(196 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a simple tubular conduit, with no mention of AI or ML.
Yes
The device is used to return oxygenated blood to the patient during cardiopulmonary bypass surgery, which is a therapeutic intervention.
No
The device is an aortic cannula used for perfusion, which is a therapeutic function, not a diagnostic one. It facilitates the return of blood to the body, as opposed to identifying a disease or condition.
No
The device description clearly describes a physical, tubular conduit (cannula) intended for insertion into the ascending aorta, which is a hardware component. The performance studies also focus on physical properties like force at break, leak, and hemolysis, further indicating 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 "perfusion of the ascending aorta during cardiopulmonary bypass surgery." This describes a surgical procedure involving direct interaction with the patient's circulatory system.
- Device Description: The description details a "tubular conduit with a tip that can be positioned into the patient's anatomy (ascending aorta) to allow the blood to re-enter the vascular blood stream." This is a device used in vivo (within the living body).
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used in vitro (outside the living body).
The Sarns™ Soft-Flow Aortic Cannula is a surgical device used directly on the patient during a medical procedure, not a device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The Sarns™ Soft-Flow Aortic Cannula is indicated for perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to 6 hours of use.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The Sarns™ Soft-Flow® Aortic Cannula is a component within the circuit that tunnels patient blood back into the body. The design of the Sams™ Soft-Flow Aortic Cannula allows patient blood to re-enter the body after the blood has routed through an extracorporeal circuit for blood oxygenation. The design of the cannula is simple in that it consists of a tubular conduit with a tip that can be positioned into the patient's anatomy (ascending aorta) to allow the blood to re-enter the vascular blood stream. The materials of construction for the Sarns™ Soft-Flow Aortic Cannula can include polyvinylchloride, PMEA polymer, polyethylene, acrylonitrile butadiene styrene and stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ascending aorta
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)
Performance assessments for safety and effectiveness were accomplished through bench studies that included the following evaluations:
- force at break
- liquid and air leak
- ink adhesion
- hemolysis
- pressure drop
- exit velocity
There are no appreciable differences between the subject devices and 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.
Sarns™ Low Jetting Aortic Arch Cannula, K934127, Sarns™ Xcoated Cannula, K083301, Medtronic Select 3D® Arterial Cannula, 18 Fr, K043179, Medtronic Select 3D® Arterial Cannula, 24 Fr, K033416
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
§ 870.4210 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/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter T inside, followed by the word "TERUMO" in bold, sans-serif font. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in a smaller, sans-serif font. The logo is black and white.
K132451
SECTION 5-510(K) SUMMARY Sarns™ Soft-Flow Aortic Cannula
FEB 1 8 2014
Date Prepared:
August 2013
Sponsor Information:
Owner/Applicant/Submitter:
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, Michigan 48103 Phone: 1-800-262-3304 Fax: 410-398-6079 Registration No. 1828100
Contact Person:
Garry A. Courtney, MBA, RAC Sr. Mgr., Regulatory Affairs Phone: 1-800-262-3304 ext. 7486 Fax: 410-398-6079 Email: garry.courtney@terumomedical.com
Device Names/Classifications:
| Device Trade Name: | SarnsTM Soft-Flow® Aortic Cannula |
|---|---|
| Device Common Name: | Aortic cannula for cardiopulmonary bypass |
| Classification Name: | Cardiopulmonary bypass vascular catheter, cannula, tubing |
| Regulation Number: | 21 CFR 807.4210 |
| Classification: | Class II |
| Product Code: | DWF |
Predicate Devices:
- Sarns™ Low Jetting Aortic Arch Cannula, K934127 �
- Sarns™ Xcoated Cannula, K083301 .
- Medtronic Select 3D® Arterial Cannula, 18 Fr, K043179 .
- Medtronic Select 3D® Arterial Cannula, 24 Fr, K033416 .
Purpose of Submission:
Terumo Cardiovascular Systems is submitting this Premarket Notification due to cumulative changes that have been made since the time that the original submissions were cleared by FDA. Although none of the individual changes were determined to be significant, Terumo Cardiovascular Systems Corporation believes it is appropriate to submit a 510(k) that represents the devices in their current design state.
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Image /page/1/Picture/0 description: The image shows the Terumo Cardiovascular Systems logo. The logo consists of a circle with a T inside, followed by the word "TERUMO" in bold, uppercase letters. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in a smaller font. The logo is black and white.
Intended Use/Indications for Use:
The Sarns™ Soft-Flow Aortic Cannula is indicated for perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to 6 hours of use.
Principles of Operation and Technology:
The subject devices are modifications of the predicate devices, and these modifications do not impact the technology of the predicate devices, the principles of operation and do not raise different or new questions of safety and effectiveness from the predicates. The Saft-Flow Aortic Cannula provides a conduit for the flow of patient blood within the extracorporeal circuit during cardiopulmonary bypass surgery. Typically, blood is gravity drained from the body into a blood reservoir. From the reservoir, blood then is propelled through the balance of the extracorporeal circuit via a roller pump or centrifugal pump. The Sarns™ Soft-Flow® Aortic Cannula is a component within the circuit that tunnels patient blood back into the body.
