The Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is also intended to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit.

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

Device Description

Each of the three sizes of the Pump Tubing that is included in this submission is Each of the tires child of the (PVC). The tubing ranges in size from a ¼" inside diameter to ½" in diameter. The durometer measurement is Shore A-68.

AI/ML Overview

Acceptance Criteria and Device Performance Study

This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the Plastron Pump Tubing to its predicate device, Pexco PVC pump tubing. The provided text is a 510(k) summary, which focuses on demonstrating equivalence rather than establishing novel performance metrics or conducting a comprehensive clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Plastron Pump Tubing were based on demonstrating equivalence to the predicate Pexco PVC pump tubing across several performance categories. The "acceptance criteria" here implicitly means that the Plastron tubing's performance in these areas should not be "clinically significantly different" from the predicate.

Performance Category	Acceptance Criteria (Implicit)	Reported Device Performance
Dimensional Analysis	Dimensions (e.g., ID, wall thickness, durometer) are equivalent to predicate.	The tubing ranges in size from a ¼" inside diameter to ½" in diameter. The durometer measurement is Shore A-68. (Implied to be equivalent to predicate in these aspects).
Leakage Testing/Structural Integrity	No leaks or structural failures under simulated use conditions, equivalent to predicate.	Tests were conducted to demonstrate equivalence.
Effects Upon Cellular Components (Hemolysis)	Hemolysis levels are clinically acceptable and equivalent to predicate.	Tests were conducted to demonstrate equivalence.
Flow Rate Testing	Flow rates under various pump conditions are equivalent to predicate.	Tests were conducted to demonstrate equivalence.
Durability Testing	Ability to withstand cyclically compressed forces for procedures up to 6 hours, equivalent to predicate.	Tests were conducted to demonstrate equivalence.
Spallation Evaluation	Minimal particulate generation, equivalent to predicate.	Tests were conducted to demonstrate equivalence.
Thrombus Formation (Visual)	Minimal visually identifiable thrombus formation, equivalent to predicate.	Tests were conducted to demonstrate equivalence.
Sterilization Conditions	Sterility Assurance Level (SAL) of 10⁻⁶.	Validated in accordance with AAMI guidelines to provide a SAL of 10⁻⁶.
Ethylene Oxide Residues	Not to exceed maximum residue limits.	Will not exceed maximum residue limits proposed for Part 821 of Title 21 of the Federal Register of June 23, 1978.
Biocompatibility	Found to be biocompatible for circulating blood, limited exposure (≤ 24 hours).	Conducted studies recommended in FDA GPM #G95-1 (ISO 10993) and found blood contacting materials to be biocompatible.

Summary of Performance: The document explicitly states: "The comparisons demonstrated that there were no clinically significant performance differences between the two devices."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes used for each individual test (Dimensional Analysis, Leakage, Hemolysis, etc.). It only mentions that "The following tests were conducted to demonstrate equivalence in performance."
Data Provenance: The origin of the data is not explicitly stated in terms of country or specific institution. Given the context of a 510(k) summary submitted to the FDA by Olson Medical Sales, Inc. (Ashland, MA), it is highly likely that the testing was conducted in the United States or by accredited laboratories adhering to US standards. The study appears to be retrospective in the sense that existing predicate device performance (which presumably has a history of safe use) is used as a benchmark for the new device. The testing of the Plastron Pump Tubing itself would have been prospective to demonstrate its equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This document describes an engineering and materials equivalence study, not a study requiring expert clinical interpretation to establish ground truth in the traditional sense. Therefore:

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

The "ground truth" for this type of submission is largely defined by the established performance and safety record of the predicate device and the objective results from standardized engineering and biocompatibility tests.

4. Adjudication Method

Not applicable, as this was not a study requiring human interpretation or adjudication for establishing ground truth. The tests conducted are objective measurements (e.g., dimensions, flow rates, chemical residues) or standardized evaluations (e.g., hemolysis, biocompatibility per ISO 10993).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is evaluated. This submission is for medical tubing, which does not involve human interpretation in this manner.

6. Standalone Performance Study

Yes, implicitly, a standalone performance study of the Plastron Pump Tubing was performed. The "Performance Evaluations" section lists several tests (Dimensional Analysis, Leakage Testing, Hemolysis, Flow Rate, Durability, Spallation, Thrombus Formation) conducted on the Plastron Pump Tubing. The results of these tests were then compared to the performance of the predicate Pexco PVC pump tubing to establish substantial equivalence.

