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.

Device Description

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.

AI/ML Overview

This document describes the premarket notification (510(k)) for the SPEC Model M23 169Ytterbium Brachytherapy Source, a device used for high-dose-rate brachytherapy. The submission demonstrates substantial equivalence to a predicate device (Implant Sciences Corp. Model HDR-4140) through nonclinical testing.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SPEC Model M23 Brachytherapy Source are primarily defined by adherence to established industry standards and mechanical performance requirements. The reported device performance is compared against these criteria.

Feature / Test Category	Acceptance Criteria (Standard / Threshold)	Reported Device Performance (SPEC Model M23)
Physical Testing (ANSI N43.6 & ISO 2919)	Equal to or exceeding requirements for classification C53211 (brachytherapy sources).	Prototype sources subjected to ANSI N43.6-2007 and ISO 2919-2012, and equaled or exceeded the requirements corresponding to a classification of C53211. This is stated to be equivalent to the physical testing of the predicate device.
Tensile Testing (Minimum Failure Load)	Minimum failure load of the source assembly welds greater than 5 times the maximum force applicable by the Varian GammaMed Plus Afterloader (16 N). This implies a minimum failure load > 80 N.	Minimum failure load of 85 N (19 lb), which is more than 5 times the maximum force (16 N, 3.6 lb) applied by the Varian GammaMed Plus Afterloader. This is stated to be equivalent to or better than the predicate device.
Tensile Fatigue Testing (Load A)	Withstand a tensile load in excess of 40 N (2.5 times the maximum force of the afterloader).	Prototype sources successfully withstood a tensile load in excess of 40 N (9 lb), which is more than 2.5 times the maximum force that can be applied by the Varian GammaMed Plus Afterloader.
Tensile Fatigue Testing (Load B)	Withstand ten sequential applications of a tensile load in excess of 16 N (the maximum load) of the afterloader.	Prototype sources successfully withstood ten sequential applications of a tensile load 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.
Tensile Fatigue Testing (Load C)	Withstand a final tensile load in excess of 40 N (2.5 times the maximum force of the afterloader) to failure of each weld. The minimum failure load should be greater than 5 times the maximum afterloader force.	Following the sequential applications, prototype sources withstood a final tensile load in excess of 40 N (9 lb), which is more than 2.5 times the maximum force. The minimum failure load was 84 N (19 lb), which is more than 5 times the maximum force.
Operational Testing (Curved Pathway Performance)	Successfully negotiate various "S" and "U" curves simulating applicator pathways, without damage to the M13 source assembly.	A prototype source assembly successfully negotiated all of these pathways (series of "S" and "U" curves with various radii, simulating GammaMed Plus Afterloader applicators). No damage to the M13 source assembly was observed.
Dosimetry (TG43)	Dose Rate Constant (λ) and Anisotropy (φav) deemed acceptable if similar to the predicate device's established values.	For Configuration H: λ = 1.17 cGy h-1 U-1, φav = 0.94. For Configuration P: λ = 1.18 cGy h-1 U-1, φav = 0.94. These values are very close to the predicate device's reported values (λ = 1.18 cGy h-1 U-1, φav = 0.94).
Sterility	Not required due to no direct patient contact.	"This source assembly never directly contacts the patient; sterility is not required."
Biocompatibility	Not applicable due to no direct patient contact; outer material (stainless steel) is biocompatible.	"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."
Chemical Safety	Not applicable due to no direct patient contact; outer material (stainless steel) 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."
Mechanical Safety Standard	Conformance to ANSI N43.6 Class C64212.	"ANSI N43.6 Class C64212 Applied for Louisiana Registration." (Implies conformance, as it's directly compared to the predicate device meeting this standard).
Radiation Safety	Appropriate precautions for handling, personnel monitoring, and use within shielded enclosures.	"[...] appropriate precautions must be taken during handling to minimize radiation exposure to personnel. Personnel monitoring is required. [...] should only be used within a properly shielded enclosure designed to maintain radiation dose rates outside the enclosure within regulatory limits." (These are operational considerations, not direct test results on the device itself, but are part of demonstrating safe use.)

