The Terumo Luer Lock Adapters are single use, disposable components, intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures. The devices may be used in procedures lasting up to 6 hours in duration.

Device Description

The adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures. For use up to six hours. One end of the luer lock adapter has a male or female luer lock connection which may be connected to any opposite luer fitting within the tubing pack. The opposite side of the luer lock adapter has a tubing connection point which is barbed for the 1/8", 3/16" and 1/4" male and female adapters. The Pressure line luer adapters have an internal slip fit connection point for tubing. The tubing connection points are generally bonded to tubing with the appropriate inner diameter (1/8", 3/16", %") or pressure line tubing using cyclohexaprope. In some cases, a tie-band is attached to the outside of the tubing connection to the luer lock adapter. The luer fitting may be pre-connected to an opposite luer fitting within the cardiopulmonary bypass circuit by Terumo Cardiovascular Systems. The luer fitting may be connected by the end-user to either another opposite " 110 160 within the cardiopulmonary bypass circuit or to an external luer fitting. The luer lock adapters provide a leak proof connection point between components and various lines within the circuit, with the ability for a user to easily disconnect and re-connect the adapters as needed to any other opposite standard luer fitting, The luer lock adapters can be disconnected and re-connected by hand.

AI/ML Overview

The provided documentation describes the Terumo Luer Lock Adapters and the performance testing conducted to demonstrate their substantial equivalence to predicate devices. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Dimensional Stability	Intended to ensure the device maintains its specified dimensions post-manufacturing and during use.	Conducted (details not provided, but implies satisfactory results as substantial equivalence was claimed).
Pre-connection	Intended to ensure proper assembly and interface with other components before clinical use.	Conducted (details not provided, but implies satisfactory results as substantial equivalence was claimed).
Connection Strength	Intended to ensure the luer lock adapters maintain a secure connection under expected forces and prevent accidental disconnections during use, providing a leak-proof connection as stated in the device description.	Conducted (details not provided, but implies satisfactory results as substantial equivalence was claimed). The device description explicitly states: "The luer lock adapters provide a leak proof connection point between components and various lines within the circuit, with the ability for a user to easily disconnect and re-connect the adapters as needed to any other opposite standard luer fitting."
Circulation Test	Intended to simulate blood flow conditions and ensure device integrity and functionality (e.g., no leaks, no material degradation, no interference with flow).	Conducted (details not provided, but implies satisfactory results as substantial equivalence was claimed).
Pressure Test	Intended to ensure the luer lock adapters can withstand the expected pressure within the cardiopulmonary bypass circuit without leaking or failure.	Conducted (details not provided, but implies satisfactory results as substantial equivalence was claimed).
Sterility Assurance Level (SAL)	SAL of 10⁻⁶ (meaning no more than 1 in a million units are non-sterile).	Validated to provide a SAL of 10⁻⁶.
Ethylene Oxide Residues	Not to exceed stated or implied maximum residue limits at the time of product distribution.	Terumo asserts that ethylene oxide residues will not exceed stated or implied maximum residue limits at the time of product distribution.
Biocompatibility	Meets requirements of ISO 10993 for external communicating devices, circulating blood, limited exposure (≤ 24 hours).	Biocompatibility studies conducted; blood contacting materials found to be biocompatible.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is an internal "Performance Testing" conducted by Terumo Cardiovascular Systems Corporation. The documentation states: "The following tests were conducted in order to demonstrate the Terumo Luer Lock Adapters are substantially equivalent to the predicate devices." The successful completion of these tests, along with the biocompatibility studies and sterility validation, formed the basis for the FDA's determination of substantial equivalence.

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

Sample Size for Test Set: The specific sample sizes for each of the performance tests (Dimensional Stability, Pre-connection, Connection Strength, Circulation Test, Pressure Test) are not detailed in the provided summary.
Data Provenance: The data provenance is internal to Terumo Cardiovascular Systems Corporation. The tests were conducted by the submitter of the 510(k). The country of origin of the data is implied to be the United States, where Terumo Cardiovascular Systems Corporation is located (Elkton, MD). The study is retrospective in the sense that the testing was performed to support a premarket notification for an existing device design.

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

This information is not applicable and not provided. The performance testing described is laboratory-based and involves objective measurements of device characteristics (e.g., strength, dimensions, leak integrity), not subjective interpretation by human experts. Therefore, there is no "ground truth" established by experts in the context of the described tests.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As the testing is objective and quantitative, there is no need for an adjudication method.

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

There was no MRMC comparative effectiveness study done. This device is a passive medical component (luer lock adapter) and does not involve AI or human readers for interpretation. The study focused on the physical and functional performance of the device itself.

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

There was no standalone (algorithm only) performance study done. This device is a passive medical component and does not utilize an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through objective engineering and laboratory measurements against predefined specifications and industry standards. For example:

Dimensional Stability: Ground truth is the device's measured dimensions compared to engineering drawings/specifications.
Connection Strength: Ground truth is the force at which the connection fails or leaks, compared to a minimum acceptable strength.
Sterility: Ground truth is the result of microbiological testing (e.g., bioburden and sterility tests) to confirm the SAL.
Biocompatibility: Ground truth is the results of biological assays confirming the absence of adverse biological reactions as per ISO 10993 standards.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a passive medical component and does not involve machine learning or a training set.

