Source Production & Equipment Co., Inc. Model M13 192Iridium Brachytherapy Source, with individual activity up to 12 Ci, is indicated for temporary interstital, intraluminal, intraoperative or surface application to treat selected localized turnors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with external beam radiation therapy.

Device Description

Source Production & Equipment Co., Inc. Model M13 192 ridium Brachytherapy Source is a sinqly-encapsulated 1921ridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 1921ridium pellet is sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: the Source Production & Equipment Co., Inc. Model M13 192Iridium Brachytherapy Source. This device is a radionuclide brachytherapy source used for targeted cancer treatment.

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to recognized standards and performance metrics compared to a legally marketed predicate device (Source Production & Equipment Co., Inc. Model M15).

Test/Characteristic	Acceptance Criteria (Standard / Predicate Equivalence)	Reported Device Performance (Model M13)
Physical Testing	- ANSI N43.6 Class C53211	- Equaled or exceeded Class C53211 requirements after testing.
	- ISO 2919	- Equaled or exceeded requirements of ISO 2919 after testing.
	- Equivalent to predicate device (SPEC Model M15)	- Equivalent to the physical testing of the predicate device.
Tensile Testing	- Minimum failure load > 5 times maximum force of afterloader (16 N)	- Minimum failure load of 85 N (19 lb), which is > 5 times 16 N.
	- Tensile fatigue: withstands loads > 2.5 times max afterloader force (40 N)	- Withstood tensile load > 40 N after multiple cycles.
	- Tensile fatigue: withstands loads > max afterloader force (16 N)	- Withstood ten sequential applications of tensile load > 16 N.
	- Final weld failure load > 5 times max afterloader force (16 N)	- Minimum failure load of 84 N (19 lb) for welds, which is > 5 times 16 N.
	- Equivalent to or better than predicate device (SPEC Model M15)	- Equivalent to or better than the tensile testing of the predicate device.
Operational Testing (Curved Pathway)	- Successfully negotiates "S" and "U" curves simulating applicators.	- Source capsule and cable successfully negotiated all pathways.
	- No damage to source assembly.	- No damage to the M13 source assembly.
	- Equivalent to physical testing of predicate device.	- Equivalent to the physical testing of the predicate device.
Operational Testing (Endurance)	- Performs a minimum number of exposure/retract cycles without failure.	- Performed > 35,000 exposure/retract cycles.
	- No failure of source cable, capsule, or connection.	- No failure of source cable, capsule, or connection.
	- Equivalent to physical testing of predicate device.	- Equivalent to the physical testing of the predicate device.
Dosimetry	- Calculated by Monte Carlo simulation.	- Calculated by Monte Carlo simulation.
	- In accordance with AAPM and ESTRO recommendations.	- In accordance with AAPM and ESTRO recommendations.
	- Equivalent to predicate device (SPEC Model M15)	- Equivalent to the dosimetry of the predicate device.
Materials (Radionuclide, Encapsulation, Cable)	- 192Iridium; Stainless Steel; Stainless Steel	- 192Iridium; Stainless Steel; Stainless Steel
Sterility	- Not required (device never directly contacts patient).	- Not required.
Biocompatibility	- Not applicable (device never directly contacts patient); external stainless steel is biocompatible.	- Not applicable; external stainless steel is a biocompatible material.
Chemical Safety	- Not applicable (device never directly contacts patient); external stainless steel is inert.	- Not applicable; external stainless steel will not chemically react with body tissue.
Energy Delivered	- 192Iridium decay with characteristic photons/electrons, betas/electrons absorbed by stainless steel.	- Identical description to predicate: 192Iridium decay, betas/electrons absorbed. Principal photon emissions (67, 201, 311, 467, 603 keV).
Compatibility with Environment & Other Devices	- Strict control of radioactive material; use per licensing authority; shielded storage; reporting loss; normal room temp storage; authorized disposal.	- Identical description to predicate for all points.
Where Used	- Within properly shielded enclosure to maintain regulatory limits.	- Identical description to predicate.
Standards Met	- Mechanical: ANSI N43.6; Dosimetry: AAPM TG-43	- ANSI N43.6; AAPM TG-43
Electrical/Thermal Safety	- Not Applicable	- Not Applicable
Radiation Safety	- Appropriate precautions, personnel monitoring, shielded enclosure, emergency operations.	- Identical description to predicate for all points.

