Who is the manufacturer of SPEC MODEL M15?

Source Production & Equipment Co., Inc. filed the 510(k) submission for SPEC MODEL M15 (K132969).

What is the FDA product code for SPEC MODEL M15?

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 M15?

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

What are the predicate devices for SPEC MODEL M15?

Alpha-Omega Services, Inc. Model CSN0010-192 (K991571).

Who can help prepare an FDA 510(k) submission like SPEC MODEL M15?

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 M15

K132969 · Source Production & Equipment Co., Inc. · KXK · Jan 2, 2014 · Radiology

Device Facts

Record ID	K132969
Device Name	SPEC MODEL M15
Applicant	Source Production & Equipment Co., Inc.
Product Code	KXK · Radiology
Decision Date	Jan 2, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5730
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The Source Production & Equipment Co., Inc. (SPEC) Model M15 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intracavitary, intraluminal, intraoperative or surface application to treat selected tumors. This source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Nucletron microSelectron Classic High Dose Rate Remote Afterloader. The Model M15 source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with external beam radiation therapy.

Device Story

SPEC Model M15 is a singly-encapsulated Iridium-192 brachytherapy source. Input: radioactive Iridium-192 pellet sealed in stainless steel capsule welded to stranded stainless steel cable. Operation: source is manipulated by Nucletron microSelectron Classic remote afterloader to deliver high-dose-rate photon radiation to tumor sites. Used in clinical settings by radiation oncology staff. Output: ionizing radiation (photons) for cancer treatment. Clinical benefit: targeted tumor irradiation via interstitial, intracavitary, intraluminal, or surface application. Device is stored in shielded containers when not in use.

Clinical Evidence

No clinical data. Evidence consists of bench testing including physical testing (ANSI N43.6-2007, ISO 2919-2012), tensile load-to-failure testing, cyclic tensile testing, and operational performance testing in the Nucletron microSelectron Classic afterloader. Dosimetry was validated via Monte Carlo simulation per AAPM and ESTRO recommendations.

Technological Characteristics

Iridium-192 radioactive source; stainless steel encapsulation; 7x7 stranded stainless steel cable. Dimensions: 1.1 mm diameter x 4.8 mm length capsule. Energy: 67 keV x-rays and 201, 311, 467, 603 keV gammas. Mechanical classification: ANSI N43.6 Class C53211. Non-patient contacting; no biocompatibility or sterility requirements.

Indications for Use

Indicated for patients requiring temporary interstitial, intracavitary, intraluminal, intraoperative, or surface radiation therapy for tumors in sites including cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and sarcomas. For use with Nucletron microSelectron Classic HDR remote afterloader.

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

Alpha-Omega Services, Inc. Model CSN0010-192 (K991571)

