(181 days)
Not Found
No
The document describes a radioactive source for brachytherapy and does not mention any AI or ML components.
Yes
The device is used for treating selected localized tumors and is indicated for various medical applications such as interstitial, intracavitary, intraluminal, intraoperative, or surface application.
No
This device is a brachytherapy source used for treating localized tumors with radiation, not for diagnosing medical conditions.
No
The device description clearly states it is a "singly-encapsulated 192Iridium Brachytherapy Source" consisting of a "stainless steel capsule containing a solid radioactive 199 ridium pellet" attached to a "cable". This describes a physical, hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Description and Intended Use: The provided text clearly describes a radioactive source (192Iridium) used for brachytherapy, which is a form of radiation therapy where a radioactive source is placed inside or next to the area requiring treatment. This is an in vivo (within the living body) treatment, not an in vitro diagnostic test.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, laboratory procedures, or diagnostic information derived from testing specimens.
Therefore, based on the provided information, the SPEC Model M-19 Source Assembly is a therapeutic device used for radiation treatment, not an in vitro diagnostic device.
N/A
Intended Use / 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.
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.
Product codes
JAQ, KXK
Device Description
SPEC Model M-19 is a singly-encapsulated 192Iridium Brachytherapy Source. It consists of a stainless steel capsule containing 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
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.(b)
Classification. Class II.
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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.
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- (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.
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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
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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)
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Over-The-Counter Use
(Optional Format 1-2-96)