(52 days)
Not Found
No
The summary describes a physical brachytherapy source and its intended use, with no mention of software, algorithms, or any terms related to AI or ML.
Yes
The device is a brachytherapy source intended to treat tumors, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a brachytherapy source used for treating tumors, not for diagnosing them. Its intended use is therapeutic, as indicated by "intended to treat localized, unresectable tumors."
No
The device description clearly states it is a physical brachytherapy source (Iodine 125 seed) made of a silver rod and titanium tube, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description and Intended Use: The description clearly states this is a brachytherapy source, an Iodine 125 seed, intended to be implanted inside the body to treat tumors. This is an in vivo (within the living organism) treatment, not an in vitro diagnostic test.
The information provided describes a therapeutic device used for radiation treatment, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The brachytherapy source is intended to treat localized, unresectable tumors with low to moderate radiosensitivity. Tumors.may be recurrent or residual, following external beam or excision of primary tumor.
Product codes
KXK
Device Description
The I-Seed Model AgX100 is an Iodine 125 brachytherapy source. A silver rod serves as the substrate for the I-125 and as a radiopaque marker and is contained within a titanium tube sealed at both ends with a laser welded dome. The seed is 4.5 mm long and 0.8 mm in diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
localized, unresectable tumors
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
Design validation and verification testing was conducted to demonstrate compliance with device performance specifications and to establish device safety. The results of the V&V testing confirmed that design inputs were achieved and the cumulative test results demonstrated the functionality, safety and effectiveness of the Model AgX100, as well as its substantial equivalence to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
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.
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HERAGENICS CORPORATION®
- 3 2010
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
Device Name:
1-Seed 1-125
AgX100
Device Model Number:
Classification Name:
Device Classification:
Predicate Devices: ·
Radionuclide Brachytherapy Source (KXK), 21 CFR 892.5730
Class II (Radiology)
Theragenics Corporation® 5203 Bristol Industrial Way
Buford, GA 30518
I-Seed I-125 Model 125.506, K021343 OncoSeed Model 6711, K914281
Manufacturer:
Establishment Registration Number:
Official Contact:
1037598
Betsy Cortelloni Corporate Director of Quality and Regulatory Affairs Theragenics Corporation 5203 Bristol Industrial Way Buford, GA 30518 Phone: 770-831-4294 Fax: 770-831-4369 cortellb@theragenics.com
Intended Use: The brachytherapy source is intended to treat localized, unresectable tumors with low to moderate radiosensitivity. Tumors.may be recurrent or residual, following external beam or excision of primary tumor.
Device Description: The I-Seed Model AgX100 is an Iodine 125 brachytherapy source. A silver rod serves as the substrate for the I-125 and as a radiopaque marker and is contained within a titanium tube sealed at both ends with a laser welded dome. The seed is 4.5 mm long and 0.8 mm in diameter.
Comparison of Technological Characteristics: The Model AgX100 is geometrically equivalent to both the Model 125.506 and the Model 6711. The seed design is equivalent to the Model 6711.
Use Type: The brachytherapy source is single patient use. The seeds may be received sterile or non-sterile for loose or magazine loaded configurations. Non-sterile orders . must be sterilized by the user facility. Custom loaded configurations are received sterile.
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THERAGENICS CORPORATION®
Sealed Source Classification: The Model AgX100 is a sealed source classified as C53211 pursuant to ISO 2919:1999E. Additionally, each source is leak-tested during manufacturing using a validated process, in accordance with internal procedures and ISO 9978:1992(E). The internal acceptance criterion for leak testing is less than 4 nCi.
Design Verification: The Model AgX100 was developed in accordance with 21 CFR 820.30 - Design Controls. Design validation and verification testing was conducted to demonstrate compliance with device performance specifications and to establish device safety.
The following standards were used in the development of the AgX100:
- . ISO 2919:1999(E), Sealed Radioactive Sources - Classification
- ISO 10993-1:2009, Biological evaluation of medical devices Part 1: . evaluation and testing
- . ISO 17665-1:2006, Sterilization of healthcare products - moist heat ~ Part 1: . Requirements for the validation and routine control of a sterilization process for medical devices
- ISO 11137-1:2006, Sterilization of healthcare products radiation Part 1: . Requirements for the validation and routine control of a sterilization process for medical devices
- . ISO 11137-2:2006, Sterilization of healthcare products – radiation – Part 2: establishing the sterilization dose
Conclusion: The results of the V&V testing confirmed that design inputs were achieved and the cumulative test results demonstrated the functionality, safety and effectiveness of the Model AgX100, as well as its substantial equivalence to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes extending from its back, 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.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Betsy Cortelloni Corporate Director of Quality and Regulatory Affairs Theragenics Corporation, Brachytherapy Division 5203 Bristol Industrial Way BUFORD GA 30518
Re: K103319
JAN - 3 2010
Trade/Device Name: I-Seed Model AgX100 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: November 10, 2010 Received: November 12, 2010
Dear Ms. Cortelloni:
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); medical device reporting (reporting of medical
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE FORM
510(K) number (if known): K103319
JAN - 3 2010
Device Name:_ _I-Seed Model AqX100
Indications for Use:
The brachytherapy source is intended to treat localized, unresectable tumors with low to moderate radiosensitivity. Tumors may be recurrent or residual, following external beam or excision of primary tumor.
Prescription Use × (Per 21 CFR 801 Subpart D) OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K163319
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