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.

Device Description

SPEC Model M15 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the SPEC Model M15 192Iridium High Dose Rate Brachytherapy Source. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness. Therefore, the study described is primarily comparative, showing that the new device meets established safety and performance standards equivalent to the predicate.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Predicate Device (Alpha-Omega Services, Inc. Model CSN0010-192) Performance	SPEC Model M15 Performance	Acceptance Criteria / Equivalence Standard
Design	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).	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).	Essentially identical design. Minor length difference in encapsulation (4.5 mm vs 4.8 mm) is considered equivalent.
Materials	Radionuclide: 192Iridium, Encapsulation: Stainless Steel, Cable: Stainless Steel	Radionuclide: 192Iridium, Encapsulation: Stainless Steel, Cable: Stainless Steel	Identical materials.
Performance Dosimetry (TG43)	Dose Rate Const (λ): 1.13 cGy h⁻¹ U⁻¹, Anisotropy (Φav): 0.95	Dose Rate Const (λ): 1.11 cGy h⁻¹ U⁻¹, Anisotropy (Φav): 0.97	Equivalent dosimetry characteristics based on Monte Carlo simulation in accordance with AAPM and ESTRO recommendations. The slight numerical difference is within expected ranges for equivalence.
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."	Not required (same as predicate).
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."	Not applicable, due to external contact only through biocompatible stainless steel (same as predicate).
Mechanical Safety	ANSI N43.6 Class C53211	ANSI N43.6 Class C53211, Applied for Louisiana Registration	Meets ANSI N43.6 Class C53211 (same as predicate). Physical testing confirmed this.
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."	Not applicable due to external contact only through stainless steel (same as predicate).
Energy Delivered	192Iridium (half-life: 73.81 days) decays by beta emission and electron capture with characteristic photons (67 keV x-rays, 201, 311, 467, 603 keV gammas). Betas and electrons absorbed by stainless steel capsule.	192Iridium (half-life: 73.81 days) decays by beta emission and electron capture with characteristic photons (67 keV x-rays, 201, 311, 467, 603 keV gammas). Betas and electrons absorbed by stainless steel capsule.	Identical radioactive properties and shielding (same as predicate).
Mechanical Performance (Tensile Strength)	Sufficient for intended application.	Minimum failure load > 10x max force of Nucletron microSelectron "Classic" afterloader. Cyclic test: after sequential loads > 10x max force, failure load > 10x max force.	Equivalent to or better than the predicate device. Demonstrated robust tensile strength exceeding operational requirements.
Operational Performance	Successfully negotiates pathways.	Successfully negotiated all "S" and "U" curves in Nucletron microSelectron "Classic" Afterloader without damage.	Equivalent to the physical testing of the predicate device; demonstrated compatibility with intended afterloader.
Standards Met	Mechanical: ANSI N43.6, Dosimetry: AAPM TG-43	Mechanical: ANSI N43.6, Dosimetry: AAPM TG-43	Device meets ANSI N43.6 for mechanical aspects and AAPM TG-43 for dosimetry, aligning with predicate device and regulatory guidance.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document refers to "Prototype sources" being subjected to tests. It does not specify an exact number of prototype sources used for each test (physical, tensile, operational). For the tensile cyclic test, it mentions "each prototype" was subjected to sequential loads, implying multiple prototypes were used, but an exact 'n' is not given.
Data Provenance: The tests were conducted by the manufacturer, Source Production & Equipment Co., Inc. (SPEC). The data is prospective as it involves new testing on the SPEC Model M15 prototypes specifically for establishing its performance. The country of origin for the data generation would be the United States, given SPEC's location in St. Rose, LA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This submission is a 510(k) for a physical medical device, not an AI/software device that requires human expert review for "ground truth" to evaluate diagnostic performance. Therefore, the concept of "experts" establishing ground truth in the context of diagnostic interpretations (e.g., radiologists reviewing images) is not applicable here.

The "ground truth" for this device's performance is based on established engineering and physics standards:

ANSI N43.6 (American National Standard)
ISO 2919 (International Organization for Standardization)
AAPM TG-43 (American Association of Physicists in Medicine Task Group 43) and ESTRO (European Society for Therapeutic Radiation Oncology) recommendations for dosimetry.

The experts involved would be the engineers and physicists who performed and analyzed these standardized tests and calculations, ensuring adherence to the specified methodologies. Their qualifications would be expertise in mechanical engineering, radiation physics, and relevant national/international standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this device does not involve subjective human interpretation or diagnostic decision-making that would require an adjudication method like 2+1 or 3+1. The tests yield objective measurements or pass/fail outcomes against predefined performance standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or decision-support AI where human readers interact with the device. The SPEC Model M15 is a physical brachytherapy source, and its performance is assessed through physical, mechanical, and dosimetric testing against established standards and comparison to a predicate device's specifications.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical radionuclide brachytherapy source, not an algorithm or AI system. Its performance is inherent to its physical properties and how it functions as part of a treatment system (e.g., with a remote afterloader). The nonclinical tests (physical, tensile, operational, dosimetry) serve as the "standalone" performance evaluation of the device itself.

7. Type of Ground Truth Used

The ground truth for evaluating the SPEC Model M15 is based on:

Established international and national standards (ANSI N43.6, ISO 2919, AAPM TG-43, ESTRO recommendations).
Physical performance characteristics of the predicate device (as defined in its 510(k) clearance and specifications).
Empirical measurements from laboratory testing (e.g., tensile strength, operational movement, Monte Carlo simulations for dosimetry).

