CLAVE CONNECTOR

K970855 · Icu Medical, Inc. · FPA · Jun 24, 1997 · General Hospital

Device Facts

• Record ID: K970855
• Device Name: CLAVE CONNECTOR
• Applicant: Icu Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

As an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

Device Story

Clave Connector is a single-use, sterile, non-pyrogenic needleless injection port accessory for intravascular administration sets. Device features a one-piece design activated by a luer connection to facilitate fluid flow. Used in clinical settings to access veins or arteries via a cannula. Operated by healthcare professionals to administer fluids. Provides a needle-free interface for fluid delivery, reducing needle-stick risks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Polycarbonate (internal conduit), Polyester (housing), Silicone Rubber (seal), Polypropylene (ring/cap), Flurosilicone (lubricant). Design: One-piece needleless valve activated by luer connection. Sterile, non-pyrogenic, single-use.

Indications for Use

Indicated for use as a needleless injection port to access any vein or artery for the administration of fluids in patients requiring intravascular therapy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• IVAC SmartSite (K970855)

Submission Summary (Full Text)

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ICU Medical Inc.
CLAVE CONNECTOR
JUN 24 1997
510(k) Notification
Page 21 of 24
K970855

# 17. Appendix H. 510(k) Summary of Safety and Effectiveness

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

Name: ICU Medical, Inc.
Address: 951 Calle Amanecer
San Clemente, CA 92673
Contact Person: Arlene Dutchik
Phone Number: [phone]
Fax Number: [phone]

## 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: K970855

### Applicant Information:

Date Prepared: May 14, 199
Name: ICU Medical Inc.
Address: 951 Calle Amanecer
San Clemente, CA 92673
Contact Person: Arlene Dutchik
Phone Number: [phone]
Fax Number: [phone]

### Device Information:

Trade Name: Clave Connector
Common Name: Intravascular Administration Set
Classification Name: Intravascular Administration Set

### Equivalent Device:

IVAC SmartSite™

### Device Description:

The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to Intravascular administration set.

### Intended Use:

As an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

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ICU Medical Inc.
CLAVE CONNECTOR
510(k) Notification
Page 22 of 24

Comparison To Predicate Device:

| Characteristic Compared | CLAVE® NEEDLELESS CONNECTOR | IVAC NEEDLE FREE VALVE ADMINISTRATION SETS (SMARTSITE™) |
| --- | --- | --- |
| Product Labeling | Sterile Use, Non-Pyrogenic, Sterile fluid pathway in unopened, undamaged package. Directions for use on labeling. | Sterile Use, Directions for use on labeling |
| Intended Use | Needleless injection port to access any vein, or artery. | Needleless valve (luer lock) |
| Design | One piece design activated by luer connection to allow fluid flow. | One piece design activated by luer connection to allow fluid flow. |
| Materials | Internal Conduit-Polycarbonate Housing-Polyester Silicone Seal-Silicone Rubber Ring-Polypropylene Lubricant-Flurosilicone Breather Cap-Polypropylene Packaging-Medical packaging grade fiber-free peelable paper lidding and pouching material. | Unknown |


Arlene Dutchik
Regulatory Affairs Specialist
ICU Medical, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

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

JUN 24 1997

Re: K970855
Trade Name: Clave Connector
Regulatory Class: II
Product Code: FPA
Dated: May 14, 1997
Received: May 19, 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 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 (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Dutchik

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone].

Sincerely yours,


Timothy A. Ulatowski
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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ICU Medical Inc.
CLAVE CONNECTOR
510(k) Notification
Page 16 of 24

## 12. Appendix C. Indications for Use

The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

(Division Sign-Off) *Patricia Cucenta*
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number *K920855*

Prescription Use ☑
(Per 21 CFR 801.109)

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