CONTURA LUMEN MARKER

K082264 · Senorx, Inc. · JAQ · Sep 12, 2008 · Radiology

Device Facts

• Record ID: K082264
• Device Name: CONTURA LUMEN MARKER
• Applicant: Senorx, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Sep 12, 2008
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The Contura Lumen Marker is an accessory to the Contura MLB Applicator intended to be used to identify treatment lumens for radiation therapy dose planning.

Device Story

Contura Lumen Marker is a reusable accessory device used to identify treatment lumens within the Contura MLB Applicator. The device is 237 mm in length. It is utilized during radiation therapy dose planning to assist clinicians in identifying specific lumens for treatment. The device provides visual identification under CT imaging, aiding in the accurate planning of radiation delivery. It is intended for use in a clinical setting by healthcare professionals.

Clinical Evidence

Bench testing only. Evaluation included marker compatibility with the Contura MLB Applicator, CT visibility, and durability.

Technological Characteristics

Reusable marker, 237 mm length. Designed for CT visibility to identify lumens in the Contura MLB Applicator. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as an accessory to the Contura MLB Applicator to identify treatment lumens for radiation therapy dose planning.

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

• Nucletron CT Marker (510(k) unknown)
• Nucletron Proguide Needle Set (K060349)
• SenoRx SenoRad Multi-Lumen Balloon Source Applicator (K071229)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "SENORx" with a ribbon in the middle of the word. The ribbon is a symbol for breast cancer awareness. The text is in a serif font and is black in color.

K682264

## 5. 510(K) SUMMARY

SEP 1 2 2008

| Date prepared | August 5, 2008 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | SenoRx, Inc.<br>11 Columbia<br>Aliso Viejo, CA 92656<br>T. 949.362.4800; F. 949.362.0300 |
| Contact person | Eben Gordon<br>Vice President, RA/QA<br>SenoRx, Inc.<br>T. 949.362.4800; F. 949.362.0300 |
| Device name | Contura Lumen Marker |
| Common name | Lumen marker |
| Classification name | Remote controlled radionuclide source applicator |
| Classification regulation | 21 CFR 892.5700<br>90 JAQ |
| Predicate devices | Nucletron CT Marker; 510(k) unknown<br>Nucletron Proguide Needle Set; K060349<br>SenoRx SenoRad Multi-Lumen Balloon Source Applicator; K071229 |
| Description | Re-usable devices that aid in the identification of lumens within the Contura<br>MLB Applicator. Each marker is 237 mm in length. |
| Indications for use | The Contura Lumen Marker is an accessory to the Contura MLB Applicator<br>intended to be used to identify treatment lumens for radiation therapy dose<br>planning. |
| Summary of substantial<br>equivalence | Preclinical testing conducted included evaluation of marker compatibility with<br>the Contura MLB Applicator, CT visibility, and durability. The Contura Lumen<br>Marker performed as intended.<br>The Contura Lumen Markers have the following similarities to the predicate<br>device: Same intended use; Same design; Same materials; Same operating<br>principle; Same technological characteristics. In summary, the Contura Lumen<br>Marker as described in this submission is substantially equivalent to the<br>predicate device. |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle emblem with its wings spread, symbolizing the department's mission to protect the health of all Americans.

SEP 1 2 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SenoRx, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313

Re: K082264

Trade/Device Name: Contura Lumen Marker Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: August 8, 2008 Received: August 11, 2008

Dear Mr. Job:

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:

Warning: The safety and effectiveness of the Contura Applicator as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

{2}------------------------------------------------

Page 2 - Mr. Job

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,

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.

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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 [phone] or [phone] 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

{3}------------------------------------------------

## 4. INDICATIONS FOR USE

510(k) Number (if known): K082264

Device Name: _________ Contura Lumen Marker __________________________________________________________________________________________________________________________________

Indications for Use:

The Contura Lumen Marker is an accessory to the Contura MLB Applicator intended to be used to identify treatment lumens for radiation therapy dose planning.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 OF NEEDED)

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tonu mWhan

Page __ of ___________________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K082264