(134 days)
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. For prescription use only
A main catheter with inflatable balloons
BRAXX Esophageal Brachytherapy Applicator
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Device Performance |
|---|---|
| Biocompatibility | Device is fully biocompatible, demonstrating compliance with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization), ISO 10993-11 (systemic toxicity), and USP 151 (pyrogenicity). |
| Sterilization | Sterilization validation resulted in a Sterility Assurance Level (SAL) of 10-6, in accordance with ISO 11135:2014. |
| Mechanical Function | Device demonstrated that design specifications from design input are fulfilled and raises no safety concern. |
| Structural Integrity | Device demonstrated that design specifications from design input are fulfilled and raises no safety concern. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes performance testing for a medical device (Esophageal Brachytherapy Applicator) based on physical and chemical properties and engineering principles, not on clinical or AI performance. Therefore, there is no mention of a "test set" in the context of clinical data, sample size, or data provenance (country of origin, retrospective/prospective). The testing involved laboratory-based evaluations of the device's materials, sterility, and mechanical properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the performance testing of this device was established based on recognized international and FDA standards for biocompatibility (ISO 10993 series, USP 151), sterilization (ISO 11135:2014), and mechanical testing. These standards define the acceptable limits and methodologies, and compliance is typically assessed by qualified laboratory personnel and engineers, rather than a panel of clinical experts establishing ground truth from patient data.
4. Adjudication Method for the Test Set
Not applicable. As described above, the performance testing involved laboratory evaluations against established standards, not a clinical test set requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is a physical medical device (an applicator for brachytherapy), not an AI-powered diagnostic or decision-support tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for the performance testing was based on:
- Established International Standards: For biocompatibility (ISO 10993 series and USP 151) and sterilization (ISO 11135:2014).
- Design Specifications/Input: For mechanical function and structural integrity, ensuring the device met its intended engineering requirements.
These are objective, quantitative, or qualitative measures derived from validated testing methodologies, rather than expert consensus on clinical cases, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
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Section 4 Indications for Use Statement
FORM FDA 3881
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K183332
Device Name Esophageal Brachytherapy Applicator
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)
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FORM FDA 3881 (7/17)
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Section 5 510(k) Summary
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
The assigned 510(k) Number: K183332
- Submitter 1.
| Mailing Address | BRAXX Biotech Co. Ltd6F., No.10, Songde Rd., Xinyi DistTaipei City, 11076, Taiwan R.O.CEstablishment Registration No.: NA (1st submission) |
|---|---|
| Contact Person | Judy Kao |
| Phone: | 886-921988206 |
| E-mail: | judy.kao@braxx.com.tw |
| Date Prepared | 2018/11/27 |
2 Device Name
Proprietary Name Common name Product Code Device CFR Classification Device Class Classification Panel
"BRAXX" Esophageal Brachytherapy Applicator Esophageal Brachytherapy Applicator JAQ System, Applicator, Radionuclide, Remote-Controlled 21 CFR 892.5700 II Remote controlled radionuclide applicator system
3 Predicate Device Name
510(k) number: Trade or proprietary name: Manufacturer:
510(k) number: Trade or proprietary name: Manufacturer:
5. Intended Use:
K142719 E-App (Esophageal Applicator) BIONIX RADIATION THERAPY, LLC
K162499
Intraluminal Balloon Applicator for Brachytherapy Best Medical International, Inc
The Esophageal Brachytherapy Applicator is intended for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery
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Image /page/3/Picture/0 description: The image shows the logo for BRAXX. The logo consists of the word "BRAXX" in a bold, sans-serif font, with a stylized "B" that incorporates a small orange circle. Below the word "BRAXX" are three Chinese characters.
of radioactive source to the esophagus. This device is sterile, disposable and single-use. For prescription use only
Special Conditions for Use Statement(s):
Characteristics and
Substantial Equivalence
Comparison with Predicate:
Technological
A comparison of the device features, intended use, and other information demonstrates that the Esophageal Brachytherapy Applicator is substantially equivalent to the predicate device as summarized in Table 1.
| Device name | Subject device:EsophagealBrachytherapyApplicator | Predicate device:E-App | Predicate device:Best® IntraluminalBalloon Applicator forBrachytherapy |
|---|---|---|---|
| Intended Use | The EsophagealBrachytherapy Applicatoris intended for use withcommercially availableafterloader duringbrachytherapy. Thepurpose of the device is fordelivery of radioactivesource to the esophagus.This device is sterile,disposable and single-use. | The GC MedtechEsophagealapplicator(E-App) is anapplicator used to facilitatedelivery of a prescription ofradiation to the esophaguswhen used in conjunctionwith a high dose rateafter-loader. | Best® IntraluminalBalloon Applicator forBrachytherapy is intendedto provide brachytherapywhen the physicianchooses to deliver radiationto an existing body sitesuch as the esophagus orbronchus. It is supplied as asingle-use sterile device.The device is indicated foruse under the directsupervision of a qualifiedphysician. |
| Target patientPopulation | Esophageal cancer patients | Same | Same |
| Target UserPopulation | Radiation oncologists | Same | Same |
| AnatomicalSite | Esophagus | Same | Same |
| Where Used | Hospital O.R. room | Same | Same |
| Design | A main catheter withinflatable balloons | Same | Same |
| Performance | For centering the treatmentcatheter (radioactivesource) within the lumenby inflated balloons. | Same | Same |
| Biocompatible | Fully biocompatible | Same | Same |
| SterilizationMethod | Ethylene Oxide | Same | Same |
| Single Use | Single use | Same | Same |
Table 1
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7. Performance Testing
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device.
Biocompatibility testing
The biocompatibility evaluation and testing of the Esophageal Brachytherapy Applicator was conducted in accordance with the following standards and guidance, as recognized by the FDA:
- FDA Draft Guidance Use of International Standard ISO- 10993, "Biological Evaluation O of Medical Devices, Part 1: Evaluation and Testing", dated 04-23-2013
- 0 ISO 10993-5, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- 10993-10, Biological evaluation of medical devices- Part 10: Tests for irritation and skin 0 sensitization
- 0 ISO 10993-11, Biological evaluation of medical devices- Part 11: Tests for systemic toxicity.
- O USP 151, Pyrogen Test in White Rabbits
Sterilization Validation
Sterilization validation was conducted in accordance with ISO 11135:2014 "Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices". Sterilization has been validated to achieve a Sterility Assurance Level (SAL) of 10-6.
Mechanical testing
Esophageal Brachytherapy Applicator's mechanical function and structure integrity were tested and demonstrated that the design specification from design input are fulfilled and that the device raises no safety concern.
8. Conclusion
Based on the intended use and/or indications for 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.
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BRAXX Biotech Co., Ltd. % Ms. Judy Kao Regulatory Affairs Representative 6F., No.10, Songde Rd., Xinyi Dist Taipei City, 11076 Taiwan REPUBLIC OF CHINA
April 16, 2019
Re: K183332
Trade/Device Name: "BRAXX" Esophageal Brachytherapy Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: Class II Product Code: JAQ Dated: February 27, 2019 Received: March 8, 2019
Dear Ms. Kao:
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 801 and Part 809; 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
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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
§ 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.