(166 days)
No
The summary describes a physical radioactive seed for brachytherapy and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "implanted as a source of nuclear radiation for therapy."
No
Explanation: The document clearly states that the 125I Brachytherapy Seeds are "intended for permanent interstitial implantation in selected localized tumors" and are used "as a source of nuclear radiation for therapy." This indicates a therapeutic, not diagnostic, purpose.
No
The device description clearly states it consists of physical components (polymeric substrate, titanium casing) and radioactive material (125I), making it a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "permanent interstitial implantation in selected localized tumors" as a "source of nuclear radiation for therapy." This describes a therapeutic device used within the body for treatment.
- Device Description: The description details a physical object (seeds) implanted into tissue.
- Lack of IVD Characteristics: An IVD is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on bodily specimens.
The device described is a therapeutic medical device used for brachytherapy, a type of radiation therapy.
N/A
Intended Use / Indications for Use
125I Brachytherapy Seeds are intended for permanent interstitial implantation in selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.
Product codes
90KXK
Device Description
The 1251 Brachytherapy Seeds consist of 1251 absorbed onto the surface of a spherical polymeric substrate sealed in a welded titanium casing. A typical Brachytherapy Seed is shown below. For higher activity levels the number of beads with absorbed 1431 may be increased from 2 to 4.
Typically, the 1351 Brachytherapy Seeds are placed within or in close to the turnor to be treated utilizing guidance. The devices are delivered using an 18 gauge or greater diameter hypodermic needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The 1351 Brachytherapy Seeds comply with the following standards, practices, and guidances:
- ISO 2919-1980(e), Sealed radioactive sources -- Classification, International Organization for Standardization, First Edition (1980)
- ISO/TR 4826-1979(E), Technical Report 4826: Sealed radioactive sources -. Leak test methods, pg 2 , International Organization for Standardization (1979)
The tissue contact materials of the 1251 Brachytherapy Seeds meet the requirements of the following recognized consensus standards.
- ASTM F 1472 -- 93, Standard Specification for Wrought Ti-6Al-4V Alloy for . Surgical Implant Applications.
- ASTM F 67 95, Standard Specification for Unalloyed Titanium for Surgical Im-. plant Applications.
The anisotropy of the 12-1 Brachytherapy Seeds and the Amersham/Medit+Physics 1-125 were compared and found to be equivalent. The 1257 Brachytherapy Seeds are substantially equivalent to the Amersham/Medi+Physics Model 6702 seeds, which are legally manufactured and distributed pursuant to 510(k) K915156. This has been demonstrated by comparison of physical characteristics, dimensional measurements, and anisotropy.
Brachytherapy is an old and well-established medical treatment. 1251 is a well-characterized radioactive source for brachytherapy treatment. The use of 1231 is has been documented by B. C. Hilaris, D. J. Holt and J. St. Germain in FDA Report 76-8022.1
Since the 1231 Brachytherapy Seeds meet the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The 1231 Brachytherapy Seeds will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Controlled 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
MAR 1 4 2000
submitted by Prostec LLC 8200 NW 27 Street Miami. Fl 33122 Phone: (305) 716-7000 Facsimile: (305) 716-7020
Identification of Device
| Classification Name: | Radionuclide brachytherapy source |
|---|---|
| Common/Usual Name: | 125I Radioactive Seeds |
| Proprietary Name: | Prostec 125I Brachytherapy Seed |
| Classification: | Class II, classification number is 90KXK |
Identification of a Legally Marketed Predicate Device
The Prostec LLC 1251 Brachytherapy Seeds are substantially equivalent to the Amersham/Medi+Physics Model 6702 seeds, which are legally manufactured and distributed pursuant to 510(k) K915156.
Device Description
The 1251 Brachytherapy Seeds consist of 1251 absorbed onto the surface of a spherical polymeric substrate sealed in a welded titanium casing. A typical Brachytherapy Seed is shown below. For higher activity levels the number of beads with absorbed 1431 may be increased from 2 to 4.
Typically, the 1351 Brachytherapy Seeds are placed within or in close to the turnor to be treated utilizing guidance. The devices are delivered using an 18 gauge or greater diameter hypodermic needle.
1
Image /page/1/Figure/2 description: The image shows a diagram of a typical 125I Brachytherapy Seed. The diagram includes labels for different parts of the seed, such as the "Plug", "Seed Half (2 Places)", "Hot Bead (125I)", and "Cold Bead". The diagram also includes measurements, such as "4.5 mm" and "0.8 mm", and labels for "Gold Alloy Radiographic Marker".
Intended Use
1251 Brachytherapy Seeds are intended for permanent interstitial implantation in selected localized turnors. The devices are implanted as a source of nuclear radiation for therapy.
Summary of Technological Characteristics
The table below compares the technological characteristics of the 1231 Brachytherapy Seeds to the predicate device.
| Feature | 125I Brachytherapy Seeds | Predicate Device |
|---|---|---|
| Manufacturer | Prostec LLC | Amersham/Medi+Physics |
| 510(k) Number | To be determined | K915156 |
| Delivered Non-sterile | Yes | Yes |
| Intended use | 125I Brachytherapy Seeds are in- | |
| tended for permanent interstitial | ||
| implantation in selected localized | ||
| tumors. The devices are implanted | ||
| as a source of nuclear radiation for | ||
| therapy. | 125I seeds are indicated for interstitial | |
| treatment of tumors which have the | ||
| following characteristics: unresectable, | ||
| localized, and moderate radiosensitiv- | ||
| ity. |
2
| Feature | 125I Brachytherapy Seeds | Predicate Device |
|---|---|---|
| Capsule | Titanium | Titanium |
| Capsule Sealing Method | Laser Weld | Weld |
| Radioisotope | 125I | 125I |
| Half-life | 59.4 days | 59.4 days |
| Principal Energy Levels | ||
| (keV | 27.4, 31.4, and 35.5 | 27.4, 31.4, and 35.5 |
| 125I Substrate | Dowex® | Dowex® |
| Radiographic Marker | Gold Alloy | None |
| Packaging | Glass vial in lead container placed | |
| in a shipping carton | Glass vial in lead container placed in a | |
| shipping carton | ||
| Length | 4.5 mm | 4.5 mm |
| Outside Diameter | 0.8 | 0.8 |
| Application Methods | Through an 18 gauge needle, needle | |
| may be attached a Mick applicator | ||
| provided that the Prostec Cartridge | ||
| is used. | Through an 18 gauge needle, needle | |
| may be attached to common applicators | ||
| such as the Mick, Henschke, or Scott | ||
| Apparent Activity Level | 0.1 to 5.0 mCi | 5.0 to 40 mCi |
| Point-source approxima- | ||
| tion anisotropy con- | ||
| stant $ϕan$ | 0.96 | 0.95 |
| Dose rate Constant | ||
| cGy/hr/U, 1999 NIST | 1.05 | 1.04 |
| Seed Strength Specifica- | ||
| tion | Apparent activity in mCi and air- | |
| kerma | Apparent activity in mCi and air-kerma | |
| Residual Activity |