The Terumo Circuit Connectors are intended to be used to interconnect tubing and other devices within a circuit during extra-corporeal bypass procedures. The devices can be used in procedures lasting up to 6 hours in duration.

Device Description

The connectors that are the subject of this premarket notification are of various designs (quick I he connection, etc.), each of which provides for the flow of blood and extracorporeal fluids through the bypass circuit. Each of the connectors is made from various plastics - all of which are common in medical devices that are already on the market. There are no new and/or exotic materials used in the manufacturing of the proposed devices.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Terumo Circuit Connectors, based on the provided text:

Acceptance Criteria and Device Performance

The provided text details that clinical studies were not necessary. Instead, substantial equivalence was demonstrated through in-vitro performance evaluations. The "acceptance criteria" are implied by the successful completion of these tests without raising new safety or effectiveness concerns compared to the predicate device.

Acceptance Criteria Category	Reported Device Performance
6-Hour Circulation Test	No clinically significant performance differences identified when compared to the predicate device. (Implied acceptance: performance within acceptable parameters for a 6-hour circulation period, comparable to predicate).
Dimensional Analysis	Performed as an attribute evaluation. (Implied acceptance: dimensions meet design specifications).
Structural Integrity / Leakage Testing	Performed as an attribute evaluation. (Implied acceptance: devices exhibit adequate structural integrity and do not leak).
Tubing Connection Strength	Performed as an attribute evaluation. (Implied acceptance: connections exhibit sufficient strength).
Sterilization Conditions	Validated to provide a Sterility Assurance Level (SAL) of 10^-6. Ethylene oxide residues will not exceed maximum residue limits at the time of product distribution. (Implied acceptance: devices are effectively sterilized and safe from residue levels).
Biocompatibility	Blood-contacting materials found to be biocompatible according to FDA General Program Memorandum #G95-1 (ISO 10993). (Implied acceptance: materials are safe for biological contact).

Study Details

The provided document describes in-vitro performance evaluations to demonstrate substantial equivalence, rather than a traditional clinical study or AI-related study. Therefore, several points are not applicable.

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 exact sample sizes for each in-vitro test (e.g., how many connectors were tested for leakage or circulation).
- Data provenance is not specified, but it's implied to be from Terumo's internal testing. The tests are "in-vitro," so country of origin for patient data is not relevant. The nature of the tests (attribute evaluations, comparative testing) makes them prospective in design for the purpose of the submission.
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):
- Not applicable. Ground truth in this context is established by engineering specifications and objective test results, not expert interpretation of diagnostic images or patient outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which are not described here.
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 a medical device submission for physical connectors, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device submission for physical connectors, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for these in-vitro studies is based on engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and standardized testing protocols designed to verify physical and chemical properties. The predicate device's established performance also serves as a comparative ground truth for the 6-hour circulation test.
The sample size for the training set:
- Not applicable. There is no machine learning or AI component requiring a training set.
How the ground truth for the training set was established:
- Not applicable. There is no machine learning or AI component requiring a training set.

Summary

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AUG 1 1 2004

Terumo Circuit Connectors

Submitter Information:

This submission was prepared in June 2004 by: Garry A. Courtney, MBA, RAC Sr. Regulatory Affairs Specialist Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921 Telephone: 1-800-283-7866, Ext. 7420

This submission was prepared for: Terumo Cardiovascular Systems Corporation 28 Howe Street Ashland, MA 01721

Device Names:

Proprietary Name: Classification Name: Common Name:

Terumo Circuit Connectors Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Circuit Connectors

Device Classification:

The Terumo Circuit Connectors are classified as: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - in the Code of Federal Regulations, 21, Parts 800 to 1299, § 870.4290.

Predicate Device:

The devices submitted in this 510(k) maintain characteristics that are substantially equivalent in intended use, design, technology/principles of operation, materials and specifications to the following devices:

Proposed Device	Predicate Device
0007-04439 - U-Tube Connector	Brevet Connector (K895753)
0007-02118 - 3/16 Male Slip Connector	Brevet Connector (K895753) - P/N 118
0007-03056 - 1/ 4" Quick Disconnect	Brevet Connector (K895753) – P/N 100
0007-04056 - 3/8" Quick Disconnect	Brevet Connector (K895753) – P/N 101
0007-05056 - 1/2" Quick Disconnect	Brevet Connector (K895753) - P/N 102

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Intended Use:

The Terumo Circuit Connectors are intended to be used to interconnect tubing and other devices The Termino Circuit Connecters are mission of the devices can be used in procedures lasting up to 6 hours in duration.

Principles of Operation and Technology:

The connectors that are the subject of this premarket notification perform by providing a connection between devices within a bypass circuit, effectively establishing a conduit between the devices for the flow of blood and other extra-corporeal fluids.

