(90 days)
Not Found
No
The summary describes a radioactive source for brachytherapy and does not mention any AI or ML components.
Yes
The device is indicated for temporary interstitial, intraluminal, intraoperative, or surface application to treat selected localized tumors, demonstrating a therapeutic purpose.
No
The device description indicates that the SPEC Model M23 is a brachytherapy source used for treating localized tumors, not for diagnosing conditions. Its function involves delivering radiation therapy, which is a treatment modality.
No
The device description clearly states it is a "singly-encapsulated 168 ftterbium Brachytherapy Source" consisting of a "stainless steel capsule containing solid radioactive 160Ytterbium Oxide pellets" attached to a "cable". This describes a physical, hardware-based medical device, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the SPEC Model M23 is a brachytherapy source containing radioactive material (Ytterbium-169). Its intended use is for the treatment of localized tumors by applying radiation directly to the affected area within the body (in vivo).
The device is a therapeutic device used for radiation therapy, not a diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
Source Production & Equipment Co., Inc. (SPEC) Model M23 Source Assembly, with individual activity up to 27 Ci, is indicated for temporary interstitial, 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 intended use of SPEC Model M23 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
SPEC Model M23 is a singly-encapsulated 169Ytterbium Brachytherapy Source. It consists of a stainless steel capsule containing solid radioactive 169Ytterbium Oxide pellets. The pellets are sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.
The source consists of solid 169Ytterbium Oxide pellets (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).
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)
Physical Testing: The Model M23 source has been subjected to the tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO) Standard 2919. 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. The testing performed 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). 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 fatigue 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: 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.
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 consists of a stylized representation of three human profiles facing to the right, arranged in a cascading manner. The profiles are depicted in a dark color, creating a silhouette effect. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2016
Source Production and Equipment Co., Inc. % Ms. Kelley Richardt Regulatory and Ouality Manager 113 Teal Street SAINT ROSE LA 70087
Re: K161396
Trade/Device Name: Source Production & Equipment Co., Inc. Model M23 169Ytterbium Brachytherapy Source Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: May 16, 2016 Received: May 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.
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)
Device Name
Source Production & Equipment Co., Inc. Model M23 169Ytterbium Brachytherapy Source
Indications for Use (Describe)
Source Production & Equipment Co., Inc. (SPEC) Model M23 Source Assembly, with individual activity up to 27 Ci, is indicated for temporary interstitial, 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.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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
- Device Name: (2)
| Classification Name: | Radionuclide Brachytherapy Source (892.5730) (90 KXK) |
|---|---|
| Common or Usual Name: | Brachytherapy Source Assembly |
| Proprietary Name: | SPEC Model M23 |
-
(3) Legally Marketed Predicate Device:
Implant Sciences Corp. Model HDR-4140, cleared under 510(k) number K042864 dated 06 Jan 2005 as described in Section 12 -
Description of SPEC Model M23 169Ytterbium Brachytherapy Source: (4)
SPEC Model M23 is a singly-encapsulated 168 ftterbium Brachytherapy Source. It consists of a stainless steel capsule containing solid radioactive 160Ytterbium Oxide pellets. The pellets are 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 M23 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation. -
(6) Technological Characteristics:
SPEC Model M23 169Ytterbium Brachytherapy Source is similar to the predicate high dose rate brachytherapy source that utilizes photons from 168Ytterbium.
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Image /page/4/Picture/0 description: The image shows the word "spec" in a sans-serif font, with each letter outlined in black. To the right of the word 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.
| Technological
Characteristic | Source Production & Equipment Co.,
Inc. (SPEC)
M23 169Ytterbium High Dose Rate
Brachytherapy Source | Implant Sciences Corp.
HDR-4140 169Ytterbium High Dose Rate
Brachytherapy Source |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | The source consists of solid 169Ytterbium
Oxide pellets (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 solid 169Ytterbium
pellets (0.65 mm dia x 4.0 mm overall
length) doubly encapsulated. The inner
capsule (0.8 mm dia x 4.5 mm lg) is
titanium and the outer capsule (0.98 mm
dia x 5.9 mm long) is stainless steel. The
outer capsule is welded to a 7x7 stranded
stainless steel cable (0.9 mm dia x 2100
mm long). |
| Materials
Radionuclide
Encapsulation | 169Ytterbium
Stainless Steel | 169Ytterbium
Titanium & Stainless Steel |
| Cable | Stainless Steel | Stainless Steel |
| Performance
Dosimetry (TG43)
Dose Rate Const (λ)
Anisotropy (φav): | Configuration H Configuration P
1.17 cGy h-1 U-1
1.18 cGy h-1 U-1
0.94
0.94 | 1.18 cGy h-1 U-1
0.94 |
| 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 C64212
Applied for Louisiana Registration | ANSI N43.6 Class C64212 |
| 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
Compatibility with
Environment and | 169Ytterbium (half-life: 32.02 days) which
decays by electron capture with the
emission of characteristic photons and
electrons. The electrons are absorbed by
the titanium and stainless steel walls of
the source encapsulation. The principal
photon emissions are 50 and 58 keV x-
rays and a 63, 94, 111, 131, 177, 198,
260 and 308 keV gammas.
169Ytterbium is a radioactive material and
should be strictly controlled. | 169Ytterbium (half-life: 32.02 days) which
decays by electron capture with the
emission of characteristic photons and
electrons. The electrons are absorbed by
the titanium and stainless steel walls of
the source encapsulation. The principal
photon emissions are 50 and 58 keV x-
rays and a 63, 94, 111, 131, 177, 198,
260 and 308 keV gammas.
169Ytterbium is a radioactive material and
should be strictly controlled. |
| Other Devices | | |
| | 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 169Ytterbium source is radioactive,
and appropriate precautions must be
taken during handling to minimize
radiation exposure to personnel.
Personnel monitoring is required. | This 169Ytterbium source is radioactive,
and appropriate precautions must be
taken during handling to minimize
radiation exposure to personnel.
Personnel monitoring is required. |
| | This source should 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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Section 807.92(b)
Nonclinical Tests (1)
Physical Testing
The Model M23 source has been subjected to the tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO) Standard 2919, as referenced in the FDA "Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources" dated 2 August 2000.
Prototype sources were subjected to the tests specified in ANSI N43.6-2007 and ISO 2919-2012 and have equaled or exceeded the requirements corresponding to a classification of C53211, which is the requirement for brachytherapy sources. Th3 testing performed 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). 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 fatigue 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
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.