(50 days)
Not Found
No
The device description and performance studies focus on the physical and radioactive properties of the brachytherapy source, with no mention of AI or ML technologies.
Yes
The device is a brachytherapy source used for treating localized tumors, which is a therapeutic purpose.
No
Explanation: The device is an Iridium-192 brachytherapy source used for the treatment of various localized tumors and cancers (as described in the "Intended Use / Indications for Use" section), not for diagnosis.
No
The device description clearly outlines physical components: a stainless steel capsule, a radioactive pellet, and a cable. The performance studies also focus on physical testing (tensile, operational) and dosimetry, not software validation.
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 cancer through radiation therapy (brachytherapy). IVDs are used for the diagnosis or monitoring of diseases or conditions by examining specimens from the human body.
- Device Description: The device is a radioactive source designed to deliver radiation directly to a tumor. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is clearly a therapeutic medical device used in the field of radiation oncology.
N/A
Intended Use / Indications for Use
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source, with individual activity up to 12 Ci, is indicated for temporary interstital, intraluminal, intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with external beam radiation therapy.
The source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Elekta/Nucletron V2/V3 Afterloaders.
Product codes
KXK
Device Description
Source Production & Equipment Co., Inc. Model M14 194ridium Brachytherapy Source is a singly-encapsulated 192 ridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 1921ridium pellet is sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical brachytherapy applications
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
Nonclinical Tests:
- Physical Testing: Prototype sources were subjected to tests specified in ANSI N43.6-2007 and ISO 2919-2012, meeting or exceeding requirements for classification C53211.
- Tensile Testing: Prototype sources underwent a series of tensile fatigue tests including a tensile load in excess of 45 N (10 lb), ten sequential applications of 22 N (5 lbs) load, and a final tensile load in excess of 45 N (10 lb). Minimum failure load was 138 N (31 lb).
- Operational Testing: A prototype source assembly was subjected to a curved pathway performance test through "S" and "U" curves, and an endurance performance test performing more than 50,000 exposure/retract cycles in an Elekta/Nucletron V2/V3 Series HDR Afterloader.
- Dosimetry: Dose distribution calculated by Monte Carlo simulation in accordance with AAPM and ESTRO recommendations.
Clinical Tests: Not Applicable
Key Results:
The source assembly successfully negotiated all curved pathways and showed no damage. There was no failure of the source cable, source capsule, or the connection of the source capsule to the source cable during endurance testing. The nonclinical physical, tensile, operational tests and dosimetric analysis demonstrate that the device is as safe, effective, and performs as well as or better than the predicate device.
Key Metrics
- Tensile strength minimum failure load: 138 N (31 lb)
- Endurance test cycles: 50,000 exposure/retract cycles.
Predicate Device(s)
Source Production & Equipment Co., Inc. Model M15, K132969
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2016
Source Production & Equipment Co., Inc. % Ms. Kelley Richardt Regulatory and Quality Manager 113 Teal Street SAINT ROSE LA 70087
Re: K162573
Trade/Device Name: Source Production & Equipment Co., Inc. Model M14 122Tridium Brachytherapy Source
Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: September 14, 2016 Received: September 19, 2016
Dear Ms. Richardt:
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.
Robert Oels
Robert Ochs, Ph.D. 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)
K162573
Device Name
Device Name: Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
Indications for Use (Describe)
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source, with individual activity up to 12 Ci, is indicated for temporary interstital, intraluminal, intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with external beam radiation therapy.
The source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Elekta/Nucletron V2/V3 Afterloaders.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "spec" in a stylized font. The letters are outlined in black and filled with white. To the right of the word is a radiation symbol, also in black.
Section 5 510(k) Summary
Section 807.92(a)
Submitter Source Production & Equipment Co., Inc. Tel: 504.464.9471 (1) 113 Teal Street 504.467.7685 Fax: St. Rose, LA 70087 Establishment Registration No.: 1000437833 Contact Person: John J. Munro III Vice President e-mail: johnm@spec150.com
- (2) Device Name:
| Classification Name: | Radionuclide Brachytherapy Source (892.5730) (90 KXK) |
|---|---|
| Common or Usual Name: | Brachytherapy Source Assembly |
| Proprietary Name: | Source Production & Equipment Co., Inc. Model M14 192 Iridium Brachytherapy Source |
-
(3) Legally Marketed Predicate Device:
Source Production & Equipment Co., Inc. Model M15, cleared under 510(k) number K132969 dated 02 January 2014 -
Description of Source Production & Equipment Co., Inc. Model M14 192 ridium (4) Brachytherapy Source:
Source Production & Equipment Co., Inc. Model M14 194ridium Brachytherapy Source is a singly-encapsulated 192 ridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 1921ridium pellet is sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system. -
(5) Intended Use
The intended use of the Source Production & Equipment Co., Inc. Model M14 194ridium Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.
