BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". Varian Medical Systems Inc. % Peter Coronado Senior Director 3100 Hansen Way, M/S/E-110 PALO ALTO CA 94304 # Re: K221797 Trade/Device Name: BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: June 16, 2022 Received: June 21, 2022 # Dear Peter Coronado: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221797 Device Name BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device #### Indications for Use (Describe) The Bravos Afterloader System is indicated for use in the treatment of both benign and malignant disease or other conditions, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy. The Transfer Guide Tubes are intended to connect between the Bravos Remote Afterloader system and its range of applicators. This connection creates a conduit for the source cable to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site. The Length Assessment Device is intended to allow the user to establish an approximate length of an unknown length channel prior to the afterloader performing definitive length verification. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| | | | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304 650.493.4000 800.544.4636 varian.com # Premarket Notification 510(k) Summary The following information is provided according to 21 CFR 807.92. | Submitter: | Varian Medical Systems, Inc.<br>3100 Hansen Way Palo Alto, CA 94304 | |------------|---------------------------------------------------------------------| | | Contact Name: Peter J. Coronado | | | Phone: 650.424.6320 | | | Fax: 650.646.9200 | | | E-mail: submissions.support@varian.com | | | Date Prepared: June 14, 2022 | | Trade/<br>Proprietary<br>Names: | BRAVOS Afterloader Family (K191580)<br>BRAVOS Afterloader System Transfer Guide Tubes (TGT) Length Assessment Device (LAD) | | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | BRAVOS Afterloader System, Transfer Guide Tubes (TGT), Length Assessment Device (LAD)<br>Classification Name:<br>Remote controlled radionuclide<br>applicator system, 21 CFR §892.5700<br>Common/Usual Name:<br>Afterloader System<br>Source Guide Tubes<br>Brachytherapy Accessory<br>Regulatory Class:<br>Class II<br>Product Code: | Predicate Device:<br>BRAVOS Afterloader Family (K191580)<br>BRAVOS Afterloader System Transfer Guide Tubes (TGT) Length Assessment Device (LAD) | | | JAQ | | | Device<br>Description: | BRAVOS Afterloader System<br>The BRAVOS Afterloader System is a computer controlled remote electro/mechanical system used for brachytherapy. The system automatically moves a stainless-steel cable incorporating a small, high activity Iridium-192 pellet in a steel capsule (sealed source) into applicator(s) or catheter(s) inserted into the patient close by a malignant tumor or tumor bed. | | | | Transfer Guide Tubes (TGT)<br>Transfer Guide Tubes (TGT) are Brachytherapy applicator accessories. They are designed<br>to provide a path for the dummy and source cable from the BRAVOS Afterloader System to<br>the Applicator. The applicator end of a Transfer Guide Tube can vary in design to<br>accommodate a range of Applicators. | | | | | | | | Length Assessment Device (LAD) | | | | The Length Assessment Device (LAD) is a Brachytherapy applicator accessory and is used<br>to determine the approximate length of the inner lumen of the Transfer Guide Tubes (TGT)<br>and applicator assembly. | | | Intended/<br>Indications<br>For Use<br>Statement: | The subject device's indications for use and the intended use have not changed since the predicate submission. | | | | BRAVOS Afterloader System | | | | Intended Use | Indications for Use | | | The BRAVOS Afterloader System is intended for<br>use in the treatment of both benign and malignant<br>disease or other conditions, for both curative and<br>palliative intent, in the delivery of remote-controlled<br>High Dose Rate (HDR) brachytherapy. | The Bravos Afterloader System is indicated for<br>use in the treatment of both benign and malignant<br>disease or other conditions, for both curative and<br>palliative intent, in the delivery of remote-<br>controlled High Dose Rate (HDR) brachytherapy. | | | Transfer Guide Tubes (TGT) | | | | Intended Use | Indications for Use | | | The Transfer Guide Tubes are intended to connect<br>between the BRAVOS Remote Afterloader system<br>and its range of Applicators. This connection<br>creates a conduit for the source cable to travel<br>through and allows the radioactive isotopes to be<br>positioned within the patient's tumor site. | The Transfer Guide Tubes are intended to<br>connect between the Bravos Remote Afterloader<br>system and its range of applicators. This<br>connection creates a conduit for the source cable<br>to travel through and allows the radioactive<br>isotopes to be