CLC2000 CATHETER PATENCY DEVICE

K021692 · Icu Medical, Inc. · FPA · Dec 4, 2003 · General Hospital

Device Facts

• Record ID: K021692
• Device Name: CLC2000 CATHETER PATENCY DEVICE
• Applicant: Icu Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Dec 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The CLC2000 is intended for use as an accessory to a vascular access device. The CLC2000 will reduce thrombotic occlusion within the internal catheter lumen and fibrin formation. The CLC2000 is designed to assist in maintaining catheter patency. The CLC2000 does not require the use of needles and therefore will passively aid in the reduction of needlestick injuries.

Device Story

CLC2000 is a swab-able, normally closed, two-way luer-activated valve; functions as accessory to vascular access devices. Device contains spring-loaded poppet with O-rings within housing. Fluid pathway opens when male luer engages female luer, pushing poppet to open position for injection/withdrawal. Upon removal of male luer, spring-loaded poppet returns to closed position; O-ring movement forces trapped fluid out through male luer (positive displacement). Positive displacement prevents blood reflux into catheter lumen. Used in clinical settings; operated by healthcare professionals. Benefits include maintained catheter patency, reduced fibrin formation/thrombotic occlusion, and reduced needlestick risk via needle-free design.

Clinical Evidence

Animal study conducted to evaluate the device's ability to reduce thrombotic occlusion and fibrin formation within the internal catheter lumen. No human clinical data provided.

Technological Characteristics

Normally closed, two-way luer-activated valve. Components: spring-loaded poppet, O-rings, housing. Materials meet ISO 10993 for external communicating, blood path indirect, prolonged contact duration. Positive displacement mechanism.

Indications for Use

Indicated for use as an accessory to a vascular access device to assist in maintaining catheter patency and reducing thrombotic occlusion and fibrin formation within the internal catheter lumen. Needle-free design aids in reducing needlestick injuries.

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

• ICU Medical CLC2000 (K973167)
• B.Braun Safsite (510(K) number unknown)

Submission Summary (Full Text)

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KO21692

DEC = 4.2003

- 3. A revision of the Summary of S&E with the correct name and indication/intended use,

| 510(K) Summary | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Name: | ICU Medical, Inc. |
| Address: | 951 Calle Amanecer<br>San Clemente, CA 92673 |
| Contact Person: | Dale Fairchild |
| Phone Number: | 949-366-2183 ext. 4319 |
| FAX: | 949-366-8368 |
| 510(K) Summary of Safety and Effectiveness | |
| The 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: | K021692 |
| Trade Name: | CLC2000® Catheter Patency Device |
| Common Name: | Accessory, Intravenous Administration Device |
| Classification Name: | Same |
| Equivalent Device: | ICU Medical CLC2000 (K973167)<br>B.Braun Safsite® (510(K) number unknown) |
| Device Description: | |
| The CLC2000 is a swab-able normally closed two-way luer activated valve. Within the housing of<br>CLC2000, is a spring-loaded poppet whose head protrudes out of the female luer of the device. The<br>poppet has an outer diameter that is smaller than the inner diameter of the housing. O-rings are<br>positioned at the head and base of the poppet and form a physical seal between the poppet and the<br>inner wall of the housing. A male luer with a rotating collar protrudes from the housing. | |
| The fluid pathway is opened when a male luer taper engages the female luer on the device. The<br>male luer will push the poppet and the O-rings from their normally closed positions. The inner wall of<br>the housing opens up at a point below the rest position of the top O-ring. When the top O-ring passes<br>this point, it looses contact with the inner wall of the housing allowing fluid to flow freely to the male<br>luer. The device at this stage is considered in the "open position". With the device in the open<br>position, fluids can be injected or withdrawn. The bottom O-ring maintains contact with the inner wall<br>of the housing at all times preventing fluid from flowing past the bottom O-ring. Once the luer taper is<br>removed from the device, the spring-loaded poppet and O-rings are allowed to return to the "closed<br>position". As the O-rings slide back up, the fluid trapped between the O-rings is forced out through<br>the male luer, creating a positive displacement of fluid. This displacement of fluid prevents blood from<br>being drawn into the lumen of the catheter when the male luer is removed from the device. | |
| Intended Use: | |
| The CLC2000 is intended for use as an accessory to a vascular access device. The CLC2000 will<br>reduce thrombotic occlusion within the internal catheter lumen and fibrin formation. The CLC2000 is<br>designed to assist in maintaining catheter patency. The CLC2000 does not require the use of needles<br>and therefore will passively aid in the reduction of needlestick injuries. | |
| Biocompatibility: | |
| The patient contacting materials used to manufacture the CLC2000 meet ISO 10993 for External<br>Communicating Devices, Blood Path Indirect, Prolonged Contact Duration. | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is positioned in the center of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 4.2003

Ms. Alison Burcar Regulatory Affairs IUC Medical, Incorporated 951Calle Amanecer San Clemente, California 92673

Re: K021692

Trade/Device Name: CLC2000 Catheter Patency Device Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 5, 2003 Received: September 8, 2003

Dear Mr. Burcar

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 - Ms. Burcar

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 Federal 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runn

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): K021692

Device Name: CLC2000®

Indications For Use:

The CLC2000 is intended for use as an accessory to a vascular access device. The CLC2000 has been shown to reduce thrombotic occlusion within the internal catheter lumen and fibrin formation in an animal study. The CLC2000 is designed to assist in maintaining catheter patency. The CLC2000 does not require the use of needles and therefore will passively aid in the reduction of needlestick injuries.

Susan Russoe

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

1421692 510(k) Number: __

Prescription Use (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)

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