Who is the manufacturer of SPEC Model M13?

Source Production and Equipment Co., Inc. filed the 510(k) submission for SPEC Model M13 (K161395).

What is the FDA product code for SPEC Model M13?

KXK. It is classified under 21 CFR 892.5730 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SPEC Model M13?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SPEC Model M13?

Source Production & Equipment Co., Inc. Model M15 (K132969).

Who can help prepare an FDA 510(k) submission like SPEC Model M13?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SPEC Model M13

K161395 · Source Production and Equipment Co., Inc. · KXK · Jul 6, 2016 · Radiology

Device Facts

Record ID	K161395
Device Name	SPEC Model M13
Applicant	Source Production and Equipment Co., Inc.
Product Code	KXK · Radiology
Decision Date	Jul 6, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5730
Device Class	Class 2
Attributes	Therapeutic

Indications for 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.

Device Story

Model M13 192Iridium Brachytherapy Source is a singly-encapsulated radioactive source used in high dose rate (HDR) brachytherapy. The device consists of a solid 192Iridium pellet sealed in a stainless steel capsule, welded to a stranded stainless steel cable. It is designed for manipulation by a remote afterloading system (e.g., Varian GammaMed Plus). The source emits photons for localized tumor treatment. It is used in clinical settings by trained personnel within shielded enclosures. The device provides targeted radiation to treat various cancers, including those of the cervix, prostate, and breast. It is intended for temporary application, allowing for precise dose delivery to the tumor site while minimizing exposure to surrounding healthy tissue.

Clinical Evidence

No clinical data. Evidence is based on bench testing, including physical, tensile, and operational performance testing, and dosimetric analysis. Prototype sources met ANSI N43.6-2007 and ISO 2919-2012 standards (Classification C53211). Tensile testing demonstrated failure loads >85 N (exceeding maximum afterloader force by >5x). Operational testing confirmed successful navigation of curved pathways and endurance over 35,000 cycles. Dosimetry was validated via Monte Carlo simulation.

Technological Characteristics

192Iridium radioactive source; stainless steel encapsulation and 7x7+4 stranded stainless steel cable. Dimensions: Configuration H (0.9mm x 4.8mm capsule), Configuration P (0.9mm x 3.3mm capsule). Energy source: 192Iridium (73.81-day half-life) emitting photons (67 keV x-rays; 201, 311, 467, 603 keV gammas). Standards: ANSI N43.6, ISO 2919, AAPM TG-43. Non-contact device; no sterilization required. Mechanical safety: ANSI N43.6 Class C53211.

