(204 days)
Not Found
No
The summary describes a physical brachytherapy source and its radioactive properties and testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for treating selected localized tumors and emits radiation for therapeutic purposes, which aligns with the definition of a therapeutic device.
No
This device is a brachytherapy source, which is used for treating localized tumors by delivering radiation, not for diagnosing them. Its intended use is treatment, not diagnosis.
No
The device description clearly states it is a physical brachytherapy source consisting of a titanium capsule containing radioactive material, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The ANT Model 1 Brachytherapy Source is a radioactive implant used directly within the body to treat tumors. It emits radiation to destroy cancer cells.
- Lack of Specimen Analysis: The device does not analyze any biological specimens (blood, tissue, etc.) outside of the body. Its function is therapeutic, not diagnostic.
The description clearly indicates it's a therapeutic device used for treating localized tumors through radiation.
N/A
Intended Use / Indications for Use
Advanced Nuclide Technologies LLC (ANT) Model 1 Brachytherapy Sources, with individual activities up to 5 mCi (185 MBq), are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors such as for lung cancer. ANT Model 1 Brachytherapy Source may be used concurrently with or following treatment with other interventions, such as external beam therapy, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.
Product codes (comma separated list FDA assigned to the subject device)
KXK
Device Description
ANT Model 1 is a singly-encapsulated Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive material. There are two versions of the ANT Model 1. The ANT Model 1 Type-Y contains a solid 169Ytterbium pellet. The ANT Model 1 Type-I contains a solid nonradioactive Ytterbium pellet onto which is plated radioactive 125Iodine. In both cases, the capsule which contains the pellet consists of a deep-drawn titanium can which is closed on the end with a titanium plug which is laser-welded to the can.
The ANT Model 1 Brachytherapy Source emits gamma rays and characteristic x-rays from the decay of the respective radionuclides.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head, neck, lung, pancreas, prostate, breast and other accessible tumors
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room
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)
Physical Testing:
The ANT Model 1 source has been subjected to the tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO) Standard 2919, as referenced in the FDA "Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources" dated 2 August 2000.
Prototype sources were subjected to the tests specified in ANSI N43.6-2007 and ISO 2919-2012 and have equaled or exceeded the requirements corresponding to a classification of C53211, which is the requirement for brachytherapy sources. This is equivalent to the physical testing of the predicate devices.
Dosimetry:
The dose distribution around the ANT Model 1 source was calculated by Monte Carlo simulation in accordance with the recommendations of the American Association of Physicists in Medicine and the European Society for Therapeutic Radiation Oncology. This is equivalent to the dosimetry of the predicate devices.
Clinical Tests:
Not Applicable
Conclusions:
The results of the nonclinical physical tests and the dosimetric analysis, demonstrate that the ANT Model 1 Brachytherapy Source is as safe, as effective, and performs as well or better than the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized emblem featuring a symbol that resembles a bird or a stylized human figure, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2014
Advanced Nuclide Technologies, LLC % Sergey Baklanov, Ph.D. President 21756 Green Stable Sgare. #309 ASHBURN VA 20147
Re: K141038 Trade/Device Name: ANT Model 1 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: November 3, 2014 Received: November 6, 2014
Dear Dr. Baklanov:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141038
Device Name
Advanced Nuclide Technologies LLC (ANT) Model 1 Brachytherapy Source
Indications for Use (Describe)