Design and Materials:

Design and Materials:
The connectors that are the subject of this premarket notification are of various designs (quick I he connection, etc.), each of which provides for the flow of blood and extracorporeal fluids through the bypass circuit. Each of the connectors is made from various plastics - all of which are common in medical devices that are already on the market. There are no new and/or exotic materials used in the manufacturing of the proposed devices.

Performance Evaluations:

I cryormance Brandiner.
Clinical studies are not necessary to demonstrate safety or substantial equivalence of the subject device to the predicate devices. Substantial equivalence is demonstrated with the following invitro performance evaluations:

6-Hour Circulation Test (Comparative v. predicate devices) .
Dimensional Analysis (Attribute Evaluation / Not compared to predicate) .
Structural Integrity / Leakage Testing (Attribute Evaluation / Not compared to predicate) .
Tubing Connection Strength (Attribute Evaluation / Not compared to predicate) .

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Substantial Equivalence Comparison:

Substantial Equivalence Compulsentially equivalent to the predicate Brevet Connector devices as follows:

The intended uses of the Terumo Connectors and the predicate Brevet Intended Use: . Intended Ose. The meentably the same. The devices are intended to interconnect tubing and other devices within a circuit during extra-corporeal bypass procedures. The devices can be used in procedures lasting up to 6 hours in duration.
Principles of Operation and Technology: The technology of the Terumo Connectors and the . I rincipes of Operators are identical. The devices operate by providing a mechanical production between and among the devices that comprise the extra-corporeal circuit. When connectors are sufficiently placed into position, they provide the necessary interface between circuit components to establish a conduit for the flow of fluids.
Design and Materials: The design and the materials of the Terumo Connectors and the . predicate Brevet Connectors are essentially the same. The design of each device is similar in produce Drover Soctured of hardened plastic – and contains the necessary interface to allow for the interconnection of other devices.
Performance: Comparisons of the performance of the Terumo Connectors and the predicate . Brevet Connectors were conducted. The comparisons demonstrated that there were no clinically significant performance differences between the devices.

Substantial Equivalence Summary:

In summary, the Terumo Connectors and the predicate Brevet Connectors (K895753) are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance. Any noted differences between the subject devices and the predicate devices do not raise new issues of safety and effectiveness.

Additional Safety Information:

Sterilization conditions have been validated in accordance with appropriate guidelines to . provide a Sterility Assurance Level (SAL) of 106. Terumo further asserts that the ethylene oxide residues will not exceed the maximum residue limits at the of product distribution.
Terumo conducted 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) Contact Duration). The blood contacting materials were found to be biocompatible.

Conclusion:

In summary, the Terumo Circuit Connectors are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the predicate Brevet Connectors (K895753).

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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2004

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

Re: K041697

Trade Name: Terumo Circuit Connectors Regulation Number: 21 CFR 870.4290 Regulation Name: Circuit Connectors Regulatory Class: Class II (two) Product Code: DTL Dated: June 18, 2004 Received: June 22, 2004

Dear Mr. Courtney:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sualed in the encreat 1976, the enactment date of the Medical Device Amendments, or to eonimered prior to 1125 20, 2017 3, 11:37 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmette (110) the efect the device, subject to the general controls provisions of the Act. I ou may, thererors, manible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification Richard Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the process (Declon 9 Portify of the Res), ce Amendments. Please note: If you purchase your device chaemient and of the Medical Bed) and further process (e.g., sterilize) you must submit a new components in van (non (non and in your kit. 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.

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Page 2 - Mr. Garry A. Courtney

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (see above) the effective major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Little 21, Parts 800 to 898. In addition, FDA may be found in the Code of I can's concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualies of a oudevice complies with other requirements of the Act that I DA has made a acterimiations administered by other Federal agencies. You must of any reach all the Act's requirements ancluding, but not limited to: registration and listing (21 comply with an the Act 8 requirements) and manufacturing practice requirements as set CFR Part 607); adomig (21 CFR Part 820); and if applicable, the electronic form in the quality of sections (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) This letter will anow you to begin maing of substantial equivalence of your device to a legally prematted predicated 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 11 you dosire specific ad 1309.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CHT Part 00717 Additionally, for questions on the promotion and advertising of Compinated at (301) 591-5619 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Thisoraneing of esponsibilities under the Act may be obtained from the Other general mionhation turers, 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,

Dma R. bohner

Bram D. Zuckerman, M.D. Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K04) & 97

Terumo Circuit Connectors Device Name:

Indications For Use:

The Terumo Circuit Connectors are intended to be used to interconnect tubing and other The Telunio Creat Connectors are incorporeal bypass procedures. The devices can be used in procedures lasting up to 6 hours in duration.

Simy A. Courtney 06/18/2007
Garry A. Courtney, MBA, RAC

Sr. Regulatory Affairs Specialist Terumo Cardiovascular Systems

X Prescription Use

AND/OR

Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

(Per 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)

Duna R. de Lunes

(Division Sign-Off) Division & Cardiovascular Devices

510(k) Number K041697

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.