(52 days)
Not Found
No
The document describes a physical device (catheter and accessories) for delivering radiation therapy. There is no mention of software, algorithms, image processing, or terms related to AI/ML.
Yes.
The device is used to deliver brachytherapy following a lumpectomy for breast cancer, which is a therapeutic intervention.
No
The device is described as a "radiation therapy system" intended to "provide brachytherapy." Its purpose is to deliver radiation, not to diagnose a condition.
No
The device description explicitly states it includes physical components like a catheter, balloon, and accessories for connecting to an afterloader, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing brachytherapy (a type of radiation therapy) to surgical margins following lumpectomy for breast cancer. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a catheter and accessories used to deliver radiation internally. This aligns with a therapeutic device, not a diagnostic one that analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver radiation therapy, which is a treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
The MammoSite device is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following · lumpectomy for breast cancer.
The MammoSite RTS 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 device is a radiation therapy system that includes the MammoSiteCatheter Tray and the MammoSite HDR Afterloader Accessories Tray. The MammoSite Catheter Tray includes the MammoSite catheter and accessories to assist with the implantation of the catheter. The MammoSite is a catheter shaft with an inflatable balloon mounted on its distal end that positions the radiation source within the resected cavity for radiation delivery. The MammoSite Afterloader Accessories Tray contains the items needed to connect the afterloader to the MammoSite.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
| Proprietary and Confidential to Hologic, Inc |
|---|
| ---------------------------------------------- |
KC9/378
510(k) Summary
JUL -222009
General information
The general information for the modified MammoSite is included in the table below:
| Manufacturer's name and address: | Hologic, Inc.
250 Campus Drive
Marlborough, MA 01752 |
|------------------------------------------|--------------------------------------------------------------------------------|
| Manufacturer's phone and fax
numbers: | Telephone: (508) 263-8912
Fax: (508) 263-2403 |
| Name of contact person: | Jennifer Sullivan
Quality Assurance Auditor |
| Trade name: | MammoSite Radiation Therapy System
(RTS) |
| Common name: | Remote-controlled radionuclide
applicator system |
| Classification name: | System, applicator, radionuclide,
remotecontrolled
(per 21 CFR 892.5700) |
| Regulatory Class: | II |
| Date summary was prepared: | May 7, 2009 |
Predicate devices
The modified MammoSite device is substantially equivalent to the following cleared devices:
| Name | Manufacturer | 510(k) Number |
|---|---|---|
| MammoSite Radiation | ||
| Therapy System – | ||
| 5-6 cm Spherical | Hologic, Inc. | K041929 |
| Multi-Lumen Source | ||
| Applicator for | ||
| Brachytherapy | Contura | K081079 |
| SAVI Applicator Kit | Cianna Medical | K081677 |
Indications for use
ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
The MammoSite device 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
Device description
The MammoSite device is a radiation therapy system that includes the MammoSiteCatheter Tray and the MammoSite HDR Afterloader Accessories Tray. The MammoSite Catheter Tray includes the MammoSite catheter and accessories to assist with the implantation of the catheter. The MammoSite is a catheter shaft with an inflatable balloon mounted on its distal end that positions the radiation source within the resected cavity for radiation delivery. The MammoSite Afterloader Accessories Tray contains the items needed to connect the afterloader to the MammoSite.
Technological characteristics
The modified MammoSite device has the same intended use, same technological characteristics, and the same materials/dimensions of the predicate MammoSite device. The indication for use is the same as the predicate MammoSite. All MammoSite devices provide a means of delivering a radiation therapy in a tumor or tumor cavity. The MammoSite device positions the radioactive source for radiation therapy and utilizes a 192Ir seed or ribbon as the radiation source with similar dosimetric properties.
Conclusion
Hologic believes that MammoSite Radiation Therapy System is substantially equivalent to currently marketed devices. No new issues of safety or effectiveness are raised.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized bird or human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer Sullivan Ouality Assurance Auditor Hologic, Inc. 250 Campus Drive MARLBOROUGH MA 01752
Re: K091378
Trade/Device Name: MammoSite Radiation Therapy System (RTS) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: May 5, 2009 Received: May 11, 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 device's labeling:
The Safety and effectiveness of the MammoSite 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
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 (OS) 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 (240) 276-3150. 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 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donna-Bea Tillman, Ph.D., M.P.A.
Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
| 510(k) Number (if known) | K091378 |
|---|---|
| Device name | MammoSite Radiation Therapy System (RTS) |
| Indications for use | The MammoSite RTS 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)
ﺮ ..
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)
logu Nhong
(Division Sign-Off) Division or Reproductive, Abdominal, and Radiological Devices 510(k) Number