The 'Blood Tubing Accessory with CLAVE Connector' is intended for use in hemodialysis and other chronic applications where blood sampling is required. Luer-locking adaptors allow secure, in-line placement between the blood tubing set and the catheter or venipuncture device. Use of a CLAVE Connector allows the clinician needle-free blood withdrawal.

Device Description

The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

AI/ML Overview

This submission describes a medical device, the "Blood Tubing Accessory with CLAVE Connector," not an AI/ML powered device. As such, the information provided does not align with the requested categories for AI/ML device studies. I will provide the acceptance criteria and study information that is available in the provided text.

Acceptance Criteria and Device Performance (based on non-AI/ML device information):

Acceptance Criteria	Reported Device Performance
Hemolysis (no significant hemolysis)	A hemolysis study conducted by an independent laboratory found no significant hemolysis occurs with the use of the CLAVE Connector.
Sterile barrier maintenance (for 6 days/144 hours with 24 activations/day)	A microbial challenge study showed that the CLAVE Connector maintained a sterile barrier for six days or 144 hours while administering 24 repeat activations per day with a standard disinfection protocol. These results indicate that the CLAVE Connector, when using a standard disinfection protocol, did not increase infection rates under worst-case clinical simulation.

Study Details (based on non-AI/ML device information):

Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are non-clinical laboratory studies, not based on patient data in the context of an "AI/ML test set."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical studies like hemolysis and microbial challenge is typically established by laboratory testing methodologies and standards, not expert consensus in the diagnostic sense.
Adjudication method: Not applicable. This applies to diagnostic assessments, not non-clinical device performance studies.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a non-AI/ML device; an MRMC study is not relevant.
If a standalone study was done: Yes, the described studies (hemolysis and microbial challenge) are standalone performance tests for the device's physical and biological properties.
The type of ground truth used:
- Hemolysis: The ground truth would be based on established laboratory methods and standards for quantifying hemolysis in blood samples.
- Microbial challenge: The ground truth would be based on microbiological techniques to assess sterility and barrier integrity, likely quantifying microbial growth or penetration under controlled conditions.
The sample size for the training set: Not applicable. This device does not involve AI/ML.
How the ground truth for the training set was established: Not applicable. This device does not involve AI/ML.

Summary

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ICCI Medical Inc.

Blood Tubing Accessory with CLAVE Connector

R983559
Page 1 of 2
510(k) Notification

Page 39 of 40

DEC 2 4 1998

10.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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

Name: Address: ICU Medical, Inc. 951 Calle Amanecer San Clemente, CA 92673

Contact Person: Phone Number: Fax Number:

Sheryl Sáenz (949)366-2183 (949)366-8368

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.

Applicant Information:

Date Prepared:	October 7, 1998
Name:	ICU Medical Inc.
Address:	951 Calle AmanecerSan Clemente, CA 92673

Contact Person:	Sheryl Sáenz
Phone Number:	(949) 366-2183
Fax Number:	(949) 366-8368

Device Information:

Trade Name:	Blood Tubing Accessory with CLAVE Connector
Common Name:	Blood Access Accessory
Classification Name:	Blood Access Device / Accessories

Equivalent Device:

MEDISYSTEMS ReadySet® Hemodialysis Blood Tubing Set, needle injection sites

Device Description:

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510(k) Notification Page 40 of 40

Blood Tubing Accessory with CLAVE Connector

Intended Use:

The 'Blood Tubing Accessory with CLAVE Connector' is intended for use in hemodialysis and other chronic applications where blood sampling is required. Luer-locking adaptors allow secure, in-line placement between the blood tubing set and the catheter or venipuncture device. Use of a CLAVE connector allows the clinician needle-free blood withdrawal.

Comparison To Predicate Device:

Characteristic	ICU MEDICAL'S BLOOD TUBINGACCESSORY WITH CLAVE®CONNECTOR	Injection sites included on MEDISYSTEMSREADYSET HEMODIALYSIS BLOODTUBING SET
ProductLabeling	Sterile Use, Non-Pyrogenic, Sterile fluidpathway in unopened, undamaged package.Directions for use on labeling.	Sterile Use, Directions for use on labeling
Intended Use	Needle-free port to access any vein, or artery.	Needle injection sites on arterial and venous tubingsides for blood aspiration from tubing.
Design	One-piece connector activated by luerconnection to allow blood withdrawal. Tubingand connectors are straight-line to minimizeturbulence.	Pierceable septum secured in durable housingwhich is bonded to blood tubing set.
Materials	Y-Connector-PolyesterMale Luer: PolypropyleneFemale Luer: PolyesterBlood Tubing Extension: PolyvinylchlorideCLAVE Connector: Polycarbonate,Polyester, Silicone, Fluorosilicone,Polypropylene, PolyethylenePackaging - Medical packaging grade fiber-free peelable paper lidding and pouchingmaterial.	Septum -Thermoplastic elastomerHousing - PolycarbonateBlood Tubing - Polyvinylchloride

Conclusions of nonclinical tests:

. Hemolysis study was conducted by independent laboratory and found that no significant hemolysis occurs with the use of the CLAVE Connector.
. Microbial challenge study showed that the CLAVE Connector maintained a sterile barrier for six days or 144 hours while administering 24 repeat activations per day. These results indicate that the CLAVE Connector, when using a standard disinfection protocol, did not increase infection rates under worst case clinical simulation

simulation.

Sheryl Sáenz

Regulatory Affairs Specialist ICU Medical, Inc.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K983559

Blood Tubing Accessory with CLAVE® Connector Dated: October 7, 1998 Received: October 13, 1998 Regulatory Class: II 21 CFR 876.5540/Procode: 78 FJK

Dear Ms. Saenz:

Ms. Sheryl Saenz

ICU Medical, Inc.

951 Calle Amanecer

Regulatory Affairs Specialist

San Clemente, CA 92673

DEC 24 1998

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 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 action. In addition, FDA may publish further announcements 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 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) 594-4613. 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/odrb/dsmaldsmamain.html".

Sincerely your

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: Blood Tubing Accessory with CLAVE Connector

INDICATIONS FOR USE

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	OR	Over-the-Counter-Use
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,and Radiological Devices
510(k) Number	K983559

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.