SMARTVALVE

K974589 · Icu Medical, Inc. · FPA · Jan 9, 1998 · General Hospital

Device Facts

• Record ID: K974589
• Device Name: SMARTVALVE
• Applicant: Icu Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jan 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve system intended for use as an accessory to Intravascular administration set. The SmartValve 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 SmartValve also provides access for the withdrawal of fluids from administration set.

Device Story

SmartValve is a single-use, sterile, non-pyrogenic pressure-activated check valve; functions as an accessory to intravascular administration sets. Device facilitates fluid administration from containers to patient vascular systems and fluid withdrawal from administration sets. Used in clinical settings by healthcare providers; integrated into existing IV administration lines. Provides controlled access to venous or arterial catheters. Benefits include simplified fluid management and access during IV therapy.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Pressure-activated check valve system; single-use; sterile; non-pyrogenic. Materials are consistent with legally marketed predicate devices.

Indications for Use

Indicated for use as an accessory to intravascular administration sets to provide access for fluid administration to or withdrawal from a patient's vascular system via a 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

• McGaw Anesthesia Triple Valve Manifold
• ICU Medical Stopcock with Extension Tubing

Submission Summary (Full Text)

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**510(k) Notification**

Page 21 of 22

#### - 9 1998 IAN Appendix F. 510(k) Summary of Safety and Effectiveness 16.

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

Name: ICU Medical, Inc. 951 Calle Amanecer Address: 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 being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## Device Information:

Trade Name: SmartValve Common Name: Intravascular Administration Set Classification Name: Intravascular Administration Set

## Equivalent Device:

McGaw Anesthesia Triple Valve Manifold ICU Medical Stopcock with Extension Tubing

## Device Description:

The SmartValve is a single use, sterile, non-pyrogenic pressure activated valve intended for use as an accessory to Intravascular administration set.

#### Intended Use:

The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve system intended for use as an accessory to Intravascular administration set. The SmartValve 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 SmartValve also provides access for the withdrawal of fluids from administration set.

#### Biocompatibility:

The materials used to manufacture the SmartValve are used in legally marketed devices under comparable conditions of use.

St. Palman

Salvadore F. Manager of Regulatory Affairs ICU Medical, Inc.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 1998

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

Re : K974589 Smartvalve Trade Name: Requlatory Class: II FPA Product Code: Dated: December 8, 1997 December 9, 1997 Received:

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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug 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 obligation 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 finding of substantial equivalence of your device to a leqally 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 [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Tin othy A. Ulatowski Diredtor 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) Notification Page 19 of 22

Appendix D. Indications for Use 14.

510(k) Number (if known):

Device Name: SmartValve

Indications For Use:

The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve system intended for use as an accessory to Intravascular administration set. The SmartValve 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 SmartValve also provides access for the withdrawal of fluids from administration set.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Palacux Cascente

(Division Sign-Off) Division of Dental, Info and General Hosp 510(k) Numb

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________