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.
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 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.

AI/ML Overview

The provided text focuses on the 510(k) summary for the Hologic MammoSite Radiation Therapy System (RTS). This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It does not describe a study that establishes acceptance criteria and then proves the device meets those criteria in the way typically seen for new AI/Diagnostic devices assessed through performance metrics.

Instead, the submission states that the modified MammoSite device has the same intended use, same technological characteristics, and the same materials/dimensions of the predicate MammoSite device. The assessment here is one of substantial equivalence to existing, cleared devices, rather than a novel performance study against specific acceptance criteria.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of regulatory submission. The "acceptance criteria" in this context are the FDA's criteria for determining substantial equivalence, not performance metrics of the device against a defined clinical outcome.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence claim, the "acceptance criteria" are based on a comparison to predicate devices, not specific performance metrics like sensitivity or specificity.

Acceptance Criteria Category	Reported Device Performance (from submission)
Intended Use	Same as predicate MammoSite for brachytherapy delivery after lumpectomy for breast cancer.
Technological Characteristics	Same as predicate MammoSite (catheter shaft, inflatable balloon, positions radiation source, utilizes 192Ir seed or ribbon).
Materials/Dimensions	Same as predicate MammoSite.
Dosimetric Properties	Similar to predicate MammoSite.
Safety and Effectiveness	Hologic believes the modified device is substantially equivalent, raising no new issues of safety or effectiveness. (FDA adds a warning that safety and effectiveness as a replacement for whole breast irradiation has not been established).

2. Sample size used for the test set and the data provenance

Not applicable. This submission does not include a test set from a clinical performance study. The assessment is based on comparison to predicate device specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No test set or ground truth in this context.

4. Adjudication method for the test set

Not applicable. No test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical instrument (applicator system for brachytherapy), not an AI algorithm for diagnostic reading.

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

Not applicable. This is a medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" for this submission is the established safety and effectiveness profile and technological characteristics of the predicate devices, which act as the benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. Not an AI algorithm.

In summary: The provided document is a 510(k) submission for a modified medical device, the MammoSite Radiation Therapy System. The regulatory pathway chosen is substantial equivalence to existing predicate devices. Therefore, the "study" proving the device meets "acceptance criteria" is a comparison of the modified device's characteristics (intended use, technological characteristics, materials, dimensions, dosimetric properties) to those of the predicate devices, rather than a clinical performance study with specific metrics. The FDA's review confirms this determination, with an added labeling limitation regarding its use as a replacement for whole breast irradiation.

Summary

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Proprietary and Confidential to Hologic, Inc
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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.250 Campus DriveMarlborough, MA 01752
Manufacturer's phone and faxnumbers:	Telephone: (508) 263-8912Fax: (508) 263-2403
Name of contact person:	Jennifer SullivanQuality Assurance Auditor
Trade name:	MammoSite Radiation Therapy System(RTS)
Common name:	Remote-controlled radionuclideapplicator system
Classification name:	System, applicator, radionuclide,remotecontrolled(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 RadiationTherapy System –5-6 cm Spherical	Hologic, Inc.	K041929
Multi-Lumen SourceApplicator forBrachytherapy	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.

Continued on next page

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510(k) Summary, Continued

Device description

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 (240) 276-3150. 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 (800) 638-2041 or (240) 276-3150 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)

(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 or 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.