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document refers to "Prototype sources" and "A prototype source assembly" for the nonclinical tests. This implies a small sample size, likely one or a few units, manufactured specifically for these rigorous engineering tests. The exact number is not explicitly stated.
Data Provenance: The tests are described as nonclinical tests conducted on prototype devices. The document does not specify the country of origin of the data, but given the company is US-based (Saint Rose, LA), it's highly probable the testing was conducted in the US or by a US-affiliated lab. These are prospective tests performed specifically to evaluate the new device model.

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

This category is not applicable in the context of this 510(k) submission.

This device is a physical medical device (a brachytherapy source), not an AI/software device that requires human expert interpretation for "ground truth" establishment in a test set.
The "ground truth" for this device's performance is established through physical measurements and engineering tests against industry standards (ANSI, ISO) and comparison to an established predicate device. For example, tensile strength is measured objectively with equipment, not adjudicated by an expert.
Dosimetry involves Monte Carlo simulations, which are computational models, and adherence to physics guidelines (AAPM, ESTRO).

4. Adjudication Method for the Test Set

This is not applicable. As explained above, the tests are objective engineering and physics evaluations, not subjective clinical assessments requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI algorithms which assess how AI impacts the performance of human readers. This device is a therapeutic source, and its evaluation focuses on its physical and dosimetric properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in essence. The entire submission details the standalone performance of the device itself and its components (source, cable, encapsulation) without human intervention in determining its core functional characteristics. The "performance" refers to its physical integrity (tensile strength, endurance, pathway negotiation) and its radiation dose distribution (dosimetry), which are intrinsic properties of the device, independent of a human operator's direct "performance interpretation" during testing. While a human initiates tests, the results themselves are objective measurements of the device's capabilities.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established through:

Objective Engineering Standards: Adherence to established standards like ANSI N43.6 and ISO 2919 for physical integrity.
Physics Principles: Use of Monte Carlo simulation and adherence to guidelines from organizations like AAPM and ESTRO for dosimetry.
Predicate Device Equivalence: Direct comparison of technological characteristics and performance test results to a legally marketed predicate device (SPEC Model M15) to demonstrate substantial equivalence. This is the primary method of evaluation for 510(k) submissions.

8. The Sample Size for the Training Set

This is not applicable. This is a physical brachytherapy source, not an AI algorithm that requires a "training set" of data. The device itself is manufactured, and its performance characteristics are tested against established criteria.

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

This is not applicable. As mentioned, there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 13, 2016

Source Production and Equipment Co.,Inc. % Ms. Kelley Richardt Regulatory and Quality Manager 113 Teal Street SAINT ROSE LA 70087

Re: K161395

Trade/Device Name: Source Production and Equipment Co., Inc. Model M13 1991ridium Brachytherapy Source Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: May 16, 2016

Dear Ms. Richardt:

Received: May 19, 2016

This letter corrects our substantially equivalent letter of July 6, 2016.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161395

Device Name

Source Production & Equipment Co., Inc. Model M13 192Iridium Brachytherapy Source

Indications for Use (Describe)

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)

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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 (2) Device Name:
- Radionuclide Brachytherapy Source (892.5730) (90 KXK) Classification Name: Brachytherapy Source Assembly Common or Usual Name: Proprietary Name: Source Production & Equipment Co., Inc. Model M13 192 Iridium Brachytherapy Source
(3) Legally Marketed Predicate Device:

Source Production & Equipment Co., Inc. Model M15, cleared under 510(k) number K132969 dated 02 January 2014

Description of Source Production & Equipment Co., Inc. Model M13 192 ridium (4) Brachytherapy Source:
Source Production & Equipment Co., Inc. Model M13 192 ridium Brachytherapy Source is a sinqly-encapsulated 1921ridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 1921ridium pellet is sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.
(5) Intended Use
The intended use of Source Production & Equipment Co., Inc. Model M13 1991ridium Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.

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(6) Technological Characteristics:
Source Production & Equipment Co., Inc. Model M13 192ridium Brachytherapy Source is similar to the predicate high dose rate brachytherapy source that utilizes photons from 192 Iridium.

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Section 807.92(b)

(1) Nonclinical Tests

Physical Testing

The Model M13 source has been subjected to the tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO) Standard 2919, as referenced in the FDA "Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources" dated 2 August 2000.

Prototype sources were subiected to the tests specified in ANSI N43.6-2007 and ISO 2919-2012 and have equaled or exceeded the requirements corresponding to a classification of C53211, which is the requirement for brachytherapy sources. This is equivalent to the physical testing of the predicate device.