4
Image /page/4/Picture/0 description: The image shows the word "spec" in a stylized font, with a radiation symbol to the right of the letter "c". The letters are outlined in black, giving them a hollow appearance. The radiation symbol consists of a central circle with three blades extending outward, also outlined in black.
- (6) Technological Characteristics:
Source Production & Equipment Co., Inc. Model M14 192ridium Brachytherapy Source is similar to the predicate high dose rate brachytherapy source that utilizes photons from 192 Iridium.
| Technological
Characteristic | Source Production & Equipment Co.,
Inc. Model M14 192Iridium
Brachytherapy Source | Source Production & Equipment Co.,
Inc. (SPEC) M15 192Iridium High Dose
Rate Brachytherapy Source |
|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | The source consists of a solid 192Iridium
pellet (0.6 mm dia x 3.5 mm long) singly
encapsulated in stainless steel (0.9 mm
dia x 4.8 mm long) and welded to a 7x7
stranded stainless steel cable (0.9 mm dia
x 2022 mm long). | The source consists of a solid 192Iridium
pellet (0.6 mm dia x 3.5 mm long) singly
encapsulated in stainless steel (1.1 mm
dia x 4.8 mm long) and welded to a 7x7
stranded stainless steel cable (1.1 mm dia
x 2000 mm long). |
| Materials
Radionuclide
Encapsulation | 192Iridium
Stainless Steel | 192Iridium
Stainless Steel |
| Cable | Stainless Steel | Stainless Steel |
| Performance
Dosimetry (TG43)
Dose Rate Const ( $\lambda$ )
Anisotropy ( $\phi_{av}$ ): | 1.11 cGy h-1 U-1
0.97 | 1.11 cGy h-1 U-1
0.97 |
| Sterility | This source assembly never directly
contacts the patient; sterility is not
required. | This source assembly never directly
contacts the patient; sterility is not
required. |
| Biocompatibility | This source assembly never directly
contacts the patient; biocompatibility
assessment is not applicable. The
outside of the entire assembly is
fabricated from stainless steel, which is a
biocompatible material. | This source assembly never directly
contacts the patient; biocompatibility
assessment is not applicable. The
outside of the entire assembly is
fabricated from stainless steel, which is a
biocompatible material. |
| Mechanical Safety | ANSI N43.6 Class C53211
Applied for Louisiana Registration | ANSI N43.6 Class C53211
Louisiana Sealed Source Registration
LA-0612-S-117-S |
| Chemical Safety | This source assembly never directly
contacts the patient; chemical safety
assessment is not applicable. The
outside of the entire assembly is
fabricated from stainless steel, which is
will not chemically react with body tissue. | This source assembly never directly
contacts the patient; chemical safety
assessment is not applicable. The
outside of the entire assembly is
fabricated from stainless steel, which is
will not chemically react with body tissue. |
| Energy Delivered | 192Iridium (half-life: 73.81 days) which
decays by beta emission and electron
capture with the emission of characteristic
photons and electrons. The betas and
electrons are absorbed by the stainless
steel wall of the source capsule. The
principal photon emissions are 67 keV x-
rays and 201, 311, 467, and 603 keV | 192Iridium (half-life: 73.81 days) which
decays by beta emission and electron
capture with the emission of characteristic
photons and electrons. The betas and
electrons are absorbed by the stainless
steel wall of the source capsule. The
principal photon emissions are 67 keV x-
rays and 201, 311, 467, and 603 keV |
| Compatibility with
Environment and
Other Devices | 192Iridium 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 remote afterloader
with which it is used or the transport
container in which it is delivered.
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. | 192Iridium 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 remote afterloader
with which it is used or the transport
container in which it is delivered.
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. |
| Where Used | This source should only be used within a
properly shielded enclosure designed to
maintain radiation dose rates outside the
enclosure within regulatory limits. | This source should only be used within a
properly shielded enclosure designed to
maintain radiation dose rates outside the
enclosure within regulatory limits. |
| Standards Met
Mechanical
Dosimetry | ANSI N43.6
AAPM TG-43 | ANSI N43.6
AAPM TG-43 |
| Electrical Safety | Not Applicable | Not Applicable |
| Thermal Safety | Not Applicable | Not Applicable |
| Radiation Safety | This 192Iridium source is radioactive, and
appropriate precautions must be taken
during handling to minimize radiation
exposure to personnel. Personnel
monitoring is required.
This source should only be used within a
properly shielded enclosure designed to
maintain radiation dose rates outside the
enclosure within regulatory limits.