Advanced Nuclide Technologies LLC (ANT) Model 1 Brachytherapy Sources, with individual activities up to 5 mCi (185 MBq), are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors such as for lung cancer. ANT Model 1 Brachytherapy Source may be used concurrently with or following treatment with other interventions, such as external beam therapy, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
P 510(k) Summary
Section 807.92(a)
| (1) | Submitter | Advanced Nuclide Technologies, LLC
21756, Green Stable Sq., #309
Ashburn, VA 20147 | | t: | 267.253.2271 |
|-----|-----------|------------------------------------------------------------------------------------------|------------------------------------------------------------------|----|-------------------|
| | | Establishment Registration No.: | | | To Be Applied For |
| | | Contact Person: | Sergey Baklanov, Ph. D., President
e-mail: Sergey_RMC@msn.com | | |
| | | Date Prepared: | 18 June 2014 | | |
- Device Name: (2)
| Classification Name: | Radionuclide Brachytherapy Source (892.5730) (90 KXK) |
|---|---|
| ---------------------- | ------------------------------------------------------- |
| Common or Usual Name: | Brachythe |
|---|---|
| ----------------------- | ----------- |
Proprietary Name: ANT Model 1
- (3) Legally Marketed Predicate Devices:
Implant Sciences Corp. I-Plant Model 3500 (1251odine Brachytherapy Seed) cleared under 510(k) number K994317 dated 21 March 2000
and
Source Production & Equipment Co., Inc. Model M-31, cleared under 510(k) number K090366 dated 22 April 2009
- (4) Description of ANT Model 1 Brachytherapy Source:
ANT Model 1 is a singly-encapsulated Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive material. There are two versions of the ANT Model 1. The ANT Model 1 Type-Y contains a solid 199Ytterbium pellet. The ANT Model 1 Type-I contains a solid nonradioactive Ytterbium pellet onto which is plated radioactive 1251odine. In both cases, the capsule which contains the pellet consists of a deep-drawn titanium can which is closed on the end with a titanium plug which is laser-welded to the can.
The ANT Model 1 Brachytherapy Source emits gamma rays and characteristic x-rays from the decay of the respective radionuclides.
- (5) Intended Use
The intended use of ANT Model 1 Brachytherapy Source is for the treatment of cancer by temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application.
4
(6) Technological Characteristics:
The ANT Model 1 Brachytherapy Source is similar to the predicate low dose rate
brachytherapy source and utilizes photons from either 16°Ytterbium or 1251odine.
| Technological
Characteristic | Advanced Nuclide
Technologies, LLC (ANT)
Model 1 Brachytherapy
Source | Source Production &
Equipment Co., Inc. (SPEC)
M-31 169Ytterbium
Brachytherapy Source
K090366 | Implant Sciences Corp.
I-Plant Model 3500 (125Iodine
Brachytherapy Seed)
K994317 |
|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | The source consists of a solid
Ytterbium rod (0.5 mm dia x
3.0 mm long) singly
encapsulated. The capsule
(0.85 mm dia x 4.5 mm long)
is titanium. The capsule is
seal welded. | The source consists of a solid
169Ytterbium rod (0.25 mm dia
x 1.25 mm long) singly
encapsulated. The capsule
(0.42 mm dia x 5.1 mm long)
is titanium. The capsule is
seal welded. | I-Plant Model 3500 (125Iodine
Brachytherapy Seed) consists
of a laser-welded titanium
capsule containing a silica
tube that serves as a
substrate for the radioactive
125Iodine source. The tube is
positioned around a silver
radiopaque x-ray marker that
identifies the source location
and orientation. The seeds
are provided non-sterile. |
| Materials
Radionuclide
Encapsulation | 169Ytterbium OR 125Iodine
Titanium (Medical Grade) | 169Ytterbium
Titanium (Medical Grade) | 125Iodine
Titanium (Medical Grade) |
| Performance
Dosimetry (TG43)
Dose Rate Const (λ)
Anisotropy (φav):
Radial Dose Fn: | (169Yb): 1.20 cGy h-1 U-1
(125I): 1.00 cGy h-1 U-1
(169Yb): 0.95
(125I): 0.93
Shown in Figure 1 | 1.24 cGy h-1 U-1
0.99
Shown in Figure 11 | 1.01 cGy h-1 U-1
0.95
Shown in Figure 12 |
| Sterility | Sources are non-sterile when
shipped. Sources are
sterilized by the user. | Sources are non-sterile when
shipped. Sources are
sterilized by the user. | Seeds are non-sterile when
shipped. Seeds are sterilized
by the user. |
| Biocompatibility | The outer encapsulation of the
ANT Model 1 Brachytherapy
Source is medical grade
titanium, which has been
determined to be
biocompatible in a large
number of medical devices. | The outer encapsulation of the
