(78 days)
Not Found
No
The document 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 "temporary interstitial, intraluminal, intraoperative or surface application to treat selected localized tumors," which is a therapeutic purpose.
No
The provided text describes a radioactive source used in brachytherapy for treating tumors. It is explicitly stated as a treatment device, not a diagnostic one.
No
The device description clearly states it is a "singly-encapsulated 192Iridium Brachytherapy Source" consisting of a "solid radioactive 192Iridium pellet" sealed in a "stainless steel capsule that is attached to a cable". This describes a physical, hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The SPEC Model M16 Source Assembly is a radioactive source used for brachytherapy, which is a form of radiation therapy where a radioactive source is placed inside or next to the area requiring treatment. This is a direct treatment method applied to the patient's body, not a test performed on a sample outside the body.
- No Mention of Samples or Testing: The description focuses on the physical characteristics of the radioactive source and its application in treating tumors within the body. There is no mention of analyzing biological samples or performing diagnostic tests.
Therefore, the SPEC Model M16 Source Assembly falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Source Production & Equipment Co., Inc. (SPEC) Model M16 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intraluminal, intraoperative or surface application to treat selected localized tumors. This source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Best Medical High Dose Rate Remote Afterloader. The Model M16 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.
Product codes (comma separated list FDA assigned to the subject device)
KXK
Device Description
SPEC Model M16 is a singly-encapsulated 192Iridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 192Iridium 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, 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: Prototype sources were subjected to tests specified in ANSI N43.6-2007 and ISO 2919-2012, meeting or exceeding requirements for classification C53211, equivalent to the predicate device.
Tensile Testing: Prototype sources withstood a tensile load of 294 N (66 lb) without failure, which is more than 17 times the maximum force applicable by the Best Medical Afterloader. They also successfully underwent tensile fatigue tests at 107 N (24 lb) and 53 N (12 lbs), concluding the tensile strength is sufficient for its intended application and is equivalent to or better than the predicate device.
Operational Testing: A prototype source assembly successfully navigated through "S" and "U" curves in a Best Medical Afterloader, simulating various applicator pathways, without damage, equivalent to the predicate device.
Dosimetry: The dose distribution around the Model M16 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, equivalent to the predicate device.
Clinical Tests: Not Applicable
Conclusions: The nonclinical tests and dosimetric analysis demonstrate that the SPEC Model M16 High Dose Rate Brachytherapy Source is as safe, as effective, and performs as well or better than the legally marketed 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features 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, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2015
Source Production and Equipment Co., Inc. % Ms. Kelly Richardt Regulatory and Quality Manager 113 Teal Street ST. ROSE LA 70087
Re: K150895
Trade/Device Name: SPEC Model M16 192Iridium Brachytherapy Source Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: May 26, 2015 Received: May 27, 2015
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.
Michael D'Hara
For
Robert Ochs, Ph.D Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150895
Device Name
Source Production & Equipment Co., Inc. (SPEC) Model M16 192Iridium Brachytherapy Source
Indications for Use (Describe)
Source Production & Equipment Co., Inc. (SPEC) Model M16 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intraluminal, intraoperative or surface application to treat selected localized tumors. This source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Best Medical High Dose Rate Remote Afterloader. The Model M16 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.
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."
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Image /page/3/Picture/1 description: The image shows the word "spec" in a stylized font. To the right of the word is a radiation symbol. The letters are outlined in black, with a white fill. The radiation symbol is solid black.
Section 5 510(k) Summary
Section 807.92(a)
| (1) Submitter | Source Production & Equipment Co., Inc. |
|---|---|
| 113 Teal Street | |
| St. Rose, LA70087 | |
| 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) Brachytherapy Source Assembly Common or Usual Name: Proprietary Name: SPEC Model M16 -
(3) Legally Marketed Predicate Device:
Source Production & Equipment Co., Inc.Model M15, cleared under 510(k) number K132969 dated 02 January 2014
Description of SPEC Model M16192Iridium Brachytherapy Source: (4)
SPEC Model M16 is a singly-encapsulated 192 ridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 1921ridium 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 M16 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation. -
Technological Characteristics: (6)
SPEC Model M16192 ridium Brachytherapy Source is similar to the predicate high dose rate brachytherapy source that utilizes photons from 1921ridium.
Model M16192Iridium HDR Source R1
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Image /page/4/Picture/0 description: The image shows the word "spec" in a stylized font. To the right of the "c" is a radiation symbol. The word "spec" is outlined in black, and the radiation symbol is solid black. The image is in black and white.
| Technological | Source Production & Equipment Co.,
Inc. (SPEC) | |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | M16 192Iridium High Dose Rate
Brachytherapy Source | 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 (1.1 mm
dia x 4.8 mm long) and welded to a 7x7
stranded stainless steel cable (1.1 mm dia
x 1800 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 ( $ϕ$ 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
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
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. | 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 | The source should only be used following
the conditions and limitations specified by
the licensing authority (NRC or |
| | | |
| | AgreementState). | AgreementState). |
| | The source should be stored in a shielded | 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. | 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 32 ridium source is radioactive, and
appropriate precautions must be taken
during handling to minimize radiation
exposure to personnel. Personnel
monitoring is required. | This 192 ridium 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. The letters are outlined in black and filled with white. To the right of the letter "c" is a black radiation symbol. The word "spec" is written in lowercase letters.
Section 807.92(b)
Nonclinical Tests (1)
Physical Testing
The Model M16 source has been subjected to the tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO)
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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 2919-2012and 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 of 294 N (66 lb) without failure. The maximum force that can be applied by the Best Medical Afterloader is 16.5 N (3.7 Ib). Therefore, this test load was more than 17 times the maximum force that can be applied by the Best Medical Afterloader.
In addition, prototypes were subjected to a series of tensile fatigue tests consisting of:
- a tensile load of 107 N (24 lb), which is more than 6 times the maximum force . than can be applied to the cable by the Best Medical Afterloader
- . ten sequential applications of a tensile load of in excess of 53 N (12 lbs) which is more than 3 times the maximum load that can be applied by the Best Medical Afterloader, and then
- . subjected to a tensile load tensile load of 294 N (66 lb) without failure. This tensile load was more than 17 times the maximum force that can be applied by the Best Medical Afterloader.
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 performance test in aBest Medical 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 Best Medical Afterloader. The source capsule and cable successfully negotiated all of these pathways. There was no damage to the M16 source assembly.
This is equivalent to the physical testing of the predicate device.
Dosimetry
The dose distribution around the Model M16 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. TThis is equivalent to the dosimetry of the predicate device.
(2) Clinical Tests
7
Not Applicable
(3) Conclusions
The results of the nonclinical physical, tensile, operational tests and the dosimetric analysis, demonstrate that the SPEC Model M16 High Dose Rate 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, MeigooniAS, Ouhib Z, Rivard MJ, Sloboda RS, Williamson JF, Dose calculation for photon-emitting brachytherapy sources with average energy higher than 50keV: report of the AAPM and ESTRO, Med Phys. 2012 May;39(5):2904-29