The chest drainage tubing is intended to serve as a conduit for the flow of body fluids that are removed from the patient, via vacuum, and delivered to a reservoir during cardiopulmonary bypass procedures.

Device Description

The chest drainage tube is piece of flexible polyvinylchloride tubing that is used as a conduit for body fluids suctioned from the chest cavity and moved into a reservoir following cardiopulmonary bypass procedures. The tubing is a 40 durometer tube with an inside diameter of 0.375" and an outside diameter of 0.562".

AI/ML Overview

The provided text describes a 510(k) submission for "Chest Drainage Tubing" and establishes its substantial equivalence to a predicate device. This type of submission relies on demonstrating similarity to an already cleared device, rather than conducting new clinical trials with acceptance criteria based on performance metrics like sensitivity or specificity.

Therefore, many of the requested points regarding acceptance criteria, study design, and ground truth are not applicable in this context. The "acceptance criteria" here are that the new device is "substantially equivalent" to the predicate device in terms of intended use, design, technology/principle of operation, materials, and performance, and that it raises no new issues of safety and effectiveness.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (vs. Predicate Device)
Intended Use	Substantially equivalent to the cleared Gish Biomedical Tubing (K870792). Intended to serve as a conduit for the flow of body fluids removed from the patient, via vacuum, and delivered to a reservoir during cardiopulmonary bypass procedures.
Design	Substantially equivalent. The tubing is a 40 durometer tube with an inside diameter of 0.375" and an outside diameter of 0.562".
Technology/Principle of Operation	Substantially equivalent. Used as a conduit for fluids being removed from the body following bypass procedures, moved from the body, via vacuum, into a reservoir.
Materials	Differences in polyvinylchloride materials "raise no new issues of safety and effectiveness." Blood contacting materials were tested according to FDA General Program Memorandum #G95-1 and found to be biocompatible.
Performance	Substantially equivalent to the performance of the cleared Gish tubing. Achieves a Sterility Assurance Level (SAL) of 10 to the negative sixth (validated per AAMI guidelines). Ethylene oxide residuals will not exceed maximum residue limits. Expiration dating controlled by shortest expiry component or two years.
Safety and Effectiveness Issues	No new issues of safety or effectiveness raised.

Study Proving Device Meets Acceptance Criteria:

The "study" here is not a typical clinical trial but rather a demonstration of substantial equivalence through comparison to a predicate device.

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

Not applicable. There is no "test set" in the traditional sense of a clinical or analytical performance study with a specific number of samples. The demonstration of equivalence relies on comparing the device's characteristics and performance to those of a predicate device.

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

Not applicable. Ground truth, in the sense of expert consensus on diagnostic accuracy or clinical outcomes, is not established for this type of 510(k) submission. The "truth" is established by showing that the characteristics of the new device are sufficiently similar to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as there isn't a test set requiring adjudication of findings.

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

Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was conducted.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" for this submission is established by the known characteristics, safety, and effectiveness of the predicate device (Gish Biomedical Tubing, K870792). The new device is compared against this established benchmark.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not a machine learning device.

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

Not applicable. There is no training set.

Summary

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DEC I 0 1996

Section II

Summary of Safety And Effectiveness Information Pertaining To Substantial Equivalence

Device Common Name: Chest Drainage Tubing

Cardiopulmonary Bypass Pump Tubing Classification Name:

Intended Use:

Description:

Substantial Equivalence:

The chest drainage tubing submitted in this 510(k) is substantially equivalent in intended use, design, technology/principle of operation, materials and performance to the cleared Gish Biomedical Tubing that is cleared through K870792.

Principle of Operation/Technology:

The chest drainage tubing is used as a conduit for fluids being removed from the body following bypass procedures. The fluid is moved from the body, via vacuum, into a reservoir. This is substantially equivalent to the operation of the Gish chest drainage tubing.

Design/Materials:

Differences in the polyvinylchloride materials between the chest drainage tubing indicated in this 510(k) and the cleared Gish tubing raise no new issues of safety and effectiveness.

Performance:

The performance of the chest drainage tubing presented in this 510(k) is substantially equivalent to the performance of the cleared Gish tubing.

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Additional Safety Information

Sterilization conditions have been validated in accordance with AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10 to the negative sixth.

Ethylene oxide residuals will not exceed the maximum residue limits imposed for Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended).

Blood contacting materials were tested in accordance with the tests 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.

The expiration dating of the submitted components is controlled by the component with the shortest expiry that is included in a kit, or two years: whichever is the shortest duration.

Conclusion

The convenience kit component submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation. materials and performance to the cleared device indicated within. Differences between the submitted components and the corresponding cleared devices do not raise any new issues of safety or effectiveness.

Olson Medical Sales' 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 a patent infringement action.

This Summary of Safety and Effectiveness was prepared on September 9, 1999.

This Summary was prepared by:	Garry A. CourtneyRegulatory Affairs Specialist
This Summary was prepared for:	OLSON MEDICAL SALES28 Howe StreetAshland, MA 01721Phone: 508-881-2250Fax: 508-881-4858

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

DEC 1 0 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olson Medical Sales, Inc Mr. Gary A. Courtney Regulatory Affairs C/O Terumo Medical Corporation. 2101 Cottontail Lane Somerset, NJ 08873

K993062 Re: Chest Drainage Tubing Regulatory Class: II (Two) Product Code: DWE September 10, 1999 Dated: September 13, 1999 Received:

Dear Mr. Courtney:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Gary A. Courtney

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Wolf Stepukon MDfor

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Component For Cardiovascular Procedure Kit - Chest Drainage Tubing Device Name:

Indications For Use:

The Chest Drainage Tubing is intended to serve as a conduit for the flow of body fluids that are removed from the patient, via vacuum, and delivered to a reservoir during cardiopulmonary bypass procedures.

Garry A. Courtney Regulatory Affairs Associate Terumo Medical Corporation

(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)

Eliza, Slinker, Jr.

ivision Sign-Off) ision of Cardiovascular, Respiratory, 510/k) Number

(Optional Format 1-2-96)

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).