(462 days)
No
The summary describes a radioactive seed implant for brachytherapy. There is no mention of AI or ML in the intended use, device description, performance studies, or any other section. The performance studies focus on radiation dose distribution, which is a physical characteristic of the radioactive source, not an AI/ML function.
Yes
Explanation: The device is a radiotherapeutic source indicated for the treatment of various tumors, directly applying radiation to affect a therapeutic outcome.
No
Explanation: The InterSeed™ device is described as a radiotherapeutic source for interstitial implantation, used for treating tumors by emitting radiation. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states that InterSeed™ is an hermetically sealed radiotherapeutic source constructed from physical materials (titanium, platinum, Palladium 103) and intended for interstitial implantation, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- InterSeed™ Function: The description clearly states that InterSeed™ implants are "hermetically sealed radiotherapeutic source[s] indicated for interstitial implantation." They are used to deliver radiation directly to tumors within the body. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use describes treating tumors by delivering radiation, not diagnosing or monitoring a condition using a sample.
Therefore, InterSeed™ is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
InterSeed™ 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. InterSeed™ 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
InterSeed™ is an hermetically sealed radiotherapeutic source indicated for interstitial implantation. The radionuclide used in InterSeed™ is Palladium 103 (Pd-103). InterSeed™ is constructed by placing a platinum radiopaque marker and Pd-103 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 0.35 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
head, lung, neck, pancreas, prostate
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
Not Found
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 SA | Date: September 2, 1997 | Page 18 of 21 | |
|---|---|---|---|
| Title: Premarket Notification - InterSeed™ | K973328 | ||
| 7 | 510(K) SUMMARY | ||
| 7.1 | General Information | ||
| Applicant / Manufacturing Site: | IBt SA | ||
| Zone Industrielle C | |||
| 7180 Seneffe - Belgium | |||
| Tel: (+32) 64 / 520 800 | |||
| FAX: (+32) 64 / 555 397 | |||
| Contact Person: | Vincent E. Coniglione | ||
| Classification Name: | Radionuclide Brachytherapy Source | ||
| Common/Usual Name: | Palladium 103 Seed | ||
| Proprietary Name: | InterSeed™ | ||
| Establishment Registration Number: | Registration application sent to FDA September 1997 | ||
| Classification: | Class II, same as the predicate device (see the Substantial Equivalence | ||
| section below for predicate device information) | |||
| Special Controls: | InterSeed™ will comply with the regulatory requirements for the Georgia | ||
| Department of Natural Resources, Environmental Protection Division, | |||
| Radioactive Materials Division for sealed sources. | |||
| Substantial Equivalence: | InterSeed™ is substantially equivalent to Modified Palladium Seed Model | ||
| 100 (Premarket Notification #K874787), a Class II post-amendment device | |||
| granted clearance to market November 23, 1987. | |||
| 7.2 | The contents of this premarket notification summary will demonstrate the | ||
| substantial equivalence of the subject device, InterSeed™, to the | |||
| predicate device, Modified Palladium Seed Model 100. The substantial | |||
| equivalence will be based on the following important features of the | |||
| device: | |||
| 7.2.1 | Indications | ||
| 7.2.2 | Physical Size | ||
| 7.2.3 | Radiopaque Marker | ||
| 7.2.4 | Biocompatibility | ||
| 7.2.5 | Radioisotope | ||
| 7.2.6 | Radiation Dose | ||
| 7.3 | InterSeed™ Description | ||
| InterSeed™ is an hermetically sealed radiotherapeutic source indicated | |||
| for interstitial implantation. The radionuclide used in InterSeed™ is | |||
| Palladium 103 (Pd-103). InterSeed™ is constructed by placing a | |||
| platinum radiopaque marker and Pd-103 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 0.35 mm with all body tissue contacting surfaces made from |
..............................................................................................................................................................................
1
Premarket Notification - InterSeed™ Title:
- Table 8 compares the indications statement drafted for InterSeed™ with 7.4 the predicate device's indications statement.
Table 8: Indications Statement Comparison Summary
| InterSeed ™ | Predicate Device |
|---|---|
| InterSeed™ 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. InterSeed™ implants are indicated for use | |
| concurrent with or at the completion of other treatment | |
| modalities, such as external beam radiation therapy. | (Found on page 20 of K874787) Palladium |
| Seeds are indicated for tumors with the | |
| following characteristics: localized, | |
| unresectable, low to moderate | |
| radiosensitivity. The tumors may be of the | |
| following type: superficial, intrathoracic, | |
| intraabdominal, lung, pancreas, prostate | |
| (stage A or B), residual following external | |
| radiation, and recurrent. |
- 7.5 Based on the intent of the indications statement for the subject device, InterSeed™ is substantially equivalent to the predicate device with respect to its indications.
- Table 9 compares the physical size, radiopaque marker, materials of 7.6 construction, and the radioisotope for the subject device and the predicate device.
| Feature Description | InterSeed™ | Predicate Device |
|---|---|---|
| Outer Tube | Medical grade titanium | Titanium |
| Length | 4.5 mm | 4.5 mm |
| Outside Diameter | 0.81 mm | 0.81 mm |
| Radiopaque Marker | Platinum | Lead |
| Isotope Carrier | Medical grade titanium | Aluminum cylinders |
| End Cup | Not Applicable | Titanium |
| Inner Tube | Medical grade titanium | Not Applicable |
| Seal Method | Laser Weld | Laser weld |
| Radioisotope | Palladium 103 | Palladium 103 |
| Half-life | 17 days | 17 days |
| Principal Energy | 20.1 keV, 20.2 keV | 20.1 keV, 20.2 keV |
| Levels | 22.7 keV, 23.2 keV | 22.7 keV, 23.2 keV |
| Distribution of Isotope | Deposited onto the surface | Distributed throughout the |
| Binder | of the isotope carrier | isotope carrier |
| Apparent Activity | 0.5 to 5.0 mCi | 0.5 to 5.0 mCi |
| Levels | ||
| Residual Activity |