← Product Code [JAQ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ) · K132097 # BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY (K132097) _Best Medical International, Inc. · JAQ · Sep 30, 2013 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K132097 ## Device Facts - **Applicant:** Best Medical International, Inc. - **Product Code:** [JAQ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ.md) - **Decision Date:** Sep 30, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.5700 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Therapeutic ## Indications for Use Best Multi-Lumen Balloon Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to utilize a High Dose Rate remote afterloader device to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer. The safety and effectiveness of The Best Multi-Lumen Balloon Applicator for Brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established. It is supplied as a single-use sterile device. The device is indicated for use under the direct supervision of a qualified physician. ## Device Story Multi-lumen catheter device with inflatable inner and outer spherical balloons; used for brachytherapy in breast cancer patients post-lumpectomy. Device inserted into resection cavity; inner balloon inflates to position four peripheral lumens symmetrically around a central lumen. Catheters connect to High Dose Rate (HDR) remote afterloader for delivery of radiation source wire. Includes removable stiffening stylet for placement and proximal ports for balloon inflation/deflation and intracavitary vacuum. Operated by physicians in clinical settings. Provides targeted radiation to surgical margins; benefits include localized treatment delivery. Output is radiation dose delivered via HDR afterloader. ## Clinical Evidence Bench testing only. Performance characterization included dimensional comparisons of inflated outer balloon at various volumes, verification of HDR source transition through treatment catheters on an inflated inner balloon, and CT image quality assessment. ## Technological Characteristics Multi-lumen catheter with inflatable inner and outer spherical balloons. Five treatment lumens (one central, four moveable). Luer-lock connectors for inflation/deflation and vacuum. Single-use, sterile. Operates with external HDR remote afterloader. No electronic components; mechanical design. ## Regulatory 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. ## Predicate Devices - Contura Multi-Lumen Balloon Source Applicator for Brachytherapy ([K081079](/device/K081079.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## Best medical international K132097 healthcare for everyone Attachment 5 (Page 1) ### 510(k) Summary ### 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, "Best" Multi-Lumen Balloon Applicator for Brachy therapy" | Manufacturer: | Best Medical International, Inc.
7643 Fullerton Road
Springfield, VA 22153
Phone: (703) 451-2378
Fax: (703) 451-4736. | SEP 3 0 2013 | |---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Contact Person: | Dharmendra Thakur
Manager, Quality and Regulatory Affairs
Phone: (703) 451-2378 Ext 162
Mobile: 703-303-8030
Fax: (703) 451-4736. | | | Device Name: | | | | Trade Name: | "Best® Multi-Lumen Balloon Applicator for Brachytherapy " | | | Common Name: | Multi Lumen Balloon Source Applicator | | | Proprietary name: | "Best® Multi-Lumen Balloon Applicator for Brachytherapy " | | | Classification: | 21 CFR 892.5700 | | | Date Prepared: | July 05, 2013 | | | Predicate Device: | Contura Multi-Lumen Balloon Source Applicator for Brachytherapy | | | Predicate Device 510(k): | K081079 | | | Trade/ Device Name: | "Best® Multi-Lumen Balloon Applicator for Brachytherapy " | | | Regulation Number: | 21 CFR 892.5700 | | | Regulatory Class: | II | | | Product code : | JAQ | | | 7643 Fullerton Road, Springfield, VA 22153 USA
phone 703 451 2378 800 336 4970 fax 703 451 5228
www.bestmedical.com | | | {1}------------------------------------------------ ## Best medical international Attachment 5 (Page 2) healthcare for everyone ### Device Description : The Best® device is a multi-catheter brachytherapy device consisting of an inflatable outer spherical balloon and an inner inflatable balloon for treatment catheter positioning. Each catheter can be attachment to a commercially available High Dose Rate remote afterloader for passage of the source wire and radiation source into each of the catheter lumens. Five treatment lumens are provided, one central lumen located along the long axis of the applicator and four moveable lumens, which are symmetrically offset from the central lumen by inflation of an inner balloon, which positions the treatment lumens at a location greater than or equal to 50% of the outer balloon diameter. A removable stiffening stylet is positioned in the central treatment lumen for initial placement into the resection cavity, as well for repositioning of the device as needed. Three proximal ports are also provided with Luer-locktype connectors for inner and outer balloon inflation/deflation and for application of intracavitary vacuum for removal of air and/or fluid. ### Intended Use: "Best Multi-Lumen Balloon Applicator for Brachytherapy" is intended to provide brachytherapy when the physician chooses to utilize a High Dose Rate remote afterloader device to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer. #### Indications for Use: "Best" Multi-Lumen Balloon Applicator for Brachytherapy" is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer. It is supplied as a single-use sterile device. The device is indicated for use under the direct supervision of a qualified physician. Comparison of Technological Characteristics: "Best" Multi-Lumen Balloon Applicator for Brachytherapy" shares many structural and functional features with the FDA-approved Contura®Multi-lumen Balloon Brachytherapy Device. Both are catheter devices that are intended to deliver radiation to the surgical margins following lumpectomy for breast cancer and both use an inflatable balloon to conform radiation delivery based on the shape and size of the tumor being treated. 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. 7643 Fullerton Road, Springfield, VA 22153 USA phone 703 451 2378 800 336 4970 fax 703 451 5228 www.bestmedical.com AFRICA | ASIA | EUROPE | LATIN AMERICA | MIDDLE EAST | NORTH AMERICA {2}------------------------------------------------ ## t medical international Attachment 5(Page 3) ### A Comparison with Predicate Device is shown in table below: | | The Best ® Device | Predicate Device | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | "Best® Multi-Lumen Balloon
Applicator for Brachytherapy" | Contura® Multi-lumen Balloon
Source Applicator for
Brachytherapy -K081079 | | Device
Description | The Best® Multi-Lumen Balloon
Applicator for Brachytherapy
consists of a multi-lumen catheter
attached to an inflatable inner and
outer spherical balloon. Lumens are
provided for attachment to a
commercially available High Dose
Rate remote afterloader for passage of
the radiation treatment delivery wire
and source. Five treatment lumens are
provided, one central lumen located
along the long axis of the applicator
and four lumens which are
symmetrically offset from the central
lumen by inflation of an inner balloon
which positions the treatment lumens
at greater than or equal to 50% of the
outer balloon diameter. A removable
stiffening stylet is located in the
central treatment lumen. Three
proximal ports are also provided with
Luer-type connectors for inner and
outer balloon inflation/deflation and
for application of intracavitary
vacuum. | The Contura® Multi-lumen
Balloon Source Applicator for
Brachytherapy consists of a
multi-lumen catheter attached to
an inflatable spherical balloon.
Lumens are provided for
attachment to a commercially
available High Dose Rate
remote afterloader for passage
of the radiation treatment
delivery wire. Five treatment
lumens are provided, one
central lumen located along the
long axis of the applicator and
four curved lumens
symmetrically offset from the
central lumen by approximately
5 mm on a fixed plastic mount.
A removable stiffening stylet is
located in the central treatment
lumen. Two proximal ports are
also provided with Luer-type
connectors for balloon
inflation/deflation and for
application of intracavitary
vacuum. | | Intended
Use | "Best® Multi-Lumen Balloon
Applicator for Brachytherapy" is
intended to provide brachytherapy
when the physician chooses to utilize a
High Dose Rate remote afterloader
device to deliver intracavitary
radiation to the surgical margins
following lumpectomy for breast
cancer. | The Contura® Multi-Lumen
Balloon is intended to provide
brachytherapy when the
physician chooses to utilize a
High Dose Rate remote
afterloader device to deliver
intracavitary radiation to the
surgical margins following
lumpectomy for breast cancer. | | | | | | Indications
for Use: | "Best® Multi-Lumen Balloon
Applicator for Brachytherapy" is
intended to provide brachytherapy
when the physician chooses to deliver
intracavitary radiation to the surgical
margins following lumpectomy for
breast cancer. It is supplied as a single-
use sterile device. The device is
indicated for use under the direct
supervision of a qualified physician. | The Contura® Multi-Lumen
Balloon Source Applicator for
Brachytherapy is intended to
provide brachytherapy when the
physician chooses to deliver
intracavitary radiation to the
surgical margins following
lumpectomy for breast cancer. | | Conclusion: Performance tests were conducted to evaluate and characterize the
performance of the “Best® Multi-Lumen Balloon Applicator for Brachytherapy”. These
tests included dimensional comparisons of the inflated outer balloon at various volumes,
HDR source transition in and out of the treatment catheters on an inflated inner balloon,
and CT image quality. The “Best® Multi-Lumen Balloon Applicator for
Brachytherapy” performed as intended. | | | | The proposed device is substantially equivalent to the approved Contura®Multi-lumen
Balloon Source Applicator for Brachytherapy and is as safe and effective as the
approved device. Upon reviewing and comparing the proposed device and predicate
device, the classification, the intended use, indication for use, method of use and
technological characteristics, it can be concluded that the proposed device (The “Best®
Multi-Lumen Balloon Applicator for Brachytherapy” is substantially equivalent to the
Predicate device (Contura®Multi-lumen Balloon Source Applicator for Brachytherapy –
510(K)# K081079) | | | AFRICA i ASIA i EUROPE i LATIN AMERICA i MIDDLE EAST i NORTH AMERICA . healthcare for everyone. . {3}------------------------------------------------ # Best medical international Attachment 5 (page4) 7643 Fullerton Road, Springfield, VA 22153 USA ohone 703 451 2378 800 336 4970 fax 703 451 5228 www.bestmedical.com AFRICA | ASIA | EUROPE | LATIN AMERICA | MIDDLE EAST } NORTH AMERICA healthcare for everyone {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left and top portions of the logo. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 30, 2013 ﺒ Best Medical International, Inc. % Mr. Dharmendra Thakur Manager, Ouality and Regulatory Affairs 7643 Fullerton Road SPRINGFIELD VA 22153 Re: K132097 Trade/Device Name: Best® Multi-Lumen Balloon Applicator for Brachytherapy Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: Class II Product Code: JAQ Dated: July 5, 2013 Received: July 17, 2013 Dear Mr. Thakur: 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 10 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {5}------------------------------------------------ ### Page 2 - Mr. Dharmendra Thakur forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Reportal?roblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, ![](https://i.imgur.com/9999999.png) for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Attachment 4 ### Indications for Use Form 510(k) Number (if known): K132097 Device Name: "Best® Multi-Lumen Balloon Applicator For Brachytherapy " Indications for Use: Best® Multi-Lumen Balloon Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer. It is supplied as a single-use sterile device. The device is indicated for use under the direct supervision of a qualified physician. The safety and effectiveness of The Best Multi-Lumen Balloon Applicator for Brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established. Prescription Use _X_ _________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR) Sm.h.7) Division Sign-Off Office of In Vitro Devices and Radiologic Health Division of Radiological Health (DRH) 510(k)________________________________________________________________________________________________________________________________________________________________________ Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K132097](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K132097) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com