POSITIVE PRESSURE CONNECTOR

K973167 · Icu Medical, Inc. · FPA · Nov 17, 1997 · General Hospital

Device Facts

• Record ID: K973167
• Device Name: POSITIVE PRESSURE CONNECTOR
• Applicant: Icu Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Nov 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The CLC 2000 is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve intended for use as an accessory to Intravascular administration set. The CLC 2000 provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein or artery). The CLC 2000 also provides access for the withdrawal of fluids from a patient's vascular system.

Device Story

The CLC 2000 is a sterile, single-use, swab-able, bi-directional luer-activated valve used as an accessory to intravascular administration sets. It functions as a closed system; insertion of a luer taper physically displaces an internal poppet and O-rings to open the valve for fluid injection or aspiration. Upon removal of the luer, the poppet and O-rings automatically return to a sealed position, displacing fluid through the male luer to prevent blood reflux into the catheter lumen. The device is used in clinical settings by healthcare providers to facilitate vascular access. It benefits patients by maintaining a closed system during fluid management, reducing the risk of contamination and blood exposure.

Clinical Evidence

bench testing only

Technological Characteristics

Materials: 30% glass-filled polyester body, polycarbonate poppet, silicone rubber O-rings, stainless steel 302 spring. Design: Swab-able, bi-directional luer-activated valve. Operation: Mechanical poppet/O-ring displacement via luer taper. Sterilization: Not specified. Connectivity: None (mechanical accessory).

Indications for Use

Indicated for patients requiring intravenous or intra-arterial access for fluid administration or fluid withdrawal via an administration set.

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

• B. Braun V2 Ultrasite Injection Site (K955585)
• ICU Medical CLAVE Connector (K970855)

Submission Summary (Full Text)

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NOV 17 1997

K473/47

# 510(k) Summary of Safety and Effectiveness

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

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

Contact Person: Salvadore F. Palomares Phone Number: [phone] [phone] Fax Number:

## 510(k) Summary of Safety and Effectiveness

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

The assigned 510(k) number is: K973167

#### Applicant Information:

| Date Prepared: | November 14, 1997 |
|----------------|----------------------------------------------|
| Name: | ICU Medical Inc. |
| Address: | 951 Calle Amanecer<br>San Clemente, CA 92673 |

Contact Person: Salvadore F. Palomares Phone Number: [phone] Fax Number: [phone]

### Device Information:

Trade Name: CLC 2000 Common Name: Intravascular Administration Set Classification Name: Intravascular Administration Set

#### Equivalent Device:

B. Braun V2 Ultrasite Injection Site (K955585) ICU Medical CLAVE Connector (K970855)

#### Device Description:

The CLC 2000 is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve intended for use as an accessory to Intravascular administration set.

#### Intended Use:

The CLC 2000 provides access for the administration of fluids from a container to a patient's vascular system through the administration sot's needle or catherer (which is inserted into a vein or artery). The CLC 2000 also provides access for the withdrawal of fluids from a patient's vascular system.

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Comparison To Predicate Device:

| Product Labeling | Sterile, Non-Pyrogenic, Single<br>Use, Swab-able, IV Connector.<br>Directions for Use included | Sterile, Non-Pyrogenic, Single<br>Use, Directions for Use<br>included |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CLC 2000 is a swab-able,<br>bi-directional valve used to<br>access any vein or artery or<br>aspiration of fluids from a<br>patient's vascular system. | The Ultrasite Injection Site Is<br>used for the injection<br>gravity/pump flow or aspiration<br>of fluids. |
| Design | Swab-able bl-directional luer<br>activated valve. Closed system<br>activated by a luer taper. The<br>luer taper physically moves the<br>poppet and O-rings, opening<br>the valve. With the valve in the<br>open position, fluids can be<br>injected or withdrawn. The<br>poppet and O-rings move to the<br>sealed position automatically<br>when the luer taper is removed.<br>As the poppet and O-rings<br>move to the seal position, fluid<br>is displaced through the male<br>luer preventing blood from<br>entering the lumen of the<br>catheter. | Swab-able cap-less two-way<br>valve. Closed system activated<br>by a luer taper. The luer taper<br>puts pressure on the plunger,<br>opening the valve. With the<br>valve in the open position,<br>fluids can be injected or<br>withdrawn. The valve closes<br>automatically when the luer<br>taper is removed. |
| Materials | Body - 30% glass filled<br>polyester<br>Poppet - Polycarbonate<br>O-rings - Silicone Rubber<br>Spring - Stainless Steel 302<br>Packaging-Medical packaging<br>grade fiber-free peelable paper<br>lidding and pouching material. | Body - Polyurethane<br>Plunger - latex free non-<br>compromised elastomeric<br>material<br>Spring - metal<br>Packaging-Medical packaging<br>grade fiber-free peelable paper<br>lidding and pouching material. |

Sffalman

Salvadore F. Palomares Manager of Regulatory Affairs iCU Medical, Inc.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES ---

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 1997

Mr. Salvadore F. Palomares Manager of Regulatory Affairs ICU Medical, Incorporated 951 Calle Amenecer San Clemente, California 92673

K973167 Re : CLC 2000 Swabbable IV Connector Trade Name: Requlatory Class: II Product Code: FPA Dated: Auqust 21, 1997 Received: August 25, 1997

Dear Mr. Palomares:

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 regulations 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 (OS) inspections, the Food and Druq 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 obliqation you might have under sections 531

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Page 2 - Mr. Palomares

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

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timo A 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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# 510(k) Number (if known): K973167

# Device Name: CLC 2000 SWahle V Connector

## Indications For Use:

The CLC 2000 is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve intended for use as an accessory to Intravascular administration set. The CLC 2000 provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein or artery). The CLC 2000 also provides access for the withdrawal of fluids from a patient's vascular system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Paulocesar Cavalcante

(Division Sign-Off) (1) wision of Dental, Infection Com a d General Hospital D E, Nik) Number .

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________