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

Sample Size: The document mentions "Prototype sources" for physical, tensile, and operational testing. It does not specify the exact number of prototype sources used for each test. For example, "Prototype sources were subjected to the tests specified..." and "A prototype source assembly was subjected to a curved pathway performance test...".
Data Provenance: The data is generated from nonclinical, bench-top testing conducted by the manufacturer, Source Production & Equipment Co., Inc. There is no mention of human clinical data, animal data, or country of origin for such data. This testing appears to be conducted in-house or by a facility contracted by the manufacturer.

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

This section is not applicable as the evaluation involves nonclinical, physical, and mechanical performance testing, not diagnostic or interpretive tasks requiring expert ground truth establishment in the traditional sense (e.g., radiologists interpreting images). The "ground truth" here is objective physical measurement against defined standards and engineering principles.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. There is no subjective interpretation or diagnostic outcome that requires an adjudication method. The tests are objective measurements (e.g., tensile strength, adherence to dimensional requirements, successful navigation of pathways).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is a physical brachytherapy source, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant.

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

This section is not applicable. The device is a physical medical device, not an algorithm or AI system. Its performance is inherent in its design and manufacturing, evaluated through physical testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's evaluation is primarily based on:

Industry Standards: Compliance with recognized international and national standards such as ANSI N43.6 (American National Standard for Radioactive Materials-Industrial and Medical), ISO 2919 (Radiological protection – Sealed radioactive sources – Classification), and AAPM TG-43 (American Association of Physicists in Medicine Task Group No. 43).
Engineering Specifications: Specific mechanical thresholds (e.g., tensile strength exceeding a certain multiple of operational force) derived from engineering analysis of the device's operational environment and safety requirements.
Predicate Device Equivalence: Demonstrating that the new device's characteristics and performance are comparable to a legally marketed predicate device (Implant Sciences Corp. Model HDR-4140).

8. The sample size for the training set

This section is not applicable. This is a nonclinical submission for a physical device. There is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as point 8.

Summary

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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.

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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. 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)

K161396

Device Name

Source Production & Equipment Co., Inc. Model M23 169Ytterbium 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
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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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.

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)M23 169Ytterbium High Dose RateBrachytherapy Source	Implant Sciences Corp.HDR-4140 169Ytterbium High Dose RateBrachytherapy Source
Design	The source consists of solid 169YtterbiumOxide pellets (Configuration H: 0.6 mmdia x 3.5 mm long; Configuration P: 0.6mm dia x 2.0 mm long)) singlyencapsulated in stainless steel(Configuration H: 0.9 mm dia x 4.8 mmlong; Configuration P: 0.9 mm dia x 3.3mm long) and welded to a 7x7+4 strandedstainless steel cable (0.9 mm dia x 2100mm long).	The source consists of solid 169Ytterbiumpellets (0.65 mm dia x 4.0 mm overalllength) doubly encapsulated. The innercapsule (0.8 mm dia x 4.5 mm lg) istitanium and the outer capsule (0.98 mmdia x 5.9 mm long) is stainless steel. Theouter capsule is welded to a 7x7 strandedstainless steel cable (0.9 mm dia x 2100mm long).
MaterialsRadionuclideEncapsulation	169YtterbiumStainless Steel	169YtterbiumTitanium & Stainless Steel
Cable	Stainless Steel	Stainless Steel
PerformanceDosimetry (TG43)Dose Rate Const (λ)Anisotropy (φav):	Configuration H Configuration P1.17 cGy h-1 U-11.18 cGy h-1 U-10.940.94	1.18 cGy h-1 U-10.94
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 C64212Applied for Louisiana Registration	ANSI N43.6 Class C64212
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 DeliveredCompatibility withEnvironment and	169Ytterbium (half-life: 32.02 days) whichdecays by electron capture with theemission of characteristic photons andelectrons. The electrons are absorbed bythe titanium and stainless steel walls ofthe source encapsulation. The principalphoton 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 andshould be strictly controlled.	169Ytterbium (half-life: 32.02 days) whichdecays by electron capture with theemission of characteristic photons andelectrons. The electrons are absorbed bythe titanium and stainless steel walls ofthe source encapsulation. The principalphoton 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 andshould be strictly controlled.
Other Devices
	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 169Ytterbium source is radioactive,and appropriate precautions must betaken during handling to minimizeradiation exposure to personnel.Personnel monitoring is required.	This 169Ytterbium source is radioactive,and appropriate precautions must betaken during handling to minimizeradiation exposure to personnel.Personnel monitoring 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.