(88 days)
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No
The summary describes a manual device for radionuclide application and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development or validation.
Yes
The device is described for "manual application of a radionuclide source into the body for radiation therapy," directly indicating its use in treating a medical condition.
No
The device is described as a "Prostate Seeding Needle" intended for "manual application of a radionuclide source into the body for radiation therapy," which indicates a therapeutic rather than a diagnostic function.
No
The device description explicitly states "Prostate Seeding Needle," which is a physical medical device used for manual application of a radionuclide source. This is not a software-only device.
No, 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. They are used outside the body (in vitro).
- Device Intended Use: The intended use of this device is "For the manual application of a radionuclide source into the body for radiation therapy." This clearly describes a procedure performed inside the body (in vivo) for therapeutic purposes.
- Device Description: A "Prostate Seeding Needle" is a tool used to deliver radioactive seeds directly into the prostate tissue. This is a surgical or interventional procedure, not a diagnostic test performed on a sample.
Therefore, based on the provided information, this device falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For the manual application of a radionuclide source into the body for radiation therapy.
Product codes
90 IWJ
Device Description
Prostate Seeding Needle
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 (inferred from device name)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the logo is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three lines that form a wing-like shape, with a snake winding around the center line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Joseph L. Mark Vice President Promex, Inc. 1125 Brookside Ave. Suite G500 Indianapolis, IN 46208 Re:
K973184 Prostate Seeding Needle Dated: August 20, 1997 Received: August 25, 1997 Regulatory class: I 21 CFR 892.5650/Procode: 90 IWJ NOV 2 1 1997
Dear Mr. Mark:
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 interest for use stated in the enolesure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 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 QS 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 funding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and this, 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) 594-4613. 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 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.
h Lillian Yin, Ph.D.
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
Ka73184 5 10(k) Number (if known):
Prostate Seeding Needle Device Name:
Indications For Use:
For the manual application of a radionuclide source into the body for radiation therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elmerd C. Seymour
(Division Sign-Off) Division of Reproductive, Abdor .. Ial. ENT. and Radiological Device :((k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
4k-31