The Cardiopulmonary Bypass Pump Tubing with X-Coating is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.

Device Description

Each size of the Pump Tubing with X-Coating that is included in this submission is comprised of polyvinyl chloride (PVC). Each tubing size is coated with a biocompatible polymer coating (X-Coating) that is intended to reduce the adhesion of platelets to the internal surface of the tubes as blood flows through the circuit.

AI/ML Overview

The provided text describes a 510(k) summary for the "Pump Tubing with X-Coating" and its substantial equivalence to an uncoated pump tubing. The performance evaluation presented is primarily a comparison with the predicate device, rather than a study establishing standalone performance against specific acceptance criteria.

Here's an analysis based on your request, highlighting what is provided and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it states that the performance of the Pump Tubing with X-Coating was evaluated against the uncoated pump tubing to demonstrate equivalence.

The "performance evaluations" section lists the types of tests conducted:

Dimensional/Visual Analysis
Leakage and Mechanical Integrity Testing
Pull Force Testing
6-hour Circulation Testing
- Flow Rate
- Durability/Spallation
- Thrombus Formation (Visual)
- Effects Upon Cellular Components (Hemolysis)

The "Substantial Equivalence Comparison" and "Substantial Equivalence Summary" sections state:

"The comparisons demonstrated that there were no clinically significant performance differences between the two devices."
"Any noted differences between the two devices do not raise new issues of safety and effectiveness."

Without specific numerical acceptance criteria or quantitative performance data, a direct table cannot be constructed from the provided text. The criteria are implied to be "no clinically significant differences" compared to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the performance evaluations (e.g., how many pump tubing samples were tested for durability, hemolysis, etc.). It also does not mention the data provenance beyond indicating that Terumo Cardiovascular Systems Corporation conducted the studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to the submitted document. The performance evaluations described are physical and chemical tests (e.g., flow rate, durability, hemolysis, visual thrombus formation), not diagnostic or interpretative tasks requiring expert annotation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the same reasons as point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is pump tubing, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is pump tubing, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance evaluations would be the results of the physical, chemical, and biological tests performed. For example:

Dimensional/Visual Analysis: Measured dimensions and visual inspection standards.
Leakage and Mechanical Integrity Testing: Pre-defined leakage rates or structural failure points.
Pull Force Testing: Defined maximum or minimum pull force thresholds.
6-hour Circulation Testing:
- Flow Rate: Measured flow rate compared to a control or specification.
- Durability/Spallation: Visual inspection for material degradation, particle generation, or functional failure.
- Thrombus Formation (Visual): Visual assessment for the presence and extent of thrombus formation against a defined scale or absence.
- Effects Upon Cellular Components (Hemolysis): Lab measurements of hemolysis levels compared to established safety limits or predicate performance.

For the biocompatibility studies, the "ground truth" was established by adhering to ISO 10993 guidelines and conducting an in-vivo animal study, where the absence of adverse conditions reflected acceptable biocompatibility.

8. The sample size for the training set

This is not applicable as the device is not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as point 8.

Summary

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1 022857

SECTION II 510(k) SUMMARY AND CERTIFICATION

510(k) Summary

Submitter Information	13
Device Names	13
Predicate Device	13
Intended Use	13
Principles of Operation and Technology	13
Design and Materials	14
Performance Evaluations	14
Substantial Equivalence Comparison	14
Substantial Equivalence Summary	15
Additional Safety Information	15
Conclusion	15

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Pump Tubing with X-Coating

Submitter Information:

Name and Address: Terumo Cardiovascular Systems Corporation 28 Howe Street Ashland, MA 01721

Contact Person: Kazuhito Inoue Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-283-7866, Ext. 7001

Date of Preparation: August 21, 2000

Device Names:

Proprietary Name: Pump Tubing with X-Coating Common Name: Pump Tubing Classification Name: Tubing, Pump, Cardiopulmonary Bypass

Predicate Device:

The Pump Tubing with X-Coating that is the subject of this premarket notification is substantially equivalent in intended use, materials, design, technology and principles of operation, and performance to the uncoated Pump Tubing (K993189).

Intended Use:

The Cardiopulmonary Bypass Pump Tubing with X-Coating is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures.

