(21 days)
The BEBIG I-125 sources are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.
The BEBIG brachytherapy I-125 sources are indicated for the treatment of selected localized turnors. 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.
The BEBIG I-125 sources are cylindrical sealed sources containing iodine-125 radioactivity. The sources are 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium, and is sealed at each end by 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 radiopaque marker is composed of gold alloy.
I-125 has a half live of 59.46 days and decays by electron capture with emission of characteristic photons and electrons. The titanium wall of the I-125 source absorbs the electrons.
The BEBIG I-125 sources are available in a range of activity levels. They are provided nonsterile and must be sterilized before use.
This document is a 510(k) summary for a medical device (BEBIG brachytherapy I-125 source), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The document explicitly states:
"In Summary, the BEBIG brachytherapy I-125 sources are substantially equivalent to a legally marketed device. Quality System Controls assure the device is substantially equivalent to the predicate device with respect to its performance, safety, and effectiveness."
This means the submission relies on the established safety and effectiveness of the predicate device (UroMed Brachytherapy Iodine-103 Source, K982226) and adherence to quality system regulations, rather than a new performance study to defined acceptance criteria.
To directly answer your request based only on the provided text, the following would be reported:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to the predicate device and adherence to regulatory standards.
- Reported Device Performance:
- "Technically identical" to the UroMed Brachytherapy Iodine-103 Source.
- Intended Use: Treatment of cancer with radioactive sources in close proximity to or within the tumor.
- Indications for Use: Treatment of selected localized tumors (superficial, intra-abdominal, intrathoracic, head, neck, lung, pancreas, prostate), alone or in combination with external beam radiation.
- Physical Characteristics:
- Cylindrical sealed source.
- Contains iodine-125 radioactivity.
- 4.5 mm long, 0.8 mm in diameter.
- Outer capsule: titanium, sealed by laser weld.
- Iodine-125 deposited as silver iodide (AgI) within a porous ceramic tube.
- Radiopaque marker: gold alloy in the center of the ceramic tube.
- Half-life of I-125: 59.46 days.
- Decays by electron capture with emission of characteristic photons and electrons (titanium wall absorbs electrons).
- Available in a range of activity levels.
- Provided non-sterile, must be sterilized before use.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable/Not provided. This document does not describe a performance study involving a test set of data. It describes a medical device and its intended use, asserting substantial equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable/Not provided. No ground truth establishment is described as there is no specific performance study outlined.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. No MRMC study or any comparative effectiveness study is mentioned. This document focuses on the device's technical specifications and substantial equivalence, not its clinical efficacy improvement with human-AI interaction.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
- No. This device is a physical brachytherapy source, not an algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission.
7. The Type of Ground Truth Used:
- Not applicable/Not provided. No performance study requiring a distinct "ground truth" (like pathology or outcomes data for diagnostic accuracy) is described. The "ground truth" for this submission is implicitly the established safety and efficacy of the predicate device and adherence to manufacturing standards.
8. The Sample Size for the Training Set:
- Not applicable/Not provided. This document does not describe a machine learning algorithm or any training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not provided. As there is no training set mentioned, no ground truth establishment for it is described.
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MAY 20 2002
510(k) Summary of Safety and Effectiveness
BEBIG brachytherapy I-125 source
April 24, 2002
Company Name
BEBIG Isotopen- and Medizintechnik GmbH Robert Rössle Str. 10 13125 Berlin, Germany phone: ++49 30 94 10 84-0
Official Contact
Sven Langer Regulatory Affairs
Device Name
Proprietary Name: BEBIG IsoSeeds 1-125 Common Name: Brachytherapy iodine-125 source 21 CFR 892.5730 Radionuclide Brachytherapy Source, KXK Classification Name:
Predicate Devices used for Substantial Equivalence
| Device | Premarket # |
|---|---|
| UroMed Brachytherapy Iodine-103 Source | K982226 |
Intended Use
The BEBIG I-125 sources 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 brachytherapy I-125 sources are indicated for the treatment of selected localized turnors. 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
The BEBIG I-125 sources are cylindrical sealed sources containing iodine-125 radioactivity. The sources are 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium, and is sealed at each end by 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 radiopaque marker is composed of gold alloy.
I-125 has a half live of 59.46 days and decays by electron capture with emission of characteristic photons and electrons. The titanium wall of the I-125 source absorbs the electrons.
The BEBIG I-125 sources are available in a range of activity levels. They are provided nonsterile and must be sterilized before use.
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K021345
Page 2 of 2
The manufacturer will adhere to the following regulations and standards:
FDA Quality System Regulation 21 CFR Part 820 Good Manufacturing Practices
ISO 9001 Quality Management Systems
EN 46001 / EN ISO 13485: Medical devices quality system
ASTM Standard for Titanium: F67-95
ISO 2919 sealed radioactive sources - General requirements and classifications ISO 9978: 1992(E) Radiation Protection-Sealed radioactive sources- Leakage test Methods
Comparison to predicate device
The BEBIG brachytherapy I-125 source is technically identical with the UroMed Brachytherapy Iodine-103 Source
Summary
In Summary, the BEBIG brachytherapy I-125 sources are substantially equivalent to a legally marketed device. Quality System Controls assure the device is substantially equivalent to the predicate device with respect to its performance, safety, and effectiveness.
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Public Health Service
MAY 2 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sven Langer Regulatory Affairs BEBIG Isotopen-und Medizintechnik GmbH Robert-Rössle-StraBe 10 D-13125 BERLIN GERMANY
Re: K021343
Trade/Device Name: BEBIG brachytherapy I-125 sources Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: April 24, 2002 Received: April 29, 2002
Dear Mr. Langer:
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.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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
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510(k) Premarket Notification Indication for Use BEBIG brachytherapy I-125 Sources
510(k) Number (if known): K___________________________________________________________________________________________________________________________________________________
Device Name: BEBIG brachytherapy I-125 source
Indications for Use:
The BEBIG brachtherapy I-125 sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intra-abdominal 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.
Prescription Use (Per 21 CFR 801.109)
David G. Byrom
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
1
§ 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.