(21 days)
No
The summary describes a physical brachytherapy applicator and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is intended to provide brachytherapy, which is a form of radiation therapy, delivered to surgical margins following lumpectomy for breast cancer. This directly treats a disease condition, classifying it as a therapeutic device.
No
Explanation: The device is intended for brachytherapy and delivering radiation, which are therapeutic actions, not diagnostic.
No
The device description clearly states it is a physical applicator made of polyurethane with an inflatable balloon, used to position tissue and a radioactive source. This indicates it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer." This describes a therapeutic procedure involving the delivery of radiation, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as an "applicator" used to "position tissue and the radioactive Device source during breast brachytherapy treatments." This further reinforces its role in a treatment delivery system.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the MammoSite ML is a therapeutic device used for delivering radiation therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MammoSite ML is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
Product codes
JAQ
Device Description
The MammoSite ML applicator is used to position tissue and the radioactive Device source during breast brachytherapy treatments. It consists of a multi-lumen description polyurethane catheter with an inflatable balloon assembly at its distal end. The MammoSite ML has the same intended use, similar technological Technological characteristics, and similar materials/dimensions of the predicate devices. The indication for use is the same as the predicate devices. Testing indicates that the MammoSite ML is substantially equivalent to the legally marketed predicate devices. All MainmoSite devices provide a means of delivering a radiation therapy in a tumor or tumor cavity. The MammoSite positions the radioactive source for radiation therapy and utilizes a 192Ir seed as the radiation source with similar dosimetric properties.
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
Physician
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.
0
AUG 2 7 2009
K092405
Page 1 of 2
510(k) Summary
General information
The general information for the MammoSite ML is included in the table below:
| Submitters name and address: | Hologic, Inc.
250 Campus Drive
Marlborough, MA 01752 |
|-----------------------------------|---------------------------------------------------------------------------------|
| Submitters phone and fax numbers: | Telephone: (508) 263-8912
Fax: (508) 263-2403 |
| Name of contact person: | Jennifer L. Sullivan
Regulatory Affairs Specialist |
| Trade name: | MammoSite Multi Lumen Radiation
Therapy System (RTS) |
| Common name: | Remote-controlled radionuclide
applicator system |
| Classification name: | System, applicator, radionuclide, remote
controlled
(per 21 CFR 892.5700) |
| Date summary was prepared: | August 5, 2009 |
Predicate devices
The MammoSite ML is substantially equivalent to the following cleared devices:
| Name | Manufacturer | 510(k) Number |
|---|---|---|
| MammoSite Radiation | ||
| Therapy System (RTS) | Hologic, Inc. | K041929 |
| SAVI Applicator Kit | Cianna Medical | K081677 |
Indications for use
The MammoSite ML is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
Continued on next page
1
510(k) Summary, Continued
K092405
Page 2 of 2
The MammoSite ML applicator is used to position tissue and the radioactive Device source during breast brachytherapy treatments. It consists of a multi-lumen description polyurethane catheter with an inflatable balloon assembly at its distal end. The MammoSite ML has the same intended use, similar technological Technological characteristics, and similar materials/dimensions of the predicate devices. The characteristics indication for use is the same as the predicate devices. Testing indicates that the MammoSite ML is substantially equivalent to the legally marketed predicate devices. All MainmoSite devices provide a means of delivering a radiation therapy in a tumor or tumor cavity. The MammoSite positions the radioactive source for radiation therapy and utilizes a 192Ir seed as the radiation source with similar dosimetric properties. :
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Jennifer Sullivan Regulatory Affairs Specialist Hologic, Inc. 250 Campus Drive MARLBOROUGH MA 01752
AUG 2 7 2009
Re: K092405
Trade/Device Name: MammoSite Multi Lumen (ML) Radiation Therapy System (RTS) -- Regulation Number: CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ
Dated: August 5, 2009 Received: August 6, 2009
Dear Ms. Sullivan:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of the MammoSite ML Radiation Therapy System (RTS) as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
3
Page 2 - Ms. Sullivan
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (301) 796-5500. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 301-796-5760. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
onna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
4
Statement of Indications for Use
| 510(k) Number (if known) | K092405 |
|---|---|
| Device name | MammoSite Multi Lumen (ML) Radiation Therapy System (RTS) |
| Indications for use | The MammoSite ML is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer. |
Prescription Use X (Part 21 CFR 801 Subpart D)
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AND/ OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_