7. Type of Ground Truth Used

The ground truth used for this equivalence study primarily relies on:

Predicate Device Performance: The established, legally marketed performance and safety profile of the Pexco PVC tubing serves as the primary "ground truth" for comparison.
Engineering Standards and Specifications: Objective measurements and adherence to specified ranges (e.g., durometer Shore A-68, ID ¼" to ½").
Biocompatibility Standards: Adherence to recognized international standards like ISO 10993 (e.g., "blood contacting materials were found to be biocompatible").
Sterilization Standards: Validated in accordance with AAMI guidelines for SAL.
Regulatory Limits: Compliance with FDA regulations for Ethylene Oxide residues.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set." The device is a physical medical component, and the testing involves laboratory evaluation, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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Section II 510(k) Summary and Certification Plastron PVC Tubing Olson Medical Sales

KD13578

Pump Tubing

JAN 2 2 2002

Submitter Information:

Name and Address: Olson Medical Sales, Inc. 28 Howe Street Ashland, MA 01721

Contact Person: Garry A. Courtney Regulatory Affairs Specialist Telephone: 1-800-283-7866, Ext. 7420

October 24, 2000 Date of Preparation:

Device Names:

Proprietary Name: Pump Tubing Pump Tubing Common Name: Classification Name: Tubing, Pump, Cardiopulmonary Bypass

Predicate Device:

The Pump Tubing that is the subject of this premarket notification is substantially equivalent to the predicate device; Pexco brand PVC tubing, which is legally marketed and has been in interstate commerce prior to May 28, 1976. As such, the predicate tubing is considered to have pre-amendment status.

Intended Use:

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

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 blood to flow through the bypass circuit. When not routed through the pump head, the tubing provides a conduit for the flow of blood throughout the circuit.

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Design and Materials:

Design and Matterials:
Each of the three sizes of the Pump Tubing that is included in this submission is Each of the tires child of the (PVC). The tubing ranges in size from a ¼" inside diameter to ½" in diameter. The durometer measurement is Shore A-68.

Performance Evaluations:

r erformance of the Plastron Pump Tubing submitted in this premarket notification is The performance of the performance of the Pexco PVC pump tubing. The following tests were conducted to demonstrate equivalence in performance:

Dimensional Analysis ●
Leakage Testing/Structural Integrity ●
Effects Upon Cellular Components (Hemolysis) .
Flow Rate Testing ●
Durability Testing .
Spallation Evaluation ●
Thrombus Formation (Visual) .

Substantial Equivalence Comparison:

The Plastron Pump Tubing is substantially equivalent to the Pexco pump tubing as follows:

Intended Use: Both the Plastron Pump Tubing and the predicate Pexco pump tubing . are intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary procedures. Each tubing is also intended to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit.
Principles of Operation and Technology: The Plastron Pump Tubing and the . predicate Pexco pump tubing each utilize the same technologies in the operation of prodicals I they are each used in a pump head and become cyclically compressed by the doviees. They are eablood to flow through the bypass circuit. When not routed through the pump head, the tubing provides a conduit for the flow of blood throughout the circuit.
Design and Materials: The design of the Plastron Pump Tubing and the predicate . Pexco tubing are the same; and are comprised of the same type of material, i.e., polyvinyl chloride.
Performance: Comparisons of the performance of the Plastron Pump Tubing and the . predicate Pexco pump tubing were conducted. The comparisons demonstrated that there were no clinically significant performance differences between the two devices.

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Substantial Equivalence Summary:

In summary, the Plastron Pump Tubing and the Pexco pump 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).
Olson Medical Sales, Inc. 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.

Conclusion:

In summary, the Plastron Pump Tubing is substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the predicate Pexco tubing, which has preamendment status (is legally marketed and was in interstate commerce prior to May 28, 1976).

Olson Medical Sale's statement that this device is substantially equivalent to any other device is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended to be the basis for patent infringement action.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines forming its body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2002

Ms. Garry A. Courtney Regulatory Affairs Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921

Re: K013578

Trade Name: Pump Tubing Regulation Number: 21 CFR 870.4390 Regulation Name: Cardiopulmonary Bypass Pump Tubing Regulatory Class: Class II (two) Product Code: DWE Dated: October 26, 2001 Received: October 29, 2001

Dear Ms. Courtney:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarent of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for aso surved in the encreated of 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 - Ms. Garry A. Courtney

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,

Dalla Miller

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory 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

Indications For Use: Intended Use Described In The 510(k):

The Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is also intended to a rollor painty authing extracorporeal blood flow when interconnecting components of the bypass circuit.

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

Barry Courtney 10/26/01
Garry A. Courtney

Regulatory Affairs Olson Medical Sales, Inc.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓

Over-The-Counter Use

(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013578

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).