The ICU Medical, Inc. Core Resistant Huber Needle Infusion Set, Core Resistant Huber Infusion Set with Y Site and Core Resistant Huber Infusion Set with Y Site and Clave are intended for use to deliver solutions and drugs through vascular implant ports.

The ICU Medical, Inc. Core Resistant Huber Infusion Set, Core Resistant Huber Infusion Set with Y Site and Core Resistant Huber Infusion Set with Y Site and CLAVE® are used to deliver solutions and drugs into vascular implant ports.

Device Description

The ICU Medical Core Resistant Huber Infusion Sets are single use, sterile and non pyrogenic devices intended for use as an accessory to deliver solutions and drugs into a patient's vascular implant port. Components used in the sets may be either manufactured by ICU Medical or purchased from approved contract manufacturers. Components will be assembled into standard configurations or configurations specified by the customer and packaged.

AI/ML Overview

The provided text is a 510(k) summary for the ICU Medical Inc. Core Resistant Huber Infusion Sets. This document establishes the safety and effectiveness of a medical device by demonstrating its substantial equivalence to a predicate device already on the market.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics typically found in AI/ML medical device submissions.

The document specifically focuses on:

Applicant and Device Information: Name, address, contact, device name, and classification.
Intended Use: What the device is designed to do.
Comparison to Predicate Device: A table detailing physical characteristics and intended use in comparison to an existing similar device. This is the primary method of demonstrating substantial equivalence for this type of device.
FDA Clearance Letter: Formal notification from the FDA that the device is substantially equivalent and can be marketed.

Therefore, I cannot fulfill your request for: a table of acceptance criteria and reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

This 510(k) pertains to an intravascular administration set (a physical medical device), not an AI/ML diagnostic or therapeutic device. The regulatory pathway for this type of device relies on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than performance metrics from a clinical study with acceptance criteria as you've described.

Summary

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ICU Medical Inc. Core Resistant Huber Infusion Sets 510(k) Notification Page 20 of 24

OCT - 1 1997

Appendix F. 510(k) Summary of Safety and Effectiveness 15.

The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

Name: Arlene Dutchik Address: 951 Calle Amanecer San Clemente, CA 92673

Contact Person:	Arlene Dutchik
Phone Number:	(714)366-2183
Fax Number:	(714)366-8368

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

Applicant Information:

Date Prepared:	July 17, 1997
Name:	ICU Medical, Inc.
Address:	951 Calle Amanecer.San Clemente, Ca 92673

Contact Person: Arlene Dutchik Phone Number: (714)366-2183 Fax Number: (714)366-8368

Device Information:

Trade Name: Intravascular Administration Set Common Name: Core Resistant Huber Needle Sets Classification Name: Intravascular Administration Set

Equivalent Device:

Micro Med/Core-Resistant Huber Infusion Set with and without Y-Site

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Device Description:

Intended Use:

Comparison To Predicate Device:

CHARACTERISTICCOMPARED	ICU MEDICAL CORERESISTANT HUBERINFUSION SET	MICRO MED, CORERESISTANT HUBERNEEDLE INFUSION SETWITH OR WITHOUT Y SITE
Product Labeling	Sterile Use, Non Pyrogenic inunopened, undamaged, package.Directions for Use on label.	Sterile Use, Non Pyrogenic inunopened, undamaged,package.
Intended Use	Deliver solutions and drugsthrough vascular implant ports.	Deliver solutions and drugsthrough vascular implant ports.
Needle Gauges	19, 20, 22 gauge	19, 20, 22 gauge
Needle Lengths	1/2", 3/4", 1", 11/2"	1/2", 3/4", 1", 11/2"
Tubing Size	Macrobore and Minibore	Macrobore and Minibore
Color Coded Wings	Yes	Yes
Wing Assembly	Fixed	Fixed
CLAVE® NeedlelessConnector	Yes	No
Luer Lock	Yes	Yes

15.1. Comparative Information

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of a human figure with three wavy lines emanating from it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 1 1997

Ms. Arlene Dutchik Requlatory Affairs Specialist ICU Medical, Incorporated 951 Calle Amanecer San Clemente, California 92673

Re: K972712 Core resistant Huber Infusion Sets Trade Name: Requlatory Class: II Product Code: FPA Dated: July 17, 1997 Received: July 21, 1997

Dear Ms. Dutchik:

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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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

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Page 2 - Ms. Dutchik

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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) 594-4618. 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" (21 CFR 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/dsmamain.html".

Sincerely yours,
K. Autrust

Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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12. Appendix C. Indications for Use

Patrici Crescenti

(Division Slets (11) (Division Status (1)
Division of Desta), infection of Democracy Division of General Finspilal Devices 1972212

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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.