(288 days)
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Not Found
No
The summary describes radioactive seeds for brachytherapy and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is used for the treatment of localized tumors, which is a therapeutic application.
No
Explanation: The device, "125 Implant Seeds," is indicated for permanent interstitial treatment of localized tumors, not for diagnosing them. It is a therapeutic device used for brachytherapy.
No
The 510(k) summary describes "125 Implant Seeds," which are physical objects used for brachytherapy. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as "Implant Seeds" for the "permanent interstitial treatment of selected localized tumors". This is a therapeutic use, not a diagnostic one.
- Lack of Diagnostic Information: There is no mention of the device being used to analyze samples (like blood, tissue, or urine) or to provide information about a patient's health status or disease state based on such analysis.
- Therapeutic Action: The description clearly indicates the device is implanted to treat tumors, which is a therapeutic action.
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 to deliver radiation therapy directly to a tumor, which is a treatment, not a diagnostic process.
N/A
Intended Use / Indications for Use
I-125 Implant Seeds are indicated for permanent interstitial treatment of selected localized tumors such as head and neck, lung, pancreas and early stage prostate. I-125 Implant Seeds may be used in superficial, intraabdominal or intra-thoracic locations. I-125 Implant Seeds may also be used in the treatment of residual tumors following completion of external beam radiation therapy and for other recurrent tumors.
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 and neck, lung, pancreas, prostate, superficial, intraabdominal, intra-thoracic
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): 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.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized emblem, which appears to be an abstract representation of an eagle or a similar bird, with its wings spread. The emblem is composed of several curved lines that create the impression of feathers and movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2000
David T. Sieracki Quality Assurance Manager SourceTech Medical, L.L.C. 295 E. Lies Road Carol Stream, IL 60188
Re:
K991881 I-125 Implant Seeds, STM 1250 Dated: December 22, 1999 Received: December 27, 1999 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK
Dear Mr. Sieracki:
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 pror 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 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 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 requlator. 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 yitr diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for question 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/cdrh/dsma/dsmamain.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
SECTION D: STATEMENT OF INDICATIONS FOR USE
Applicant:
510(k) Number:
Device Name:
SourceTech Medical, L.L.C.
K991881
125 Implant Seeds
Indications for use:
125 Implant Seeds are indicated for permanent interstitial treatment of selected localized tumors such as head and neck, lung, pancreas and early stage prostate. 125 mplant Seeds may be used in superficial, intraabdominal or intra-thoracic locations. 125 Implant Seeds may also be used in the treatment of residual tumors following completion of external beam radiation therapy and for other recurrent tumors.
Prescription Use
(Per 21 CFR 801.109)
David A. Symm
Division Sign-Off Division of Reproductive. Ahdominal. F and Radiological 510(k) Number