The MammoSite ML 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 ML applicator is used to position tissue and the radioactive Device source during breast brachytherapy treatments. It consists of a multi-lumen description polyurethane catheter with an inflatable balloon assembly at its distal end. The MammoSite ML has the same intended use, similar technological Technological characteristics, and similar materials/dimensions of the predicate devices. The characteristics indication for use is the same as the predicate devices. Testing indicates that the MammoSite ML is substantially equivalent to the legally marketed predicate devices. All MainmoSite devices provide a means of delivering a radiation therapy in a tumor or tumor cavity. The MammoSite positions the radioactive source for radiation therapy and utilizes a 192Ir seed as the radiation source with similar dosimetric properties.

AI/ML Overview

Analysis of Acceptance Criteria and Device Performance for MammoSite Multi Lumen (ML) Radiation Therapy System (RTS) (K092405)

Based on the provided FDA 510(k) summary documents, the MammoSite ML Radiation Therapy System (RTS) was reviewed for substantial equivalence to predicate devices, rather than against specific performance-based acceptance criteria in a traditional clinical study format. The core of this 510(k) submission relies on demonstrating substantial equivalence to already legally marketed devices, the MammoSite Radiation Therapy System (RTS) (K041929) and the SAVI Applicator Kit (K081677).

Therefore, the "acceptance criteria" here are largely implicit in the demonstration of similar intended use, technological characteristics, and materials/dimensions to the predicate devices, substantiated by testing. The focus is on safety and effectiveness being comparable, not on achieving specific performance metrics in a standalone study.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as per 510(k) Summary)
Intended Use: Device performs as intended for intracavitary breast brachytherapy.	The MammoSite ML has the same intended use as the predicate devices: "to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer."
Technological Characteristics: Similar to predicate devices, including mechanism of action.	Has similar technological characteristics to the predicate devices. It positions the radioactive source (192Ir seed) for radiation therapy and has similar dosimetric properties.
Materials/Dimensions: Comparable to predicate devices.	Uses similar materials/dimensions as the predicate devices. It consists of a multi-lumen polyurethane catheter with an inflatable balloon assembly.
Safety: Device operates without undue risk of harm.	"Testing indicates that the MammoSite ML is substantially equivalent to the legally marketed predicate devices." This implies safety is comparable to cleared devices. Note: A specific labeling limitation was added by the FDA: "The safety and effectiveness of the MammoSite ML Radiation Therapy System (RTS) as a replacement for whole breast irradiation in the treatment of breast cancer has not been established." This indicates a specific unproven claim rather than an inherent safety issue of the device itself for its cleared indication.
Effectiveness: Device achieves its stated purpose comparably to predicate devices.	As with safety, the claim of substantial equivalence implies comparable effectiveness for the cleared indication.

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

The 510(k) summary does not describe a specific clinical "test set" in the context of human subjects or patient data. The evaluation for this device appears to be primarily based on bench testing and engineering comparisons to demonstrate similar technological characteristics and performance to predicate devices.

Sample Size: Not applicable in the context of a clinical test set. The review focuses on device specifications and comparative analysis.
Data Provenance: Not applicable. If any testing involved specific physical samples, they would be lab-based.

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

Not applicable. This 510(k) submission does not detail a study involving expert review to establish ground truth for a test set of clinical data. The judgment of "substantial equivalence" is made by the FDA's Office of Device Evaluation based on the provided technical documentation, testing reports (not detailed in the summary), and comparison to predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring adjudication in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in these documents. The submission focuses on demonstrating substantial equivalence of the device's technical specifications and intended use to existing devices, not on evaluating its impact on human reader performance.

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

This refers to a physical device, an applicator system for brachytherapy, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The device's performance is inherently linked to its physical properties and interaction with a radioactive source and, ultimately, human medical professionals.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices. The MammoSite ML is deemed substantially equivalent because its intended use, technological characteristics, and materials/dimensions are similar, implying it will perform comparably to the devices that have already demonstrated their safety and effectiveness (as determined by prior FDA clearances).

8. The Sample Size for the Training Set

Not applicable. As this is a medical device (applicator system) approval based on substantial equivalence, there is no "training set" in the context of machine learning. The design and manufacturing processes follow established engineering principles and quality systems, which are implicitly "trained" through prior device development and regulatory experience.

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

Not applicable. There is no training set for this type of device submission.

Summary

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AUG 2 7 2009

K092405
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510(k) Summary

General information

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

Submitters name and address:	Hologic, Inc.250 Campus DriveMarlborough, MA 01752
Submitters phone and fax numbers:	Telephone: (508) 263-8912Fax: (508) 263-2403
Name of contact person:	Jennifer L. SullivanRegulatory Affairs Specialist
Trade name:	MammoSite Multi Lumen RadiationTherapy System (RTS)
Common name:	Remote-controlled radionuclideapplicator system
Classification name:	System, applicator, radionuclide, remotecontrolled(per 21 CFR 892.5700)
Date summary was prepared:	August 5, 2009

Predicate devices

The MammoSite ML is substantially equivalent to the following cleared devices:

Name	Manufacturer	510(k) Number
MammoSite RadiationTherapy System (RTS)	Hologic, Inc.	K041929
SAVI Applicator Kit	Cianna Medical	K081677

Indications for use

The MammoSite ML 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

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510(k) Summary, Continued

K092405
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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Jennifer Sullivan Regulatory Affairs Specialist Hologic, Inc. 250 Campus Drive MARLBOROUGH MA 01752

AUG 2 7 2009

Re: K092405

Trade/Device Name: MammoSite Multi Lumen (ML) Radiation Therapy System (RTS) -- Regulation Number: CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ

Dated: August 5, 2009 Received: August 6, 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 section of the device's labeling:

The safety and effectiveness of the MammoSite ML 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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Page 2 - Ms. Sullivan

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 (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.

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 (301) 796-5500. 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 301-796-5760. 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 at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

onna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

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Statement of Indications for Use

510(k) Number (if known)	K092405
Device name	MammoSite Multi Lumen (ML) Radiation Therapy System (RTS)
Indications for use	The MammoSite ML 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)

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AND/ OR

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)

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

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.