Related Devices

K150895 — SPEC Model M16 · Source Production and Equipment Co., Inc. · Jun 19, 2015
K052947 — SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE · Source Production & Equipment Co., Inc. · Apr 19, 2006
K162573 — Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source · Source Production and Equipment Co., Inc. · Nov 4, 2016
K991571 — 10 CURIE IRDIUM 192, CSN00100-192 · Alpha-Omega Services, Inc. · Feb 22, 2000
K161395 — SPEC Model M13 · Source Production and Equipment Co., Inc. · Jul 6, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the text "K132969 Page 1 of 5 spec" in a handwritten style. The text "K132969" is at the top, followed by "Page 1 of 5" below it. The word "spec" is at the bottom in a larger, stylized font. There is a radiation symbol to the right of the word "spec". 510(k) Summary Section 807.92(a) | (1) Submitter | Source Production & Equipment Co., Inc. | |---------------|-----------------------------------------| | | 113 Teal Street | | | St. Rose, LA 70087 | | Tel: | 504.464.9471 | | Fax: | 504.467.7685 | Establishment Registration No.: 1000437833 Contact Person: John J. Munro III Vice President e-mail: johnm@spec150.com - (2) Device Name: | Classification Name: | Radionuclide Brachytherapy Source (892.5730) (90 KXK) | |-----------------------|-------------------------------------------------------| | Common or Usual Name: | Brachytherapy Source Assembly | | Proprietary Name: | SPEC Model M15 | - (3) Legally Marketed Predicate Device: Alpha-Omega Services, Inc. Model CSN0010-192, cleared under 510(k) number K991571 dated 22 February 2000 - Description of SPEC Model M15 1921ridium Brachytherapy Source: (4) SPEC Model M15 is a singly-encapsulated 194ridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 1931ridium pellet. The pellet is sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system. - (5) Intended Use The intended use of SPEC Model M15 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation. - Technological Characteristics: (6) SPEC Model M15 19eridium Brachytherapy Source is similar to the predicate high dose rate brachytherapy source that utilizes photons from 1921ridium.` {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "spec" in a stylized font. To the right of the word is a radiation symbol. The letters of the word "spec" are outlined in black. The radiation symbol is also black. | Technological Characteristic | Source Production & Equipment Co., Inc. (SPEC) M15 192Iridium High Dose Rate Brachytherapy Source | Alpha-Omega Services, Inc. Model CSN0010-192 K991571 | |---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design | 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). | 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 4.5 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 ( $Φ$ av): | 1.11 cGy h⁻¹ U⁻¹ 0.97 | 1.13 cGy h⁻¹ U⁻¹ 0.95 | | Sterility | This source assembly never directly | This source assembly never directly | | | contacts the patient; sterility is not required. | 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 LA-0760-S-106-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 principal photon emissions are 67 keV x- rays and 201, 311, 467, and 603 keV gammas. | 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. | | Compatibility with Environment and Other Devices | 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). | 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 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 | ANSI N43.6 | | | AAPM TG-43 | AAPM TG-43 | | Electrical Safety | Not Applicable | Not Applicable | | Thermal Safety | Not Applicable | Not Applicable | | Radiation Safety | This 192Iridium source is radioactive, 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. | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "spec" in a stylized font. To the right of the word is a symbol that looks like a radiation warning symbol. The word "spec" is written in all lowercase letters. The letters are rounded and have a thick outline. #### (7) Nonclinical Tests # Physical Testing The Model M15 source has been subjected to the tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO) Standard 2919, as referenced in the FDA "Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources" dated 2 August 2000. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "spec" in a bold, outlined font. To the right of the "c" is a radiation symbol. The word and symbol are in black and white. The image is simple and clear. Prototype sources were subjected to the tests specified in ANSI N43.6-2007 and ISO 2919-2012 and have equaled or exceeded the requirements corresponding to a classification of C53211, which is the requirement for brachytherapy sources. This is equivalent to the physical testing of the predicate device. # Tensile Testing Prototype sources were subjected to a tensile load to failure. The minimum failure load was found to be more than 10 times the maximum force that can be applied by the Nucletron microSelectron "Classic" remote afterloader. Additionally, prototypes were subjected to the conditions of a cvclic tensile test. After application of a tensile load in excess of 10 times the maximum load that can be applied by the Nucletron microSelectron "Classic" remote afterloader, each prototype was subjected to 10 sequential applications of tensile loads in excess of the maximum load that can be applied by the Nucletron microSelectron "Classic". After these sequential loads, each sample was subjected to a tensile test to failure. The tensile load at failure was found to be more than 10 times the maximum force that can be applied by the Nucletron microSelectron "Classic" remote afterloader. It is concluded that that the tensile strength of this source assemble is sufficient for its intended application. This is equivalent to or better than the tensile testing of the predicate device. # Operational Testing A prototype source assembly was subjected to a performance test in a Nucletron microSelectron "Classic" Afterloader, consisting of driving the source cable through a series of "S" and "U" curves with a variety of radii which simulate the various pathways of applicators used with the Nucletron microSelectron "Classic". The source capsule and cable successfully negotiated all of these pathways. There was no damage to the M15 source assembly. This is equivalent to the physical testing of the predicate device. # Dosimetry The dose distribution around the Model M15 source was calculated by Monte Carlo simulation in accordance with the recommendations of the American Association of Physicists in Medicine and the European Society for Therapeutic Radiation Oncology.1 This is equivalent to the dosimetry of the predicate device. - Clinical Tests (8) Not Applicable {4}------------------------------------------------ K132969 Page 5 of 5 spec * #### Conclusions (ਰ) The results of the nonclinical physical, tensile, operational tests and the dosimetric analysis, demonstrate that the SPEC Model M15 High Dose Rate Brachytherapy Source is as safe, as effective, and performs as well or better than the legally marketed predicate device, Alpha-Omega Services, Inc. Model CSN0010-192. 1 Perez-Calatayud J, Ballester F, Das RK, Dewerd LA, Ibbott GS, Meigooni AS, Ouhib Z, Rivard MJ, Sloboda RS, Williamson JF, Dose calculation for photon-emitting brachytherapy sources with average energy higher than 50 keV: report of the AAPM and ESTRO, Med Phys. 2012 May;39(5):2904-റു {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 2, 2014 Source Production & Equipment Co., Inc. % Ms. Kelley Richardt Regulatory and Quality Manager 113 Teal Street SAINT ROSE LA 70087 Re: K132969 Trade/Device Name: SPEC Model M-15 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: December 2, 2013 Received: December 4, 2013 Dear Ms. Richardt: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (2 ) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {6}------------------------------------------------ Page 2-Ms. Richardt If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.cov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Michael D. O'Hara for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. 510(k) Number (if known) K132969 ### Device Name Source Production and Equipment Co. Model M15 1921ridium High Dose Rate Brachytherapy Source #### Indications for Use (Describe) The Source Production & Equipment Co., Inc. (SPEC) Model M15 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intracavitary, intraluminal, intraoperative or surface application to treat selected tumors. This source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Nucletron microSelectron Classic High Dose Rate Remote Afterloader. The Model M15 source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with external beam radiation therapy. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpant C) # PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED. | FOR FDA USE ONLY | |-------------------------| |-------------------------| | Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Mechal D. O'Hara | |------------------------------------------------------------------------------|------------------| |------------------------------------------------------------------------------|------------------| FORM FDA 3881 (9/13) PSC Publishing Services ( 101 ) 441-67 at

SPEC MODEL M15

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

SPEC MODEL M15

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Welcome

Check your email

Welcome!