(123 days)
MBI I-125 Brachytherapy Seeds with apparent activities between 3.7 MBq (0.1 mCi) to 37 MBq (1.0 mCi) are indicated for permanent interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, slow growing, and exhibit low to moderate radiosensitivity. Intra abdominal, intrathoracic and superficial tumors may be treated with seeds containing apparent activities within this range. Tumors commonly treated are prostate (early stage), pancreas, head, neck, and lung.
MBI I-125 Brachytherapy Seeds containing apparent activities greater than 37 MBq (1.0 mCi) are indicated for temporary interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, and exhibit moderate radiosensitivity. Temporary implants are indicated in breast, brain and eye tumors.
MBI I-125 Brachytherapy Seeds are indicated for treatment of residual tumors and recurrent tumors following external radiation therapy, hyperthermia, or chemotherapy or concurrent with these treatment modalities.
Each MBI I-125 Brachytherapy Seed external dimensions of 4.55 mm ± 0.35 mm in length and 0.865 mm ± 0.095 mm in diameter. The cylindrical metal casing is titanium having a wall thickness of 0.06 mm ± 0.02 mm laser welded at both ends. Both models: 125SL and 125SH have three to five silver spheres which are used to absorbed iodine-125 and provide X-ray contrast.
The provided text describes the K984446 Premarket Notification 510(k) Summary for the MBI I-125 Brachytherapy Seed. This document is a 510(k) summary, not a detailed study report. Therefore, it focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical or standalone performance studies with specific statistical acceptance criteria and results.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) summary demonstrating substantial equivalence, formal acceptance criteria in a statistical sense (e.g., minimum sensitivity/specificity) are not explicitly stated for device performance in the same way they would be for a novel device. Instead, the acceptance criterion implicitly is "substantial equivalence" to the predicate device, Model 6711 by Amersham/Medi-Physics, Inc. (K914281), based on technological characteristics and non-clinical data.
The "reported device performance" is a comparison of key physical and radiation characteristics.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (MBI I-125 Brachytherapy Seed) |
|---|---|
| Technological Characteristics: encapsulation material and sealing method to be similar. | Met: Both MBI I-125 (Models 125SL and 125SH) and Predicate Model 6711 encapsulate with titanium and seal by welding the ends closed. |
| Photon Emission Spectra: comparable spectral photon peaks. | Met: The emission spectra consisted of five energy peaks at 22.1, 25.5, 27.4, 31.4, 35.5 keV. This is stated to be consistent with the predicate device. |
| Total Radiation Fluence Distribution: comparable spatial radiation distribution. | Met: Total radiation fluence distribution is stated to be similar between MBI I-125 (Models 125SL and 125SH) and the predicate Model 6711, when compared to published data for Model 6711 (Ling, C.C., Yorke, E.D., Spiro, I.J., Kubiatowicz, D., Bennett, D .: Physical dosimetry of 1251 seeds of a new design for interstitial implant. Int. J. Radiation Oncology Biol. Phys., 9:1747-52, 1983). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Five I-125 seeds were analyzed for the total radiation fluence distribution. The emission spectra analysis was also performed on an unspecified, but likely small, number of seeds.
- Data Provenance: The data appears to be from non-clinical laboratory testing conducted by Mills Biopharmaceuticals, Inc. The country of origin for the testing facility/data is implied to be the United States (Oklahoma City, Oklahoma, where the company is located). The testing is prospective for the purpose of this submission, meaning it was conducted to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a non-clinical device, and the "ground truth" for the test set was established through physical measurements using scientific instruments (e.g., intrinsic Ge detector), not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no human adjudication for establishing "ground truth" from the device's physical and radioactive properties. The measurements are objective scientific data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes a physical brachytherapy seed, not an AI or imaging device involving human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The "performance" described is the physical and radiation characteristics of the brachytherapy seed itself. The device functions as intended by its physical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical evaluation was established by objective physical measurements using scientific instrumentation (e.g., intrinsic Ge detector) and comparison to published scientific literature for the predicate device. For example, the total radiation fluence distribution data was compared to published data (Ling, C.C., et al., 1983) for the predicate Model 6711.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Premarket Notification 510(k) Summary
Mills Biopharmaceuticals, Inc. 120 N.E. 26th Street Oklahoma City, Oklahoma 73105 Phone 405-525-3141 Fax 405-525-3143 Contact Person: Stanley L. Mills, Ph.D. Date of Summary Preparation: 10 December 1998
| Device Classification | |
|---|---|
| Name: | SOURCE, BRACHYTHERAPY, RADIONUCLIDE |
| Trade Name: | MBI I-125 Brachytherapy Seed |
| Common Name: | I-125 Brachytherapy Seed |
