(231 days)
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Not Found
No
The summary describes radioactive seeds for brachytherapy and does not mention any AI or ML components.
Yes
The device is described as delivering radiation for brachytherapy in the treatment of cancer, which directly indicates a therapeutic purpose.
No
Explanation: The device, BT-103-3 seeds, is described as delivering radiation for brachytherapy in the treatment of cancer, indicating it is a therapeutic device, not a diagnostic one.
No
The device description clearly states "PharmaSeed BT-103-3 Brachytherapy Seeds," indicating a physical, hardware-based medical device used for radiation delivery.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the BT-103-3 seeds are used to "deliver radiation for brachytherapy in the treatment of cancer with sources in close proximity to, or within, the tumor." This involves implanting the device inside the body to directly treat the tumor.
Therefore, since the device is used in vivo (inside the body) for therapeutic purposes, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of Syncor Pharmaceuticals' BT-103-3 seeds is to deliver radiation for brachytherapy in the treatment of cancer with sources in close proximity to, or within, the tumor.
These seeds are indicated for permanent interstitial treatment of tumors which are localized and unresectable, and which have a slow growth rate and low to moderate radiosensitivity. Superficial, intrathoracic, and intraabdominal tumors, such as those in the head, neck, lungs, pancreas and prostate are commonly treated in this manner. The seeds may also be implanted in recurrent tumors or in residual tumors following completion of a course of external radiation therapy.
Total activity of BT-103-3 seeds required for treatment is dependent upon the tumor volume and the radiation history of the site. To calculate the total activity needed, determine the placement of the sources in the tissue, and evaluate the dose distribution achieved, established practice should be followed.
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
head, neck, lungs, pancreas and 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 (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)
Not Found
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2000
Gary Gilmore President and General Manager Syncor® Pharmaceuticals, Inc. 1313 Washington Avenue Golden, CO 80401
Re:
K994016 Pharmaseed Model BT-103-3 Dated: April 24, 2000 Received: April 25, 2000 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK
Dear Mr. Gilmore:
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 Amerionents, or to devices that have been reclassified in accordance with 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 equivalion 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 requlation 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 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 yifro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions 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 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/odrh/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
1
510(k) Number (if known):
Device Name:
PharmaSeed BT-103-3 Brachytherapy Seeds
Indications for Use:
The intended use of Syncor Pharmaceuticals' BT-103-3 seeds is to deliver radiation for brachytherapy in the treatment of cancer with sources in close proximity to, or within, the tumor.
These seeds are indicated for permanent interstitial treatment of tumors which are localized and unresectable, and which have a slow growth rate and low to moderate radiosensitivity. Superficial, intrathoracic, and intraabdominal tumors, such as those in the head, neck, lungs, pancreas and prostate are commonly treated in this manner. The seeds may also be implanted in recurrent tumors or in residual tumors following completion of a course of external radiation therapy.
Total activity of BT-103-3 seeds required for treatment is dependent upon the tumor volume and the radiation history of the site. To calculate the total activity needed, determine the placement of the sources in the tissue, and evaluate the dose distribution achieved, established practice should be followed.
(PLEASE 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)
David C. Syson
(Division Sign-Off)
Division of Reproductive, Abdominal, E. and Radiological Devi
510(k) Number
OR
Over-The-Counter Use
(Optional Format 1-2-96)
2-1