MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY

K041929 · Proxima Therapeutics, Inc. · JAQ · Aug 26, 2004 · Radiology

Device Facts

• Record ID: K041929
• Device Name: MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
• Applicant: Proxima Therapeutics, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Aug 26, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

MammoSite Radiation Therapy System (RTS) is a remote-controlled radionuclide applicator system used for intracavitary brachytherapy. The device consists of a catheter shaft with an inflatable balloon at the distal end, which is positioned within the resected tumor cavity. An afterloader accessory tray connects the catheter to an external radiation afterloader. The system utilizes an Ir-192 seed or ribbon as the radiation source. The device is operated by a physician in a clinical setting to deliver targeted radiation to surgical margins. By inflating the balloon, the device ensures precise positioning of the radioactive source within the cavity, facilitating localized radiation delivery to treat residual cancer cells while sparing surrounding healthy tissue.

Clinical Evidence

Supported by a multi-center clinical study evaluating safety and effectiveness in breast cancer patients undergoing tumor resection. Assessment included radiological and clinical measures, confirming successful delivery of brachytherapy. Pre-clinical evidence includes in vitro laboratory studies under simulated use, biocompatibility testing, and previously conducted animal studies (K011690) demonstrating successful dose delivery.

Technological Characteristics

Remote-controlled radionuclide applicator system. Components: catheter shaft, inflatable balloon, afterloader accessories. Radiation source: Ir-192 seed or ribbon. Materials meet biocompatibility requirements. System is designed for intracavitary placement within resected tumor cavities.

Indications for Use

Indicated for breast cancer patients undergoing lumpectomy requiring intracavitary brachytherapy 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 (RTS) - 4-5 cm Spherical (K011690)
• MammoSite RTS - 5-6 cm Spherical (K030558)

Submission Summary (Full Text)

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## 510(k) Summary

041929

The general information for the modified MammoSite is included in the table General information below:

| Submitters name and address: | Proxima Therapeutics, Inc.<br>2555 Marconi Drive, Suite 220<br>Alpharetta, Georgia 30005 |
|-----------------------------------|------------------------------------------------------------------------------------------|
| Submitters phone and fax numbers: | Telephone: [phone]<br>Fax: [phone] |
| Name of contact person: | Deborah J. Moore<br>VP, RA, CA, & QA |
| Trade name: | MammoSite 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: | July 16, 2004 |

#### The modified MammoSite device is substantially equivalent to the following Predicate devices cleared MammoSite devices:

| Name | Manufacturer | 510(k) Number |
|-------------------------------------------------------------------|----------------------------|---------------|
| MammoSite Radiation<br>Therapy System (RTS) -<br>4-5 cm Spherical | Proxima Therapeutics, Inc. | K011690 |
| MammoSite RTS -<br>5-6 cm Spherical | Proxima Therapeutics, Inc. | K030558 |

Indications for The MammoSite is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following use lumpectomy for breast cancer.

Continued on next page

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# 510(k) Summary, Continued

| Device<br>description | The MammoSite is a radiation therapy system that includes the MammoSite<br>Catheter Tray and the MammoSite HDR Afterloader Accessories Tray. The<br>MammoSite Catheter Tray includes the MammoSite catheter and accessories<br>to assist with the implantation of the catheter. The MammoSite is a catheter<br>shaft with an inflatable balloon mounted on its distal end that positions the<br>radiation source within the resected cavity for radiation delivery. The<br>MammoSite Afterloader Accessories Tray contains the items needed to<br>connect the afterloader to the MammoSite. Any device specifications that<br>have changed as a result of the modifications to the device presented in this<br>510(k) have been documented in Proxima's product specifications for the<br>MammoSite. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>characteristics | The modified MammoSite has the same intended use, same technological<br>characteristics, and similar materials/dimensions of the predicate<br>MammoSite. The indication for use is the same as the predicate MammoSite.<br>All MammoSite devices provide a means of delivering a radiation therapy in<br>a tumor or tumor cavity. The MammoSite positions the radioactive source for<br>radiation therapy and utilizes a $^{192}Ir$ seed or ribbon as the radiation source<br>with similar dosimetric properties. |
| | Any differences that exist between the modified MammoSite and the<br>predicate MammoSite devices were discussed and shown they do not affect<br>the safety or effectiveness of the MammoSite device. It was demonstrated<br>that the modified MammoSite is substantially equivalent to the predicate<br>MammoSite. |

Continued on next page

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### 1141929 510(k) Summary, Continued

Extensive pre-clinical studies were performed to support the MammoSite. Preclinical Preclinical studies conducted included in vitro laboratory studies to studies demonstrate that the MammoSite device, accessories, and packaging, performed as intended under simulated use and challenge conditions. Biocompatibility testing was performed to demonstrate that the materials meet the biocompatibility requirements. The dosimetry of the MammoSite was characterized and is similar to the predicate MammoSite devices. Previously conducted animal studies (included in the cleared K011690) illustrate the performance of the device, and demonstrate a clinical dose of brachytherapy could successfully be delivered. Based on these findings, it was concluded that the modified MammoSite delivers an equivalent radiation dose compared to the predicate MammoSite devices. Clinical studies The multi-center phase clinical study initially done to evaluate the safety and effectiveness of the MammoSite supports the modified MammoSite. The clinical study included breast cancer patients who were undergoing tumor resection. Assessment methods used to evaluate safety and effectiveness included radiological and clinical measures. Brachytherapy was successfully delivered to the patients.

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Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 2 6 2004

Ms. Martine D. Schneider Manager, Worldwide Regulatory Affairs & Compliance Proxima Therapeutics, Inc. 2555 Marconi Drive, Suite 220 ALPHARETTA GA 30005-2066 Re: K041929

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: 90 JAQ

Dated: July 16, 2004 Received: July 27, 2004

Dear Ms. Schneider:

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 for associated in the 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 may or our 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ought in."
Premarket notification. The FDA finding of substantial equivalence of your device to a legally premaired predication. The 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 If you desire specifice at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. Ixxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of [phone]. Also, please note the regulation entitled, "Misbranding Other of Othphares as (snotification" (21CFR Part 807.97) you may obtain. Other general by recented to promative sunder the Act may be obtained from the Division of Small miormation on your responsible and Consumer Assistance at its toll-free number [phone] or Manataorarers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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# Statement of Indications for Use

| 510(k) Number (if known) | K041929 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |

David A. Lynn

Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 6 510();) Number

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |