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

K030558 · Proxima Therapeutics, Inc. · JAQ · May 21, 2003 · Radiology

Device Facts

• Record ID: K030558
• Device Name: MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
• Applicant: Proxima Therapeutics, Inc.
• Product Code: JAQ · Radiology
• Decision Date: May 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MammoSite 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 RTS is a remote-controlled radionuclide applicator system for breast brachytherapy. Device consists of a catheter shaft with an inflatable balloon at the distal end and an afterloader accessories tray. Physician implants catheter into the resected tumor cavity; balloon is inflated to position the radiation source (192Ir seed or ribbon) within the cavity. System delivers intracavitary radiation to surgical margins post-lumpectomy. Used in clinical settings by physicians to provide localized radiation therapy, potentially benefiting patients by targeting surgical margins while sparing surrounding tissue.

Clinical Evidence

Supported by a multi-center phase II clinical study involving breast cancer patients undergoing tumor resection. Study evaluated safety and effectiveness using radiological and clinical measures. Results demonstrated successful delivery of brachytherapy to surgical margins. Preclinical evidence included in vitro laboratory testing under simulated conditions, biocompatibility testing, and animal studies confirming the ability to deliver an equivalent radiation dose to existing brachytherapy applicators.

Technological Characteristics

Remote-controlled radionuclide applicator system. Components: catheter shaft with inflatable balloon, afterloader accessories. Radiation source: 192Ir seed or ribbon. Materials meet biocompatibility requirements. System is designed for intracavitary positioning of radiation sources.

Indications for Use

Indicated for breast cancer patients undergoing tumor resection (lumpectomy) requiring 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 (RTS) (K011690)

Submission Summary (Full Text)

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MAY 21 2003

# Section 3

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## 510(k) Summary

| General<br>information | The general information for the MammoSite RTS is included in the table<br>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: | Martine D. Schneider<br>Manager, Regulatory Affairs & Quality Assurance | |
| | Trade name: | MammoSite Radiation Therapy System (RTS) | |
| | Common name: | Remote-controlled radionuclide applicator system | |
| | Classification name: | System, applicator, radionuclide, remote-<br>controlled (per 21 CFR 892.5700) | |
| | Date summary was prepared: | February 19, 2003 | |
| Predicate<br>devices | The additional MammoSite RTS size (variable 5-6 cm) is substantially<br>equivalent to the following legally marketed medical devices in terms of its<br>technical specification, intended use, and method of application: | | |
| | Name | Manufacturer | 510(k) Number |
| | MammoSite Radiation<br>Therapy System (RTS) | Proxima Therapeutics, Inc. | K011690 |

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#### 510(k) Summary, Continued

| Device description | The MammoSite RTS is a radiation therapy system that includes the MammoSite RTS Catheter Tray and the MammoSite HDR Afterloader Accessories Tray. The MammoSite RTS 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. Any device specifications that have changed as a result of the modifications to the device presented in this 510(k) have been documented in Proxima's product specifications for the MammoSite RTS. |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological characteristics | The MammoSite has the same intended use, similar technological characteristics, and similar materials/dimensions of the predicate MammoSite device. The indication for use is identical to the predicate MammoSite RTS that is commercially available and is similar to the other predicate devices. Both MammoSite devices provide a means of delivering a radiation therapy in a tumor or tumor cavity. The MammoSite and brachytherapy applicators position the radioactive source for radiation therapy. The MammoSite and brachytherapy applicators utilize ¹⁹² Ir seed or ribbon as the radiation source with similar dosimetric properties.<br>Any differences that exist between the MammoSite RTS and the predicate device were discussed and it has been shown that these differences do not affect safety or effectiveness. It was demonstrated that the MammoSite RTS is substantially equivalent to the predicate device. |

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## 510(k) Summary, Continued

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| Preclinical studies | Extensive pre-clinical studies were performed to support the modifications to the device presented in this 510(k). Preclinical studies conducted included in vitro laboratory studies to demonstrate that the MammoSite catheter, its 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. Animal studies illustrate the performance of the device, and demonstrate a clinical dose of brachytherapy can successfully be delivered. Based on these findings, it was concluded that the MammoSite RTS could deliver an equivalent radiation dose to current commercially available brachytherapy applicators. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical studies | The multi-center phase II clinical study initially done to evaluate the safety and effectiveness of the MammoSite RTS supports the changes to the device presented in this 510(k). 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. A complete clinical summary including data analysis and individual patient data was provided to FDA. The clinical study demonstrated that the MammoSite RTS provides brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer. |

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2003

Ms. Martine D. Schneider Manager, Regulatory Affairs and Quality Assurance Proxima Therapeutics, Inc. 2555 Marconi Drive, Suite 220 ALPHARETTA GA 30005-2066 Re: K030558

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: February 19, 2003 Received: February 21, 2003

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 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 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.

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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. 1xxx | [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 Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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131558

## Statement of Indications for Use

| 510(k) Number<br>(if known) | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | MammoSite Radiation Therapy System (RTS) |
| Indications for<br>use | The MammoSite is intended to provide brachytherapy when the physician<br>chooses to deliver intracavitary radiation to the surgical margins following<br>lumpectomy for breast cancer. |

Prescription Use

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abd and Radiological Device 510(k) Number .

#### Proxima MammoSite® RTS 510(k) Application