The Adapters with X-Coating are intended to be used to interconnect tubing and other devices within a circuit during extracorporeal bypass procedures.

The adapters are intended for use in procedures lasting up to 6-hours in duration.

The blood-contacting surfaces of the adapters are coated with X-Coating, which is a biocompatible coating that reduces the adhesion of platelets to the surfaces.

Device Description

The Adapters with X-Coating are of various designs (Male luer lock adapters, Female luer lock adapters, Needle/Slip adapters, Straight adapters, Y-adapters), each of which provide for the flow of blood and extracorporeal fluids through the bypass circuit. Each adapter is molded from polycarbonate or acrylic resin. The blood-contacting surfaces of the adapters are coated with X-Coating, which is a biocompatible coating that reduces the adhesion of platelets to the surfaces.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Adapters with X-Coating) seeking substantial equivalence to a predicate device. This type of submission does not typically involve complex AI algorithms or extensive clinical trials with human readers. Instead, it focuses on demonstrating that the new device performs similarly to an already legally marketed device through engineering and bench testing.

Therefore, many of the requested categories for AI/MRMC studies, expert ground truth, and training data will not be applicable.

Here's the information extracted from the document:

Acceptance Criteria and Device Performance

The core of this submission is demonstrating "substantial equivalence." The acceptance criteria are implicitly defined by showing that the Adapters with X-Coating perform equivalently to the uncoated predicate adapters in key areas.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Intended Use	To interconnect tubing and other devices in extracorporeal bypass procedures for up to 6 hours.	Same as predicate device.	Demonstrates equivalence.
Principles of Operation & Technology	Provide connection for blood/extracorporeal fluid flow within a bypass circuit.	Same as predicate device.	Demonstrates equivalence.
Design and Materials	Similar designs (luer lock, needle/slip, straight, Y-adapters) and molded from polycarbonate or acrylic resin.	Same as predicate device, with the addition of the X-Coating polymer.	The coating is the primary differentiator, and its biocompatibility and performance are addressed.
Performance	- Dimensional/Visual Analysis	No clinically significant performance differences compared to uncoated adapters.	Demonstrated through various tests.
	- Leakage and Mechanical Integrity Testing	No clinically significant performance differences compared to uncoated adapters.	Demonstrated through various tests.
	- Pull Force Testing (Against Tubing)	No clinically significant performance differences compared to uncoated adapters.	Demonstrated through various tests.
	- 6-hour Circulation Testing (Damage & Thrombus formation - Visual)	No clinically significant performance differences compared to uncoated adapters.	Specifically addresses the 6-hour use duration and the X-Coating's effect on thrombus.
Sterilization	Sterility Assurance Level (SAL) of 10⁻⁶	Validated in accordance with AAMI guidelines.	Standard for sterilized medical devices.
Ethylene Oxide Residues	Not to exceed maximum residue limits.	Will not exceed maximum residue limits.	Addresses potential toxicity from sterilization.
Biocompatibility	Blood-contacting materials must be biocompatible (ISO 10993). In-vivo animal study for coating material.	Blood-contacting materials found to be biocompatible. No adverse conditions noted in in-vivo animal study.	Critical for a blood-contacting device. The animal study specifically evaluates the X-Coating.

Study Details (Applicable Sections)

Given this is a 510(k) for a physical medical device, not an AI algorithm, most of the AI-specific questions are not applicable.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a single "test set" in the context of an AI model. Performance evaluations (Dimensional/Visual Analysis, Leakage and Mechanical Integrity Testing, Pull Force Testing, 6-hour Circulation Testing) were conducted. The sample sizes for each of these engineering tests are not detailed in the summary but would be part of the full 510(k) submission.
- Data Provenance: The studies were conducted by Terumo Cardiovascular Systems Corporation. No information is provided regarding country of origin for any human data (as there isn't any directly involved in performance validation) nor whether they were retrospective or prospective studies (as these are bench/engineering tests).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of AI, refers to expert-labeled data. For this device, "ground truth" for the performance evaluations would be objective measurements and observations (e.g., specific pull force values, absence of leaks, visual assessment of damage/thrombus). The expertise would be in conducting the tests and interpreting the results, rather than establishing a "ground truth" label.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are typically used when multiple human experts are labeling data for AI ground truth. For engineering tests, results are typically objective or interpreted by a single qualified individual, or a team agrees on a finding based on established protocols.
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 device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance relies on objective engineering measurements, visual inspection criteria, and biocompatibility testing standards (ISO 10993). For the 6-hour circulation test, "thrombus formation (visual)" would rely on trained observers. The animal study for the coating also provides in-vivo objective data on biological response.
The sample size for the training set:
- Not Applicable. This device does not use an AI training set.
How the ground truth for the training set was established:
- Not Applicable. This device does not use an AI training set.

