ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES

K082836 · Icu Medical, Inc. · FMG · Feb 25, 2009 · General Hospital

Device Facts

• Record ID: K082836
• Device Name: ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
• Applicant: Icu Medical, Inc.
• Product Code: FMG · General Hospital
• Decision Date: Feb 25, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Universal Spikes are used to build Intravascular Administration Sets which are Single Use, sterile, non- pyrogenic device and provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter inserted into a vein.

Device Story

Universal Single-Use Spikes are components used to construct intravascular administration sets. These spikes provide a fluid path from a container to a patient's vascular system via a needle or catheter inserted into a vein. The device is intended for single use and is provided sterile and non-pyrogenic. It is used in clinical settings by healthcare professionals to facilitate fluid therapy. The device is assembled into various configurations based on customer specifications, utilizing components manufactured by ICU Medical or sourced from third-party manufacturers.

Clinical Evidence

Bench testing only. The device conforms to published international and FDA-recognized standards. No clinical data was required for this submission.

Technological Characteristics

Single-use, sterile, non-pyrogenic fluid transfer spike. Constructed from medical-grade materials consistent with predicate IV administration sets. Designed for integration into custom or standard IV administration set configurations. No electronic or software components.

Indications for Use

Indicated for use in patients requiring intravenous fluid administration via an administration set connected to a fluid container and a venous access device (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

• IV Sets- ICU Medical, Inc. (K964435)

Submission Summary (Full Text)

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## ICU MEDICAL INC.

4455 Atherton Drive Salt Lake City, Utah (801) 264 - 1410, Phone (801) 264 - 1755, Fax Niloufar Samimi, Regulatory Affairs Specialist Preparation Date: February 23, 2009

FEB 2 5 2009

# Special 510(K) Summary of Safety and Effectiveness for the:

Trade Name: Universal Single-Use Spikes

Common Name: Set IV, Fluid transfer

Classification Name: Set IV, Fluid transfer, 21 CFR 880.5440, Class II Device

## Legally Marketed Predicate Devices for Substantial Equivalence:

K964435- IV Sets- ICU Medical, Inc.

#### Rationale for SE:

Spikes in this submission have a same intended use and materials as predicate device. Therefore, ICU Medical believes they are substantially equivalent to the predicate device.

#### Description of Submitted Device:

Universal Spikes are used to build Intravascular Administration Sets which are Single Use, sterile, non- pyrogenic device and provides access for the administration of fluids from a controliner to a patient's vascular system through the administration set's needle or catheter inserted into a ven. Each set will be manufactured to unique specifications using dimensions, components, and configurations specified by the customer. Standard sets will also be offered. Components used in the IV sets may be either manufactured by ICU medical or purchased from other manufacturers. Components will be assembled into configurations specified by the customer and packaged.

## Intended Uses of the ICU Medical Universal Single-Use Spikes:

Universal Spikes are used to build Intravascular Administration Sets which are Single Use, sterile, non- pyrogenic device and provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter inserted inato er vein.

#### Safety and Performance:

ICU Medical Universal Single-Use Spikes conform to the requirements of published international standards as well as those FDA recognized standards and/or published guidelines prior to marketing the device. Additionally, ICU Medical's Sterility Assurance Level, (SAL) has an established history

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#### : Conclusion:

The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent and are safe and effective for their intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in uppercase letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Niloufar Samimi Regulatory Affairs Specialist ICU Medical, Incorporated 4455 Atherton Drive Salt Lake City, Utah 84123

**FEB 2 2009**

Re: K082836

Trade/Device Name: Universal Single-Use Spikes Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: January 29, 2009 Received: February 2, 2009

Dear Ms. Samimi:

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. Samimi

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (QSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Anthony J. Martin for
City of Valdosta, GA M.D.

Ginette Y. Michaud, M.D. Acting 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):

#### Device Name:

ICU Medical Universal Single -Use Spikes

### Indications for Use:

Universal Spikes are used to build Intravascular Administration Sets which are Single Use, sterile, non- pyrogenic device and provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter inserted into a vein.

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOTHER PAGE IF NEEDED)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

(DIVISION SE

Division of Anasthesiology, General Ho Infection Control, Dental Device

**510(k) Number:** K082854