Indications for Use

Indicated for temporary interstitial, intraluminal, intraoperative or surface application to treat selected localized tumors. Used as primary treatment for anatomical sites including cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast, and for sarcomas and intraoperative radiation therapy. May be used concurrently with or following external beam radiation therapy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Source Production & Equipment Co., Inc. Model M15 (K132969)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) 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. | 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." {3}------------------------------------------------ Image /page/3/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, set against a white background. The overall design is simple and graphic. # 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "spec" in a bold, sans-serif font. To the right of the word is a radiation symbol. The word and symbol are both outlined in black, with a white fill. - (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. | Technological Characteristic | Source Production & Equipment Co., Inc. (SPEC) M13 192Iridium High Dose Rate Brachytherapy Source | Source Production & Equipment Co., Inc. (SPEC) M15 192Iridium High Dose Rate Brachytherapy Source | |-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design | The source consists of a solid 192Iridium pellet (Configuration H: 0.6 mm dia x 3.5 mm long; Configuration P: 0.6 mm dia x 2.0 mm long)) singly encapsulated in stainless steel (Configuration H: 0.9 mm dia x 4.8 mm long; Configuration P: 0.9 mm dia x 3.3 mm long) and welded to a 7x7+4 stranded stainless steel cable (0.9 mm dia x 2100 mm long). | The source consists of a 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). | | Materials Radionuclide Encapsulation | 192Iridium Stainless Steel | 192Iridium Stainless Steel | | Cable | Stainless Steel | Stainless Steel | | Performance Dosimetry (TG43) Dose Rate Const (λ) Anisotropy (φav): | Configuration H 1.11 cGy h-1 U-1 0.97 | Configuration P 1.12 cGy h-1 U-1 0.97 | | Sterility | This source assembly never directly contacts the patient; sterility is not required. | This source assembly never directly contacts the patient; sterility is not required. | | Biocompatibility | This source assembly never directly contacts the patient; biocompatibility assessment is not applicable. The outside of the entire assembly is fabricated from stainless steel, which is a biocompatible material. | This source assembly never directly contacts the patient; biocompatibility assessment is not applicable. The outside of the entire assembly is fabricated from stainless steel, which is a biocompatible material. | | Mechanical Safety | ANSI N43.6 Class C53211 Applied for Louisiana Registration | ANSI N43.6 Class C53211 Louisiana Sealed Source Registration LA-0612-S-117-S | | Chemical Safety | This source assembly never directly contacts the patient; chemical safety assessment is not applicable. The outside of the entire assembly is fabricated from stainless steel, which is will not chemically react with body tissue. | This source assembly never directly contacts the patient; chemical safety assessment is not applicable. The outside of the entire assembly is fabricated from stainless steel, which is will not chemically react with body tissue. | | Energy Delivered | 192Iridium (half-life: 73.81 days) which decays by beta emission and electron capture with the emission of characteristic photons and electrons. The betas and electrons are absorbed by the stainless steel wall of the source capsule. The | 192Iridium (half-life: 73.81 days) which decays by beta emission and electron capture with the emission of characteristic photons and electrons. The betas and electrons are absorbed by the stainless steel wall of the source capsule. The | | | principal photon emissions are 67 keV x- rays and 201, 311, 467, and 603 keV gammas. | principal photon emissions are 67 keV x- rays and 201, 311, 467, and 603 keV gammas. | | Compatibility with Environment and Other Devices | 192Iridium is a radioactive material and should be strictly controlled. | 192Iridium is a radioactive material and should be strictly controlled. | | | The source should only be used following the conditions and limitations specified by the licensing authority (NRC or Agreement State). | The source should only be used following the conditions and limitations specified by the licensing authority (NRC or Agreement State). | | | The source should be stored in a shielded container, either the remote afterloader with which it is used or the transport container in which it is delivered. | The source should be stored in a shielded container, either the remote afterloader with which it is used or the transport container in which it is delivered. | | | If any source cannot be accounted for, the loss should be reported to the federal or state licensing agency. | If any source cannot be accounted for, the loss should be reported to the federal or state licensing agency. | | | Store at normal room temperature. | Store at normal room temperature. | | | When disposal is indicated, radioactive material should be transferred to an authorized recipient, typically the source supplier. Radioactive material should never be disposed of in normal waste. | When disposal is indicated, radioactive material should be transferred to an authorized recipient, typically the source supplier. Radioactive material should never be disposed of in normal waste. | | Where Used | This source should only be used within a properly shielded enclosure designed to maintain radiation dose rates outside the enclosure within regulatory limits. | This source should only be used within a properly shielded enclosure designed to maintain radiation dose rates outside the enclosure within regulatory limits. | | Standards Met Mechanical Dosimetry | ANSI N43.6 AAPM TG-43 | ANSI N43.6 AAPM TG-43 | | Electrical Safety | Not Applicable | Not Applicable | | Thermal Safety | Not Applicable | Not Applicable | | Radiation Safety | This 192Iridium source is radioactive, and appropriate precautions must be taken during handling to minimize radiation exposure to personnel. Personnel monitoring is required. | This 192Iridium source is radioactive, and appropriate precautions must be taken during handling to minimize radiation exposure to personnel. Personnel monitoring is required. | | | This source should only be used within a properly shielded enclosure designed to maintain radiation dose rates outside the enclosure within regulatory limits. | This source should only be used within a properly shielded enclosure designed to maintain radiation dose rates outside the enclosure within regulatory limits. | | | In circumstances where emergency operations must be performed within protective barriers, the operator should use proper applicators, maintain safe working distances and work as rapidly as safely possible to minimize radiation exposure. | In circumstances where emergency operations must be performed within protective barriers, the operator should use proper applicators, maintain safe working distances and work as rapidly as safely possible to minimize radiation exposure. | {5}------------------------------------------------ Image /page/5/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 black radiation symbol. The word and the symbol are the only elements in the image, set against a white background. The overall design is simple and graphic. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "spec" in a bold, outlined font. To the right of the word "spec" is a radiation symbol. The word "spec" is written in all lowercase letters. The radiation symbol is black. #### 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 {7}------------------------------------------------ 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

SPEC Model M13

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