In circumstances where emergency
operations must be performed within
protective barriers, the operator should
use proper applicators, maintain safe
working distances and work as rapidly as
safely possible to minimize radiation
exposure | This 192Iridium source is radioactive, and
appropriate precautions must be taken
during handling to minimize radiation
exposure to personnel. Personnel
monitoring is required.
This source should only be used within a
properly shielded enclosure designed to
maintain radiation dose rates outside the
enclosure within regulatory limits.
In circumstances where emergency
operations must be performed within
protective barriers, the operator should
use proper applicators, maintain safe
working distances and work as rapidly as
safely possible to minimize radiation
exposure |
5
Image /page/5/Picture/0 description: The image shows the word "spec" in a stylized font. To the right of the word is a radiation symbol. The word is outlined in black, and the radiation symbol is solid black. The image is simple and clear.
6
Image /page/6/Picture/0 description: The image shows the word "spec" in a stylized font. The letters are outlined in black and filled with white. To the right of the "c" is a radiation symbol. The symbol is black and consists of a small circle in the center with three curved shapes radiating outwards.
Section 807.92(b)
Nonclinical Tests (1)
Physical Testing
The Source Production & Equipment Co., Inc. Model M14 194ridium Brachytherapy Source has been subjected to the tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO) Standard 2019, 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 device.
Tensile Testing
The ultimate criteria for these categories of weld is to have sufficient tensile strength for the application. As described in Registry of Radioactive Sealed Sources and Devices Safety Evaluation of Source No. MD-0497-S-107-S, all welded connections of the sources used in the Elekta/Nucletron V2/V3 Series High Dose Rate (HDR) are mechanically tested by a pull test of 15 N of force. We have conservatively interpreted this value to be the maximum force that the afterloader can apply to the source assembly. We believe this is conservative because if the afterloader could apply a greater force than this, Nucletron would have applied a greater tensile test requirement. In all likelihood, the maximum force that can be applied to the source assembly would be less than this value. Therefore, under this interpretation, we have adopted a production tensile test requirement that is 2.5 times this specified force or 37.5 Newtons (8.4 lbs).
Prototype sources were subjected to a series of tensile fatigue tests consisting of:
- a tensile load in excess of 45 N (10 lb). which is more than 2.5 times the . maximum force than can be applied to the cable by the Elekta/Nucletron V2/V3 Series HDR Afterloader
- ten sequential applications of a tensile load of in excess of 22 N (5 lbs) which is . more than the maximum load that can be applied by the Elekta/Nucletron V2/V3 Series HDR Afterloader, and then
- a tensile load in excess of 45 N (10 lb). which is more than 2.5 times the . maximum force than can be applied to the cable by the Elekta/Nucletron V2/V3 Series HDR Afterloader
- and finally a tensile load to failure of each of the welds of the source assembly, . where the minimum failure load was 138 N (31 lb) which is more than 9 times the maximum force that can be applied by the Elekta/Nucletron V2/V3 Series HDR Afterloader.
7
Image /page/7/Picture/0 description: The image shows the word "spec" in a bold, outlined font. To the right of the word is a radiation symbol. The word and symbol are in black and white.
It is concluded that the tensile strength of this source assemble is sufficient for its intended application. This is equivalent to or better than the tensile testing of the predicate device.
Operational Testing
A prototype source assembly was subjected to a curved pathway performance test consisting of driving the source cable through a series of "S" and "U" curves with a variety of radii which simulate the various pathways of applicators used with the Elekta/Nucletron V2/V3 Series HDR Afterloader. The source capsule and cable successfully negotiated all of these pathways. There was no damage to the M14 source assembly.
Subsequently, the same source assembly was subjected to an endurance performance test in an Elekta/Nucletron V2/V3 Series HDR Afterloader, where the source assembly performed more than 50.000 exposure/retract cvcles. As a result of these tests, there was no failure of the source cable, the source capsule or the connection of the source capsule to the source cable.
This is equivalent to the physical testing of the predicate device.
Dosimetry
The dose distribution around the Source Production & Equipment Co., Inc. Model M14 192 ridium Brachytherapy 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. 1 This is equivalent to the dosimetry of the predicate device.
-
(2) Clinical Tests
Not Applicable -
(3) Conclusions
The results of the nonclinical physical, tensile, operational tests and the dosimetric analysis, demonstrate that the Source Production & Equipment Co., Inc. Model M14 192 ridium Brachytherapy Source is as safe, as effective, and performs as well or better than the legally marketed predicate device, SPEC Model M15 High Dose Rate Brachytherapy Source.
1 Perez-Calatayud J, Ballester F, Das RK, Dewerd LA, Ibbott GS, Meigooni AS, Ouhib 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