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.

Device Description

SPEC Model M16 is a singly-encapsulated 192Iridium Brachytherapy Source. It consists of 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 is a 510(k) premarket notification for a medical device (SPEC Model M16 ¹⁹²Iridium Brachytherapy Source) and does not contain information about acceptance criteria and a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or a clinical outcome.

Instead, this document focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (SPEC Model M15) through non-clinical testing. The "acceptance criteria" discussed are related to physical and mechanical properties and dosimetry, not diagnostic performance or clinical effectiveness studies in the context of AI/software as a medical device.

Therefore, I cannot extract the requested information (points 1-9) in the format you provided because the document describes a different type of device and regulatory submission.

Specifically:

There's no mention of a "device performance" that would typically be reported for an AI/diagnostic device (e.g., sensitivity, specificity).
There's no test set, data provenance, ground truth, experts, adjudication methods, MRMC studies, or standalone performance evaluation in the context of an AI/diagnostic device.
The "training set" and "ground truth for the training set" are not applicable to this type of physical brachytherapy source.

The document describes the following non-clinical tests and their "acceptance criteria" in a general sense:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Physical Device):

Acceptance Criterion (Standard)	Reported Device Performance (SPEC Model M16)
Physical Testing (ANSI N43.6, ISO 2919)	Equaled or exceeded requirements for classification C53211 (same as predicate device).
Tensile Testing	Withstood 294 N (66 lb) without failure (more than 17x max force of afterloader). Withstood tensile fatigue tests (107 N > 6x max force; 10 sequential applications of >53 N > 3x max load; then 294 N without failure). Concluded sufficient for intended application (equivalent to or better than predicate).
Operational Testing	Successfully negotiated "S" and "U" curves in a Best Medical Afterloader, simulating various applicator pathways. No damage to source assembly (equivalent to predicate).
Dosimetry (AAPM TG-43, ESTRO)	Dose distribution calculated by Monte Carlo simulation in accordance with recommendations. Dose Rate Constant ($\lambda$): 1.11 cGy h⁻¹ U⁻¹ Anisotropy ($\phi$ av): 0.97 (Equivalent to predicate device).
Biocompatibility	Not applicable as source never directly contacts patient; outside is stainless steel (biocompatible material).
Sterility	Not required as source never directly contacts patient.
Chemical Safety	Not applicable as source never directly contacts patient; outside is stainless steel, will not chemically react with body tissue.
Radiation Safety	Adherence to appropriate precautions during handling to minimize radiation exposure to personnel, personnel monitoring required, use within properly shielded enclosure within regulatory limits, emergency operations precautions (equivalent to predicate).
Compatibility with Environment & Other Devices	Source is radioactive material, strictly controlled, used with specified conditions and limitations by licensing authority, stored in shielded container, loss reported to agency, stored at normal room temperature, disposed of by authorized recipient (equivalent to predicate).

Points 2-9 (Not Applicable as per document content):

Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical engineering and physics tests on prototype devices, not a test set for diagnostic accuracy with patient data.
Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth in this context refers to physical material properties and engineering standards, not expert medical opinion on patient data.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not a diagnostic device involving human readers.
If a standalone performance was done: Not applicable in the context of AI/diagnostic software. The performance mentioned is the physical and dosimetric performance of the source itself.
The type of ground truth used: For physical/mechanical tests, the "ground truth" is adherence to established engineering standards (ANSI N43.6, ISO 2919) and physical principles. For dosimetry, it's compliance with established calculation methodologies (AAPM TG-43, ESTRO).
The sample size for the training set: Not applicable. This is not a machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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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.

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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

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K150895

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)

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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K150895

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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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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

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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

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.

Technological	Source Production & Equipment Co.,Inc. (SPEC)
Characteristic	M16 192Iridium High Dose RateBrachytherapy Source	M15 192Iridium High Dose RateBrachytherapy Source
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 1800 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 ( $ϕ$ av):	1.11 cGy h-1 U-10.97	1.11 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, whichwill 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, whichwill 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 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.
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	The source should only be used followingthe conditions and limitations specified bythe 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 afterloaderwith which it is used or the transportcontainer in which it is delivered.	container, 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 32 ridium source is radioactive, andappropriate precautions must be takenduring handling to minimize radiationexposure to personnel. Personnelmonitoring is required.	This 192 ridium 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.