(90 days)
The N.I.T., Inc. Needle Guiding Template is a device with needle guidance holes in a grid for the placement of radionuclide seeds into the body. Coordinate system assure to place the template in proximity to, but not touching the perineum for seed placement into and around the prostate.
The N.I.T., Inc. Needle Guiding Template is a device with needle guidance holes in a grid
The provided text is a 510(k) clearance letter from the FDA for the NIT Needle Guiding Template (Seed Applicator). It is a regulatory document confirming substantial equivalence to a predicate device, which allows the company to market the device.
This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent...". This means the clearance is based on the device being similar enough to an already approved device, rather than requiring new performance studies meeting specific acceptance criteria as would be needed for a novel device or pre-market approval (PMA).
Therefore, I cannot fulfill your request for the tables and information about the study, as the provided text does not contain this data.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Joseph E. Harms President Needle Infusion Technologies, Inc. 390 Scarlet Blvd. Oldsmar, FL 34667
Re: K973638
NIT Needle Guiding Template (Seed Applicator) Dated: September 17, 1997 Received: September 24, 1997 Regulatory Class: I 21 CFR 892.5650/Procode: 90 IWJ DEC 2 3 1997
Dear Mr. Harms:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the includes 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, 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 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
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 virgo diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbanding 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name:________ N.I.T., Inc. Needle Guiding Template
Indications For Use:
The N.I.T., Inc. Needle Guiding Template is a device with needle guidance holes in a grid The I ... Inc. Hoodio Galles for the placement of radionuclide seeds into the body. Coordinate system assure to place the template in proximity to, but not touching the perineum for seed placement into and around the prostate.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel a. Segmen
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
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EXHIBIT
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§ 892.5650 Manual radionuclide applicator system.
(a)
Identification. A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.