.
5
Summary of Performance Data H.
The modified CentriMag Return (Arterial) Cannula Kit has successfully undergone performance testing to demonstrate substantial equivalence to the predicate device.
The following performance and dimensional verification tests have been conducted on the redesigned cannula with successful results:
- . Flex Test
- . Tensile Strength Test
- . Chemical Resistance Test
- . Pressure Test
- Suture and Tip Ring Security and Deformation Test
- . Dimensional Verification Examination
- Cannula Body Material Examination
All testing employed devices that were exposed to 2x sterilized, acceleratedaging to simulate a real-time equivalent of 1-year, and heated saline soak for 30days.
Additional verification involved materials evaluation for chemical characterization and biocompatibility to address raw material supplier changes. Lastly, a reduced confirmatory microbiological performance qualification revalidation) was conducted.
The risk management methods used to assess the design modifications to the CentriMag Return (Arterial) Cannula were a Risk Analysis and a Failure Modes and Effects Analysis (FMEA).
l. Clinical Performance
Clinical testing was not performed.
J. Conclusion
The redesigned CentriMag Return (Arterial) Cannula Kit is substantially equivalent to the current CentriMag Return Cannula Kit (K110980).