(583 days)
Best® Intraluminal Balloon Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intraluminal radiation to an existing body lumen such as the esophagus or bronchus. It is supplied as a single-use sterile device. The device is indicated for use under the direct supervision of a qualified physician.
The Best® device is a single catheter brachytherapy device consisting of an inflatable distal spherical balloon for anchoring and/or stabilizing and a series of inflatable balloons for centering the treatment catheter within the lumen. The catheter can be attachment to a commercially available High Dose Rate remote afterloader for passage of the source wire and radiation source into the catheter lumen. A removable flexible guide cable is positioned in the central treatment catheter for initial placement in the existing body lumen. Proximal ports are also provided with Luer-lock type connectors for inflation of the distal anchoring/stabilizing balloon inflation/deflation and for inflation of the series of centering balloons, either simultaneously or individually.
The Best® Intraluminal Balloon Applicator for Brachytherapy underwent non-clinical performance testing to evaluate its functionality. No clinical performance data was collected or reviewed in support of this premarket notification.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimensional comparisons of inflation regions at various volumes | Performed as intended. Specific numerical acceptance criteria and corresponding performance metrics are not provided in the summary. |
| HDR source transition into and out of the treatment catheter | Performed as intended. Specific numerical acceptance criteria and corresponding performance metrics are not provided in the summary. |
| Device materials not significantly affected by radiation | Device is constructed of materials that are not significantly affected by radiation to which they will be exposed during the lifetime of the product (single use). Specific test methods or numerical criteria are not provided. |
| Effective sterilization | The device may be sterilized effectively. Method of sterilization is Ethylene Oxide. Specific test methods or numerical criteria are not provided. |
| No re-sterilization | The device will not be re-sterilized. This indicates the device is intended for single use. This is a design/usage criterion rather than a performance metric. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the performance tests. The data provenance is not explicitly stated, but as it's part of a 510(k) summary for a US FDA submission, it can be inferred to be from the manufacturer's testing (likely in the US). The tests are non-clinical, implying prospective testing specific to this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This device underwent non-clinical performance testing, not a study requiring expert-established ground truth for diagnostic or clinical evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no expert-based ground truth was established.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a physical medical device (applicator), not an AI diagnostic tool. No AI assistance is mentioned or involved.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For non-clinical performance tests, "ground truth" typically refers to engineering specifications and measurements rather than clinical ground truth derived from expert consensus, pathology, or outcomes data. The performance was evaluated against internal design specifications and functional requirements.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
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Image /page/0/Picture/0 description: The image contains the logo of 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 acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, while the Department of Health & Human Services logo is in black.
April 13, 2018
Best Medical International, Inc. % Manny Subramanian, Ph.D. Director, Research & Development 7643 Fullerton Road SPRINGFIELD VA 22153
Re: K162499
Trade/Device Name: Best Instruminal Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: March 9, 2018 Received: March 12, 2018
Dear Dr. Subramanian:
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. 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162499
Device Name
Best® Intraluminal Balloon Applicator for Brachytherapy
Indications for Use (Describe)
Best® Intraluminal Balloon Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intraluminal radiation to an existing body lumen such as the esophagus or bronchus. It is supplied as a single-use sterile device. The device is indicated for use under the direct supervision of a qualified physician.
| 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) |
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Best Medical International, Inc. Best Intraluminal Balloon Applicator 510(k) Summary (K162499)
Summary of Safety and Effectiveness
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the proposed Best Medical International, "Beste Intraluminal Balloon Applicator for Brachytherapy "
| 1. Manufacturer: | Best Medical International, Inc. |
|---|---|
| 7643 Fullerton Road | |
| Springfield, VA 22153 | |
| Phone: (703) 451-2378 | |
| Fax: (703) 451-4736. |
| Contact Person: | Manny Subramanian, PhDDirector, Research and DevelopmentPhone: (703) 451-2378 Ext 151Fax: (703) 451-4736. |
|---|---|
| ----------------- | ----------------------------------------------------------------------------------------------------------------------- |
Original Submission Date: August 30, 2016 Updated Submission Date: April 11, 2018
2. Device Name:
| Trade Name: | Intraluminal Balloon Applicator for Brachytherapy |
|---|---|
| Name: | "Best® Intraluminal Balloon Applicator for Brachytherapy” K162499 |
| Classification: | Remote Controlled Radionuclide Source Applicator21 CFR 892.5700 |
| Regulatory Class: | II |
Product Code: JAQ
3. Predicate Device: Varian® Centering Intraluminal Applicator - 510(k) K082653
4. Device Description:
The Best® device is a single catheter brachytherapy device consisting of an inflatable distal spherical balloon for anchoring and/or stabilizing and a series of inflatable balloons for centering the treatment catheter within the lumen. The catheter can be attachment to a commercially
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available High Dose Rate remote afterloader for passage of the source wire and radiation source into the catheter lumen. A removable flexible guide cable is positioned in the central treatment catheter for initial placement in the existing body lumen. Proximal ports are also provided with Luer-lock type connectors for inflation of the distal anchoring/stabilizing balloon inflation/deflation and for inflation of the series of centering balloons, either simultaneously or individually.
5. Intended Use:
Best® Intraluminal Balloon Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver radiation to an existing body site such as the esophagus or bronchus. It is supplied as a single-use sterile device is indicated for use under the direct supervision of a qualified physician.
- Comparison of Technological Characteristics: "Best® Intraluminal Balloon Applicator for Brachytherapy" shares many structural and functional features with the FDA-approved Varian® Centering Intraluminal Applicator. Both are single catheter devices that are intended to deliver radiation to cancerous region within an existing body lumen. They have similar design characteristics, same operating principle and similar technological characteristics. Therefore, it can be concluded that the proposed device is substantially equivalent to the Predicate device.
| The Best ® Device | Predicate Device | |
|---|---|---|
| Device | Best® Intraluminal BalloonApplicator for BrachytherapyK162499 | Varian® Intraluminal Applicator SetGM 1000620 – K151022 |
| Design | Treatment Catheter - 6 Fr (2.0 mm)Extruded thermoplasticGuide Tube - 4mm – 10 mm O.D.Length - 70 cm – 150 cmExtruded thermoplasticGuide Wire – 0.9 mm O.D.Length - 80 cm – 160 cmStainless steelX-ray marker – Tungsten | Treatment Catheter - 5 FR (1.67 mm)Extruded thermoplasticGuide Tube – 3 mm O.D.Length - 90 cmExtruded thermoplasticGuide Wire – 0.9 mm O.D.Length - 260 cmStainless steelX-ray marker - Tungsten |
| Packaging | Individual provided sterile | Individual provided sterile |
| SterilizationMethod | Ethylene Oxide | Gamma sterilization |
| Biocompatible | Fully biocompatible – single use | Fully biocompatible – single use |
| AnatomicalSites | Intralumenal, esophageal, endo-bronchial | Intralumenal, esophageal, endo-bronchial, bile duct |
| Where used | Brachytherapy treatment roomPhysician guidance | Brachytherapy treatment roomPhysician guidance |
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7. Non-Clinical Performance Data
Performance tests were conducted to evaluate and characterize the performance of the Best® Intraluminal Balloon Applicator for Brachytherapy. Preclinical tests included dimensional comparisons of the inflation regions at various volumes and HDR source transition into and out of the treatment catheter (see Attachment 9). The Best® Intraluminal Balloon Applicator for Brachytherapy performed as intended. Additionally,
- the device is constructed of materials that are not significantly affected by radiation to । which they will be exposed during the lifetime of the product (single use)
- the device may be sterilized effectively
- the device will not be resterilzed -
8. Clinical Performance Data
No clinical performance data was collected in support of this premarket notification.
9. Conclusion
The Best® Intraluminal Balloon Applicator for Brachytherapy has the above similarities to the predicated device in that: it has the same intended use; it has similar design characteristics; same operating principle and similar technological characteristics. Therefore, it can be concluded that the proposed device is substantially equivalent to the Predicate device.
§ 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.