(200 days)
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No
The summary describes a physical device (spacers) used in a brachytherapy procedure and contains no mention of software, algorithms, image processing, or AI/ML terms.
No.
The device's intended use is to provide space between radionuclide seeds during their introduction into the body for Brachytherapy procedures, not to directly treat or diagnose a disease.
No
The device's intended use is to create space for radionuclide seeds during brachytherapy, not to diagnose a condition.
No
The intended use describes a physical device ("Seeding Spacers") used to provide space between radionuclide seeds, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide space between radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. This is a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Anatomical Site: The anatomical site is the prostate, which is within the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural, facilitating the placement of radioactive seeds within the body.
N/A
Intended Use / Indications for Use
The Worldwide Medical Technologies Seeding Spacers intended use is to provide space between radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach for radionuclide seed application in and around the prostate.
Product codes
90 KXK
Device Description
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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
transperineal approach for radionuclide seed application in and around the 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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/0/Picture/3 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes.
NOV - 5 1999
Mr. Gary A. Lamoureux Worldwide Medical Technologies 426 Main Street. North Woodbury, CT 06798
Dear Mr. Lamoureux:
Re:
K991344 Worldwide Medical Technologies Seeding Spacers Dated: August 13, 1999 Received: August 16, 1999 Product Code: 90 KXK Regulatory Class: Il (two) 21.CFR 892.5730
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 legally marketed predicate 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 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 (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 requirements, 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 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 the Electronic Product 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 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/dsma/dsmamain.html".
Sincerely yours,
CART Daniel C. Schultz, M.D.
CAPT Daniel G. Schultz, M.D. Acting 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: Worldwide Medical Technologies Seeding Spacers
Indications For Use:
The Worldwide Medical Technologies Seeding Spacers intended use is to provide space between radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach for radionuclide seed application in 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)
Prescription Use
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Uhrid U. Segrom
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices :510(k) Number 1196