(90 days)
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No
The summary describes a physical template with guidance holes and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is a template used for guiding needle placement, not for treating a condition itself. It facilitates a therapeutic procedure (radionuclide seed placement) but does not provide therapy.
No
Explanation: The device is described as a "Needle Guiding Template" used for the "placement of radionuclide seeds into the body," specifically for the "prostate." This indicates a therapeutic or interventional function, not a diagnostic one. It assists in a procedure rather than providing information for diagnosis.
No
The device description explicitly states it is a "device with needle guidance holes in a grid," indicating a physical, hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states the device is a "Needle Guiding Template" used for the "placement of radionuclide seeds into the body." This is an in vivo procedure (performed within the living body), not an in vitro procedure.
- Lack of IVD characteristics: The description does not mention any analysis of biological samples, detection of substances, or diagnostic testing performed outside the body.
Therefore, the N.I.T., Inc. Needle Guiding Template is a surgical or procedural device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
90 IWJ
Device Description
The N.I.T., Inc. Needle Guiding Template is a device with needle guidance holes in a grid
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
prostate
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three abstract human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the caduceus.
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
1
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
1
EXHIBIT
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