(32 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a cannula and introducer, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to facilitate extracorporeal life support procedures, which is a form of life support that temporarily takes over the function of the heart or lungs, making it a therapeutic intervention.
No
The device is a cannula set intended for use in extracorporeal life support procedures by facilitating blood drainage and reinfusion. It is a medical instrument used for treatment, not for diagnosing conditions or diseases.
No
The device description clearly outlines physical components (cannula, introducer) and their material properties and mechanical testing, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures." This describes a therapeutic procedure involving the physical manipulation and circulation of blood within the body, not the examination of specimens derived from the human body for diagnostic purposes.
- Device Description: The description details a cannula and introducer designed for insertion into a blood vessel to facilitate blood flow for life support. This is a medical device used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on the examination of specimens.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases, monitor conditions, or screen for health issues. This device's function is entirely focused on supporting physiological function through extracorporeal circulation.
N/A
Intended Use / Indications for Use
The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
Product codes
DWF
Device Description
The PROTEK Duo 31 Fr. Veno-Venous Cannula Set consists of two components: a 31 Fr. Dual lumen Veno-Venous Cannula and a 15.5 Fr. Introducer. The Introducer is designed to accept a standard 0.038 inch guidewire. The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is intended as a single patient, single use, sterile device.
The PROTEK Duo 31 Fr. Veno-Venous Cannula (Figure 1) consists of two distinct lumens with a wire-reinforced cannula body. The inner lumen is located entirely within the outer lumen forming two concentric channels.
The distal section (inner lumen/cannula) of the cannula body has six side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during setup and removal of the cannula from the extracorporeal circulatory support equipment (see Figure 1). A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8 inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment.
The introducer (Figure 2) consists of a tube with a luer hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a luer hub at its proximal end to manage introducer insertion and removal from the cannula. The luer hub can also enable contrast injection, if necessary, to facilitate placement and final positioning of the cannula within the target vessel. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque material for visualization under fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular vein
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)
Non-clinical testing included comparative hemolysis, pressure-flow testing, tensile strength, pathway integrity, kink radius, and stiffness.
- Comparative Hemolysis: Side-by-side comparison with predicate of bench top hemolysis levels over 6 hours. Conclusion: No difference in hemolysis levels between test articles and predicate controls.
- Pressure-Flow: Measured pressure losses across cannula at different flow rates. Conclusion: Measured flow rates exceed the smaller predicate at all levels of pressure difference across the cannula. Design specifications were met.
- Tensile Strength: Pull testing of both cannula and introducer. Conclusion: Acceptance criteria were identical to those of the predicate and were met in all tests.
- Pathway Integrity: Pressure testing. Conclusion: Acceptance criterion was identical to that of the predicate and was met in all tests.
- Kink Radius: Flow rate reduction caused by specified minimum bend radius was measured. Conclusion: Acceptance criterion was identical to that of the predicate and was met in all tests.
- Stiffness: Deflection testing to measure force required to bend cannula a specified distance. Conclusion: The cannula, the introducer, and the cannula/introducer assembly met acceptance criteria established to ensure the cannula is stiff enough to insert while remaining flexible enough to avoid vessel injury.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2016
Cardiac Assist, Inc. Greg Johnson, PhD Director of Regulatory Affairs 240 Alpha Drive Pittsburgh, PA 15238
Re: K160257
Trade/Device Name: PROTEK Duo 31 Fr. Veno-Venous Cannula Set Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF Dated: January 27, 2016 Received: February 1, 2016
Dear Greg Johnson:
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 devicerelated 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 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" (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 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,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICE
Food and Drug Administration | orm Approved: OMB No. 0910-0120
piration Date: January 31, 201 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Indications for Use | See PRA Statement below |
| 510(k) Number (if known)
K160257 | |
| PROTEK Duo 31 Fr. Veno-Venous Cannula Set
Device Name | |
| Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and
reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
Indications for Use (Describe) The PROTEK Duo 31 Fr. ' | |
| | |
| | |
| | |
| | |
| | |
| | |
| or both, as applicable)
Type of Use (Select one | |
| 🇿 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED | |
| *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
This section applies only to requirements of the Paperwork Reduction Act of 1995 | |
| 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 complete and review the collection of information. Send comments regarding this burden estimate or any o | |
| Department of Health and Human Services
Paperwork Reduction Act (PRA) Staff
Office of Chief Information Officer
ood and Drug Administration
PRAStaff@fda.hhs.gov | |
| An agency may not conduct or sponsor, and a person is not respond to, a collection | |
| Page 1 of 1
FORM FDA 3881 (8/14) | PSC Publishing Services (301) 443-6740 |
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Image /page/3/Picture/0 description: The image contains the logo for CardiacAssist, Inc. The logo features a circular graphic with arrows pointing in different directions, followed by the company name in a bold, blue font. The text "CardiacAssist, Inc." is written in a clear, sans-serif typeface, making it easily readable. The overall design is clean and professional, conveying a sense of reliability and innovation.
