J-TIP NEEDLESS INJECTOR

K980082 · National Medical Products, Inc. · KZE · Mar 4, 1998 · General Hospital

Device Facts

• Record ID: K980082
• Device Name: J-TIP NEEDLESS INJECTOR
• Applicant: National Medical Products, Inc.
• Product Code: KZE · General Hospital
• Decision Date: Mar 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5430
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The J-Tip Needleless Injector system is used for the subcutaneous administration of medications which are appropriate to deliver by jet injection.

Device Story

J-Tip Needleless Injector is a mechanical device for subcutaneous medication delivery. It utilizes jet injection technology to propel medication through the skin without the use of a traditional needle. Operated by healthcare professionals or patients in clinical or home settings, the device eliminates needle-stick risks and reduces injection pain. It functions by creating a high-pressure stream of liquid medication that penetrates the dermal layers. The device is intended for medications compatible with jet delivery methods. It provides a needle-free alternative for subcutaneous administration, potentially improving patient compliance and safety.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on technological characteristics and intended use.

Technological Characteristics

Mechanical jet injector; subcutaneous delivery mechanism; non-needle based; manual operation.

Indications for Use

Indicated for subcutaneous administration of medications appropriate for jet injection in patients requiring such delivery.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rohit Patel Official Correspondent National Medical Products, Incorporated 57 Parker Street Irvine, California 92718

MAR - 4 1998

Re : K980082 J-Tip Needles Injector Trade Name: Requlatory Class: II Product Code: KZE Dated: January 6, 1998 Received: January 9, 1998

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, Drug, 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 aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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 not affect any obligation you might have under sections 531

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Page 2 - Mr. Patel

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patucia Cuente Hoz

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) number (if known):_

Device Name: J-Tip Needleless Injector

Indications For Use:

The J-Tip Needleless Injector system is used for the subcutaneous administration of medications which are appropriate to deliver by jet injection.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Patrice Cifuent Concurrence of CDRH, Office of Device Evaluation (ODE)

ivinion &

Over-the-Counter Use (optional Format 1-2-96)

Inddications for Use

Prescription Use (Per 21 CFR 801.109)