(151 days)
Hypodermic single lumen needle: To inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Piston Syringe: To inject fluids into, or withdraw fluids from the body.
Not Found
This is an FDA 510(k) clearance letter for the "KG Medix Disposable Syringe 1, 3, 5, 10, 20, 30, 50, ML's" and "KG Medix Device Name : SafeOne Disposable Syringe & Needle."
Based on the provided text, there is no information regarding acceptance criteria or a study that proves the device meets those criteria, as this document is a regulatory clearance letter, not a performance study report. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, but it does not detail specific performance metrics or clinical study results.
Therefore, I cannot provide the requested information.
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Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Rockville MD 20850
Mr. Byung Doo President Kyung Gi Medical Industrial Company Limted 529-4, Yulsaeng-Ri, Daegot-Myun, Kimpo-City, Kyunggi-Do, 415-854 KOREA
Re: K022057
Trade/Device Name: KG Medix Disposable Syringe 1, 3, 5, 10, 20, 30, 50, ML's KG Medix Regulation Number: 880.5860 and 880.5570 Regulation Name: Lice Removal Kit and Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMF and FMI Dated: September 25, 2002 Received: October 3, 2002
Dear Mr. Jee:
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. Lee
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 i 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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of 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/cdrb/dsma/dsmamain.html
Sincerely yours,
Pelloux Curritter
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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501(k) Number(if known) : K022057
KG Medix Device Name : SafeOne Disposable Syringe & Needle
Intended For Use :
Hypodermic single lumen needle
To inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin
Piston Syringe :
To inject fluids into, or withdraw fluids from the body
Patricia Cucente
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:________________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE(IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use
(Per 21 CFR 801.109)
OR Over-The Counter Use_
(Optional Format 1-2-96)
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).