(87 days)
Injector used for the subcutaneous administrations of xylocaine or calcimar/calcitonin which are appropriate for subcutaneous injection using jet injection or needleless injection systems. For subcutaneous injections only. The device serves as an alternative to the subcutaneous delivery of xylocaine or calcimar/calcitonin medications with needle and syringe.
J-Tip Needleless Injection System
This document is a 510(k) premarket notification decision letter from the FDA regarding the "J-Tip Needleless Injection System". It primarily focuses on regulatory approval and does not contain information about acceptance criteria or a study proving device performance in the manner requested.
Therefore, I cannot provide the detailed information about acceptance criteria and a performance study based on this document. The document confirms that the device is "substantially equivalent" to previously marketed devices, which is a regulatory determination, not a clinical performance validation against specific acceptance criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 24 1997
Mr. Danny Patel ·President National Medical Products, Incorporated 57 Parker Street 92718 Irvine, California
K973254 Re : J-Tip Needleless Injection System For Trade Name: Subcutaneous Injection of Xylocaine or Calcimar/ Calcitonin Regulatory Class: * II · · Product Code: KZE Dated: August 26, 1997 Received: August 29, 1997
Dear Mr. Patel:
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, Druq, 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 Regulations, Title 21, Parts 800 to 895. ਕ 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 (QS) 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
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Page 2 - Mr. Patel
not affect any obligation you might have under sections 531 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 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 and additionally 809.10 for in vitro diagnostic devices), 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 enc regatacion chercred, "hibranding of other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
L. A. Wilmot
mothy 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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1973254 510(k) Number (if known):
Device Name: J-Tip Needleless Injection System
Indications For Use:
Injector used for the Needleless System ਨੇ ਤ The The J-Tip administrations of xylocaine or subcutaneous calcimar/calcitonin which are appropriate for the injection using jet injection or needleless injection systems. For The device serves subcutaneous injections only. 경 동 an xylocaine alternative to the subcutaneous delivery of OL needle calcimar/calcitonin medications with and syringe.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1
Patricia Caccavale
on Sign-Off) fon of Dental, Infection Control, and General Hospital Devices __ . - -K973254 510(k) Number
Prescription Use_ (Par 21 CFR 801.109)
.
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 880.5430 Nonelectrically powered fluid injector.
(a)
Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.(b)
Classification. Class II (performance standards).