J-TIP NEEDLESS INJECTOR

• K Number: K980082
• Device Name: J-TIP NEEDLESS INJECTOR
• Manufacturer: NATIONAL MEDICAL PRODUCTS, INC.
• Date Cleared: 1998-03-04 ( 54 days)
• Product Code: KZE
• Regulation Number: 880.5430
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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 Description

J-Tip Needles Injector

AI/ML Overview

Apologies, but the provided text from the FDA 510(k) letter for the "J-Tip Needleless Injector" does not contain the information requested regarding acceptance criteria and details of a study proving device performance.

The document is a substantial equivalence determination letter, which means the FDA has determined that the J-Tip Needleless Injector is as safe and effective as a legally marketed predicate device. This letter typically does not include the detailed study methodology, acceptance criteria, or performance data that would be found in a 510(k) summary or the actual submission itself.

Therefore, I cannot provide the specific details you've asked for based on the input document, such as:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set details.
9. Ground truth establishment for the training set.

The letter focuses on the regulatory decision and the device's classification, not the technical study details.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with flowing lines suggesting movement or progress.

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)

Regulation Number and Section

§ 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).