Date: 3/3/2016
Applicant
CardiacAssist, Inc. 240 Alpha Drive Pittsburgh, PA 15238 Telephone: 412-963-7770 Fax: 412-963-0800
Contact person
Greg Johnson, PhD Title: Director of Regulatory Affairs Phone: 412-963-7770 x266 e-mail: gjohnson@tandemheart.com
Device
| Trade/Proprietary Name: | PROTEK Duo 31 Fr. Veno-Venous Cannula Set |
|---|---|
| Common Name: | Veno-Venous Cannula and Introducer |
| Classification Name: | Cardiopulmonary bypass vascular catheter, cannula, or |
| tubing. (21 CFR 870.4210, Product Code DWF) |
Predicate Device
PROTEK Duo 29 Fr. Veno-Venous Cannula (K140999)
Reference Device
Avalon Elite 31 Fr. Veno-Venous Cannula (K081820)
Device Description
The PROTEK Duo 31 Fr. Veno-Venous Cannula Set consists of two components: a 31 Fr. Dual lumen Veno-Venous Cannula and a 15.5 Fr. Introducer. The Introducer is designed to accept a standard 0.038 inch guidewire. The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is intended as a single patient, single use, sterile device.
4
Image /page/4/Picture/0 description: The image shows the logo for CardiacAssist, Inc. The logo features a circular graphic with arrows pointing in different directions. The text "CardiacAssist, Inc." is written in a bold, sans-serif font to the right of the graphic.
Image /page/4/Figure/2 description: This image shows a medical device with several labeled components. The device features barbed connectors at one end and tantalum markers along its length. Insertion depth markers are visible, labeled with numbers 52, 50, and 48, and a wire-reinforced area is indicated in the middle section of the device.
Figure 1. PROTEK Duo 31 Fr. Veno-Venous Cannula
The PROTEK Duo 31 Fr. Veno-Venous Cannula (Figure 1) consists of two distinct lumens with a wire-reinforced cannula body. The inner lumen is located entirely within the outer lumen forming two concentric channels
The distal section (inner lumen/cannula) of the cannula body has six side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during setup and removal of the cannula from the extracorporeal circulatory support equipment (see Figure 1). A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8 inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment.
The introducer (Figure 2) consists of a tube with a luer hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a luer hub at its proximal end to manage introducer insertion and removal from the cannula. The luer hub can also enable contrast injection, if necessary, to facilitate placement and final positioning of the cannula The hemostasis cap minimizes blood loss when the within the target vessel. cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque material for visualization under fluoroscopy.
Image /page/4/Figure/7 description: The image shows a medical device, specifically an introducer needle. The device has a long, thin needle with a sharp tip on the right side of the image. On the left side of the image, there is an introducer hub and hemostasis cap, which are labeled with arrows pointing to them.
Figure 2: 15.5 Fr. Introducer
5
Image /page/5/Picture/0 description: The image contains the logo for CardiacAssist, Inc. The logo features a stylized graphic to the left of the company name. The graphic consists of a circle with arrows pointing in different directions, suggesting circulation or assistance. The text "CardiacAssist, Inc." is written in a bold, sans-serif font, with the company name in a dark blue color.
Indications for Use
The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
Comparison of Technological Characteristics
The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is identical to the predicate PROTEK Duo 29 Fr. Veno-Venous Cannula Set, with the exception that it is two French larger in diameter along the proximal length, 2.5 Fr larger in diameter along the distal portion of the device, and approximately 1.97 inches (5.0 cm) longer. It is designed for the same intended use as the PROTEK Duo 29 Fr. Veno-Venous Cannula Set, but in larger patients and/or those who require additional blood flow. All materials and methods of manufacture are identical.
Summary of Non-clinical Testing
Testing of the PROTEK Duo 31 Fr. Veno-Venous Cannula Set included comparative hemolysis, pressure-flow testing, tensile strength, pathway integrity, kink radius, and stiffness.
| Test | Method | Conclusion |
|---|---|---|
| Comparative | ||
| Hemolysis | Side-by-side comparison with | |
| predicate of bench top | ||
| hemolysis levels over 6 hours. | No difference in hemolysis levels | |
| between test articles and predicate | ||
| controls. | ||
| Pressure-Flow | Measure pressure losses across | |
| cannula at different flow rates. | Measured flow rates exceed the | |
| smaller predicate at all levels of | ||
| pressure difference across the | ||
| cannula. Design specifications | ||
| were met. | ||
| Tensile Strength | Pull testing of both cannula and | |
| introducer | Acceptance criteria were identical | |
| to those of the predicate and were | ||
| met in all tests. | ||
| Pathway Integrity | Pressure testing | Acceptance criterion was identical |
| to that of the predicate and was met | ||
| in all tests. | ||
| Kink Radius | Flow rate reduction caused by | |
| specified minimum bend radius | ||
| was measured | Acceptance criterion was identical | |
| to that of the predicate and was met | ||
| in all tests. | ||
| Stiffness | Deflection testing to measure | |
| force required to bend cannula | ||
| a specified distance | The cannula, the introducer, and the | |
| cannula/introducer assembly met | ||
| acceptance criteria established to | ||
| ensure the cannula is stiff enough to | ||
| insert while remaining flexible | ||
| enough to avoid vessel injury. |
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Image /page/6/Picture/0 description: The image features the logo of CardiacAssist, Inc. The logo consists of a stylized graphic to the left of the company name. The graphic appears to be a circular design with internal elements, possibly representing a heart or circulatory system. The text "CardiacAssist, Inc." is written in a bold, sans-serif font, with the company name clearly emphasized.
Conclusion
The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is made from the same materials, using the same manufacturing processes and sterilization techniques as the predicate device. Testing demonstrated that hemolysis, tensile strength, pathway integrity, and kink radius are identical to the predicate. Stiffness and pressure-flow properties differed as expected for the larger diameter cannula and met established acceptance criteria. The PROTEK Duo 31 Fr. Veno-Venous Cannula Set is determined to be substantially equivalent to the predicate PROTEK Duo 29 Fr. Veno-Venous Cannula Set.
{End of Section}