CML 1000

K051437 · Icu Medical, Inc. · FPA · Aug 3, 2005 · General Hospital

Device Facts

• Record ID: K051437
• Device Name: CML 1000
• Applicant: Icu Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Aug 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

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

Device Story

CML (Closed Male Luer) is a single-use, sterile, swab-able, bi-directional valve accessory for intravascular administration sets. Device features a spring-loaded poppet within a hard plastic housing; O-rings form a physical seal. Operation: normally closed; female luer engagement pushes poppet to open position, allowing fluid injection or withdrawal; removal of female luer allows spring to return poppet to closed position. Used in clinical settings to facilitate fluid delivery to patient's vascular system via needle or catheter. Benefits include closed-system access for fluid administration.

Clinical Evidence

bench testing only

Technological Characteristics

Hard plastic housing; silicone seal; silicone spring retention; liquid silicone lubricant. Normally closed two-way luer-activated valve. Single-use, sterile, non-pyrogenic.

Indications for Use

Indicated for use as an accessory to intravascular administration sets to provide access for fluid administration from a container to a patient's vascular system via an inserted needle or catheter.

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

• Clave Connector (K970855)

Submission Summary (Full Text)

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## AUG 3 - 2005

## 510(k) SUMMARY

| §807.92(a)(1) | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Jim Coombes<br>ICU Medical, Inc.<br>951 Calle Amanecer<br>San Clemente, CA 92673<br>949-366-3571 |
| Contact Person | Jim Coombes<br>Quality Engineer |
| Date of Summary Preparation: | May 23, 2005 |
| §807.92(a)(2) | |
| Trade Name: | CML ^TM |
| Common Name: | Closed Male Luer |
| Classification Name: | Intravascular administration set (21 CFR 880.5440) |
| §807.92(a)(3) | |
| Legally Marketed Substantially Equivalent Device: | Clave Connector K970855 |
| §807.92(a)(4) | |
| Description of Device: | The Closed Male Luer is a normally closed two-way luer activated valve. Within the housing of the Closed Male Luer is a spring-loaded poppet whose head is flush with the male luer of the device. The poppet has an outer diameter that is smaller than the inner diameter of the housing. O-rings are positioned between the housing and poppet that form a physical seal between the poppet and the inner wall of the housing. The fluid pathway is opened when a female luer engages the male luer of the |

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device. The female luer will push the poppet from its normally closed position, allowing fluid to flow freely to the female luer. The device at this stage is considered in the "open position". With the device in the open position, fluids can be injected or withdrawn. The O-rings maintain contact with the inner wall of the housing and the poppet at all times preventing fluid from flowing past the O-rings. Once the female luer connector is removed from the device, the spring-loaded poppet is allowed to return to the "closed position".

8807.92(a)(5)

Intended Use:

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

\$807.92(a)(6)

Summary of Technological Characteristics

| Characteristic Compared | CML | Clave Connector |
|-------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Product Labeling | See Directions for Use,<br>Sterile, Do Not Reuse, No<br>Latex | See Directions for Use, Sterile,<br>Do Not Reuse, No Latex |
| Intended Use | Intended for use as an<br>accessory to intravascular<br>administration set | Intended for use as an<br>accessory to intravascular<br>administration set |
| Design | One piece design activated<br>by luer connection to allow<br>fluid flow | One piece design activated by<br>luer connection to allow fluid<br>flow |
| Materials | Hard plastic housing, fluid<br>path. Silicone seal, silicone<br>spring retention, liquid<br>silicone lubricant | Hard plastic housing, fluid<br>path. Silicone seal, silicone<br>spring compression, liquid<br>silicone lubricant |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 - 2005

Mr. Jim Coombes Quality Engineer ICU Medical, Incorporated 951 Calle Amanecer San Clemente, California 92673

Re: K051437

Trade/Device Name: CML 1000 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA Dated: May 24, 2005 Received: June 1, 2005

Dear Mr. Coombes:

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 - Mr. Coombes

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/industry/support/index.html.

Sincerely yours,

Chris Liu, Ph.D.

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): K051437

Device Name: CML TM

Indications For Use: The CML™ is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve device intended for use as an accessory to intravascular administration set. The CML provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).

Prescription Use V (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)

Draon
5/3/2008

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

510(k) Number: K051437

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