RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for "RADIADYNE". Above the company name is a stylized atom symbol. Below the company name is the phrase "REDEFINING RADIATION THERAPY". 120344 MAY - 3, 2012 # 5. 510(K) Summary Submission Correspondent Company Name: Company Address: Company Contact: Country: Phone: Fax: Submission Date: Website: Submission Sponsor Company Name: Company Address: Country: Phone: Fax: Website: Device Classification Device Trade Name: Product Classification Name: Product Code: Emergo Group, Inc. 611 West 5th Street Third Floor Austin, TX 78701 Stuart R. Goldman Senior Consultant project.management@emergogroup.com USA 512.327.9997 512.327.9998 January 16, 2012 www.emergogroup.com RadiaDyne, LLC (Specification Developer) 11931 Wickchester Lane Suite 360 Houston, TX 77043 USA 281.759.9600 281.759.9609 www.radiadyne.com RadiaPak™ Brachytherapy Applicator Balloon Device System, Applicator, Radionuclide, Remote-Controlled JAQ {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for "RADIADYNE REDEFINING RADIATION THERAPY". Above the text is a symbol that looks like three intersecting circles. The text is in all caps and is a sans-serif font. Image /page/1/Picture/1 description: The image shows the logo for Emergo Group. The logo consists of the words "EMERGO" and "GROUP" in a simple, sans-serif font, with a stylized circular graphic between them. The graphic is black and white and appears to be an abstract representation of a globe or a spiral. | Regulation Number: | 892.5700 | | |-----------------------|-----------|--| | Classification Panel: | Radiology | | | Regulatory Class: | Class 2 | | ## Predicate Devices 1. Capri™ Applicator (K092822) 2. Alatus® Vaginal Balloon Packing System (K092534) ### Indications for Use The RadiaPak™ Brachytherapy Applicator Balloon Device is a single use, non-sterile, disposable, inflatable, non-powered positioning device, manufactured without the use of latex, intended to be used on a daily treatment basis to position and stabilize the brachytherapy radiation delivery applicator within the vagina or rectum during brachytherapy radiation therapy procedures, x-ray, or computed tomography (CT) exam. The placement of the balloon device requires a physician directed healthcare professional. ### Device Description The RadiaPak™ Device is designed to position and stabilize the brachytherapy applicator and to space the applicator surface from the targeted vaginal or rectal mucosa during computed tomography and brachytherapy procedures. The proposed device is a latex free balloon and can be inflated with either air or saline, is provided non-sterile, and is intended for single use. ### Predicate Device Comparison | Comparison Of<br>RadiaPak™ vs. Alatus® vs. Capri™ Devices | | | | |-----------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------| | Device Information | RadiaPak™ | Alatus®<br>(K092534) | Capri™<br>(K092822) | | Product Code | JAQ | JAQ | JAQ | | Regulation Number | 892.5700 | 892.5700 | 892.5700 | | Classification Name | System, applicator,<br>radionuclide, remote-<br>controlled | System, applicator,<br>radionuclide, remote-<br>controlled | System, applicator,<br>radionuclide, remote-<br>controlled | | Device Material | Polyurethane<br>(balloon/shaft) | Polyurethane<br>(balloon/shaft) | PVC<br>(bulb/lumens) | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Radiadyne, a company that specializes in radiation therapy. The logo features a stylized atom symbol above the company name, which is written in a modern, sans-serif font. Below the company name is the tagline "Redefining Radiation Therapy," which highlights the company's mission and focus. | Flexible | Yes | Yes | Yes | |-------------------|--------------------------|--------------------|--------------------------| | Treatment Area | Vaginal or rectal mucosa | Vaginal mucosa | Vaginal or rectal mucosa | | Body Contact Area | Mucosal Membrane | Mucosal Membrane | Mucosal Membrane | | Procedure Time | $≈≤$ 90 minutes | $≈≤$ 90 minutes | $≈≤$ 90 minutes | | Single Use | Yes | Yes | Yes | | Supplied Sterile | No | No | Yes | | Inflatable | Yes | Yes | Yes | | Pressurized With | Air, saline, water | Air, saline, water | Air or saline | | Connection Type | Stopcock valve | Stopcock valve | Not applicable | | Expands | Yes | Yes | Yes | | Deflates | Yes | Yes | Yes | ## Non-Clinical Data - Biocompatibility & Performance Testing As part of demonstrating the safety and effectiveness of the RadiaPak™ Device and in showing substantial equivalence to the predicate devices. RadiaDyne performed biocompatibility testing in accordance with ISO 10993-1, as well as performance testing to determine balloon fill volume and fill pressure. ## Clinical Data RadiaDyne's is not submitting any clinical data in support of its 510(k) submission to the FDA for the RadiaPak™ Device as no such clinical data was submitted by VivaRay for its Capri™ Applicator or by RadiaDyne for its Alatus® Vaginal Balloon Packing System. ### Substantial Equivalence By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the new device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness compared to the predicate device. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for "RADIADYNE REDEFINING RADIATION THERAPY". Above the word RADIADYNE is a symbol that looks like an atom with three rings around it. The words "REDEFINING RADIATION THERAPY" are in smaller font below the word RADIADYNE. Image /page/3/Picture/1 description: The image shows the logo for EMERGO GROUP. The logo consists of the words "EMERGO" and "GROUP" in a sans-serif font, with a stylized globe symbol in between. The globe symbol is black and white and appears to be made up of curved lines. lt has been shown in this 510(k) submission that the differences between the RadiaPak™ Brachytherapy Applicator Balloon Device and both the Capri™ Applicator and the Alatus® Vaginal Balloon Packing System do not raise any questions regarding its safety and effectiveness. RadiaDyne's RadiaPak™ Device, as designed and manufactured, is therefore determined to be substantially equivalent to the Capri™ and Alatus® devices previously cleared under K092822 and K092534, respectively. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 image of an eagle with its wings spread, rendered in a simple, abstract design. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 RadiaDyne, LLC % Mr. Stuart R. Goldman Senior Consultant Emergo Group, Inc. 611 West 5th Street, Third Floor AUSTIN TX 78701 MAY - 3 2012 Re: K120344 Trade/Device Name: RadiaPak™ Brachytherapy Applicator Balloon Device Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ and IYE Dated: January 16, 2012 Received: February 3, 2012 Dear Mr. Goldman: 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or any 1 vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of {5}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications For Use 510(k) Number (if known): The RadiaPak™ Brachytherapy Applicator Balloon Device is a single use, non-sterile, disposable, inflatable, non-powered positioning device, manufactured without the use of latex, intended to be used on a daily treatment basis to position and stabilize the brachytherapy radiation delivery applicator within the vagina or rectum during brachytherapy radiation therapy procedures, x-ray, or computed tomography (CT) exam. The placement of the balloon device requires a physician directed healthcare professional. Prescription Use 区 (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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Muht DDK (Division Sign-Off) Division of Radiological De Office of In Vitro Diag tion and Selety K120344