(16 days)
The Contura Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
The Contura MLB Applicator consists of a multi-lumen catheter connected to an inflatable spherical balloon that can be attached to commercially available High Dose Rate remote afterloader equipment for passage of the radiation source delivery wire. Five radiation source wire lumens are provided; one central lumen located along the long axis of the applicator and four lumens symmetrically offset from the central lumen. The balloon is inflated to a 4.5 - 6 cm spherical shape by a controlled volume injection of a saline/contrast solution.
This document is a 510(k) summary for the Contura MLB Source Applicator for Brachytherapy, which is a medical device. This is NOT a study describing device performance against acceptance criteria in the typical sense of a clinical or statistical study with acceptance criteria often seen for AI/ML devices.
Instead, the document details preclinical studies demonstrating the device's intended performance under simulated use conditions and its dosimetry equivalence to predicate devices. The "acceptance criteria" here are generally implied as meeting the functional requirements for a remote-controlled radionuclide source applicator and demonstrating similar radiation dose distribution to already cleared devices.
Here's an attempt to structure the information based on your request, understanding that this is a device submission and not a typical performance study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance under Simulated Use Conditions: | Performed as intended under simulated use conditions. |
| * Ability to connect to commercially available HDR afterloaders. | (Implied: Yes, designed for this, and preclinical studies confirmed.) |
| * Ability to pass radiation source delivery wire through lumens. | (Implied: Yes, 5 lumens provided for this purpose, and preclinical studies confirmed.) |
| * Ability to inflate balloon to 4.5 - 6 cm spherical shape. | (Implied: Yes, by controlled volume injection of saline/contrast solution.) |
| Dosimetry Equivalence to Predicate Devices: | Demonstrated that the Contura MLB Applicator could deliver an equivalent radiation dose to predicate devices. |
| * Radiation dose distribution patterns. | (Implied: Similar patterns to K071229 and K030558.) |
| * Target tissue coverage. | (Implied: Adequate for the indicated use, similar to predicate.) |
| Safety: | (Implied: Safe for its intended use, based on preclinical studies and comparison to predicates.) |
| * Biocompatibility of materials. | (Not explicitly stated here, but generally part of device evaluation.) |
| * Mechanical integrity. | (Not explicitly stated, but part of preclinical studies.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of human subjects or data sets for an AI/ML device. The "test set" would refer to the physical device prototypes or simulations. The document does not specify the number of devices or simulated scenarios tested in the preclinical studies.
- Data Provenance: Not applicable. The "study" refers to internal preclinical testing conducted by SenoRx, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable as this is not a diagnostic AI/ML device relying on expert-established ground truth from images or clinical data. The "ground truth" here would be established by engineering and dosimetry measurements and comparisons. Experts involved would be engineering, physics, and potentially clinical personnel involved in designing and testing the device. Their number and qualifications are not specified in this summary.
4. Adjudication Method for the Test Set
- Not applicable. There is no mention of adjudication for "test sets" in the context of human expert disagreement on classifications. Adjudication methods are typically relevant for human-interpretable data where ground truth is ambiguous or requires consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a physical medical instrument, not a diagnostic AI/ML algorithm that assists human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is not an AI/ML algorithm. The "standalone" performance refers to the device's functional and dosimetric performance on its own, which was evaluated through preclinical studies.
7. The Type of Ground Truth Used
- The "ground truth" for this device's evaluation was primarily based on engineering measurements, physical properties, simulated use conditions, and dosimetric calculations/measurements. This would involve:
- Functional tests: Verifying inflation mechanics, lumen patency, compatibility with afterloaders.
- Material properties: Ensuring biocompatibility and structural integrity.
- Dosimetry: Measuring or calculating radiation dose distribution and comparing it to known predicate devices and established radiation physics principles.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that uses a "training set." The development of the device would involve engineering design, prototyping, and testing, which isn't analogous to training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no "training set" for this device.
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Image /page/0/Picture/0 description: The image shows the word "SenorRx" in a stylized font. The "O" in "Senor" is replaced with a ribbon symbol, commonly associated with awareness campaigns. The text is in black and white, with a slightly distressed or textured appearance.
MAY - 2 2008
5. 510(K) SUMMARY
| Date prepared | April 2, 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 MLB Source Applicator for Brachytherapy |
| Common name | Multi-Lumen balloon source applicator |
| Classification name | Remote controlled radionuclide source applicator |
| Classification regulation | 21 CFR 892.5700;90 JAQ |
| Predicate devices | SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy(K071229) |
| MammoSite Radiation Therapy System (K030558) | |
| Description | The Contura MLB Applicator consists of a multi-lumen catheter connected toan inflatable spherical balloon that can be attached to commercially availableHigh Dose Rate remote afterloader equipment for passage of the radiationsource delivery wire. Five radiation source wire lumens are provided; onecentral lumen located along the long axis of the applicator and four lumenssymmetrically offset from the central lumen. The balloon is inflated to a 4.5 - 6cm spherical shape by a controlled volume injection of a saline/contrastsolution. |
| Indications for use | The Contura Multi-Lumen Balloon Source Applicator for Brachytherapy isintended to provide brachytherapy when the physician chooses to deliverintracavitary radiation to the surgical margins following lumpectomy for breastcancer. |
| Summary of substantialequivalence | Preclinical studies demonstrated that the Contura MLB Applicator performed asintended under simulated use conditions. The dosimetry of the Contura MLBApplicator and the predicate devices demonstrated that the Contura MLBApplicator could deliver an equivalent radiation dose. In summary, the ConturaMLB Applicator as described in this submission is substantially equivalent tothe predicate devices. |
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2008
SenoRx, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1393 25th Street NW BUFFALO MN 55313
Re: K081079
Trade/Device Name: Contura Multi-Lumen Balloon Source Applicator for Brachytherapy Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: April 15, 2008 Received: April 16, 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:
The safety and effectiveness of the Contura Multi-Lumen Balloon Source Applicator for Brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.
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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): KU81079
Device Name: _______ Contura Multi-Lumen Balloon Source Applicator for Brachytherapy _
Indications for Use:
The Contura Multi-Lumen Balloon Source Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.
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)
signature
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
Page __ of ___________________________________________________________________________________________________________________________________________________________________
510(k) Number K081079
§ 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.