PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118

K041410 · Icu Medical, Inc. · FPA · Jul 28, 2004 · General Hospital

Device Facts

• Record ID: K041410
• Device Name: PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118
• Applicant: Icu Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jul 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The intended use of the device is to inject fluids into, or withdraw fluids from, parts of body below the surface of the skin.

Device Story

PUNCTUR-GUARD is a winged needle set for blood collection and intravenous infusion. Device features integrated safety mechanism designed to blunt needle tip after insertion into patient vein; mechanism protects healthcare workers from accidental needlestick injuries. Operated by clinicians in clinical settings. Device facilitates fluid withdrawal or injection below skin surface. Safety feature renders needle safe post-insertion, reducing occupational exposure risk.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Winged needle set for intravascular access. Features mechanical blunting safety mechanism. Single lumen needle design. Class II device under 21 CFR 880.5570.

Indications for Use

Indicated for use in patients requiring intravenous fluid infusion or blood collection. Intended for use by healthcare professionals to enhance safety needle programs by reducing risk of accidental 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2004

Mr. Dale Fairchild Regulatory Manager ICU Medical, Incorporated 951 Calle Amaneccr San Clemente, California 92673

Re: K041410

Trade/Device Name: PUNCTUR-GUARD® Winged Sct For Blood Collection and Intravenous Infusion Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle, Intravascular Administration Set Regulatory Class: II Product Code: FMI, FPA Dated: May 26, 2004 Received: May 27, 2004

Dear Mr. Fairchild:

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 cnactment date of the Medical Device Amerate ecomments, 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 (1 mr. ), it ina) 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. Fairchild

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advance a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the ret or any 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 and listing (21 CF read 807), a marting (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), rl you dontact 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 Inter 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,

Chiu Lin, 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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K041410

## Indications for Use Statement

| 510 (k) | K041410 |
|---------|---------|
|---------|---------|

| Device Name | PUNCTUR-GUARD® Winged set for Blood Collection and Intravenous Infusion. |
|-------------|--------------------------------------------------------------------------|
|-------------|--------------------------------------------------------------------------|

The PUNTUR-GUARD protects the health care worker from accidental needlestick by providing a blunting that renders safe the needle once it has entered the patient's vein.

The PUNCTUR-GUARD is intended to enhance current safety needle programs

| Indications For Use | The intended use of the device is to inject fluids into, or withdraw fluids from, parts of body below the surface of the skin. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------|
|---------------------|--------------------------------------------------------------------------------------------------------------------------------|

| Prescription Use (Per 21 CFR 801.109 | <div> <span style="text-decoration: overline;">X</span> OR Over-The- Counter Use <span style="text-decoration: underline;"> </span> </div> |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|

PLEASE DO WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aren Nareau for ADu 7/27/04
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K041410