(323 days)
Not Found
No
The device description and intended use are solely focused on the physical characteristics and application of radioactive sources for brachytherapy. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as "intended for use in the treatment of cancer" and "indicated for the treatment of selected localized tumors," which directly aligns with the definition of a therapeutic device.
No
The device, UroMed I-125 Sources, is described as intended for the treatment of cancer with radioactive sources. Its function is to deliver radiation to tumors to treat them, not to diagnose conditions.
No
The device description clearly states it is a physical, sealed source containing radioactive material within a titanium capsule, which is a hardware component.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The UroMed Brachytherapy Iodine-125 Sources are described as sealed radioactive sources intended for direct placement within or in close proximity to a tumor for therapeutic treatment (brachytherapy). This is a form of radiation therapy, not a diagnostic test performed on a sample outside the body.
The device's function is to deliver radiation to treat cancer, not to analyze a biological sample to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
The UroMed Brachytherapy Iodine-125 Sources are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.
The UroMed I-125 Radionuclide Brachytherapy Sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intra-abdominal, and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.
Product codes
90 KXK
Device Description
UroMed I-125 Sources are cylindrical sealed sources containing iodine-125 radioactivity. The sources are 4.5mm long and 0.8mm in diameter. The outer capsule of the source is composed of titanium, and is sealed at each end by a laser weld. The iodine-125 is deposited within a porous ceramic tube as silver iodide (AgI). A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The marker will be composed of gold alloy or iridium.
Iodine seeds have a half-life of 59.6 days and are available in a range of activity levels. The UroMed I-125 Sources are provided non-sterile and must be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tumors of the head, neck, lung, pancreas and prostate
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)
K801748, K972271, K964647, K874787
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
MAY 1 3 1999
K98 2224
510(k) Summary of Safety and Effectiveness UroMed Brachytherapy Iodine-125 Sources
Company Name
UroMed Corporation 64 A Street Needham, MA 02194
Official Contact
Nancy MacDonald 이 제공 사용자 : 2017-0 Manager, Clinical and Regulatory Affairs
Device Name
Proprietary Name: Common Name:
UroMed Brachytherapy Iodine-125 Sources Brachytherapy Iodine-125 Sources
Classification Name(s):
21 CFR 892.5730 Radionuclide Brachytherapy Source
Predicate Devices used for Substantial Equivalence
| Device | Premarket # |
|---|---|
| Amersham I-125 Seeds in Absorbable Carrier | |
| (formerly marketed by 3M Co.) | K801748 |
| North American Scientific I-125 | |
| Radionuclide Brachytherapy Sources | K972271 |
| North American Scientific I-125 | |
| Radionuclide Brachytherapy Sources | K964647 |
| Theragenics Modified Paladium Seed | K874787 |
Intended Use
The UroMed Brachytherapy Iodine-125 Sources are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.
UroMed Brachytherapy I-125 Sources - 510(k)
1
Indications for Use
The UroMed I-125 Radionuclide Brachytherapy Sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intra-abdominal, and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.
Description
UroMed I-125 Sources are cylindrical sealed sources containing iodine-125 radioactivity. The sources are 4.5mm long and 0.8mm in diameter. The outer capsule of the source is composed of titanium, and is sealed at each end by a laser weld. The iodine-125 is deposited within a porous ceramic tube as silver iodide (AgI). A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The marker will be composed of gold alloy or iridium.
Iodine seeds have a half-life of 59.6 days and are available in a range of activity levels. The UroMed I-125 Sources are provided non-sterile and must be sterilized prior to use.
Summary of Standards Achieved
FDA Quality System Regulation 21 CFR Part 820 Good Manufacturing Practice.
ISO 46001: Quality System
ISO 10993-1: 1992 (E), "Biological Evaluation of Medical Devices".
ASTM Standard for Titanium: F136-96e; Titanium alloy ASTM Grade 5 6AI-4V ELI Electro low interstitial elements.
ANSI Standards for Brachytherapy: N44.1 - 1973: "Integrity and Testing Specifications for Selected Brachytherapy Sources."
N44.2 - 1973: "Leak Testing Radioactive Brachytherapy Sources."
ISO 9978: 1992(E), "Radiation protection - Sealed radioactive sources - Leakage test Methods".
A AMI document, "Recommended Practice for Determining Residual Ethylene Oxide in Medical Devices".
UroMed Brachytherapy I-125 Sources - 510(k)
2
Summary
In summary, the UroMed I-125 Radionuclide Brachytherapy Sources are substantially equivalent to legally marketed devices. Quality System Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness.
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UroMed Brachytherapy I-125 Sources - 510(k)
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 1999
Frederick Tobia Director, Clinical And Regulatory Affairs UroMed Corporation 1400 Providence Highway, Bldg. 2 Norwood, MA 02062
RE:
K982226 UroMed Brachytherapy Seeds Dated: February 17, 1999 Received: February 18, 1999 Regulatory Class: II 21 CFR 892.5730/Procode: 90 KXK
Dear Mr. Tobia:
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 II (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 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 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,
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
4
510(k) Premarket Notification UroMed Brachytherapy Iodine-125 Sources
510(k) Number (if known): K
Device Name: UroMed I-125 Radionuclide Brachytherapy Sources
Indication for Use:
The UroMed I-125 Radionuclide Brachytherapy Sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intraabdominal, and intrathoracic turnors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.
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2017 11:51
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | |||
| (Division Sign-Off) | |||
| Division of Reproductive, Abdominal, ENT, | |||
| and Radiological Devices | |||
| 510(k) Number | K982226 |
UroMed Brachytherapy I-125 Sources - 510(k)
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