(406 days)
Not Found
Not Found
No
The summary describes a simple dosimeter that provides an audible tone or digital readout based on the presence of a brachytherapy seed and dose rate, with no mention of AI or ML technologies.
No
The device is described as a quality assurance device for checking brachytherapy seeds and providing dose rate indication, not for treating any medical condition.
No
Explanation: The device is described as a "quality assurance device" used to "check for the presence of a brachytherapy seed and give indication of dose rate." This function is for verifying the quality and presence of a therapeutic element, not for diagnosing a medical condition in a patient. It performs "relative dosimetry," which suggests measurement for quality control rather than for clinical diagnostic purposes.
No
The device description explicitly states "Scintillating Fiber Dosimeter (SFD)", which implies a physical hardware component (the scintillating fiber) is part of the device. The intended use also describes checking for a brachytherapy seed and giving indications via audible tone or digital readout on a multimeter, further suggesting hardware interaction and components beyond just software.
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 Intended Use: The intended use of this device is to check for the presence of a brachytherapy seed and give an indication of dose rate. This is a quality assurance and dosimetry function related to a medical procedure (brachytherapy), not a diagnostic test performed on a biological sample.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples.
Therefore, the device's function falls outside the scope of in vitro diagnostics. It is a device used in the context of a medical treatment (brachytherapy) for quality assurance and relative dosimetry.
N/A
Intended Use / Indications for Use
The intended use of this device is to act as a quality assurance device to check for the presence of a brachytherapy seed and give indication of dose rate by an audible tone or digital readout on a standard multi meter. The SDF will be used for 'relative' dosimetry.
Product codes
90 KXK
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 10 2003
Mr. Donald Francis Riibe Regulatory Affairs Med Tec, Inc. P.O. Box 320 ORANGE CITY IA 51041 Re: K021360 Trade/Device Name: Scintillating Fiber Dosimeter (SFD) Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: March 10, 2003 Received: March 12, 2003
Dear Mr. Riibe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ATTACHMENT E-3.4
Page 1 of 1
510(k) Number (if known): K021360
Device Name: _ Scintillating Fiber Dosimeter (SFD)
Indications For Use:
The intended use of this device is to act as a quality assurance device to check for the presence of a brachytherapy seed and give indication of dose rate by an audible tone or digital readout on a standard multi meter. The SDF will be used for 'relative' dosimetry.
The SDF will be used for 'relative' dosimetry.
(PLEAS DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109
OR
Over-The-Counter USE
(Optional Format 1-2-96)
ductive. Abdom and Radiological De 510(k) Number