The MammoSite Cavity Evaluation Device (CED) may be used to assess the lumpectomy cavity and aid in the selection of the appropriate MammoSite Radiation Therapy System (RTS) applicator. It may be used during surgery to assess skin spacing and conformance. The CED may also be left in the lumpectorny cavity as a placeholder until it is exchanged for the MammoSite RTS applicator.

Device Description

The MammoSite CED is used to assess the lumpectomy cavity and aid in the selection of the appropriate MammoSite RTS applicator for delivery of intracavitary radiation. It may be used during surgery to assess skin spacing and conformance, but it is not intended to deliver radiation therapy. It may be left in the lumpectomy cavity as a placeholder for up to 29 days until it is exchanged for the MammoSite RTS applicator.

The CED consists of a single-lumen silicone shaft, approximately six and one half inches long, with an inflatable silicone balloon bonded to the distal end of the catheter shaft. A rounded silicone tip caps the distal end of the catheter. A female luer and valve are connected to the proximal end of the catheter shaft. The silicone shaft has an outer diameter of 0.214" and a durometer of 65 Shore A. The MammoSite CED is available in a spherical 4-5 cm. balloon size.

AI/ML Overview

The MammoSite Cavity Evaluation Device (CED) is a balloon catheter intended to be placed in a lumpectomy cavity for assessment and temporary maintenance of the cavity. The device's acceptance criteria and performance are established through non-clinical bench testing, as no clinical performance data was collected.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Visual Inspection
Rough edges	Not explicitly stated as "passed," but the overall conclusion is that "the device meets or exceeds its performance specification." Implicitly, no rough edges were observed.
Appropriate printed shaft markings	Not explicitly stated as "passed," but the overall conclusion is that "the device meets or exceeds its performance specification." Implicitly, markings were appropriate.
Ink adherence (after wiped with alcohol and saline)	Not explicitly stated as "passed," but the overall conclusion is that "the device meets or exceeds its performance specification." Implicitly, ink adherence was satisfactory.
Balloon Dimensional Consistency
Inflated dimensions at 1st, 4th, and 8th cycle	Measured and evaluated. Implies consistency was within acceptable limits, contributing to the conclusion that "the device meets or exceeds its performance specification." The testing covers a safety factor of 1.6 times the anticipated clinical inflation cycles.
Balloon Assembly Integrity
Strength of bonds	Assessed by inflating to failure with water after 8 inflation cycles. Results are not explicitly quantified but contribute to the conclusion that "the device meets or exceeds its performance specification."
Strength of balloon material	Assessed by inflating to failure with water after 8 inflation cycles. Results are not explicitly quantified but contribute to the conclusion that "the device meets or exceeds its performance specification."
Strength of joint between shaft and barb adapter	Tested to failure separately with a tensile test after the balloon burst. Results are not explicitly quantified but contribute to the conclusion that "the device meets or exceeds its performance specification."
Sterilization Compatibility
Device integrity after gamma sterilization (25-40kGy)	Tested and visually inspected for rough edges, printed shaft markings, and ink adherence. Implies compatibility, as the testing was performed after sterilization and led to the conclusion that "the device meets or exceeds its performance specification."

Sample Size Used for Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify the exact number of CED catheters tested for each non-clinical performance test. It states "samples in the verification were tested to 8 cycles" for balloon inflation, and "The sterilized CED catheters and components were tested." This implies multiple units were used, but the specific count is not provided.
- Data Provenance: The data is based on non-clinical bench testing performed by Hologic, Inc. (the submitter) in Marlborough, MA. This is internal, prospective testing conducted specifically for this 510(k) submission. No external or retrospective data sources are mentioned.
Number of Experts Used to Establish Ground Truth for Test Set and Qualifications:
- Not applicable. The ground truth for the non-clinical bench testing is based on objective measurements and engineering specifications, not expert consensus or human interpretation.
Adjudication Method for the Test Set:
- Not applicable, as the tests are objective mechanical and material performance evaluations, not subjective clinical assessments requiring adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. No clinical performance data was collected, and therefore no human-in-the-loop studies were performed. The device is a physical medical device (balloon catheter), not an AI or imaging diagnostic tool that would typically involve MRMC studies.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device is a physical medical device, not an algorithm. The non-clinical testing evaluates the inherent physical and mechanical properties of the device itself.
Type of Ground Truth Used:
- Engineering specifications and objective physical measurements. For example, visual inspections against defined criteria, dimensional measurements, and force-to-failure testing. The "ground truth" aligns with pre-defined performance requirements for the device.
Sample Size for the Training Set:
- Not applicable. This is a physical medical device undergoing non-clinical bench testing, not an algorithm that requires a training set. The device's design was likely refined through iterative development, but there's no "training set" in the context of an algorithm.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set. The design of the CED leverages the established design principles and materials of its predicate device, the MammoSite Radiation Therapy System (RTS) applicator, which would have undergone its own developmental and testing phases.