Tensile Testing

Prototype sources were subiected to a tensile load to failure with the minimum failure load of 85 N (19 lb). The maximum force that can be applied by the Varian GammaMed Plus Afterloader is 16 N (3.6 lb). Therefore, this test load was more than 5 times the maximum force that can be applied by the Varian GammaMed Plus Afterloader.

In addition, prototypes were subjected to a series of tensile fatique tests consisting of:

a tensile load in excess of 40 N (9 lb), which is more than 2.5 times the maximum . force than can be applied to the cable by the Varian GammaMed Plus Afterloader
ten sequential applications of a tensile load of in excess of 16 N (3.6 lbs) which is . more than the maximum load that can be applied by the Varian GammaMed Plus Afterloader, and then
a tensile load in excess of 40 N (9 lb), which is more than 2.5 times the maximum ● force than can be applied to the cable by the Varian GammaMed Plus Afterloader
. and finally a tensile load to failure of each of the welds of the source assembly, where the the minimum failure load was 84 N (19 lb) which is more than 5 times the maximum force that can be applied by the Varian GammaMed Plus Afterloader.

It is concluded that that the tensile strength of this source assemble is sufficient for its intended application. This is equivalent to or better than the tensile testing of the predicate device.

Operational Testing

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Image /page/7/Picture/0 description: The image shows the word "spec" in a stylized font, with each letter outlined in black. To the right of the word, there is a radiation symbol, also in black. The word and the symbol are the only elements in the image, and they are set against a white background. The overall design is simple and graphic.

A prototype source assembly was subjected to a curved pathway performance test consisting of driving the source cable through a series of "S" and "U" curves with a variety of radii which simulate the various pathways of applicators used with the GammaMed Plus Afterloader. The source capsule and cable successfully negotiated all of these pathways. There was no damage to the M13 source assembly.

Subsequently, the same source assembly was subjected to an endurance performance test in a simulated GammaMed Plus Afterloader, where the source assembly performed more than 35,000 exposure/retract cycles. As a result of these tests, there was no failure of the source cable, the source capsule or the connection of the source capsule to the source cable.

This is equivalent to the physical testing of the predicate device.

Dosimetry

The dose distribution around the Model M13 source was calculated by Monte Carlo simulation in accordance with the recommendations of the American Association of Physicists in Medicine and the European Society for Therapeutic Radiation Oncology. 1 This is equivalent to the dosimetry of the predicate device.

(2) Clinical Tests
Not Applicable
(3) Conclusions
The results of the nonclinical physical, tensile, operational tests and the dosimetric analysis, demonstrate that the SPEC Model M13 High Dose Rate Brachytherapy Source is as safe, as effective, and performs as well or better than the leqally marketed predicate device, SPEC Model M15 High Dose Rate Brachytherapy Source.

1 Perez-Calatayud J, Ballester F, Das RK, Dewerd LA, Ibbott GS, Meigooni AS, Ouhib Z, Rivard MJ, Sloboda RS, Williamson JF, Dose calculation for photon-emitting brachytherapy sources with average energy higher than 50 keV: report of the AAPM and ESTRO, Med Phys. 2012 May;39(5):2904-29

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)M13 192Iridium High Dose RateBrachytherapy Source	Source Production & Equipment Co.,Inc. (SPEC)M15 192Iridium High Dose RateBrachytherapy Source
Design	The source consists of a solid 192Iridiumpellet (Configuration H: 0.6 mm dia x 3.5mm long; Configuration P: 0.6 mm dia x2.0 mm long)) singly encapsulated instainless steel (Configuration H: 0.9 mmdia x 4.8 mm long; Configuration P: 0.9mm dia x 3.3 mm long) and welded to a7x7+4 stranded stainless steel cable (0.9mm dia x 2100 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 4.8 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 (φav):	Configuration H1.11 cGy h-1 U-10.97	Configuration P1.12 cGy h-1 U-10.97
Sterility	This source assembly never directlycontacts the patient; sterility is notrequired.	This source assembly never directlycontacts 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 C53211Louisiana Sealed Source RegistrationLA-0612-S-117-S
Chemical Safety	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.	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. The	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. The
	principal photon emissions are 67 keV x-rays and 201, 311, 467, and 603 keVgammas.	principal 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.	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 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 MetMechanicalDosimetry	ANSI N43.6AAPM TG-43	ANSI N43.6AAPM 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.