(48 days)
Not Found
No
The device description and performance studies focus on the physical properties and dosimetry of a radioactive source, with no mention of AI or ML.
Yes
The device is indicated for temporary interstitial, intraluminal, intraoperative, or surface application to treat selected localized tumors, which is a therapeutic purpose.
No
The device is an Iridium Brachytherapy Source used for treatment, not for diagnosing medical conditions.
No
The device description clearly states it is a physical brachytherapy source consisting of a stainless steel capsule containing a radioactive pellet attached to a cable, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "temporary interstitial, intraluminal, intraoperative or surface application to treat selected localized tumors." This describes a therapeutic application, not a diagnostic one.
- Device Description: The device is a "singly-encapsulated 192Iridium Brachytherapy Source" which is a radioactive source used for radiation therapy. This is a treatment device.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, tissue), detect biomarkers, or provide information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is used for treatment itself.
N/A
Intended Use / Indications for Use
Source Production & Equipment Co., Inc. Model M13 192Iridium Brachytherapy Source, with individual activity up to 12 Ci, is indicated for temporary interstital, intraluminal, intraoperative or surface application to treat selected localized turnors. 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 intended use of Source Production & Equipment Co., Inc. Model M13 192Iridium Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.
Product codes (comma separated list FDA assigned to the subject device)
KXK
Device Description
Source Production & Equipment Co., Inc. Model M13 192Iridium Brachytherapy Source is a sinqly-encapsulated 192Iridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 192Iridium 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
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)
Nonclinical Tests (Physical Testing, Tensile Testing, Operational Testing, Dosimetry)
Key Results:
Physical Testing: 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: Prototype sources were subjected to a tensile load to failure with the minimum failure load of 85 N (19 lb), which is more than 5 times the maximum force that can be applied by the Varian GammaMed Plus Afterloader. Prototypes were also subjected to a series of tensile fatigue tests with loads significantly exceeding the maximum force applied by the afterloader. The minimum failure load was 84 N (19 lb). It is concluded that the tensile strength of this source assembly 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, successfully negotiating "S" and "U" curves simulating various applicator pathways without damage. The same source assembly performed more than 35,000 exposure/retract cycles in a simulated GammaMed Plus Afterloader without failure of the source cable, source capsule, or connection. This is equivalent to the physical testing of the predicate device.
Dosimetry: The dose distribution around the Model M13 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 device.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2016
Source Production and Equipment Co.,Inc. % Ms. Kelley Richardt Regulatory and Quality Manager 113 Teal Street SAINT ROSE LA 70087
Re: K161395
Trade/Device Name: Source Production and Equipment Co., Inc. Model M13 1991ridium Brachytherapy Source Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: May 16, 2016
Dear Ms. Richardt:
Received: May 19, 2016
This letter corrects our substantially equivalent letter of July 6, 2016.
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 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
1
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.
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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
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) K161395
Device Name
Source Production & Equipment Co., Inc. Model M13 192Iridium Brachytherapy Source
Indications for Use (Describe)
Source Production & Equipment Co., Inc. Model M13 192Iridium Brachytherapy Source, with individual activity up to 12 Ci, is indicated for temporary interstital, intraluminal, intraoperative or surface application to treat selected localized turnors. 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/0 description: The image shows the word "spec" in a stylized font, with each letter outlined in black. To the right of the word, there is a radiation symbol, also in black. The word and the symbol are the only elements in the image, set against a white background. The overall design is simple and graphic.
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:
- Radionuclide Brachytherapy Source (892.5730) (90 KXK) Classification Name: Brachytherapy Source Assembly Common or Usual Name: Proprietary Name: Source Production & Equipment Co., Inc. Model M13 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 M13 192 ridium (4) Brachytherapy Source:
Source Production & Equipment Co., Inc. Model M13 192 ridium Brachytherapy Source is a sinqly-encapsulated 1921ridium 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 Source Production & Equipment Co., Inc. Model M13 1991ridium Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.
