(196 days)
InterSource125 implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. InterSource125 implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy.
InterSource125 is a hermetically sealed radiotherapeutic source indicated for interstitial implantation. The radionuclide used in InterSource125 is Iodine-125 (I-125). InterSource125 is constructed by placing a platinum / iridium radiopaque marker and I-125 on the surface of a medical grade titanium inner tube. The device is sealed by sliding an outer tube, also medical grade titanium, over the inner tube and laser welding both ends. The resulting device has a hollow center with an inner diameter of 0.37 mm with all body tissue contacting surfaces made from medical grade titanium.
The InterSource125 device, an Iodine-125 seed for brachytherapy, demonstrated substantial equivalence to its predicate device, the Amersham/Medi+Physics Model 6711 Therapeutic Seed Source, rather than a direct performance study against acceptance criteria from a standalone test. The assessment of substantial equivalence was based on a comparison of key characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission, direct "acceptance criteria" as would be seen in a performance study with defined thresholds for metrics like sensitivity or specificity are not present. Instead, the "acceptance criteria" are implied by the similarity to the predicate device's characteristics. The "reported device performance" is the InterSource125's characteristics and its computed radiation distribution compared to the predicate's known characteristics and measured radiation distribution.
| Feature Description | Acceptance Criteria (Predicate Device) | Reported Device Performance (InterSource125) | Basis of Equivalence |
|---|---|---|---|
| Indications for Use | For interstitial treatment of tumors with specific characteristics (unresectable, localized, slow growth rate, low to moderate radiosensitivity). | Interstitial implantation of select localized tumors with low to moderate radiosensitivity. Used as primary treatment or for residual disease after excision. Used concurrently or after other modalities like external beam radiation therapy. | Indication statements were compared and found to be substantially equivalent in intent. |
| Physical Size | Length: 4.5 mm, Outside Diameter: 0.8 mm (Outer Tube) | Length: 4.5 mm, Outside Diameter: 0.8 mm (Outer Tube) | Identical dimensions. |
| Radiopaque Marker | Silver | Platinum / Iridium | Both devices incorporate a radiopaque marker. The material difference was assessed as not affecting equivalence. |
| Biocompatibility | Titanium (Outer Tube), Silver (Isotope Carrier) | Medical grade titanium (Outer Tube, Inner Tube, Isotope Carrier) | Both use known biocompatible materials. Titanium is specified for all body-tissue contacting surfaces in InterSource125. |
| Radioisotope | Iodine-125 | Iodine-125 | Identical radioisotope. |
| Half-life | 59.4 days | 59.4 days | Identical. |
| Principal Energy Levels | 27.2 keV, 27.5 keV, 31.0 keV, 35.5 keV | 27.2 keV, 27.5 keV, 31.0 keV, 35.5 keV | Identical. |
| Distribution of Isotope | Deposited onto the surface of the isotope carrier | Deposited onto the surface of the isotope carrier | Identical method. |
| Apparent Activity Levels | 0.18 to 5.99 mCi | 0.1 to 5.0 mCi | Comparable range, with InterSource125's range falling largely within or closely to the predicate's. |
| Residual Activity | < 1.3 µCi at 2 years | < 1.1 µCi at 2 years | InterSource125's residual activity is slightly lower, indicating comparable or better performance. |
| Radiation Dose | Measured values from published data | Computed values (Figure 5) | Figure 5 demonstrates a similar distribution of radiation dose between the InterSource125 (computed) and the predicate device (measured). |
2. Sample Size Used for the Test Set and the Data Provenance
This submission is a comparison to a predicate device for substantial equivalence, not a standalone clinical performance study with a distinct "test set" of patients or cases. The "test set" in this context refers to the characteristics and properties of the InterSource125 device itself, which were compared against the known characteristics of the predicate device.
- Sample Size: Not applicable in the traditional sense of patient data. The "sample" is the InterSource125 device's design, materials, and its computed radiation characteristics.
- Data Provenance: The data for the InterSource125 is based on its design specifications, material compositions, and computational modeling (for radiation dose). The predicate device's data is based on its known characteristics as a legally marketed device and previously published measured values for radiation dose. The submission originated from the USA (IBt, Inc.) and Belgium (IBt SA) in 1998/1999.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth for device characteristics (like physical dimensions, materials, and radioisotope properties) is established through technical specifications, manufacturing processes, and validated measurement methods, not typically by expert consensus in this context. For the radiation dose comparison, the "ground truth" for the predicate device was based on previously published measured values, implying a scientific consensus or accepted measurement methodology, rather than specific expert adjudication for this submission.
4. Adjudication Method for the Test Set
Not applicable. This was a comparative analysis based on objective device specifications and published data for the predicate, not a subjective assessment requiring adjudication.