Principles of Operation and Technology:

The pump tubing that is the subject of this premarket notification is used in a pump head and becomes cyclically compressed by the pump to cause the blood to flow through the bypass circuit.

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Design and Materials:

Each size of the Pump Tubing with X-Coating that is included in this submission is comprised of polyvinyl chloride (PVC).

TubingIdentification	Pump Tubing with X-Coating
	End		Mid	Durom.
	I.D.	O.D.	I.D.	O.D.
Tubing number 1	.25"	.375"	.375"	.50"	68
Tubing number 2	.375"	.561"	.50"	.686"	68

The tubing size transitions in the raceway section. The specifications are as follows:

Each tubing size is coated with a biocompatible polymer coating (X-Coating) that is intended to reduce the adhesion of platelets to the internal surface of the tubes as blood flows through the circuit.

Performance Evaluations:

The performance of the Pump Tubing with X-Coating submitted in this premarket notification is substantially equivalent to the performance of the uncoated pump tubing. The following tests were conducted to demonstrate equivalence in performance:

Dimensional/Visual Analysis ●
Leakage and Mechanical Integrity Testing ●
Pull Force Testing
6-hour Circulation Testing .
- Flow Rate .
- Durability/Spallation .
- Thrombus Formation (Visual) .
- Effects Upon Cellular Components (Hemolysis)

Substantial Equivalence Comparison:

The Pump Tubing with X-Coating is substantially equivalent to the uncoated pump tubing as follows:

. Intended Use: Both the Pump Tubing with X-Coating and the uncoated pump tubing are intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary procedures.
. Principles of Operation and Technology: The Pump Tubing with X-Coating and the uncoated pump tubing each utilize the same technologies in the operation of the devices. They are each used in a pump head and become cyclically compressed by the pump rollers to cause the blood to flow through the bypass circuit.

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Design and Materials: The design and the materials of the Pump Tubing with X-. Coating and the uncoated tubing are exactly the same with the exception of the X-Coating polymer that is applied to the coated tubing.
Performance: Comparisons of the performance of the Pump Tubing with X-Coating . and the uncoated pump tubing were conducted. The comparisons demonstrated that there were no clinically significant performance differences between the two devices.

Substantial Equivalence Summary:

In summary, the Pump Tubing with X-Coating and the uncoated tubing are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance. Any noted differences between the two devices do not raise new issues of safety and effectiveness.

Additional Safety Information:

Sterilization conditions have been validated in accordance with AAMI guidelines to . provide a Sterility Assurance Level (SAL) of 106.
. Ethylene Oxide residues will not exceed the maximum residue limits proposed for Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended).
Terumo Cardiovascular Systems Corporation (TCVS) conducted the biocompatibility studies recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices -- Part 1: Evaluation and Testing." {External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) Contact Duration]. The blood contacting materials were found to be biocompatible.
TCVS conducted studies for materials characterization, including physico-chemical . profiles.
The polymer coating material that is applied to the blood-contacting surfaces of the . device was also evaluated in an in-vivo animal study. No adverse conditions were noted.

Conclusion:

In summary, the Pump Tubing with X-Coating is substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the predicate uncoated tubing (K993189).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a symbol of three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2002

Terumo Medical Corporation c/o Mr. Kazuhito Inoue Regulatory Affairs 125 Blue Ball Road Elkton, Maryland 21921

Re: K022857

Trade Name: Pump Tubing with X-Coating Regulation Number: 21 CFR 870.4390 Regulation Name: Cardiopulmonary Bypass Pump Tubing Regulatory Class: Class II (two) Product Code: DWE Dated: August 26, 2002 Received: August 28, 2002

Dear Mr. Inoue:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Kazuhito Inoue

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

V.A.R. B.Zuk MD

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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510(k) Number (if known):

Device Name: Pump Tubing with X-coating

Indications For Use:

The Cardiopulmonary Bypass Pump Tubing with X-Coating is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures.

The tubing is intended for use in procedures lasting up to 6-hours in duration.

Kazuhito Inoue Regulatory Affairs Terumo Cardiovascular Systems

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K022857

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

Regulation Number and Section

§ 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).