(196 days)
No
The device description and intended use focus on a radioactive implant for brachytherapy, with no mention of AI/ML in the text provided.
Yes
The device description clearly states it is a "radiotherapeutic source" and the intended use specifies it is for "primary treatment" or "for residual disease after excision of the primary tumor" for various localized tumors, indicating its therapeutic purpose.
No
The device is described as a "hermetically sealed radiotherapeutic source" used for treating tumors (e.g., primary treatment, residual disease) through interstitial implantation, not for diagnosing them.
No
The device description clearly states it is a hermetically sealed radiotherapeutic source constructed from physical materials (titanium, platinum/iridium) containing a radionuclide (Iodine-125). This is a physical medical device, not a software-only one.
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 tumors through interstitial implantation of a radioactive source. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is a sealed radioactive source designed to deliver radiation directly to tissue. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
Therefore, InterSource125 implants are a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes
KXK
Device Description
InterSource125 is a hermetically sealed radiotherapeutic source indicated for interstitial implantation. The radionuclide used in InterSource125 is lodine-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.
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, prostate, and 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
The performance of InterSource125 is based on a comparison to the predicate device, Amersham/Medi+Physics Model 6711 Therapeutic Seed Source. The substantial equivalence is based on similar characteristics for indications, physical size, radiopaque marker, biocompatibility, radioisotope, and radiation dose distribution.
A polar plot (Figure 5) compares the computed values for the radiation dose delivered by InterSource125 and the measured values for the radiation dose delivered by the predicate device as a function of angle. Both devices show similar radiation patterns.
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.
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 107 | ||||
| Norcross, 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 C | ||||
| 7180 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 Substantial | |||||
| Equivalence section below for predicate device information) | ||||||
| Special Controls: | InterSource125 will comply with the regulatory requirements for the | |||||
| Georgia Department of Natural Resources, Environmental Protection | ||||||
| Division, Radioactive Materials Division for sealed brachytherapy | ||||||
| implant sources. | ||||||
| Substantial Equivalence: | InterSource125 is substantially equivalent to the | |||||
| Amersham/Medi+Physics Model 6711 Therapeutic Seed Source | ||||||
| (Premarket Notification #K914281), a Class II post-amendment device | ||||||
| granted clearance to market on 22 Nov 1991. | ||||||
| 8.2 | The contents of this premarket notification summary will demonstrate the | |||||
| substantial equivalence of the subject device, InterSource125, to the predicate | ||||||
| device, the Amersham/Medi+Physics Model 6711 Therapeutic Seed Source. | ||||||
| The substantial equivalence will be based on the following important features of | ||||||
| the device: | ||||||
| 8.2.1 | Indications | |||||
| 8.2.2 | Physical Size | |||||
| 8.2.3 | Radiopaque Marker | |||||
| 8.2.4 | Biocompatibility | |||||
| 8.2.5 | Radioisotope |
1
| IBt
| November 24, 1998 | Page 17 of 19 | ||
|---|---|---|---|
| Title: Premarket Notification - InterSource125 | |||
| 8.3 InterSource125 Description | |||
| InterSource125 is a hermetically sealed radiotherapeutic source indicated | |||
| for interstitial implantation. The radionuclide used in InterSource125 is | |||
| lodine-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. | |||
| 8.4 Table 6 compares the indications statement drafted for InterSource125 with the | |||
| predicate device's indications statement. | |||
| Table 6: Indications Statement Comparison Summary | |||
| InterSource125 | Predicate Device | ||
| InterSource125 implants are indicated for | |||
| interstitial implantation of select localized | |||
| tumors with low to moderate radiosensitivity. | |||
| They are used either as primary treatment | I-125 Seeds are indicated for interstitial treatment of | ||
| tumors which have the following characteristics: | |||
| unresectable, localized, slow growth rate, and low to | |||
| moderate 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 surface | |
| of the isotope carrier | Deposited onto the surface | |
| of the isotope carrier | ||
| Apparent Activity | ||
| Levels | 0.1 to 5.0 mCi | 0.18 to 5.99 mCi |
| Residual Activity |