positioned within the patient's<br>tumor site. | | | Length Assessment Device (LAD) | | | | Intended Use | Indications for Use | | | The Length Assessment Device is intended to<br>allow the user to establish an approximate length of<br>an unknown length channel prior to the afterloader<br>performing definitive length verification. | The Length Assessment Device is intended to<br>allow the user to establish an approximate length<br>of an unknown length channel prior to the<br>afterloader performing definitive length<br>verification. | K221797 Image /page/3/Picture/10 description: The image contains three blue circles arranged horizontally against a white background. The circles are evenly spaced and appear to be of the same size. The color of the circles is a bright, solid blue, and they are the only objects in the image. {4}------------------------------------------------ The purpose of this submission is to provide details on the updated BRAVOS Afterloader System which is a part of the Varian's BRAVOS Afterloader Family (K191580) for which we are claiming substantial equivalence. There have been no updates to the accessories Transfer Guide Tubes (TGT) and Length Assessment Device (LAD) since the previous submission (K191580). ### The subject device Indications for Use and Intended Use are identical to the predicate device. {5}------------------------------------------------ # varian # Comparison of Technological Characteristics with the Predicate Device At a high level, the subject and predicate devices are based on the following similar technological elements: ### BRAVOS Afterloader System: - Same Intended Use and Indications for Use as Predicate device - Similar Design and Technology as Predicate device ● - Similar Jaguar Console Software (subject device updated to version 2.1) Transfer Guide Tubes (TGT) and Length Assessment Device (LAD): - . Same as Predicate device (no changes in the subject device) ### Significant Difference BRAVOS Afterloader System: The significant differences compared to the predicate device are - BRAVOS Control Software introduced new and modified risks plus risk control measures - Warning statement added to the labeling ● In addition to the changes listed above, other cumulative non-significant changes since the predicate device include the following: - Firmware, Control Software & Service Software: . - Minor enhancements and bug fixes O - . Afterloader: - O Minor feature enhancements # Performance Data Software verification and validation was conducted according to QSR §820.30 and ISO 13485;2016 design control requirements. Submission documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for BRAVOS Afterloader System was determined to be a "major" level of concern. Varian's BRAVOS Afterloader Family which consists of the updated BRAVOS Afterloader System is substantially equivalent to the predicate device (K191580). Compared to the predicate device, the basic operation and technological characteristics are substantially the same. The above changes do not affect the intended use or indications for use of the BRAVOS Afterloader System. No animal studies or clinical tests have been included in this pre-market submission. Verification testing was performed to demonstrate that the performance and functionality of the updated BRAVOS Afterloader System meets the initial design input requirements. Verification testing was performed to verify the integrity of any changes. Validation testing was performed on production equivalent devices, under clinically representative conditions by qualified personnel. {6}------------------------------------------------ # varian ### Standards Conformance The subject device conforms in whole or in part with the following standards: - IEC 60601-1-2: 2014 Edition 4.0 - IEC 60601-1-6: Edition 3.2 2020 - IEC 60601-1-8:2006 + A1:2012 ● - IEC 60601-2-17:2013 - IEC 62304: 2006 + A1:2015 ● - UL 2900-1:2017 - UL 2900-2-1:2017 - IEC 80001-1:2010 - IEC/TR 80001-2-2:2012 - ANSI / AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD) + A1 2012 ● - IEC 62366-1:2015+A1:2020 - EN ISO 14971:2019 - ISO 15223-1:2021 - EN ISO 17664:2017 - AAMI TIR-12:2010 - AAMI TIR-30: 2011 The subject device also complies with the following non-FDA recognized standards: - IEC 60825-1: 2014 ● - . EN ISO 13485:2016 # Conclusion The non-clinical data for the updated BRAVOS Afterloader System from the BRAVOS Afterloader Family supports the safety of the device and the software verification and validation demonstrate that the subject device should perform as intended in the specified use conditions. Varian considers the updated BRAVOS Afterloader System from the BRAVOS Afterloader Family to be as safe and effective as the predicate device and substantially equivalent to the predicate device.