| Equivalence: | Model 6711 by Amersham/Medi-Physics, Inc.(K914281) |
| Description: | Each MBI I-125 Brachytherapy Seed external dimensions of 4.55 mm ± 0.35 mm in length and 0.865 mm ± 0.095 mm in diameter. The cylindrical metal casing is titanium having a wall thickness of 0.06 mm ± 0.02 mm laser welded at both ends. Both models: 125SL and 125SH have three to five silver spheres which are used to absorbed iodine-125 and provide X-ray contrast. |
| Intended use: | MBI I-125 Brachytherapy Seeds with apparent activities between 3.7 MBq (0.1 mCi) to 37 MBq (1.0 mCi) are indicated for permanent interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, slow growing, and exhibit low to moderate radiosensitivity. Intra abdominal, intrathoracic and superficial tumors may be treated with seeds containing apparent activities within this range. Tumors commonly treated are prostate (early stage), pancreas, head, neck, and lung. MBI I-125 Brachytherapy Seeds containing apparent activities greater than 37 MBq (1.0 mCi) are indicated for temporary interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, and exhibit moderate radiosensitivity. Temporary implants are indicated in breast, brain and eye tumors. MBI I-125 Brachytherapy Seeds are indicated for treatment of residual tumors and recurrent tumors following external radiation therapy, hyperthermia, or chemotherapy or concurrent use with these treatment modalities. |
| TechnologicalCharacteristics: | Model 6711, Model 125SL, and 125SH all encapsulate with titanium and seal by welding the ends closed. Model 6711, I-125 Seeds differ from our design in the composition of the interior absorbing material. Model 6711, I-125 Seeds the I-125 is adsorbs onto a single silver rod which also provides for radiographic visualization. In the Model 125SL and 125SH the I-125 is adsorbed onto silver spheres which also provide radiographic visualization. |
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NonClinical Data:
Photon emission spectra was determined using an intrinsic Ge detector. The spectrum was obtained transverse to the seed axis and consisted of three photon peaks of energy 27.4. 31.4. and 35.5 keV. In addition, two additional peaks at 22.1 and 25.5 keV were identified as fluorescent xrays from the silver spheres.
Total radiation fluence distribution data as determined by an intrinsic Ge detector analyzed with a multichannel analyzer. The I-125 seeds were mounted on a thin plastic rod capable of being precisely rotated about 360° in 5° increments. The mounting rod was designed to be adjusted to place the seed in the center of the detector and at a distance of one meter. Five I-125 seeds were analyzed along both the short and long axis. The data was averaged and plotted in the polar coordinate system where the radial distance represents the relative magnitude of photon fluence in various directions with respect to the seed axis.
Conclusion:
The photon emisson spectra and total radiation fluence distribution data is consistant between Amersham/Medi-Physics, Inc. Model 6711 and Mills Biopharmaceuticals, Inc. Model 125SL. The emission spectra consisted of five energy peaks at 22.1, 25.5, 27.4, 31.4, 35.5 keV. Total radiation fluence distribution is similar between the two different models when compared to published data for the Model 6711 (Ling, C.C., Yorke, E.D., Spiro, I.J., Kubiatowicz, D., Bennett, D .: Physical dosimetry of 1251 seeds of a new design for interstitial implant. Int. J. Radiation Oncology Biol. Phys., 9:1747-52, 1983).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 16 1999
Stanley L. Mills. Ph.D. Mills Biopharmaceuticals Incorporated 120 N.E. 26th Street Oklahoma City, OK 73105
Re:
K984446 MBI I-125 Brachytherapy Seed Models 125SL and 125SH Dated: March 26, 1998 Received: March 29, 1998 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK
Dear Dr. Mills:
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). 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 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 requlatory 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
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510(k) Number (if known):
Device Name: MBI I-125 Brachytherapy Seed
INDICATIONS FOR USE:
MBI I-125 Brachytherapy Seeds with apparent activities between 3.7 MBq (0.1 mCi) to 37 MBq (1.0 mCi) are indicated for permanent interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, slow growing, and exhibit low to moderate radiosensitivity. Intra abdominal, intrathoracic and superficial tumors may be treated with seeds containing apparent activities within this range. Tumors commonly treated are prostate (early stage), pancreas, head, neck, and lung.
MBI I-125 Brachytherapy Seeds containing apparent activities greater than 37 MBq (1.0 mCi) are indicated for temporary interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, and exhibit moderate radiosensitivity. Temporary implants are indicated in breast, brain and eye tumors.
MBI I-125 Brachytherapy Seeds are indicated for treatment of residual tumors and recurrent tumors following external radiation therapy, hyperthermia, or chemotherapy or concurrent with these treatment modalities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | (Per 21 CFR 801.109) |
|---|---|
| Over-The-Counter Use |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K984446 |
|---|---|
| --------------- | -------------------------------------------------------- |
Page -13-
§ 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.