(62 days)
The intended use of the device is to inject fluids into, or withdraw fluids from, parts of body below the surface of the skin.
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
The provided text is a 510(k) premarket notification approval letter for the PUNCTUR-GUARD® Winged Set for Blood Collection and Intravenous Infusion. This document does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.
The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information submitted in the 510(k) application, which typically includes device description, indications for use, comparison to predicates, and sometimes performance data if necessary to establish substantial equivalence. However, the details of any performance studies, acceptance criteria, or their results are not present within this specific document.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than a detailed technical report of device performance and testing.
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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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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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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 | X OR Over-The- Counter Use |
|---|---|
| -------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------- |
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
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.