← Product Code [JAQ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ) · K052947 # SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE (K052947) _Source Production & Equipment Co., Inc. · JAQ · Apr 19, 2006 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K052947 ## Device Facts - **Applicant:** Source Production & Equipment Co., Inc. - **Product Code:** [JAQ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ.md) - **Decision Date:** Apr 19, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.5700 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Therapeutic ## Indications for Use The intended use of SPEC Model M-19 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation. ## Device Story SPEC Model M-19 is a singly-encapsulated 192Iridium brachytherapy source; consists of solid radioactive 192Iridium pellet sealed in stainless steel capsule; attached to cable for manipulation by remote afterloading system. Used in clinical settings for temporary interstitial, intracavitary, intraluminal, intraoperative, or surface irradiation to treat localized tumors. Device provides radiation therapy; clinical decision-making relies on physician-directed treatment planning for cancer management. Benefits include targeted delivery of radiation to tumor sites. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to legally marketed predicate devices. ## Technological Characteristics Singly-encapsulated 192Iridium brachytherapy source; stainless steel capsule; solid radioactive 192Iridium pellet; cable attachment for remote afterloading system; maximum activity 12 Ci. ## Regulatory Identification A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories. ## Predicate Devices - Varian Medical Systems GammaMed 232 ([K030745](/device/K030745.md)) - Nucletron Corp. Model 105.002 ([K953946](/device/K953946.md)) - Alpha-Omega Services, Inc. Model CSN0010-192 ([K991571](/device/K991571.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "spec" in a stylized font. To the right of the "c" is a radiation symbol. The word and symbol are outlined in black. APS : 0 : 0 : # Section 5 510(k) Summary | Section 807.92(a) | K052947 | |---------------------------------|----------------------------------------------------------------------------------| | (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.: | to be Applied For | | 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 M-19 | #### (3) Legally Marketed Predicate Devices: Varian Medical Systems GammaMed 232, cleared under 510(k) number K030745 dated 12 March 2003, and Nucletron Corp. Model 105.002, cleared under 510(k) number K953946 dated 13 August 1996, and Alpha-Omega Services, Inc. Model CSN0010-192, cleared under 510(k) number K991571 dated 22 February 2000 Description of SPEC Model M-19 192 Iridium Brachytherapy Source: (4) > SPEC Model M-19 is a singly-encapsulated 1921ridium Brachytherapy Source. It consists of a stainless steel capsule containing a solid radioactive 199 ridium 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 M-19 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "spec" in a stylized font. To the right of the "c" is a radiation symbol. The word and the symbol are both outlined in black. - (6) Technological Characteristics: : SPEC Model M-19 192 tridium Brachytherapy Source is similar to the predicate high dose rate brachytherapy sources that utilize photons from 192Iridium. : 上 : {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 APR 1 9 2006 Mr. John J. Munro III Vice President Source Production & Equipment Co., Inc. 113 Teal Street ST. ROSE LA 70087 Re: K052947 Trade/Device Name: Model M-19 1921ridium Brachytherapy Source Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: JAQ and KXK Dated: March 10, 2006 Received: March 13, 2006 Dear Mr. Munro: 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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. Image /page/2/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo, the text "Protecting and Promoting Public Health" is written in a decorative font. The logo is circular and contains the letters "FDA" in a bold, stylized font. The text is centered and appears to be part of a larger document or poster. {3}------------------------------------------------ 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. 1f you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you done office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html Sincercly yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number: K052a47 Device Name: Source Production & Equipment Co., Inc. Model M-19 121ridium Brachytherapy Source Indications for Use: Source Production & Equipment Co., Inc. (SPEC) Model M-19 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intracavitary, intraluminal or 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. Dormit R. Legnon (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _ ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ### Concurrence of CDRH, Office of Device Evaluation (ODF.) Prescription Use X (Per 21 CFR 801.109) ()[ર Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K052947](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K052947) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com