Design and Materials:
The design of the Sams™ Soft-Flow Aortic Cannula allows patient blood to re-enter the body after the blood has routed through an extracorporeal circuit for blood oxygenation. The design of the cannula is simple in that it consists of a tubular conduit with a tip that can be positioned into the patient's anatomy (ascending aorta) to allow the blood to re-enter the vascular blood stream.
The materials of construction for the Sarns™ Soft-Flow Aortic Cannula can include polyvinylchloride, PMEA polymer, polyethylene, acrylonitrile butadiene styrene and stainless steel.
Performance Evaluations:
Clinical studies involving patients are not necessary to demonstrate the safety and effectiveness of the subject devices. Performance assessments for safety and effectiveness were accomplished through bench studies that included the following evaluations:
- force at break
- liquid and air leak
- ink adhesion .
- hemolysis
- pressure drop .
- exit velocity .
Substantial Equivalence Comparison:
The information presented in this section depicts a comparison between the subject device, the modified Sarns™ Soft-Flow® Aortic Cannula and the predicate device, the unmodified Sams™ Soft-Flow Aortic Cannula.
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Image /page/2/Picture/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with a stylized "T" inside, followed by the word "TERUMO" in bold, sans-serif font. Below "TERUMO" are the words "Cardiovascular Systems" in a smaller, less bold font. The logo is black and white.
Comparison of Intended Use:
The modified Sarns™ Soft-Flow® Aortic Cannula and the predicate Sarns™ Soft-Flow Aortic Cannula have the exact same intended use statements:
The modified and the unmodified Sams™ Soft-Flow Aortic Cannulae are each indicated for perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to 6 hours of use.
Duration of Use:
The modified Sarns™ Soft-Flow Aortic Cannula and the predicate Sarns™ Soft-Flow® Aortic Cannula can both be used in procedures lasting up to 6 hours in duration.
Comparison of Labeling:
The labeling that will be used for the modified device is similar to the labeling used with the predicate device, although some labeling is revised to provide greater clarity for the user. The revised instructions labeling accurately presents the directions that are necessary for the end-user to employ the device in a safe and effective manner. Terumo submits that the labeling complies with applicable regulations in those regions where the device is to be distributed.
Comparison of Operation and Technology:
The modified Sams™ Soft-Flow Aortic Cannula and the predicate Sams™ Soft-Flow Aortic Cannula utilize the exact same technologies and principles of operation. The technology of the modified Cannula is not impacted by the modifications made to the subject device.
Comparison of Design:
With respect to the design of the modified Sarns™ Soft-Flow® Aortic Cannula, there have been no significant design changes implemented. Terumo has made non-significant changes since the original submission of these devices - each of which has been determined to maintain the integrity of the product without adversely impacting safety and/or performance.
Comparison of Materials:
The materials of construction used in the modified Sams™ Soft-Flow Aortic Cannula are the same generic materials that are used in the predicate device. The only difference between the subject and predicate devices is a luer cap manufactured with acrylonitrile butadiene styrene, and the predicate device luer cap was manufactured with polypropylene.
Comparison of Performance:
Terumo Cardiovascular has conducted performance studies with the modified devices to ensure that they all continue to satisfy appropriate device performance specifications and to ensure that they satisfy customer needs. There are no appreciable differences between the subject devices and the predicate devices.
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Image /page/3/Picture/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with a T inside of it, followed by the word "TERUMO" in bold, black letters. Below the word "TERUMO" are the words "Cardiovascular Systems" in a smaller font.
Conclusion:
The information and data included in the 510(k) notice demonstrate the Sarns™ Soft-Flow Aortic Cannula is substantially equivalent to the predicate devices for perfusion of the ascending aorta during cardiopulmonary bypass for up to 6 hours of use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
ood and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 18, 2014
Terumo Cardiovascular Systems Corporation Eileen Dorsey, Regulatory Affairs Manager 125 Blue Ball Road Elkton, MD 21921
Re: K132451
Trade Name: Sams™ Soft Flow Aortic Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF Dated: January 13, 2014 Received: January 14, 2014
Dear Ms. Dorsey:
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 - Ms. Eileen Dorsey
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" (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,
MAHillenm
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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Image /page/6/Picture/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter T inside, followed by the word "TERUMO" in bold, sans-serif font. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in a smaller, sans-serif font.
SECTION 4 - INDICATION FOR USE Sarns™ Soft-Flow® Aortic Cannula
510(k) Number (if known):
K132451 Unknown at time of submission
Device Name:
Sarns™ Soft-Flow® Aortic Cannula
Indications for Use:
Device Intended Use - The device is indicated for perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to six hours of use.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Or
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Hillman