“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. BRAXX Biotech Co. Ltd % Anita Chen Consultant ZhengCheng Consulting Limited Company 6F., No.148, Sec. 1, Jianguo N. Rd., Jhongshan Dist. Taipei City, Taiwan 10489 Taiwan Re: K243045 Trade/Device Name: "BRAXX" Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAO Dated: November 14, 2024 Received: November 14, 2024 Dear Anita Chen: 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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 {2}------------------------------------------------ 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, Image /page/2/Picture/3 description: The image shows the name "JULIE SULLIVAN -S" in a bold, sans-serif font. The text is black and appears to be centered. The background is white, and there is a faint, light blue watermark behind the text, adding a subtle visual texture to the image. Julie Sullivan, Ph.D. 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 {3}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K243045 Device Name "BRAXX" Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) Indications for Use (Describe) The Esophageal Brachytherapy Applicator is intended for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to the esophagus. This device is sterile, disposable and single-use. Type of Use (Select one or both, as applicable) 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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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 510(k) Summary of Safety and Effectiveness This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92 - 1. Submitter Mailing Address BRAXX Biotech Co. Ltd 6F., No.10, Songde Rd., Xinyi Dist Taipei City, 11076, Taiwan R.O.C Contact Person Wilson Lai Phone: 886-658786670 E-mail: Wilson.lai@braxx.com.tw Date Prepared 2024.09.20 | 2 | Subject Device | | | |---|----------------------|-----------------------------------------------------|--| | | Proprietary Name: | “BRAXX” Esophageal Brachytherapy Applicator | | | | Model Name | BKMI2001, BKMI2002 | | | | Common or usual name | Esophageal Brachytherapy Applicator | | | | Product Code | JAQ | | | | Device | System, Applicator, Radionuclide, Remote-Controlled | | | | CFR classification | 21 CFR 892.5700 | | | | Device Class | II | | | | Classification Panel | Remote controlled radionuclide applicator syst | | - 3 Predicate Device | 510(k) number: | |----------------------| | Proprietary name: | | Model Name | | Common or usual name | | Product Code | | Device Class | K183332 "BRAXX" Esophageal Brachytherapy Applicator BKMI2001 Esophageal Brachytherapy Applicator JAQ II - 4 Device Description: ## [BKMI2001] The device has 6 independently balloons. Each balloon corresponds to a specified needle free connector (valve). The #1 valve is connected to the most distal balloon and the #6 valve corresponds with the proximal balloon. {5}------------------------------------------------ There is an indication balloon on each valve unit, which can indicate the inflated balloon. The distance between first marker printed on the main catheter and the distal tip is 19.8 cm. This device is disposable and designed for sterile and single use. ## [BKMI2002] The device has 8 independently balloons. Each balloon corresponds to a specified needle free connector (valve). The #1 valve is connected to the most distal balloon and the #8 valve corresponds with the proximal balloon. The distance between first marker printed on the main catheter and the distal tip is 40 cm. This device is disposable and designed for sterile and single use. The Esophageal Brachytherapy Applicator is intended 5. Intended Use: for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to the esophagus. This device is sterile, disposable and single-use. - 6. Technological A comparison of the device features, intended use, and Characteristics and other information demonstrates that the "BRAXX" Substantial Equivalence Esophageal Brachytherapy Applicator (BKMI2001 and Comparison with Predicate: BKMI2002) is substantially equivalent to the predicate device as summarized in below table. | Device | “BRAXX” Esophageal<br>Brachytherapy Applicator<br>(K183332) | “BRAXX” Esophageal<br>Brachytherapy Applicator | | |--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | Model | BKMI2001 | BKMI2001 | BKMI2002 | | Intended use | The Esophageal Brachytherapy<br>Applicator is intended for use<br>with commercially available<br>afterloader during brachytherapy.<br>The purpose of the device is for<br>delivery of radioactive source to<br>the esophagus. This device is<br>sterile, disposable and single-use. | The Esophageal Brachytherapy<br>Applicator is intended for use with<br>commercially available<br>afterloader during brachytherapy.<br>The purpose of the device is for<br>delivery of radioactive source to the<br>esophagus. This device is sterile,<br>disposable and single-use. | | {6}------------------------------------------------ | Device | "BRAXX" Esophageal<br>Brachytherapy Applicator<br>(K183332) | "BRAXX" Esophageal<br>Brachytherapy Applicator | | |-------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------| | Model | BKMI2001 | BKMI2001 | BKMI2002 | | Key<br>Components | A main catheter, balloons,<br>controller part (with needle-free<br>connectors). | A main catheter, balloons, controller<br>part (with needle-free connectors and<br>indication balloons). | | | Mechanics<br>of Action | Inflate the balloons by air or<br>liquid via syringe. The inflatable<br>balloons can expand the<br>esophagus. | Inflate the balloons by air or liquid<br>via syringe. The inflatable balloons<br>can expand the esophagus. | | | Number of<br>Balloons | 8 | 6 | 8 | | Balloon<br>length | 30 | 24 | 30 | | Indication<br>ballon | No | Yes | No | | Device<br>length | 1300 | 950 | 950 | | Sterilization<br>method | EO | EO | | The subject device has the same intended use/indications for use as the predicate device (K183332). The subject device has the same manufacturing process, principle of operation, sterilization method as the predicate device (K183332). The difference of technological characteristics was verified by functional testing, biocompatibility testing and sterilization validation. The testing data demonstrates the proposed device performs as safely and effectively as the predicate device. ### 7. Performance Testing Mechanical testing on balloon burst, fatigue, leakage and specification was verified and the test results pass the acceptance criteria. Mechanical testing on joint was verified and the test results pass the acceptance criteria. The performance testing data demonstrate that this device meets the performance/ function specifications. {7}------------------------------------------------ | Mechanical Test | Acceptance Criteria | |-----------------------------|---------------------| | Ballon Burst test | > 30.0 Kpa, CV<10% | | Balloon Fatigue test | > 30.0 Kpa, CV<10% | | Balloon Diameter and Volume | SD <5 %, CV<5 % | | Leakage test | No leakage | | Tensile Strength test | >30N, CV<10 % | ## 8.Biocompatibility testing In vitro cytotoxicity, Skin Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity and Pyrogen test were evaluated. 9.Sterilization Validation Sterilization validation was conducted in accordance with ISO 11135:2014. ### 10. Conclusion Based on the intended use, technological characteristics, performance testing and comparison to the predicate device, the Esophageal Brachytherapy Applicator is substantially equivalent to the predicate device and raises no new questions of safety or effectiveness.