MAMMOSITE II RADIATION THERAPY SYSTEM

K091378 · Hologic, Inc. · JAQ · Jul 2, 2009 · Radiology

Device Facts

• Record ID: K091378
• Device Name: MAMMOSITE II RADIATION THERAPY SYSTEM
• Applicant: Hologic, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Jul 2, 2009
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

MammoSite Radiation Therapy System (RTS) is a remote-controlled radionuclide applicator system used for breast brachytherapy. The device consists of a catheter shaft with an inflatable balloon at the distal end and an afterloader accessories tray. The catheter is implanted into the resected tumor cavity; the balloon is inflated to position the radiation source (192Ir seed or ribbon) within the cavity. The system is operated by a physician in a clinical setting to deliver targeted radiation to surgical margins. The device facilitates precise positioning of the radioactive source to treat the tumor site. It is not intended as a replacement for whole breast irradiation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Remote-controlled radionuclide applicator system. Components include a catheter shaft with an inflatable balloon and afterloader accessories. Uses 192Ir seed or ribbon as the radiation source. Designed for intracavitary radiation delivery in tumor cavities.

Indications for Use

Indicated for patients undergoing lumpectomy for breast cancer who require intracavitary radiation therapy to surgical margins.

Regulatory Classification

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

• MammoSite Radiation Therapy System – 5-6 cm Spherical (K041929)
• Multi-Lumen Source Applicator for Brachytherapy (K081079)
• SAVI Applicator Kit (K081677)

Submission Summary (Full Text)

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| 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.<br>250 Campus Drive<br>Marlborough, MA 01752 |
|------------------------------------------|--------------------------------------------------------------------------------|
| Manufacturer's phone and fax<br>numbers: | Telephone: [phone]<br>Fax: [phone] |
| Name of contact person: | Jennifer Sullivan<br>Quality Assurance Auditor |
| Trade name: | MammoSite Radiation Therapy System<br>(RTS) |
| Common name: | Remote-controlled radionuclide<br>applicator system |
| Classification name: | System, applicator, radionuclide,<br>remotecontrolled<br>(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<br>Therapy System –<br>5-6 cm Spherical | Hologic, Inc. | K041929 |
| Multi-Lumen Source<br>Applicator for<br>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.

·

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## 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.

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### 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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

logu Nhong

(Division Sign-Off) Division or Reproductive, Abdominal, and Radiological Devices 510(k) Number