(32 days)
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.
Re-usable devices that aid in the identification of lumens within the Contura MLB Applicator. Each marker is 237 mm in length.
The provided document describes the Contura Lumen Marker, an accessory for the Contura MLB Applicator, used to identify treatment lumens for radiation therapy dose planning. This device is not an AI/ML powered device, and therefore the majority of the requested information regarding AI/ML studies is not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a non-AI/ML device, the concept of "acceptance criteria" is typically tied to functional performance and safety, rather than diagnostic accuracy metrics. The document summarizes "preclinical testing" rather than formal performance studies with explicit acceptance criteria and corresponding reported device performance values as would be seen for a diagnostic or AI/ML device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility with Contura MLB Applicator | Performed as intended |
| CT visibility | Performed as intended |
| Durability | Performed as intended |
| Same intended use as predicate device | Yes, similar to predicate device |
| Same design as predicate device | Yes, similar to predicate device |
| Same materials as predicate device | Yes, similar to predicate device |
| Same operating principle as predicate device | Yes, similar to predicate device |
| Same technological characteristics as predicate device | Yes, similar to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of device. The document mentions "preclinical testing" but does not specify a "test set" in the context of diagnostic performance. The testing would have involved prototypes of the marker and applicator.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. "Ground truth" in the context of diagnostic accuracy is not relevant for this device. The assessment of compatibility, CT visibility, and durability would likely be conducted by engineers and medical physicists, but these are not "experts" establishing a diagnostic ground truth.
4. Adjudication Method
Not applicable. This is not a diagnostic device requiring adjudication of different expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This device is not an AI/ML system and does not involve human readers interpreting images.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
Not applicable. The "performance" of this device is assessed by its physical characteristics and functionality, not by its ability to accurately identify or diagnose a condition. The "ground truth" would be established by direct observation and measurement of its physical properties and interactions with the Contura MLB Applicator and CT imaging.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Device and Evidence Presented:
The K082264 submission for the Contura Lumen Marker is focused on demonstrating substantial equivalence to predicate devices rather than establishing novel performance metrics through extensive clinical or diagnostic studies. The "Summary of substantial equivalence" section highlights the "preclinical testing" conducted, which assessed:
- Marker compatibility with the Contura MLB Applicator: This would involve testing if the marker fits and functions correctly within the applicator.
- CT visibility: This would involve imaging the marker within the applicator using a CT scanner to ensure it is clearly visible for radiation therapy dose planning.
- Durability: This would involve testing the marker's ability to withstand repeated use or conditions it is expected to encounter.
The document states that the Contura Lumen Marker "performed as intended" in these preclinical tests. The primary argument for substantial equivalence is based on the device having the "Same intended use; Same design; Same materials; Same operating principle; Same technological characteristics" as its predicate devices.
Conclusion:
The provided document describes a physical medical device (Contura Lumen Marker) that aids in radiation therapy planning. The regulatory submission (510(k)) focuses on demonstrating substantial equivalence to existing devices through preclinical testing of its physical and functional properties, rather than diagnostic accuracy studies or AI/ML performance evaluations. Therefore, most of the requested information regarding AI/ML study components is not pertinent to this device.
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5. 510(K) SUMMARY
SEP 1 2 2008
| Date prepared | August 5, 2008 |
|---|---|
| Name | SenoRx, Inc.11 ColumbiaAliso Viejo, CA 92656T. 949.362.4800; F. 949.362.0300 |
| Contact person | Eben GordonVice President, RA/QASenoRx, 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 892.570090 JAQ |
| Predicate devices | Nucletron CT Marker; 510(k) unknownNucletron Proguide Needle Set; K060349SenoRx SenoRad Multi-Lumen Balloon Source Applicator; K071229 |
| Description | Re-usable devices that aid in the identification of lumens within the ConturaMLB Applicator. Each marker is 237 mm in length. |
| Indications for use | The Contura Lumen Marker is an accessory to the Contura MLB Applicatorintended to be used to identify treatment lumens for radiation therapy doseplanning. |
| Summary of substantialequivalence | Preclinical testing conducted included evaluation of marker compatibility withthe Contura MLB Applicator, CT visibility, and durability. The Contura LumenMarker performed as intended.The Contura Lumen Markers have the following similarities to the predicatedevice: Same intended use; Same design; Same materials; Same operatingprinciple; Same technological characteristics. In summary, the Contura LumenMarker as described in this submission is substantially equivalent to thepredicate device. |
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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.
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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
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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
§ 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.