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The device's performance is based on its physical design, manufacturing, and inherent properties of the radioactive material, all of which are validated through nonclinical testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

Summary

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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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(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

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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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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.

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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

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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)

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

Regulation Number and Section

§ 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.

TechnologicalCharacteristic	Source Production & Equipment Co.,Inc. (SPEC)M15 192Iridium High Dose RateBrachytherapy Source	Alpha-Omega Services, Inc.Model CSN0010-192K991571
Design	The source consists of a solid 192Iridiumpellet (0.6 mm dia x 3.5 mm long) singlyencapsulated in stainless steel (1.1 mmdia x 4.8 mm long) and welded to a 7x7stranded stainless steel cable (1.1 mm diax 2000 mm long).	The source consists of a solid 192Iridiumpellet (0.6 mm dia x 3.5 mm long) singlyencapsulated in stainless steel (1.1 mmdia x 4.5 mm long) and welded to a 7x7stranded stainless steel cable (1.1 mm diax 2000 mm long).
MaterialsRadionuclideEncapsulation	192IridiumStainless Steel	192IridiumStainless Steel
Cable	Stainless Steel	Stainless Steel
PerformanceDosimetry (TG43)Dose Rate Const ( $λ$ ).)Anisotropy ( $Φ$ av):	1.11 cGy h⁻¹ U⁻¹0.97	1.13 cGy h⁻¹ U⁻¹0.95
Sterility	This source assembly never directly	This source assembly never directly
	contacts the patient; sterility is notrequired.	contacts the patient; sterility is notrequired.
Biocompatibility	This source assembly never directlycontacts the patient; biocompatibilityassessment is not applicable. Theoutside of the entire assembly isfabricated from stainless steel, which is abiocompatible material.	This source assembly never directlycontacts the patient; biocompatibilityassessment is not applicable. Theoutside of the entire assembly isfabricated from stainless steel, which is abiocompatible material.
Mechanical Safety	ANSI N43.6 Class C53211Applied for Louisiana Registration	ANSI N43.6 Class C53211LA-0760-S-106-S
Chemical Safety	This source assembly never directlycontacts the patient; chemical safetyassessment is not applicable. The .outside of the entire assembly isfabricated from stainless steel, which iswill not chemically react with body tissue.	This source assembly never directlycontacts the patient; chemical safetyassessment is not applicable. Theoutside of the entire assembly isfabricated from stainless steel, which iswill not chemically react with body tissue.
Energy Delivered	192Iridium (half-life: 73.81 days) whichdecays by beta emission and electroncapture with the emission of characteristicphotons and electrons. The betas andelectrons are absorbed by the stainlesssteel wall of the source capsule. Theprincipal photon emissions are 67 keV x-rays and 201, 311, 467, and 603 keVgammas.	192Iridium (half-life: 73.81 days) whichdecays by beta emission and electroncapture with the emission of characteristic.photons and electrons. The betas andelectrons are absorbed by the stainlesssteel wall of the source capsule. Theprincipal photon emissions are 67 keV x-rays and 201, 311, 467, and 603 keVgammas.
Compatibility withEnvironment andOther Devices	192Iridium is a radioactive material andshould be strictly controlled.The source should only be used followingthe conditions and limitations specified bythe licensing authority (NRC or AgreementState).	192Iridium is a radioactive material andshould be strictly controlled.The source should only be used followingthe conditions and limitations specified bythe licensing authority (NRC or AgreementState).

	The source should be stored in a shieldedcontainer, either the remote afterloaderwith which it is used or the transportcontainer in which it is delivered.	The source should be stored in a shieldedcontainer, either the remote afterloaderwith which it is used or the transportcontainer in which it is delivered.
	If any source cannot be accounted for, theloss should be reported to the federal orstate licensing agency.	If any source cannot be accounted for, theloss should be reported to the federal orstate licensing agency.
	Store at normal room temperature.	Store at normal room temperature.
	When disposal is indicated, radioactivematerial should be transferred to anauthorized recipient; typically the sourcesupplier. Radioactive material shouldnever be disposed of in normal waste.	When disposal is indicated, radioactivematerial should be transferred to anauthorized recipient; typically the sourcesupplier. Radioactive material shouldnever be disposed of in normal waste.
Where Used	This source should only be used within aproperly shielded enclosure designed tomaintain radiation dose rates outside theenclosure within regulatory limits.	This source should only be used within aproperly shielded enclosure designed tomaintain radiation dose rates outside theenclosure within regulatory limits.
Standards Met
MechanicalDosimetry	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, andappropriate precautions must be takenduring handling to minimize radiationexposure to personnel. Personnelmonitoring is required.	This 192Iridium source is radioactive, andappropriate precautions must be takenduring handling to minimize radiationexposure to personnel. Personnelmonitoring is required.
	This source should only be used within aproperly shielded enclosure designed tomaintain radiation dose rates outside theenclosure within regulatory limits.	This source should only be used within aproperly shielded enclosure designed tomaintain radiation dose rates outside theenclosure within regulatory limits.
	In circumstances where emergencyoperations must be performed withinprotective barriers, the operator shoulduse proper applicators, maintain safeworking distances and work as rapidly assafely possible to minimize radiationexposure.	In circumstances where emergencyoperations must be performed withinprotective barriers, the operator shoulduse proper applicators, maintain safeworking distances and work as rapidly assafely possible to minimize radiationexposure.