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

This information is not applicable and not provided. As there is no training set for this type of device, no ground truth was established for it.

Summary

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K093992

() TERUMO

Section 5 510(k) Summary

		Page
Submitter Information	MAY 19 2010	22
Device Names / Classification	:	22
Identification of Predicate Device		22
Device Indications/Intended Uses		· 22
Device Description		23
Performance Testing		23
Additional Safety Information		23
Conclusion for 510(k) Summary		24

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TERUMO

Submitter Information:

This submission was prepared in December 2009 by:

Eileen Dorsey Regulatory Affairs Specialist Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-283-7866, Ext. 7406 Fax: 410-398-6079

This submission was prepared for: Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Registration #1124841

Device Names/Classifications:

Proprietary Name Terumo Luer Lock Adapters Classification Name Adapter, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Common Name Adapters

Predicate Device(s):

The Terumo Luer Lock Adapters are substantially equivalent to following predicate Luer Lock Adapters (510(k): K992906) with respect to intended use, design,

Corresponding New Terumo	Terumo Luer Lock	Predicate Description
Luer Lock Adapter Part #	Predicate Part #
0001-11302	0001-11301	1/8" Female Luer Adapter
0001-12302	0001-12301	1/8" Male Luer Adapter
0001-21302	0001-21301	3/16" Female Luer Adapter
0001-22302	0001-22301	3/16" Male Luer Adapter
0001-31302	0001-31012	Threaded Female Luer Adapter
0001-32302	0001-22301	3/16" Male Luer Adapter
0001-71303	0001-71302	Female Luer Lock Adapter
0001-72303	0001-72302	Male Luer Lock Adapter

technology/principles of operation, materials and performance:

The differences between the devices do not raise any new issues of safety or effectiveness.

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T TERUMO

Device Indications/Intended Uses:

The adapters are single use, disposable components, intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures. The devices may be used in procedures lasting up to 6 hours in duration.

Device Description:

The adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures. For use up to six hours.

One end of the luer lock adapter has a male or female luer lock connection which may be connected to any opposite luer fitting within the tubing pack. w The opposite side of the luer lock adapter has a tubing connection point which is barbed for the 1/8", 3/16" and 1/4" male and female adapters. The Pressure line luer adapters have an internal slip fit connection point for tubing.

The tubing connection points are generally bonded to tubing with the appropriate inner diameter (1/8", 3/16", %") or pressure line tubing using cyclohexaprope. In some cases, a tie-band is attached to the outside of the tubing connection to the luer lock adapter.

The luer fitting may be pre-connected to an opposite luer fitting within the cardiopulmonary bypass circuit by Terumo Cardiovascular Systems. The luer fitting may be connected by the end-user to either another opposite " 110 160 within the cardiopulmonary bypass circuit or to an external luer fitting.

The luer lock adapters provide a leak proof connection point between components and various lines within the circuit, with the ability for a user to easily disconnect and re-connect the adapters as needed to any other opposite standard luer fitting, The luer lock adapters can be disconnected and re-connected by hand.

Performance Testing:

The following tests were conducted in order to demonstrate the Terumo Luer Lock Adapters are substantially equivalent to the predicate devices.

Dimensional Stability �
Pre-connection ●
. Connection Strength
Circulation Test
. Pressure Test

Additional Safety Information:

Sterilization conditions for the Terumo Luer Lock Adapters are validated to provide a Sterility Assurance Level (SAL) of 10 . Terumo further asserts that the ethylene oxide residues will not exceed stated or implied maximum residue limits at the time of product distribution.

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Terumo maintains biocompatibility studies as 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) Contract Duration]. The blood contacting materials were found to be biocompatible.

Conclusion:

Based upon the comparative studies and analyses, Terumo Cardiovascular Systems concludes that the Terumo Luer Lock Adapters are substantially equivalent to the predicate Luer Lock Adapters. It is further concluded that any recognized differences noted during the assessments do not raise any new issues of patient/user safety or product effectiveness.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around a central emblem. The emblem depicts a stylized human figure with three faces in profile, suggesting a sense of community and care.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUL -8 2010

Terumo Cardiovascular Systems Corporation c/o Ms. Eileen Dorsey Regulatory Affairs Specialist 125 Blue Ball Rd. Elkton, MD 21921

K093992 Re: Terumo Luer Lock Adapter Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass adaptor, stopcock, manifold, or fitting Regulatory Class: Class II (two) Product Code: DTL Dated: April 2, 2010 Received: April 5, 2010

Dear Ms. Dorsey:

This letter corrects our substantially equivalent letter of May 19, 2010.

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 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. Eileen Dorsey

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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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· Section 4 Indications for Use

Unknown-at-time-of-submission-> K. 0 93992 510(k) Number (if known):

Device Name: Terumo Luer Lock Adapters

Indications for Use:

Prescription Use XX (Part 21 CFR 801 Subpart D)

OROver-The-Counter Use (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)


(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K093992

Regulation Number and Section

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.