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Image /page/4/Picture/0 description: The image shows the word "spec" in a bold, sans-serif font. To the right of the word is a radiation symbol. The word and symbol are both outlined in black, with a white fill.
- (6) Technological Characteristics:
Source Production & Equipment Co., Inc. Model M13 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. (SPEC)
M13 192Iridium High Dose Rate
Brachytherapy Source | Source Production & Equipment Co.,
Inc. (SPEC)
M15 192Iridium High Dose Rate
Brachytherapy Source |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | The source consists of a solid 192Iridium
pellet (Configuration H: 0.6 mm dia x 3.5
mm long; Configuration P: 0.6 mm dia x
2.0 mm long)) singly encapsulated in
stainless steel (Configuration H: 0.9 mm
dia x 4.8 mm long; Configuration P: 0.9
mm dia x 3.3 mm long) and welded to a
7x7+4 stranded stainless steel cable (0.9
mm dia x 2100 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 (λ)
Anisotropy (φav): | Configuration H
1.11 cGy h-1 U-1
0.97 | Configuration P
1.12 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 | 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
gammas. | principal photon emissions are 67 keV x-
rays and 201, 311, 467, and 603 keV
gammas. |
| Compatibility with
Environment and
Other Devices | 192Iridium is a radioactive material and
should be strictly controlled. | 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 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. | 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. | If any source cannot be accounted for, the
loss should be reported to the federal or
state licensing agency. |
| | Store at normal room temperature. | 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. | 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 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. | 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. | 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. |
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Image /page/5/Picture/0 description: The image shows the word "spec" in a stylized font, with each letter outlined in black. To the right of the word, there is a black radiation symbol. The word and the symbol are the only elements in the image, set against a white background. The overall design is simple and graphic.
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Image /page/6/Picture/0 description: The image shows the word "spec" in a bold, outlined font. To the right of the word "spec" is a radiation symbol. The word "spec" is written in all lowercase letters. The radiation symbol is black.
Section 807.92(b)
(1) Nonclinical Tests
Physical Testing
The Model M13 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 subiected 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
Prototype sources were subiected to a tensile load to failure with the minimum failure load of 85 N (19 lb). The maximum force that can be applied by the Varian GammaMed Plus Afterloader is 16 N (3.6 lb). Therefore, this test load was more than 5 times the maximum force that can be applied by the Varian GammaMed Plus Afterloader.
In addition, prototypes were subjected to a series of tensile fatique tests consisting of:
- a tensile load in excess of 40 N (9 lb), which is more than 2.5 times the maximum . force than can be applied to the cable by the Varian GammaMed Plus Afterloader
- ten sequential applications of a tensile load of in excess of 16 N (3.6 lbs) which is . more than the maximum load that can be applied by the Varian GammaMed Plus Afterloader, and then
- a tensile load in excess of 40 N (9 lb), which is more than 2.5 times the maximum ● force than can be applied to the cable by the Varian GammaMed Plus Afterloader
- . and finally a tensile load to failure of each of the welds of the source assembly, where the the minimum failure load was 84 N (19 lb) which is more than 5 times the maximum force that can be applied by the Varian GammaMed Plus Afterloader.
It is concluded that 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
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Image /page/7/Picture/0 description: The image shows the word "spec" in a stylized font, with each letter outlined in black. To the right of the word, there is a radiation symbol, also in black. The word and the symbol are the only elements in the image, and they are set against a white background. The overall design is simple and graphic.
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 GammaMed Plus Afterloader. The source capsule and cable successfully negotiated all of these pathways. There was no damage to the M13 source assembly.
Subsequently, the same source assembly was subjected to an endurance performance test in a simulated GammaMed Plus Afterloader, where the source assembly performed more than 35,000 exposure/retract cycles. 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 Model M13 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 SPEC Model M13 High Dose Rate Brachytherapy Source is as safe, as effective, and performs as well or better than the leqally 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