(84 days)
Not Found
No
The device description focuses on mechanical components and their function in delivering brachytherapy. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies are also focused on physical characteristics and source movement, not algorithmic performance.
Yes
The device is used to deliver brachytherapy, which is a form of radiation therapy for treating cancer. It directly applies radiation to the surgical margins following lumpectomy for breast cancer.
No
The device is described as an applicator for delivering brachytherapy (radiation), which is a treatment, not a diagnostic procedure. While it mentions "CT image quality" in performance tests, the device itself is not presented as providing diagnostic information.
No
The device description clearly details a physical, multi-component hardware device including balloons, catheters, lumens, ports, and a stylet. It is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer." This describes a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical applicator designed to deliver radiation. It does not involve the analysis of biological samples (like blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any process that would involve testing samples in vitro.
Therefore, the "Best® Multi-Lumen Balloon Applicator for Brachytherapy" is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
"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.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Best medical international
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,
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)________________________________________________________________________________________________________________________________________________________________________
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