(163 days)
Not Found
No
The device description focuses on the physical characteristics and radioactive properties of the brachytherapy seeds, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is used for the treatment of cancer with radioactive sources within or near the tumor, which qualifies it as a therapeutic device.
No
The device is described as a treatment for cancer, specifically "radioactive source in close proximity to or within the tumor" and "treatment of selected localized tumors," indicating a therapeutic rather than diagnostic function.
No
The device description clearly describes a physical, radioactive seed (hardware) used for brachytherapy, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of cancer by placing radioactive sources directly within or near the tumor. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a sealed radioactive source designed to deliver radiation for therapeutic purposes. It does not involve the examination of specimens derived from the human body for diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to perform tests on samples taken from the human body (like blood, urine, tissue) to diagnose, monitor, or screen for diseases or conditions. This device is a therapeutic tool used to treat a diagnosed condition.
N/A
Intended Use / Indications for Use
The BEBIG IsoSeeds® Pd-103 are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.
The BEBIG Pd-103 Radionuclide Brachtherapy Sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intraabdominal 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 (comma separated list FDA assigned to the subject device)
90 KXK
Device Description
The BEBIG IsoSeeds® Pd-103 are cylindrical sealead sources containing Pd-103 radioactivity. The sources are 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium being closed at one end and sealed by a laser weld at the other end in a final step. The metallic palladium-103 is deposited within a porous ceramic tube. A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The radiopaque marker is composed of gold wire.
Palladium seeds have a half live of 16,97 days and are available in a range of activity levels. The BEBIG IsoSeeds® Pd-103 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): 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.
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.
Not Found
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).
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
HAR 3 1 2006
510(k) Summary of Safety and Effectiveness
BEBIG IsoSeeds® Pd-103
Company Name
BEBIG Isotopentechnik und Umweltdiagnostik GmbH Robert Rössle Str. 10 13125 Berlin, Germany
Official Contact
Sven Langer Regulatory Affairs
Device Name
| Proprietary Name: | BEBIG IsoSeeds® Pd-103 |
|---|---|
| Common Name: | Brachytherapy Palladium-103 Sources |
| Classification Name: | 21 CFR 892.5730 Radionuclide Brachytherapy Source |
Predicate Devices used for Substantial Equivalence
| Device | Premarket # |
|---|---|
| UroMed Brachytherapy Iodine-103 Source | K982226 |
| Theragenics Modified Palladium Seed | K874787 |
Intended Use
The BEBIG IsoSeeds® Pd-103 are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.
Indications for use
The BEBIG Pd-103 Radionuclide Brachtherapy Sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intraabdominal 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
The BEBIG IsoSeeds® Pd-103 are cylindrical sealead sources containing Pd-103 radioactivity. The sources are 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium being closed at one end and sealed by a laser weld at the other end in a final step. The metallic palladium-103 is deposited within a porous ceramic tube. A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The radiopaque marker is composed of gold wire.
Palladium seeds have a half live of 16,97 days and are available in a range of activity levels. The BEBIG IsoSeeds® Pd-103 are provided non-sterile and must be sterilized prior to use.
1
Summary of Standards Achieved
Medizinproduktegesetz (German Law concerning medical devices)
Directive 90/385/EEC for active implants
DIN EN 1441 Medical devices- Risk analysis
DIN EN 25426 Sealed radioactive sources - Classification, requirements, test methods
ISO 2919 sealed radioactive sources - General requirements and classifications
ISO 9978: 1992(E), Radiation Protection-Sealed radioactive sources- Leakage test Methods
ANSI/HPS N43.6-1997-Sealed Radioactive Sources Classification
ASTM Standard for Titanium: F67-95 rev. 95 grade 2
DIN EN 554 Sterilization of medical devices - Validation and routine control of steam sterilization
DIN EN 980 Graphic Symbols used for labeling of medical devices
DIN EN 1041 Terminology, symbols and information associated with medical devices
DIN EN 25430 Radiation safety labeling
ISO 90001: Quality Management Systems
ISO 46001: Medical devices quality system
FDA Quality System Regulation 21 CFR Part 820 Good Manufacturing Practice.
DIN EN 6804 Radiation safety regulations for handling sealed radiation sources
DIN EN 25407 Shielding from ionizing radiation
DIN EN 25422 Storing of radioactive devices - Protection from radiation fire and theft
DIN EN 25425 Radionuclide labs - Design, radiation safety and fire protection
Summary
In Summary, the BEBIG IsoSeeds® Pd-103 are substantially equivalent to legally marketed devices. Quality System Controls assure the device is substantially equivalent to predicate devices with respect to its performance, safety, and effectiveness.
2
Certificates 10.
- TÜV Certificate for quality system according to 46001
- Certificate of ISO-Classification with protocol
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three horizontal lines curving upwards, resembling a bird in flight or a symbolic representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2000
Dear Mr. Langer:
Sven Langer Regulatory Affairs BEBIG Isotopentechnik und Unweltdiagnostik GMBH Robert-Rossle/Str.10 D-13125 Berlin-Buch, Germany
Re:
K993552 IsoSeed Pd-103 Dated: January 10, 2000 Received: January 19, 2000 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK
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 Aproval), 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 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 notfication submission does not affect any obligation you micht 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 vitro diagnostic devices), please contact the Office of Compiance 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) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
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)
4
1 of 1 510(k) Premarket Notification Indication for Use BEBIG Brachytherapy Palladium-103 Sources
510(k) Number (if known): K
Device Name: BEBIG IsoSeed® Pd-103
Indications for Use:
The BEBIG Pd-103 Radionuclide Brachtherapy Sources are indicated for the treatment of The DEDIS I a 105 rainers. These sources are commonly used to treat superficial, intrasereotico roundou tumors. There box. Tumors of the head, neck, lung, pancreas and prostate aboommal and marations may be used alone, or in combination with external beam radiation.
Elvin A. Segears
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) ivumber .
Prescription Use _ (Per 21 CFR 801.109)