(20 days)
No
The summary describes a modified brachytherapy device for delivering radiation, focusing on mechanical and functional changes (reducing channels). There is no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
Explanation: The device is described as a high-dose-rate remotely controlled afterloading brachytherapy system for the treatment of breast cancer and other cancers, directly indicating its therapeutic purpose.
No
Explanation: The device is described as a high-dose-rate remotely controlled afterloading brachytherapy system for cancer treatment, which delivers radiation rather than diagnosing conditions.
No
The device description clearly describes a hardware device (GammaMed Plus) that has been modified, and it manipulates a radioactive source. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "high-dose-rate remotely controlled afterloading brachytherapy for the treatment of breast cancer and other cancers." This describes a therapeutic procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device description details a system that delivers radiation to tissue and organs within or on a patient. This is a treatment delivery system, not a diagnostic device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MammoSource device is a therapeutic device used to treat cancer.
N/A
Intended Use / Indications for Use
MammoSource is indicated for high-dose-rate remotely controlled afterloading brachytherapy for the treatment of breast cancer and other cancers that can be treated with a single channel HDR system.
Product codes
JAQ
Device Description
The GammaMed Plus device has been modified to reduce the number of channels from 24 channels to one channel that will simplify the device and make the MammoSource ideal for treating breast tumors with the MammoSite RTS applicators, K011690 and K030558, as well as other cancers where a single channel HDR system would be useful. The system is designed to provide a predetermined dose of radiation to tissue and organs by means of manipulating a radioactive source from a shielded position within in the device into a catheter, applicator, or needle, which has been placed within or on a patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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.
0
MAR 2 2 2004
510(k) Summary
The following information is provided following the format of 21 CFR 807.92 for the MammoSource High Dose Rate (HDR) Afterloader:
- Varian Medical Systems, Inc., Submitter: 1. 3100 Hansen Way M/S E-110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: (650) 424-5731 Fax: (650) 842-5040 Email: vy.tran@varian.com Date: March 1, 2003
-
- Device Name: MammoSource High Dose Rate (HDR) Remote Afterloader
| Classification Name and No: | System, Applicator, Radionuclide, Remote-Controlled |
|---|---|
| 21 CFR §892.5700 | |
| Class II | |
| Product Code: JAQ | |
| Common/Usual Name: | MammoSource HDR Remote Afterloader |
| Proprietary Name: | MammoSource HDR Remote Afterloader |
-
- Predicate Device: GammaMed plus HDR Remote Afterloader, K983436
-
- Device Description: The GammaMed Plus device has been modified to reduce the number of channels from 24 channels to one channel that will simplify the device and make the MammoSource ideal for treating breast tumors with the MammoSite RTS applicators, K011690 and K030558, as well as other cancers where a single channel HDR system would be useful. The system is designed to provide a predetermined dose of radiation to tissue and organs by means of manipulating a radioactive source from a shielded position within in the device into a catheter, applicator, or needle, which has been placed within or on a patient.
- న్. Statement of Indications for Use: MammoSource is indicated for high-dose-rate remotely controlled afterloading brachytherapy for the treatment of breast cancer and other cancers that can be treated with a single channel HDR system.
- Q. Technological Characteristics: See the "Substantial Equivalence Comparison Chart", Tab 6
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is an abstract symbol consisting of three stylized, curved lines that resemble a human form. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2004
Ms. Vy Tran Corporate Director of Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038 USA
Re: K040541 Trade/Device Name: MammoSource HDR Remote afterloader Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: 90 JAQ Dated: March 1, 2004 Received: March 2, 2004
Dear Ms. Tran:
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 (PMA), 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.
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.
2
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. Ixxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brigdon
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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PAGE 1 of 1
510(k) Number (if known): _(C040541 Device Name: MammoSource HDR Remote afterloader
Indications For Use:
MammoSource is indicated for high-dose-rate remotely controlled afterloading brachytherapy for the treatment of breast cancer and other cancers that can be treated with a single channel HDR system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use
Nancy Hoylon
(Division Sign-Off)
Division of Reproductive, Abdomina and Radiological Devices 510(k) Number __