(41 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 curved lumens symmetrically offset from the central lumen. The balloon is inflated to a 4 or 5 cm spherical shape by a controlled volume injection of physiological saline to approximately 33 or 58 ml, respectively.
This question refers to a 510(k) premarket notification for a medical device called the "Contura Multi-Lumen Balloon Source Applicator for Brachytherapy" (K080791). This submission focuses on a modification to a warning statement in the labeling and does not contain information about acceptance criteria or a study proving device performance against such criteria.
The submission explicitly states: "The device design, materials, processes, etc. have not been changed with this application. The modification is to a warning only, therefore, the Contura Multi-Lumen Balloon Source Applicator as described in this submission is substantially equivalent to the predicate device."
Therefore, I cannot extract the requested information from the provided text for the following reasons:
* **No Acceptance Criteria or Performance Study:** The document does not describe any acceptance criteria or any study designed to prove the device's performance against such criteria. The focus is solely on a labeling change.
* **No AI Component:** The device is a physical medical instrument (a multi-lumen balloon source applicator for brachytherapy), and the submission does not mention any artificial intelligence or software component. Therefore, questions related to AI performance, such as MRMC studies or standalone algorithm performance, are not applicable.
* **No Test Set or Training Set Information:** Since no performance study is described, there is no information on sample sizes for test or training sets, data provenance, ground truth establishment, or expert qualifications.
Conclusion:
The provided document K080791 does not contain the information requested regarding acceptance criteria, device performance studies, or details relevant to AI/software performance evaluation. The submission is a 510(k) for a labeling modification to an existing physical device, relying on substantial equivalence to a predicate device rather than new performance data.
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APR 30 2008 . . .
SENORX
7.
| Date prepared | March 14, 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 device | SenoRad Multi-Lumen Balloon Source Applicator for Brachytherapy(K071229) |
| Description | The Contura MLB applicator consists of a multi-lumen catheter connected to aninflatable spherical balloon that can be attached to commercially available HighDose Rate remote afterloader equipment for passage of the radiation sourcedelivery wire. Five radiation source wire lumens are provided; one centralIumen located along the long axis of the applicator and four curved lumenssymmetrically offset from the central lumen. The balloon is inflated to a 4 or 5cm spherical shape by a controlled volume injection of physiological saline toapproximately 33 or 58 ml, respectively. |
| 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 | The device design, materials, processes, etc. have not been changed with thisapplication. The modification is to a warning only, therefore, the ConturaMulti-Lumen Balloon Source Applicator as described in this submission issubstantially equivalent to the predicate device. |
.
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Third Party Review Quality Assessment
| Section 1 - Submission Information | |
|---|---|
| 510(k) No.: | K080791 |
| Third Party Organization: | REGULATORY TECHNOLOGIES Services |
| Third Party's Primary Reviewer(s): | MARK JOB |
| ODE/OIVD Division: | ORAO |
| Branch/Team: | RAOB |
| Section 2 - 510(k) Decision | ||
|---|---|---|
| Third party recommendation: | SE ✓ NSE Other (specify): | |
| ODE/OIVD final decision: | SE ✓ NSE Other (specify): |
Section 3 - Assessment of Third Party Review
| Review Element | Rating (check one) | |||
|---|---|---|---|---|
| Adequate | Minor | Major | ||
| Issue(s) | Issue(s) | |||
| a. Determination of device eligibility for third party review | ✓ | |||
| b. Extent of pre-submission consultation with ODE/OIVD division | ✓ | |||
| c. Organization and format of review documentation | ✓ | |||
| d. Determination of 510(k) administrative completeness (screeningreview) | ✓ | |||
| e. Summary of device characteristics, intended use, and performance(including accessories, if applicable) and reason for 510(k) submission | ✓ | |||
| f. Comparison to legally marketed devices-identification and analysis ofkey similarities and differences | ✓ | |||
| g. Rationale for conclusions and recommendation | ✓ | |||
| h. Use of guidance documents and standards | N/A | |||
| i. Resolution of 510(k) deficiencies and FDA requests for additionalinformation | ✓ | |||
| j. Scope of reviewer expertise and use of consulting reviewers | ✓ | |||
| k. Other (specify): |
Comments (explanation of ratings/issues): ____________________________________________________________________________________________________________________________________
Section 4 - ODE/OIVD Assessor Information R. PHILLIPS Date: 4/20/08 Tel. No.: 240-276-366
Assessed by:
Routing: Division -- Clip completed assessment (this page only) to inside front cover of 510(k). DMC-Forward this page only to Eric Rechen, POS/ODE, Rm. 120J, Corp. Blvd. (HFZ-402).
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Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2008
SenoRx, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1393 25th Street NW BUFFALO MN 55313
Re: K080791
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 14, 2008 Received: April 15, 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, 1 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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6. INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
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 | 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aopi Nha
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(Division Sign=Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
12
§ 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.