SPEC M31 169Ytterbium
Brachytherapy Source is
medical grade titanium, which
has been determined to be
biocompatible in a large
number of medical devices. | The outer encapsulation of the
I-Plant Model 3500 (125Iodine
Brachytherapy Seed) is
medical grade titanium, which
has been determined to be
biocompatible in a large
number of medical devices. |
| Mechanical Safety | ANSI N43.6 Class C54212 | ANSI N43.6 Class C54212 | ANSI N43.6 Class C54213 |
| Energy Delivered | For the ANT Model 1 Type-Y:
169Ytterbium (half-life: 32.02
days) which decays by
electron capture with the
emission of characteristic
photons and electrons. The
electrons are absorbed by the
titanium wall of the source
encapsulation. The principal
photon emissions are 50, 51, | 169Ytterbium (half-life: 32.02
days) which decays by
electron capture with the
emission of characteristic
photons and electrons. The
electrons are absorbed by the
titanium wall of the source
encapsulation. The principal
photon emissions are 50, 51,
57 and 59 keV x-rays and a | 125Iodine (half-life: 59.43 days)
which decays by electron
capture with the emission of
characteristic photons and
electrons. The electrons are
absorbed by the titanium wall
of the seed. The principal
photon emissions are 27.4
and 31.4 keV x-rays and a
35.5 keV gamma. Also |
| | 63, 94, 110, 118, 131, 177,
198, 261 and 308 keV
gammas.
For the ANT Model 1 Type-I:
125Iodine (half-life: 59.43 days)
which decays by electron
capture with the emission of
characteristic photons and
electrons. The electrons are
absorbed by the titanium wall
of the source. The principal
photon emissions are 27.4
and 31.4 keV x-rays and a
35.5 keV gamma. Also
emitted are 22.1 and 25.2 keV
fluorescent x-rays from the
silver substrate. | 198, 261 and 308 keV
gammas. | fluorescent x-rays from the
silver marker. |
| Compatibility with
Environment and
Other Devices | 169Ytterbium and 125Iodine are
radioactive materials and
should be strictly controlled. If
any source cannot be
accounted for, the loss should
be reported to the federal or
state licensing agency.
The source should only be
used following the conditions
and limitations specified by
the licensing authority (NRC
or Agreement State).
The source should be stored
in a shielded container, either
the transport container in
which it is delivered or other
suitable container.
Store at normal room
temperature.
When disposal is indicated,
radioactive material should be
transferred to an authorized
recipient, typically the source
supplier. Radioactive material
should never be disposed of in
normal waste. | 169Ytterbium is a radioactive
material and should be strictly
controlled.
The source should only be
used following the conditions
and limitations specified by
the licensing authority (NRC
or Agreement State).
The source should be stored
in a shielded container, either
the transport container in
which it is delivered or other
suitable container.
If any source cannot be
accounted for, the loss should
be reported to the federal or
state licensing agency.
Store at normal room
temperature.
When disposal is indicated,
radioactive material should be
transferred to an authorized
recipient, typically the source
supplier. Radioactive material
should never be disposed of in
normal waste. | 125Iodine is a radioactive
material and should be strictly
controlled. If any significant
material cannot be accounted
for, the loss should be
reported to the federal or state
licensing agency.
When disposal is indicated,
radioactive material should be
transferred to an authorized
radioactive waste disposal
agency. Radioactive material
should never be disposed of in
normal waste. |
| Where Used | ANT Model 1 Brachytherapy
Source is designed to be
opened and used in the
operating room. | SPEC Model M31
Brachytherapy Source is
designed to be opened and
used in the operating room. | I-Plant Model 3500 (125Iodine
Brachytherapy Seed) is
designed to be opened and
used in the operating room. |
| Standards Met
Mechanical
Dosimetry | ANSI N43.6
AAPM TG-43 | ANSI N43.6
AAPM TG-43 | ANSI N43.6
AAPM TG-43 |
| Electrical Safety | Not Applicable | Not Applicable | Not Applicable |
| Thermal Safety | Not Applicable | Not Applicable | Not Applicable |
| Radiation Safety | These 169Ytterbium and
125Iodine sources are
radioactive, and appropriate
precautions must be taken
during handling to minimize
radiation exposure to
personnel. Personnel
monitoring is required.
