(59 days)
Not Found
Not Found
No
The description focuses on the physical properties and performance of the tubing, with no mention of AI or ML.
No.
The device description and intended use clearly state that the tubing provides a conduit for fluid flow through a roller pump during bypass procedures, which is a supportive rather than a therapeutic function.
No
The device is described as "Pump Tubing" intended to "provide a conduit for extracorporeal fluid flow through a roller pump during cardiopulmonary bypass procedures." This function is for fluid transport, not for the detection, diagnosis, or treatment of a disease or condition. The performance studies focus on the tubing's physical and functional properties, not diagnostic accuracy.
No
The device description clearly states it is comprised of physical materials (polyvinyl chloride resin) and describes its physical dimensions and properties, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the tubing is for "extracorporeal fluid flow through a roller pump during cardiopulmonary bypass procedures." This describes a device used outside the body to manage blood flow during surgery, not a device used to test samples in vitro (in a lab setting).
- Device Description: The description focuses on the physical properties of the tubing (material, dimensions, hardness), which are relevant to its function as a conduit for fluid flow. There is no mention of reagents, assays, or any components typically associated with diagnostic testing.
- Performance Studies: The performance studies described are focused on the physical and functional performance of the tubing (connection strength, leak testing, durability, etc.), not on the accuracy or reliability of diagnostic results.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This tubing does not perform any such function.
N/A
Intended Use / Indications for Use
The Terumo® Pump Tubing is intended to provide a conduit for extracorporeal fluid flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.
Product codes
DWF
Device Description
The Terumo® Pump Tubing is comprised of a commonly used polyvinyl chloride resin (PVC) that includes a plasticizer recognized as Di-(2-ethylhexyhl) phthalate (DEHP). The PVC tubing that is the subject of this application is 68 durometer pump tubing (Shore A Hardness nominal measurement). It has a nominal inside diameter of 3/32" and a nominal wall thickness of 1/16". The outside diameter measures 7/32" (nominal).
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
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
Terumo Cardiovascular Systems Corporation conducted the following in-vitro performance evaluations to demonstrate the functional equivalence of the 68D PVC Pump Tubing to the predicate, 70D PVC Pump Tubing: Visual Analysis, Connection Strength, Connection Leak Testing, Roller Pump Performance (Durability), Dimensional Analysis, Spallation, Packaging Integrity Evaluation, Shelf Life Evaluation.
Key Metrics
Not Found
Predicate Device(s)
Pre-Amendment 70D PVC Pump Tubing 3/32'' x 1/16''
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4390 Cardiopulmonary bypass pump tubing.
(a)
Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2015
Terumo Cardiovascular Systems Corporation Joshua P. Ewing Senior Regulatory Affairs Associate 125 Blue Ball Road Elkton, MD 21921
Re: K150542
Trade/Device Name: Terumo Pump Tubing Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF Dated: April 9, 2015 Received: April 10, 2015
Dear Mr. Ewing:
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
1
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 (OS) 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. Hilleman
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/2/Picture/0 description: The image shows the Terumo company logo. The logo consists of a green circle with a stylized "T" inside, followed by the word "TERUMO" in green, sans-serif font. There is a small circle to the right of the word "TERUMO".
SECTION 4 Indications for Use
K150542 510(k) Number (if known):
Terumo® Pump Tubing Device Name:
Indications for Use:
The Terumo® Pump Tubing is intended to provide a conduit for extracorporeal fluid flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.
OR Prescription Use XX Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Submitter Information:
Primary Contact: This submission was prepared in March 2015 by: Joshua Ewing Senior Regulatory Affairs Associate Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-262-3304, Ext. 7473 Fax: 410-392-7171
Alternate Contact:
Garry A. Courtney, MBA, RAC Senior Manager, Regulatory Affairs Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-262-3304, Ext. 7486 Fax: 410-392-7171
This submission was prepared for: Terumo Cardiovascular Systems Corporation
28 Howe Street Ashland. MA 01721 Registration #1212122
Device Names/Classifications:
Proprietary Name Terumo® Pump Tubing Classification Name Tubing, Pump, Cardiopulmonary Bypass (Code: DWE)
Common Name Pump Tubing, Cardiovascular Procedure Kits
Predicate Device(s):
The device submitted in this 510(k) maintains characteristics that are substantially equivalent to the following devices:
- 70D PVC Pump Tubing 3/32'' x 1/16'' (Pre-Amendment) o
Indications for Use:
The Terumo® Pump Tubing is intended to provide a conduit for extracorporeal fluid flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.
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Image /page/4/Picture/0 description: The image shows the Terumo logo. The logo consists of a green circle with a stylized "T" inside, followed by the word "TERUMO" in green, sans-serif font. The logo is simple and modern, and the green color suggests health and wellness.
Principles of Operation and Technology:
The 68D PVC Pump Tubing and the predicate device, 70D PVC Pump Tubing, use the same principles of operation and technology. The pump tubing that is the subject of this premarket notification may be used in a pump head and becomes cyclically compressed by the pump to cause the fluid to flow through the bypass circuit.
