The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.

Device Description

The Clave® Stopcock is a device that incorporates the functionality of needleless connectivity with the 4-way flow valve of a stopcock. The fluid path has three positions: Flush Position; Flow Position; and Port Access Position. The proprietary technology of the Clave enables the device to have a needleless port for administration of medications or other IV fluids as directed by the physician.

AI/ML Overview

The provided document is a 510(k) summary for the Clave® Stopcock, a physical medical device. It describes the device's components, intended use, and substantial equivalence to predicate devices, focusing on materials and operational characteristics.

This type of submission focuses on demonstrating safety and effectiveness by showing substantial equivalence to existing legally marketed devices, rather than through a traditional clinical study with detailed performance metrics and acceptance criteria in the way new AI/software as a medical device (SaMD) clearances would.

Therefore, the requested information, such as specific acceptance criteria for a device's performance, the details of a study proving those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, is not applicable to this submission. These elements are typically found in regulatory submissions for AI/ML-based devices or devices requiring extensive clinical trials to establish efficacy and performance de novo.

The document states:

Safety and Performance: "ICU Medical Clave Stopcock conform to the requirements of published international standards as well as those FDA recognized standards and/or published guidelines prior to marketing the device." This indicates compliance with established industry standards for mechanical devices, not performance metrics derived from a study comparing algorithms or human readers.
Rationale for SE: "This submission is a combination of two devices that have been in the field for more than 15 years. These two devices are regarded highly within the industry and valued by our customers. This device will integrate the spike portion of the Clave into the molded portion of the Stopcock... There are no functional differences between any of the predicate devices or the proposed devices in terms of use." This is the core argument for substantial equivalence, implying that the combined device's performance is assumed to be equivalent to its well-established components.
Conclusion: "The materials, performance, and operational features of both the submitted device and the predicate devices are substantially equivalent and safe and effective for their intended use." This states the conclusion of the 510(k) review process based on the comparison to predicate devices and adherence to standards, not on a new performance study.

In summary, none of the requested specific acceptance criteria or study details are present because the submission is for a physical device demonstrating substantial equivalence, not an AI/ML-based device requiring detailed performance metric studies.

Summary

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FEB 1 3 2008

ICU MEDICAL INC. 4455 Atherton Drive Salt Lake City, Utah (801) 264 - 1332, Phone (801) 264 - 1755, Fax Tracy S. Best, Sr. Regulatory Affairs Specialist Preparation Date: January 09, 2008

SPECIAL 510(K) Summary of Safety and Effectiveness for the:

Trade Name:	Clave® Stopcock
Common Name:	Accessory, Set, Administration, I.V.
Classification Name:	Set, Administration, Intravascular, 21 CFR 880.5440, Class II Device
Product Code:	Primary Code: FMG, Secondary Code: LHI

Legally Marketed Predicate Devices for Substantial Equivalence:

K 941190 - Clave Connector - ICU Medical, Inc. * K970855 - Clave Connector - ICU Medical, Inc. *K953573 - ICU Stopcock with Extension Tubing -- ICU Medical, Inc.

Rationale for SE:

This submission is a combination of two devices that have been in the field for more than 15 years. These two devices are regarded highly within the industry and valued by our customers. This device will integrate the spike portion of the Clave into the molded portion of the Stopcock or the spike portion will function separately as it does now and be used as the base plug for the Stopcock portion. Then the other portions of the device remain the same as does the indications for use. There are no functional differences between any of the predicate devices or the proposed devices in terms of use.

Description of Submitted Device:

Intended Use:

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Component:	ICU Medical, Inc.Clave Stopcock	ICU Medical, Inc.Clave	ICU Medical, Inc.Stopcock with ext. Tubing
Stopcock Housing:	Polycarbonate		Polycarbonate
Stopcock Plug:	Polycarbonate		Polycarbonate
Stopcock Handle:	HD Polyethylene		Polyethylene & HDPE
Clave Body:	Valox	Valox	N/A
Clave Plug:	Silicone	Silicone	N/A
Clave Spike	Polycarbonate	Polycarbonate	N/A
Package:	Peel Blister pak	Peel Blister Pak	Peel Blister Pak
Sterilization method:	EtO or E-Beam	E-Beam	EtO or E-Beam
510(k) Approval	This submission	K941190 or K970855	K953573

Technological Characteristics and Substantial Equivalence Table:

The operational characteristics are identical as they have only changed to morph two devices together. Operation is the same for all Clave or Stopcocks, including the predicate devices .

Safety and Performance:

ICU Medical Clave Stopcock conform to the requirements of published international standards as well as those FDA recognized standards and/or published guidelines prior to marketing the device, Additionally, ICU Medical's Sterility Assurance Level, (SAL) has an established and validated history of meeting the 10° level. These devices will be packaged in a way as to ensure conformity with that SAL level. The manufacturing of these devices will be assembled in a quality environmy that is certified independently and complies with cGMPs.

Conclusion:

The materials, performance, and operational features of both the submitted device and the predicate devices are substantially equivalent and safe and effective for their intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2008

Mr. Tracy S. Best Senior Regulatory Affairs Specialist ICU Medical, Incorporated 4455 Atherton Drive Salt Lake City, Utah 84123

Re: K080077

Trade/Device Name: ICU Medical Clave® Stopcock Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG, LHI Dated: January 9, 2008 Received: January 15, 2008

Dear Mr. Best:

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.

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Page 2 - Mr. Best

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 I ederal 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clu S

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

ICU Medical Clave® Stopcock

Indications for Use:

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

China man

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: ____ ├ ψ ふゆゅ2つ

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.