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

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 catheter is a shaft with an inflatable balloon that positions the radiation source within the resected cavity for radiation delivery. The MammoSite is a variable 4 cm - 5 cm spherically inflated balloon. The MammoSite Afterloader Accessories Tray contains the items needed to connect the afterloader to the MammoSite RTS.

AI/ML Overview

Here's an analysis of the provided text regarding the MammoSite™ Radiation Therapy System (RTS) and its clinical study, organized according to your requested criteria:

Device: MammoSite™ Radiation Therapy System (RTS)
Intended Use: The MammoSite Radiation Therapy System is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (510(k) Summary) is for a substantial equivalence determination, not a post-market performance report. Therefore, it does not explicitly define quantitative "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy, or reduction in recurrence rates with specific thresholds) that the device must meet, nor does it provide a direct table of these criteria alongside reported device performance against those specific numbers.

Instead, the implied acceptance criterion for this 510(k) submission is to demonstrate safety and effectiveness equivalent to predicate devices for its intended use.

The device performance is reported qualitatively:

Criterion Type	Acceptance Criteria (Implied)	Reported Device Performance
Safety	No new safety concerns compared to predicate devices.	- Biocompatibility testing demonstrated materials meet requirements. - Animal studies illustrated successful delivery of a clinical dose of brachytherapy. - Clinical study evaluated safety; "Brachytherapy was successfully delivered to all patients." - No new questions about safety identified. - FDA added a warning regarding unestablished safety/effectiveness for replacement of whole breast irradiation in the treatment of breast cancer.
Effectiveness (Clinical)	Equivalent clinical performance for delivering brachytherapy to surgical margins following lumpectomy for breast cancer, compared to predicate devices.	- "Brachytherapy was successfully delivered to all patients." - "The clinical study demonstrated that 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." - "Could deliver an equivalent radiation dose to current brachytherapy applicators" (based on dosimetry characterization).
Technological Equivalence	Similar technological characteristics, materials, dimensions, and method of application to predicate devices.	- "MammoSite has the same intended use, similar technological characteristics, and similar materials/dimensions of the predicates." - Compared implant duration, target sites, component materials and dimensions, radionuclide source, and clinical usage. - "Utilize 1921 seed or ribbon as the radiation source with similar dosimetric properties." - "Differences do not affect safety or effectiveness."
Pre-clinical Performance	Catheter, accessories, and packaging perform as intended under simulated use and challenge conditions.	- "In vitro laboratory studies to demonstrate that the MammoSite catheter, its accessories and packaging performed as intended under simulated use and challenge conditions."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document states that a "multi-center phase II clinical study was conducted." It indicates that "all patients" (implied, the patients in this study) successfully received brachytherapy, and a "complete clinical summary including data analysis and individual patient data was provided to FDA." However, the exact number of patients (sample size) in this multi-center phase II clinical study is not explicitly stated in the provided 510(k) summary.
Data Provenance: The study was a "multi-center phase II clinical study." Given the applicant's address (Alpharetta, GA, USA) and the FDA approval, it is highly probable the centers were primarily in the United States. The study was prospective as it "included breast cancer patients who were undergoing tumor resection" and evaluated safety and effectiveness based on radiological and clinical measures post-treatment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number or qualifications of experts used to establish a "ground truth" for the test set in the way one might for an imaging algorithm studying diagnostic accuracy.

For this device, the "ground truth" or primary outcome measures were related to the delivery of radiation therapy and patient outcomes (safety and effectiveness). These would typically be assessed by:

Treating physicians (e.g., radiation oncologists, surgeons) at the clinical sites for successful delivery and clinical measures.
Radiologists for radiological assessments.
Pathologists for initial tumor resection confirmation (though not directly for device performance evaluation in the clinical study).

The document states, "Assessment methods used to evaluate safety and effectiveness included radiological and clinical measures." This implies a standard clinical evaluation by the attending medical staff, rather than a separate "ground truth panel" for retrospective assessment as might be seen for AI diagnostic devices.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method for the test set outcomes (e.g., 2+1, 3+1 consensus). Clinical studies of this nature typically rely on individual site investigators' assessments and then aggregate data. If discrepancies arose in clinical data reporting, they would usually be handled by a clinical review committee (e.g., Data Safety Monitoring Board or study principal investigators), but this is not detailed in the summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done.

MRMC studies typically compare human reader performance (with or without AI assistance) in tasks like diagnosis or detection using a specific set of cases. The MammoSite RTS is an interventional device for delivering brachytherapy, not a diagnostic or screening tool. The clinical study evaluated the device's ability to safely and effectively deliver radiation, not how human readers interpret images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done.

The MammoSite RTS is a physical medical device (catheter and accessories) used to deliver radiation, not an algorithm or AI software intended to perform a task independently. Its "performance" inherently involves human-in-the-loop (physician-guided implantation and radiation delivery).

