(32 days)
Not Found
No
The summary describes a physical accessory for identifying lumens and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is described as an accessory to identify treatment lumens for radiation therapy dose planning, indicating it's for planning/localization and not directly for therapy.
No
The device is used to identify treatment lumens for radiation therapy dose planning. It does not diagnose diseases or conditions.
No
The device description explicitly states it is a "Re-usable device" and provides a physical dimension ("237 mm in length"), indicating it is a physical object, not software.
Based on the provided information, the Contura Lumen Marker is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "identify treatment lumens for radiation therapy dose planning." This is a function related to medical imaging and treatment planning, not the diagnosis of a disease or condition using in vitro methods (testing samples like blood, urine, or tissue outside the body).
- Device Description: The device is described as a "re-usable device that aids in the identification of lumens." This aligns with a physical tool used in a medical procedure, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases.
The device's function is to assist in the visualization and planning of radiation therapy, which falls under the category of medical devices used in treatment and planning, not in vitro diagnosis.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
Re-usable devices that aid in the identification of lumens within the Contura MLB Applicator. Each marker is 237 mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical testing conducted included evaluation of marker compatibility with the Contura MLB Applicator, CT visibility, and durability. The Contura Lumen Marker performed as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Nucletron CT Marker; 510(k) unknown, Nucletron Proguide Needle Set; K060349, SenoRx SenoRad Multi-Lumen Balloon Source Applicator; K071229
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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.
5. 510(K) SUMMARY
SEP 1 2 2008
| Date prepared | August 5, 2008 |
|---|---|
| Name | SenoRx, Inc. |
| 11 Columbia | |
| Aliso Viejo, CA 92656 | |
| T. 949.362.4800; F. 949.362.0300 | |
| Contact person | Eben Gordon |
| Vice President, RA/QA | |
| SenoRx, Inc. | |
| 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 |
| 90 JAQ | |
| Predicate devices | Nucletron CT Marker; 510(k) unknown |
| Nucletron Proguide Needle Set; K060349 | |
| SenoRx SenoRad Multi-Lumen Balloon Source Applicator; K071229 | |
| Description | Re-usable devices that aid in the identification of lumens within the Contura |
| MLB Applicator. Each marker is 237 mm in length. | |
| 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. | |
| Summary of substantial | |
| equivalence | Preclinical testing conducted included evaluation of marker compatibility with |
| the Contura MLB Applicator, CT visibility, and durability. The Contura Lumen | |
| Marker performed as intended. | |
| The Contura Lumen Markers have the following similarities to the predicate | |
| device: Same intended use; Same design; Same materials; Same operating | |
| principle; Same technological characteristics. In summary, the Contura Lumen | |
| Marker as described in this submission is substantially equivalent to the | |
| predicate device. |
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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 (240) 276-0100. 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 (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
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