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 is a submission for a brachytherapy seed, a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable to a physical medical device like a brachytherapy seed. Performance is inherent to the device's physical and radioactive properties. The "device performance" relies on the accurate emission of radiation and reliable physical integrity, not an algorithm. The computation of radiation dose can be considered a "standalone" assessment of a device characteristic.
7. The Type of Ground Truth Used
The "ground truth" for the InterSource125 device and its comparison to the predicate device relied on:
- Device Specifications: Engineering drawings, material lists, and manufacturing process descriptions for both devices.
- Published Data/Measurements: For the predicate device's radiation dose distribution.
- Radioisotope Properties: Established physics data for Iodine-125 (e.g., half-life, principal energy levels).
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set."
{0}------------------------------------------------
| IBt | November 24, 1998 | Page 16 of 19 | ||||
|---|---|---|---|---|---|---|
| Title: | Premarket Notification -- InterSource125 | |||||
| K984235 | ||||||
| 8 | 510(K) SUMMARY | |||||
| 8.1 | General Information | |||||
| Applicant: | IBt, Inc. | 6000 Live Oak Parkway, Suite 107Norcross, GA 30093 | ||||
| Tel: | (770) 582 0662 | |||||
| Fax: | (770) 582 0657 | |||||
| Contact Person IBt, Inc.: | Ruth Feicht | |||||
| Establishment Registration Number: | 9035105 (IBt, Inc.) | |||||
| Manufacturing Site: | IBt SA | Zone Industrielle C7180 Seneffe - Belgium | ||||
| Tel: | (+32) 64 / 520 811 | |||||
| Fax: | (+32) 64 / 520 801 | |||||
| Contact Person IBt SA: | Vincent Coniglione | |||||
| Establishment Registration Number: | 9031509 (IBt SA) | |||||
| Classification Name: | Radionuclide Brachytherapy Source | |||||
| Common/Usual Name: | Iodine-125 Seed | |||||
| Proprietary Name: | InterSource125 (InterSource125 is a Trademark of IBt SA.) | |||||
| Model Number: | 1251L | |||||
| Establishment Registration Number: | 9035105 (IBt, Inc.) | |||||
| Classification: | Class II, same as the predicate device (see the SubstantialEquivalence section below for predicate device information) | |||||
| Special Controls: | InterSource125 will comply with the regulatory requirements for theGeorgia Department of Natural Resources, Environmental ProtectionDivision, Radioactive Materials Division for sealed brachytherapyimplant sources. | |||||
| Substantial Equivalence: | InterSource125 is substantially equivalent to theAmersham/Medi+Physics Model 6711 Therapeutic Seed Source(Premarket Notification #K914281), a Class II post-amendment devicegranted clearance to market on 22 Nov 1991. | |||||
| 8.2 | The contents of this premarket notification summary will demonstrate thesubstantial equivalence of the subject device, InterSource125, to the predicatedevice, the Amersham/Medi+Physics Model 6711 Therapeutic Seed Source.The substantial equivalence will be based on the following important features ofthe device: | |||||
| 8.2.1 | Indications | |||||
| 8.2.2 | Physical Size | |||||
| 8.2.3 | Radiopaque Marker | |||||
| 8.2.4 | Biocompatibility | |||||
| 8.2.5 | Radioisotope |
{1}------------------------------------------------
| IBtNovember 24, 1998 | Page 17 of 19 | ||
|---|---|---|---|
| Title: Premarket Notification - InterSource125 | |||
| 8.3 InterSource125 Description | |||
| InterSource125 is a hermetically sealed radiotherapeutic source indicatedfor interstitial implantation. The radionuclide used in InterSource125 islodine-125 (I-125). InterSource125 is constructed by placing a platinum /iridium radiopaque marker and I-125 on the surface of a medical gradetitanium inner tube. The device is sealed by sliding an outer tube, alsomedical grade titanium, over the inner tube and laser welding both ends.The resulting device has a hollow center with an inner diameter of 0.37mm with all body tissue contacting surfaces made from medical gradetitanium. | |||
| 8.4 Table 6 compares the indications statement drafted for InterSource125 with thepredicate device's indications statement. | |||
| Table 6: Indications Statement Comparison Summary | |||
| InterSource125 | Predicate Device | ||
| InterSource125 implants are indicated forinterstitial implantation of select localizedtumors with low to moderate radiosensitivity.They are used either as primary treatment | I-125 Seeds are indicated for interstitial treatment oftumors which have the following characteristics:unresectable, localized, slow growth rate, and low tomoderate radiosensitivity. I-125 Seeds may be used to | ||
| for tumors such as those of the head, lung | treat superficial, intraabdominal or intrathoracic |
InterSource125 is substantially equivalent to the predicate device with respect to its indications. 8.6 Table 7 compares the physical size, radiopaque marker, materials of construction, and the radioisotope for the subject device and the predicate
Based on the intent of the indications statement for the subject device,
neck, pancreas, prostate, and unresectable
tumors, or for residual disease after excision
implants are indicated for use concurrent
with or at the completion of other treatment
modalities, such as external beam radiation
of the primary tumor. InterSource125
therapy.
device.