Summary

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KO22918 P& I of 4

Traditional 510k - Adapter w X-coating Terumo Cardiovascular Systems Section 11 510(k) Summary and Certification

NOV 2 7 2002

Adapters with X-Coating

Submitter Information:

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

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

September 3, 2002 Date of Preparation:

Device Names:

Proprietary Name: Adapters with X-Coating Common Name: Adapters Classification Name: Adapter, Stopcock, Manifold, Fitting Cardiopulmonary Bypass

Predicate Device:

The Adapters with X-Coating that are the subject of this premarket notification are substantially equivalent to the predicate devices, the uncoated adapters, which are legally marketed and have been in interstate commerce prior to May 28, 1976. As such, the predicate adapters are considered to have preamendment status.

Intended Use:

The Adapters with X-Coating are intended to be used to interconnect tubing and other devices within a circuit during extracorporeal bypass procedures.

The adapters are intended for use in procedures lasting up to 6-hours in duration.

The blood-contacting surfaces of the adapters are coated with X-Coating, which is a biocompatible coating that reduces the adhesion of platelets to the surfaces.

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KO22918 PG20F4

Traditional 510k - Adapter w X-coating Terumo Cardiovascular Systems Section II 510(k) Summary and Certification

Principles of Operation and Technology:

The adapters 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 extracorporeal fluids.

Design and Materials:

Performance Evaluations:

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

Dimensional/Visual Analysis .
Leakage and Mechanical Integrity Testing .
. Pull Force Testing (Against Tubing)
6-hour Circulation Testing ●
- · Damage
- Thrombus formation (Visual) .

Substantial Equivalence Comparison:

The Adapters with X-Coating are substantially equivalent to the uncoated adapters as follows:

. Intended Use: The Adapters with X-Coating and the uncoated adapters are intended to be used to interconnect tubing and other devices within a circuit during extracorporeal bypass procedures. Both are intended to be used during procedures lasting up to 6 hours duration.
. Principles of Operation and Technology: The Adapters with X-Coating and the uncoated adapters each utilize the same technologies in the operation of the devices. The adapters provide a connection between devices within a bypass circuit, effectively establishing a conduit between the devices for the flow of blood and other extracorporeal fluids.
. Design and Materials: The design and the materials of the Adapters with X-Coating and the uncoated adapters are exactly the same with the exception of the X-Coating polymer that is applied to the coated adapters.

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Performance: Comparisons of the performance of the Adapters with X-Coating and . the uncoated adapters were conducted. The comparisons demonstrated that there were no clinically significant performance differences between the coated and uncoated devices.

Substantial Equivalence Summary:

In summary, the Adapters with X-Coating and the uncoated adapters 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 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.
. 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.

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Conclusion:

In summary, the Adapters with X-Coating are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the uncoated adapters which have preamendment status (i.e., legally marketed and in interstate commerce prior to May 28, 1976).

Terumo Cardiovascular Systems Corporation's statement that these devices are substantially equivalent to any other devices 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Terumo Cardiovascular Systems Corp. c/o Mr. Kazuhito Inoue 125 Blue Ball Road Elkton, MD 21921

Re: K022918

Adapters with X-Coating Regulation Number: 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II (two) Product Code: DTL Dated: September 3, 2002 Received: September 4, 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.

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

NOV. 27 2002

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Page 2 - Mr. Kazuhito Inoue

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), 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Karthik Vallam

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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KO22918 510(k) Number (if known):

Device Name: Adapters with X-Coating

Indications For Use:

Intended Use Described In The 510(k):

The Adapters with X-Coating are intended to be used to interconnect tubing and other devices within a circuit during extracorporeal bypass procedures.

The adapters are intended for use in procedures lasting up to 6-hours in duration.

The blood-contacting surfaces of the adapters are coated with X-Coating, which is a biocompatible coating that reduces the adhesion of platelets to the surfaces.

Kazuhito Inoue

Kazuhito Inoue Regulatory Affairs Terumo Cardiovascular Systems Corp.

(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
K022917

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.