(101 days)
Not Found
No
The summary describes a radioactive source for brachytherapy and its physical characteristics and testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for treating various tumors through temporary applications, which is a therapeutic purpose.
No
The device is described as a brachytherapy source used for treating selected tumors, which is a therapeutic rather than a diagnostic application.
No
The device description clearly states it is a "singly-encapsulated 192Iridium Brachytherapy Source" consisting of a "stainless steel capsule containing a solid radioactive 192Iridium pellet." This describes a physical, hardware component, not a software-only device.
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 tumors through brachytherapy, which is a form of radiation therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a radioactive source used for delivering radiation directly to a tumor. This is a treatment device.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue) or to provide information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on delivering therapeutic radiation.
N/A
Intended Use / Indications for Use
The intended use of SPEC Model M15 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.
The Source Production & Equipment Co., Inc. (SPEC) Model M15 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intracavitary, intraluminal, intraoperative or surface application to treat selected tumors. This source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Nucletron microSelectron Classic High Dose Rate Remote Afterloader. The Model M15 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 for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with external beam radiation therapy.
Product codes
KXK
Device Description
SPEC Model M15 is a singly-encapsulated 194ridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 1931ridium pellet. The 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
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)
Physical Testing: Prototype sources were subjected to the tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO) Standard 2919. They equaled or exceeded the requirements corresponding to a classification of C53211. This is equivalent to the physical testing of the predicate device.
Tensile Testing: Prototype sources were subjected to a tensile load to failure. The minimum failure load was found to be more than 10 times the maximum force that can be applied by the Nucletron microSelectron "Classic" remote afterloader. They also underwent a cyclic tensile test. After consecutive applications of tensile loads in excess of 10 times the maximum load, the tensile load at failure was still found to be more than 10 times the maximum force. 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 performance test in a Nucletron microSelectron "Classic" Afterloader, driving the source cable through "S" and "U" curves simulating real-world pathways. The source capsule and cable successfully negotiated all pathways without damage to the M15 source assembly. This is equivalent to the physical testing of the predicate device.
Dosimetry: The dose distribution around the Model M15 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)
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.
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Image /page/0/Picture/0 description: The image shows the text "K132969 Page 1 of 5 spec" in a handwritten style. The text "K132969" is at the top, followed by "Page 1 of 5" below it. The word "spec" is at the bottom in a larger, stylized font. There is a radiation symbol to the right of the word "spec".
510(k) Summary
Section 807.92(a)
| (1) Submitter | Source Production & Equipment Co., Inc. |
|---|---|
| 113 Teal Street | |
| St. Rose, LA 70087 | |
| Tel: | 504.464.9471 |
| Fax: | 504.467.7685 |
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: | SPEC Model M15 |
-
(3) Legally Marketed Predicate Device:
Alpha-Omega Services, Inc. Model CSN0010-192, cleared under 510(k) number K991571 dated 22 February 2000 -
Description of SPEC Model M15 1921ridium Brachytherapy Source: (4)
SPEC Model M15 is a singly-encapsulated 194ridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 1931ridium pellet. The 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 SPEC Model M15 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation. -
Technological Characteristics: (6)
SPEC Model M15 19eridium Brachytherapy Source is similar to the predicate high dose rate brachytherapy source that utilizes photons from 1921ridium.`
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| Technological
Characteristic | Source Production & Equipment Co.,
Inc. (SPEC)
M15 192Iridium High Dose Rate
Brachytherapy Source | Alpha-Omega Services, Inc.
Model CSN0010-192
K991571 |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | 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). | 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 4.5 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 ( $Φ$ av): | 1.11 cGy h⁻¹ U⁻¹
0.97 | 1.13 cGy h⁻¹ U⁻¹
0.95 |
| Sterility | This source assembly never directly | This source assembly never directly |
| | contacts the patient; sterility is not
required. | 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
LA-0760-S-106-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
gammas. | 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. |
| 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). | 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. | 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 | ANSI N43.6 |
| | AAPM TG-43 | 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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(7) Nonclinical Tests
Physical Testing
The Model M15 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.
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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. The minimum failure load was found to be more than 10 times the maximum force that can be applied by the Nucletron microSelectron "Classic" remote afterloader.
Additionally, prototypes were subjected to the conditions of a cvclic tensile test. After application of a tensile load in excess of 10 times the maximum load that can be applied by the Nucletron microSelectron "Classic" remote afterloader, each prototype was subjected to 10 sequential applications of tensile loads in excess of the maximum load that can be applied by the Nucletron microSelectron "Classic". After these sequential loads, each sample was subjected to a tensile test to failure. The tensile load at failure was found to be more than 10 times the maximum force that can be applied by the Nucletron microSelectron "Classic" remote 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
A prototype source assembly was subjected to a performance test in a Nucletron microSelectron "Classic" Afterloader, 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 Nucletron microSelectron "Classic". The source capsule and cable successfully negotiated all of these pathways. There was no damage to the M15 source assembly.
This is equivalent to the physical testing of the predicate device.
Dosimetry
The dose distribution around the Model M15 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.
- Clinical Tests (8)
Not Applicable
4
K132969
Page 5 of 5
spec *
Conclusions (ਰ)
The results of the nonclinical physical, tensile, operational tests and the dosimetric analysis, demonstrate that the SPEC Model M15 High Dose Rate Brachytherapy Source is as safe, as effective, and performs as well or better than the legally marketed predicate device, Alpha-Omega Services, Inc. Model CSN0010-192.
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-റു
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 2, 2014
Source Production & Equipment Co., Inc. % Ms. Kelley Richardt Regulatory and Quality Manager 113 Teal Street SAINT ROSE LA 70087
Re: K132969
Trade/Device Name: SPEC Model M-15 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: December 2, 2013 Received: December 4, 2013
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 (2 ) 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.
6
Page 2-Ms. Richardt
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/Safetv/ReportaProblem/dcfault.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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.cov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'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
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K132969
Device Name
Source Production and Equipment Co. Model M15 1921ridium High Dose Rate Brachytherapy Source
Indications for Use (Describe)
The Source Production & Equipment Co., Inc. (SPEC) Model M15 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intracavitary, intraluminal, intraoperative or surface application to treat selected tumors. This source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Nucletron microSelectron Classic High Dose Rate Remote Afterloader. The Model M15 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 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 Subpant C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY |
|---|
| ------------------------- |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Mechal D. O'Hara |
|---|---|
| ------------------------------------------------------------------------------ | ------------------ |
FORM FDA 3881 (9/13)
PSC Publishing Services ( 101 ) 441-67 at