This sources should be
handled with as much
distance as practical between
sources and the operator.
Any manipulation of ANT
Model 1 sources should be
carried out behind shielding of
adequate thickness.
The first half value thickness
of lead for 169Ytterbium is 0.25
mm. A 6.7 mm lead sheet will
provide >99% reduction in
exposure.
The half value thickness of
lead for 125Iodine is 0.025 mm.
Thus, a 0.25 mm lead sheet
will provide >99% reduction in
exposure. | This 169Ytterbium source is
radioactive, and appropriate
precautions must be taken
during handling to minimize
radiation exposure to
personnel. Personnel
monitoring is required.
This source should be
handled with as much
distance as practical between
sources and the operator.
Any manipulation of SPEC
Model M31 sources should be
carried out behind shielding of
adequate thickness. The first
half value thickness of lead for
169Ytterbium is 0.25 mm. A 6.7
mm lead sheet will provide
99% reduction in exposure. | I-Plant Model 3500 (125Iodine
Brachytherapy Seed) is
radioactive, and appropriate
precautions must be taken
during handling to minimize
radiation exposure to
personnel. Personnel
monitoring is required.
I-Plant Model 3500 (125Iodine
Brachytherapy Seed) should
be handled with forceps only
and with as much distance as
practical between seeds and
the operator.
Any manipulation of I-Plant
Model 3500 (125Iodine
Brachytherapy Seed) should
be carried out behind
shielding of adequate
thickness. The half value
thickness of lead for 125Iodine
is 0.025 mm. Thus, a 0.25 mm
lead sheet will provide >99%
reduction in exposure. |
5
6
Section 807.92(b)
- Nonclinical Tests (1)
Physical Testing
The ANT Model 1 source has been subjected to the tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO) Standard 2919, as referenced in the FDA "Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources" dated 2 August 2000.
Prototype sources were subjected to the tests specified in ANSI N43.6-2007 and ISO 2919-2012 and have equaled or exceeded the requirements corresponding to a classification of C53211, which is the requirement for brachytherapy sources. This is equivalent to the physical testing of the predicate devices.
Dosimetry
The dose distribution around the ANT Model 1 source was calculated by Monte Carlo simulation in accordance with the recommendations of the American Association of Physicists in Medicine and the European Society for Therapeutic Radiation Oncology. 3 This is equivalent to the dosimetry of the predicate devices.
7
-
(2) Clinical Tests
Not Applicable -
(3) Conclusions
The results of the nonclinical physical tests and the dosimetric analysis, demonstrate that the ANT Model 1 Brachytherapy Source is as safe, as effective, and performs as well or better than the legally marketed predicate devices:
Implant Sciences Corp. I-Plant Model 3500 (128)odine Brachytherapy Seed) cleared under 510(k) number K994317 dated 21 March 2000
and
Source Production & Equipment Co., Inc. Model M-31, cleared under 510(k) number K090366 dated 22 April 2009
1 Currier B, Munro JJ and Medich DC, Dosimetric characterization of the GammaClip™ 169Yb low dose rate permanent implant brachytherapy source for the treatment of nonsmall cell lung cancer postwedge resection. Med Phys. 2013 Aug:40(8):080701
2 Duggan DM, Johnson BL, "Dosimetry of the I-Plant Model 3500 iodine-125 brachytherapy source", Med Phys 2001 Apr;28(4):661-70
3 Perez-Calatayud J. Ballester F. Das RK, Dewerd LA, Ibbott GS, Meigooni AS, Quhib Z, Rivard MJ, Sloboda RS, Williamson JF, Dose calculation for photon-emitting brachytherapy sources with average energy higher than 50 keV: report of the AAPM and ESTRO, Med Phys. 2012 May;39(5):2904-29