8.5
| Feature Description | InterSource125 | Predicate Device |
|---|---|---|
| Outer Tube | Medical grade titanium | Titanium |
| Length | 4.5 mm | 4.5 mm |
| Outside Diameter | 0.8 mm | 0.8 mm |
| Radiopaque Marker | Platinum / Iridium | Silver |
| Isotope Carrier | Medical grade titanium | Silver |
| Inner Tube | Medical grade titanium | Not Applicable |
| Seal Method | Laser Weld | Plasma Arc Weld |
| Radioisotope | Iodine-125 | Iodine-125 |
tumors. Tumors of the head, neck, lung, pancreas,
125 Seeds are indicated to treat residual tumors
therapy. In addition, recurrent tumors may be
implanted with I-125 Seeds.
and prostate (early stages) are commonly treated. I-
following completion of a course of external radiation
{2}------------------------------------------------
IBt
November 24, 1998
Premarket Notification - InterSource125 Title:
| Half-life | 59.4 days | 59.4 days |
|---|---|---|
| Principal Energy | 27.2 keV, 27.5 keV | 27.2 keV, 27.5 keV |
| Levels | 31.0 keV, 35.5 keV | 31.0 keV, 35.5 keV |
| Distribution of Isotope | Deposited onto the surfaceof the isotope carrier | Deposited onto the surfaceof the isotope carrier |
| Apparent ActivityLevels | 0.1 to 5.0 mCi | 0.18 to 5.99 mCi |
| Residual Activity | < 1.1 µCi at 2 years | < 1.3 µCi at 2 years |
8.7 Based on the outside dimensions of the subject device being the same as the predicate device, both devices having a radiopaque marker, the body tissue contacting materials being made of a known biocompatible material, titanium, and both devices using lodine-125 as the radionuclide, the subject device, InterSource125 is substantially equivalent to the predicate device with respect to the physical size, presence of a radiopaque marker, biocompatibility, and radioisotope used.
- The radiation dose of InterSource125 and the therapeutic effect of the ionizing 8.8 radiation emitted are characteristics of the radionuclide used, lodine-125, and the shape and placement of the internal components. Figure 5 shows the computed values for the radiation dose delivered by InterSource125 and the measured values for the radiation dose delivered by the predicate device (as previously published) as a function of angle.
Image /page/2/Figure/7 description: The image is a polar plot comparing two different devices, "InterSource125" and "Predicate Device". The plot shows the radiation pattern of each device, with the angle in degrees around the circle and the magnitude of the radiation along the radial axis. The "InterSource125" is represented by a solid line, while the "Predicate Device" is represented by a dashed line. The plot also includes labels for the angles in degrees, ranging from 0 to 360, and a label indicating the location of the "Seed".
Figure 5: InterSource125 Distribution of Radiation Dose
{3}------------------------------------------------
| IBt | November 24, 1998 | Page 19 of 19 |
|---|---|---|
| Title: | Premarket Notification – InterSource125 | |
| 8.9 | Based on InterSource125 and the predicate device having a similar distribution ofradiation dose and using the same radioisotope, InterSource125 is substantiallyequivalent to the predicate device with respect to radiation dose. | |
| 8.10 | Substantial Equivalence Summary | |
| 8.10.1 | Based on the similar characteristics for indications, physical size,radiopaque marker, biocompatibility, radioisotope, and radiation dosebetween the subject device, InterSource125, and the predicate device,InterSource125 is substantially equivalent to the predicate device. |
:
:
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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is likely part of a document header or title. The words are all capitalized, and the ampersand symbol (&) is used to connect "HEALTH" and "HUMAN".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
d 1999 JUN
Ruth Feicht President International Brachytherapy, Inc. 6000 Live Oak Parkway, Suite 107 Norcross, GA 30093
Re:
K984235 InterSource125 Radionuclide Brachytherapy Source Dated: March 10, 1999 Received: March 12, 1999 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK
Dear Ms. Feicht:
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 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
{5}------------------------------------------------
510(k) Number (if Known): K984235
Device Name:____InterSource125
Indications For Use:
InterSource125 implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease InterSource125 implants are after excision of the primary tumor. indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Colui k Pollard
Abdominal, ENT
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
§ 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.