Design and Materials:
The Terumo® Pump Tubing is comprised of a commonly used polyvinyl chloride resin (PVC) that includes a plasticizer recognized as Di-(2-ethylhexyhl) phthalate (DEHP).
PVC is a plastic polymer that is used in a wide array of products. Unplasticized PVC is hard and brittle at room temperature. The plasticizer (softener) is typically added to increase the flexibility of the polymer. DEHP is the plasticizer for most PVC medical devices.
Image /page/4/Figure/6 description: The image shows the chemical structure of Di(2-ethylhexyl) phthalate, also known as DEHP. The structure consists of a benzene ring with two ester groups attached. Each ester group is connected to a 2-ethylhexyl group. The chemical formula and name are written below the structure.
The PVC tubing that is the subject of this application is 68 durometer pump tubing (Shore A Hardness nominal measurement). It has a nominal inside diameter of 3/32" and a nominal wall thickness of 1/16". The outside diameter measures 7/32" (nominal).
The design differences between the 68D PVC Pump Tubing and the predicate device, 70D PVC Pump Tubing, include durometer, and print indicating manufacturer symbol, size, durometer, and part number:
| Device Characteristics | 68D PVC Pump Tubing | Predicate: 70D PVC Pump Tubing |
|---|---|---|
| Durometer | 68D (nominal) | 70D (nominal) |
| Print on Outside of Tubing | Present | Not Present |
The 68D PVC Pump Tubing will have a Shore A nominal durometer of 68D while the predicate device, the 70D PVC Pump Tubing, has a Shore A nominal durometer of 70D. The durometer dictates the hardness of the tubing.
There are no internal markings on the subject tubing. Outside markings consist of the Terumo symbol, followed by inner diameter (in inches) x wall thickness (in inches), durometer, and TCVS part number as shown below.
Image /page/4/Picture/12 description: The image shows the text "3/32 X 1/16 68D 0017-40252" along with the Terumo symbol. The text is likely a code or size indication. The image also contains labels pointing to the Terumo symbol and the code/size indication.
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Image /page/5/Picture/0 description: The image shows the Terumo company logo. The logo consists of a green circle with a stylized "T" inside, followed by the word "TERUMO" in green, sans-serif font. The logo is simple and modern, and the green color suggests health and vitality.
The texts of the notation are repeated every 5.75 to 6.25 inches as shown below.
Image /page/5/Figure/2 description: The image shows the text "3/32 X 1/16 68D 0017-40252" repeated twice. The text is likely a product code or specification. An arrow labeled "Repeat Length" is between the two instances of the text, indicating the distance between the repetitions.
Terumo Cardiovascular Systems Corporation concludes that the differences between the 68D PVC Pump Tubing and the predicate, 70D PVC Pump Tubing, do not affect the intended surgical use of the device nor do they affect safety and effectiveness of the device when used as intended.
Performance Evaluations:
Terumo Cardiovascular Systems Corporation conducted the following in-vitro performance evaluations to demonstrate the functional equivalence of the 68D PVC Pump Tubing to the predicate, 70D PVC Pump Tubing.
The following tests were performed, and summaries are presented on the ensuing pages:
- Visual Analysis
- Connection Strength ●
- Connection Leak Testing
- Roller Pump Performance (Durability) ●
- Dimensional Analysis
- Spallation
- Packaging Integrity Evaluation ●
- Shelf Life Evaluation ●
Substantial Equivalence Comparison:
In demonstrating substantial equivalence of the 68D PVC Pump Tubing to the predicate, 70D PVC Pump Tubing, a comparative study and/or assessment was performed in each of the following areas:
- Intended use .
- Target Population o
- Duration of use .
- Product design .
- Materials used in device construction .
- Principles of Operation and Technology .
- Product Specifications .
- Product Performance .
- Method of Sterilization o
- Product labeling .
Substantial Equivalence Statement:
The 68D PVC Pump Tubing is substantially equivalent in intended use, target population, duration of use, labeling, design, materials, principles of operation and technology, and performance to the predicate, 70D PVC Pump Tubing.
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Image /page/6/Picture/0 description: The image shows the Terumo Corporation logo. The logo consists of a green circle with a stylized "T" inside, followed by the word "TERUMO" in green, sans-serif font. A small registration mark is present to the right of the word "TERUMO".
Additional Safety Information:
- Sterilization conditions for any packs containing 68D PVC Pump Tubing are validated to . meet the requirements established in EN ISO 11135-1:2007. The validated processes ensure a minimum Sterility Assurance Level of 10-6. Product sterilization is controlled through strict maintenance of the processing parameters and, in some cases, post-sterilization biological indicator testing (if required for routine processing). Post-sterilization release for use is determined with consideration to maximum. Ethylene Oxide and Ethylene Chlorhydrin residue limits and maximum levels of exposure in accord with ANSVAAMI/ISO 10993-7.
Conclusion:
Based upon the comparative studies and analyses, Terumo Cardiovascular Systems Corporation concludes that the 68D PVC Pump Tubing is substantially equivalent to the predicate, 70D PVC Pump Tubing. It is further concluded that any recognized differences noted during the assessments do not raise new issues of patient/user safety or product effectiveness.