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the ultimate determination of safety and effectiveness as evaluated in the clinical trial. This would implicitly be based on:

Clinical Outcomes/Measures: Direct observation of successful brachytherapy delivery, patient safety profiles (adverse events), and response to treatment as determined by treating physicians and follow-up.
Radiological Measures: Imaging studies (e.g., mammograms, ultrasound, MRI) to assess the treated area, cavity size, and recurrence (or lack thereof) during follow-up.
Dosimetry Characterization: For the pre-clinical phase, physical measurements and calculations confirmed the delivered radiation dose, which forms a basis for effectiveness.

It is not based on:

Expert consensus (in the sense of a panel reviewing diagnostic images).
Pathology (as in determining a diagnosis from tissue, though pathology of the initial lumpectomy would define the patient population).
Outcomes data specific to a pre-defined "gold standard" for AI, but rather broad patient outcome data.

8. The Sample Size for the Training Set

Not applicable.

The MammoSite RTS is a physical medical device. It does not involve a "training set" in the context of machine learning algorithms. The preclinical and clinical studies were designed to validate the device's performance and safety, not to train an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

As there is no "training set" for an algorithm associated with this physical device, there is no ground truth established for it in that sense.

Summary

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510(k) Summary of Safety and Effectiveness

1. General Information

Applicant's Name and Address:

Contact Person:

Proxima Therapeutics, Inc. 2555 Marconi Drive, Suite 220 Alpharetta, GA 30005-2066

Deborah J. Moore VP. Regulatory and Clinical Affairs Telephone: 770-753-4848 Fax: 770-753-4937

Proprietary Name:

Common Name:

MammoSite™ Radiation Therapy System (RTS)

Remote-controlled radionuclide applicator system

2. Device Description

3. Intended Use of Device

4. Predicate Devices

The MammoSite RTS is substantially equivalent to Proxima Therapeutics, Inc.'s GliaSite Radiation Therapy System (K003206) and Nucletron Corporation radionuclide applicator systems (K853912, K864210, K953946, K98337, K98341) in terms of its technical specifications, intended use and method of application.

5. Comparison of Technological Characteristics

The intended use, clinical performance, and technological characteristics of the MammoSite RTS are similar to those of commercially available brachytherapy applicators used with sealed radiation sources. Comparison of the MammoSite RTS to these devices included implant duration, target sites, component materials and dimensions, radionuclide source, and clinical usage.

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The MammoSite has the same intended use, similar technological characteristics, and similar materials/dimensions of the predicates. Although the indication for use is not identical to the predicate devices, the intended use is the same and the difference does not introduce any new questions about safety or effectiveness. These 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 1921 seed or ribbon as the radiation source with similar dosimetric properties.

Any differences that exist between the MammoSite RTS and the predicate devices were discussed and have shown that these differences do not affect safety or effectiveness. It was demonstrated that the MammoSite RTS is substantially equivalent to the predicate devices.

6. Preclinical Tests

Extensive preclinical testing was conducted to evaluate and characterize the performance of the MammoSite RTS. Preclinical studies conducted 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 requirements. The dosimetry of the MammoSite was characterized. Based on these findings, it was concluded that the MammoSite RTS could deliver an equivalent radiation dose to current brachytherapy applicators. Finally, animal studies were conducted to illustrate the performance of the device that included successfully delivering a clinical dose of brachytherapy.

7. Clinical Studies

A multi-center phase II clinical study was conducted to evaluate the safety and effectiveness of the MammoSite RTS. The 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 all patients. A complete clinical summary including data analysis and individual patient data was provided to FDA. The clinical study demonstrated that 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.

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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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2002

Ms. Deborah Moore Vice-President, Regulatory & Clinical Affairs PROXIMA THERAPEUTICS, Inc. 2555 Marconi Drive, Suite 220 ALPHARETTA GA 30005-2066

Re: K011690

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 7, 2002 Received: February 8, 2002

Dear Ms. Moore:

This letter corrects our substantially equivalent letter of May 6, regarding the contents of the Statement of the Indications for Use enclosure.

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 RTS as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

The Warning must be presented within a black box, and the font should be bold and the same size as any surrounding text. The Warning should be the first item in your list of warnings.

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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 (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.

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 above is added to your labeling, as described.

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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4654. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Ronald E. Stathard, M.D., Ph.D.

Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K011690

Device Name:

MammoSite Radiation Therapy System (RTS)

FDA's Statement of the Indications for Use for device:

The MammoSite Radiation Therapy System is intended to provide
System in the collection chooses to deliver intracavitary The MammoSite Radianon Theirapy System to deliver intracavitary
brachytherapy when the physician chooses to deliver intractorny for breast c brachytherapy when the priysician chooses to deliver the survey.
radiation to the surgical margins following lumpectomy for breast cancer.

David G. Segerson

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

Prescription Use_ × (Per 21 CFR 801.109) Over-The-Counter Use_

Regulation Number and Section

§ 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.