(114 days)
Not Found
No
The 510(k) summary describes a purely mechanical medical device (cannula and introducer) and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The performance studies are focused on physical properties and mechanical performance.
No
The device is used to cannulate vessels or organs and facilitate extracorporeal circulatory support, which is a supportive rather than a therapeutic function.
No.
The device is a venous cannula and introducer intended to cannulate vessels or organs and/or connect with extracorporeal circulatory support equipment. Its function is interventional (to facilitate blood flow for support), not diagnostic.
No
The device description clearly outlines physical components (cannula, introducer) made of materials like polyurethane and PVC, and the performance studies focus on physical properties and interactions (hemolysis, pressure-flow, tensile strength, etc.). There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cannulate vessels or organs and/or connect with accessory extracorporeal circulatory support equipment." This describes a device used in vivo (within the body) for a therapeutic or supportive purpose, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a cannula and introducer designed for insertion into the body to facilitate blood flow for extracorporeal support. This is consistent with an in vivo medical device.
- Performance Studies: The performance studies focus on physical characteristics and performance within a circulatory system (hemolysis, pressure-flow, tensile strength, etc.), not on the accuracy or reliability of diagnostic measurements from biological samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The Protek Solo 24 Fr Venous Cannula is intended to cannulate vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
Product codes
DWF
Device Description
The Protek Solo 24 Fr Venous Cannula Set consists of two components: a 24 Fr single lumen cannula and a 21 Fr. Introducer. The Introducer is designed to accept a standard 0.038 inch guidewire. The Protek Solo 24 Fr Venous Cannula Set is intended as a single patient, single use, sterile device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels or organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
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: Measure 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): 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
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 the U.S. Department of Health & Human Services. 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 symbol featuring three abstract human profiles facing to the right, stacked one behind the other. The profiles are depicted with flowing lines, creating a sense of movement and unity.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cardiac Assist, Inc. Greg Johnson VP Regulatory Affairs and Quality Assurance 240 Alpha Dr. Pittsburgh, Pennsylvania 15238
Re: K162214
Trade/Device Name: Protek Solo 24 Fr 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: August 5, 2016 Received: August 8, 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
1
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" (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,
M.R. Hilleman
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Protek Solo 24 Fr Venous Cannula Set
Indications for Use (Describe)
、、
The Protek Solo 24 Fr Venous Cannula is intended to cannulate vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for CardiacAssist, Inc. The logo consists of a circular graphic to the left of the company name. The graphic contains four arrows pointing in different directions. The company name is written in a bold, sans-serif font.
Date: 8/5/2016
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 Solo 24 Fr Venous Cannula Set |
|---|---|
| Common Name: | Venous Cannula and Introducer |
| Classification Name: | Cardiopulmonary bypass vascular catheter, cannula, or |
| tubing. (21 CFR 870.4210, Product Code DWF) |
Predicate Device
TandemHeart 21 Fr Venous Cannula (K133236)
Protek Duo Veno-Venous Cannula Introducer (K140999)
Device Description
The Protek Solo 24 Fr Venous Cannula Set consists of two components: a 24 Fr single lumen cannula and a 21 Fr. Introducer. The Introducer is designed to accept a standard 0.038 inch guidewire. The Protek Solo 24 Fr Venous Cannula Set is intended as a single patient, single use, sterile device.
Image /page/3/Figure/14 description: The image shows a diagram of a medical device with several labeled components. The device features a 'Barbed Connector' at one end, followed by a 'Clamping Area' and a 'Suture Wing'. Along the length of the device, there are 'Insertion Depth Markers' labeled with numbers ranging from 60 to 10, and the area is marked as 'Wire Reinforced Area'. The opposite end has 'Distal Holes (16)'.
Image /page/3/Figure/15 description: The image shows the title of a figure, which is "Figure 1. Protek 24 Fr Venous Cannula". The title is written in a clear, bold font, making it easily readable. The title indicates that the figure is the first one in a series or document. The figure likely depicts or discusses the Protek 24 Fr Venous Cannula, which is a medical device used for venous access.
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A. 24 Fr Venous Cannula
The 24 Fr Venous Cannula (Figure 1) consists of a single lumen made of polyurethane with a wire-reinforced cannula body. The cannula has an insertable length of 60 cm. The distal section (insertable length) is 24 Fr with sixteen side holes spanning the distal 6.6" (16.8 cm) of the cannula. The proximal section of the cannula is clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during set-up and removal. A non-vented barbed connector is affixed to the proximal end of the cannula and allows for connection of standard 3/8" blood circuit tubing. The cannula has printed insertion depth markings every 10 centimeters from 10 to 40 cm followed by every 2 centimeters for the rest of the insertable length measured from the distal end. The cannula also has a suture wing that can be used for securing the cannula in place to the patient.
Image /page/4/Figure/4 description: The image shows a medical instrument labeled as an introducer. The introducer has a long, thin shaft that tapers to a point at one end. At the opposite end, there is an introducer hub and a hemostasis cap. The text in the image labels the introducer hub and hemostasis cap.
Image /page/4/Figure/5 description: The image shows the text "Figure 2: 21 Fr. Introducer". The text is in bold font and is likely a figure caption. The figure number is 2, and the figure is about a 21 Fr. Introducer.
- B. Introducer
The 21 Fr introducer (Figure 2) consists of a PVC tube with a PVC hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer (Figure 2) is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a hub at its proximal end to manage introducer insertion and removal from the cannula. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque PVC material for visualization under fluoroscopy.
Indications for Use
The Protek Solo 24 Fr. Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
Comparison of Technological Characteristics
The Protek Solo 24 Fr Venous Cannula is substantially equivalent to the TandemHeart 21 Fr. Venous Cannula (Catalog Number 5140-2163) in design characteristics, performance, and
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intended use. The two cannula products differ in diameter (24 Fr vs 21 Fr), length (24 Fr is 2 cm longer than the predicate), and the number and precise location of side holes. All materials and methods of manufacture are identical. The Protek Solo 24 Fr Venous Cannula Introducer is substantially equivalent in design characteristics and intended use to the Protek Duo Veno-Venous Cannula Set Introducers. The two components differ only in length and diameter. All materials and methods of manufacture are identical.
Summary of Non-clinical Testing
Testing of the Protek Solo 24 Fr Venous Cannula Set included comparative hemolysis, pressureflow 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 |
Conclusion
The Protek Solo 24 Fr Venous Cannula is made from the same materials, using the same manufacturing processes and sterilization techniques as the predicate TandemHeart 21 Fr Venous Cannula. Testing demonstrated that hemolysis, tensile strength, pathway integrity, and kink radius are identical to the predicate. Stiffness and pressure-flow properties differed as
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expected for the larger diameter cannula and met established acceptance criteria. The Protek Solo 24 Fr Venous Cannula Introducer is made from the same materials, using the same manufacturing processes and sterilization techniques as the predicate Protek Duo Veno-Venous Cannula Introducer. Stiffness differed as expected for the larger diameter introducer and met established acceptance criteria. The Protek Solo 24 Fr Venous Cannula Set is determined to be substantially equivalent to the predicates.
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