Summary

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510(k) Summary

MAY - 9 2008 Summary of Safety and Effectiveness for MammoSite® Cavity Evaluation Device

MAY - 9 2008

1. Submitter Information:

Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Establishment Registration Number: 1222780

Contact Person: Randall J. Covill Senior Regulatory Affairs Specialist Telephone No .: (508) 263-8853 Fax No.: (508) 263-2403

Prepared: March 10, 2008

2. Device Name:

Proprietary Name:	MammoSite Cavity Evaluation Device
Common Name:	Cavity Evaluation Device
Classification Name:	Remote controlled radionuclide applicator system
Classification Regulation:	21 CFR 892.5700, Product Code JAQ
Device Classification:	Class II

3. Predicate Device:

The MammoSite Radiation Therapy System (RTS) (K011690 and K030558) has been selected as the predicate device for the MammoSite Cavity Evaluation Device (CED).

4. Device Description:

Hologic, Inc.

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silicone shaft has an outer diameter of 0.214" and a durometer of 65 Shore A. The MammoSite CED is available in a spherical 4-5 cm. balloon size.

5. Intended Use:

The MammoSite Cavity Evaluation Device (CED) is a balloon catheter intended to be placed in the lumpectomy cavity and inflated with sterile saline or contrast solution for the purposes of:

. assessing the size and shape of the lumpectomy cavity in order to choose the appropriate MammoSite RTS applicator
. assessing skin spacing (between outer skin surface and balloon surface)
assessing cavity conformance (fit between cavity walls and balloon . surface)
. maintaining the size and shape of the cavity (acting as a placeholder) until it is exchanged for a MammoSite RTS applicator

Similar to the MammoSite RTS applicator, the CED is intended to assess skin spacing and cavity conformance; however, it differs from the MammoSite RTS applicator in that it is not intended to deliver radiation therapy and therefore has no therapeutic effect.

6. Technical Characteristic Comparison to Predicate Devices:

The MammoSite CED is similar in materials and construction to other MammoSite RTS applicators, utilizing the same silicone balloon and similar shaft materials. The CED can be considered a 'simplified' version of the MammoSite RTS applicator in that it does not contain an inner lumen in the shaft (through which the radiation source is inserted in the MammoSite RTS applicator) or the associated bifurcation on the proximal end (needed to allow for both a radiation port and needle-free injection port).

7. Non-clinical performance data

The bench testing performed for the CED was intended to address design differences with respect to its predicate. Testing that pertains to design aspects that have remained unchanged will reference MammoSite 4-5cm RTS applicator (silicone) 510(k) filing K011690.

The sterilized CED catheters and components were tested after gamma sterilization at 25-40kGy exposure. The catheters were visually inspected for rough edges, appropriate printed shaft markings, and ink adherence after wiped with alcohol and saline.

The inflated dimensions of the CED catheters were measured at several inflation cycles. The anticipated number of inflation/deflation cycles in a standard clinical procedure is three. The first is used by the physician to assess any leaks or asymmetry as specified in the IFU. The second cycle may be used by the Hologic, Inc.

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physician to position the inflated balloon in the cavity prior to closing the surgical site. The balloon could then be inflated to a third cycle for an evaluation of the cavity or to become a placeholder for the MammoSite RTS. The samples in the verification were tested to 8 cycles which represent a safety factor of 1.6.

Balloon dimensional consistency was evaluated by measuring the inflated balloon dimensions at the first, fourth and eighth cycle.

Balloon assembly integrity, including the strength of the bonds and the strength of the balloon material, was assessed after the eighth cycle by inflating it to failure with water. After the samples burst, the strength of the joint between the shaft and the barb adapter was tested to failure separately with a tensile test.

In combination with the results from the design verification performed for the predicate device, the tests performed for the CED demonstrate that the device meets or exceeds its performance specification and therefore performs as well or better than its predicate device.

8. Clinical performance data

No clinical performance data was collected in support of this premarket notification.

9. Conclusion

The data presented in this premarket notification provides evidence of substantial equivalence of the MammoSite CED to the chosen predicate devices, the MammoSite RTS applicators, for assessing skin spacing and conformance of the lumpectomy cavity prior to delivery of intracavitary radiation treatment using the MammoSite RTS. In addition, the CED may be used as a placeholder in the lumpectomy cavity for up to 29 days until it is replaced with the MammoSite RTS applicator.

Hologic, Inc.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around the top half of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2008

Hologic, Inc. % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. MELVILLE NY 11747

Re: K081179

Trade/Device Name: MammoSite® Cavity Evaluation Device Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: April 23, 2008 Received: April 25, 2008

Dear Mr. Conry:

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 such 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.

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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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely yours,

Nancy 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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4. Indications for Use

510(k) Number (if known):

MammoSite® Cavity Evaluation Device Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

MammoSite® Cavity Evaluation Device
Traditional 510(k) Notification

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number	K081179

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.