"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.

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.

AI/ML Overview

The document provided is a 510(k) Summary for a medical device called the "Best® Multi-Lumen Balloon Applicator for Brachytherapy." This device is a physical medical instrument, not a software-based AI/ML device. Therefore, the typical acceptance criteria and study designs applicable to AI/ML devices, such as those related to diagnostic performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not relevant or provided in this submission.

The acceptance criteria and "study" described in this document are focused on the physical and functional performance of the device, primarily by demonstrating substantial equivalence to a legally marketed predicate device.

Here's an analysis of the provided information, framed within the context of a physical medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of "acceptance criteria" and "reported device performance" in the way one would for a diagnostic accuracy study. Instead, it demonstrates performance through functional testing and comparison to a predicate device. The implicit acceptance criteria are that the device performs its intended mechanical functions reliably and safely, similar to the predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance
Functional Equivalence to Predicate Device	"The Best® Multi-Lumen Balloon Applicator for Brachytherapy performed as intended."
Dimensional integrity of the inflated outer balloon	"Performance tests were conducted to evaluate and characterize the performance... These tests included dimensional comparisons of the inflated outer balloon at various volumes." (No specific values reported, but implies acceptable performance)
Smooth HDR source transition in and out of catheters	"Performance tests... included HDR source transition in and out of the treatment catheters on an inflated inner balloon." (Implies successful, smooth transition)
Adequate CT Image Quality	"Performance tests... included... CT image quality." (Implies the device is visible and distinguishable on CT scans as needed for brachytherapy planning)
Similarity in Design Characteristics to Predicate Device	"They have similar design characteristics; same operating principle and similar technological characteristics."
Intended Use matching Predicate Device	The "Best® Multi-Lumen Balloon Applicator for Brachytherapy" has the same intended use as the predicate device.
Indications for Use matching Predicate Device	The "Best® Multi-Lumen Balloon Applicator for Brachytherapy" has the same indications for use as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not applicable in the context of human data or AI model evaluation. The "tests" performed were engineering and functional assessments of the physical device. The sample size would refer to the number of physical devices tested, which is not specified but is typically a small number for design verification.
Data Provenance: Not applicable. This is not a study involving patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Ground truth in this context relates to the physical and mechanical properties and functionality of the device, which are established through engineering measurements and design specifications, not expert interpretation of medical images or outcomes.

4. Adjudication Method for the Test Set:

Not applicable. There is no "adjudication" in the sense of reconciling divergent expert opinions on medical diagnoses. Performance is assessed against engineering specifications and functional requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not the function of this physical brachytherapy applicator.
Effect Size of Human Readers with/without AI assistance: Not applicable.

6. If a Standalone (Algorithm Only without Human-in-the-Loop Performance) was done:

Not applicable. This device is a physical instrument used by a human physician, not a standalone algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on engineering specifications, manufacturing tolerances, and the demonstrated functional behavior of the device (e.g., successful balloon inflation, unimpeded source wire movement, acceptable imaging properties) when subjected to defined tests. The comparison to the predicate device's established safety and effectiveness also serves as a benchmark for "ground truth" regarding substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device, and there is no "training set" in the context of AI/ML model development.

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reason as above.

In summary: The provided document is a 510(k) submission for a physical medical device. It demonstrates safety and effectiveness through mechanical performance testing and a detailed comparison to a legally marketed predicate device, rather than through clinical trials or performance studies relevant to AI/ML diagnostic tools. The "study" here is a series of engineering and functional tests to confirm the device operates as intended and meets design specifications, ensuring it is substantially equivalent to the predicate.

Summary

{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 RoadSpringfield, VA 22153Phone: (703) 451-2378Fax: (703) 451-4736.	SEP 3 0 2013
Contact Person:	Dharmendra ThakurManager, Quality and Regulatory AffairsPhone: (703) 451-2378 Ext 162Mobile: 703-303-8030Fax: (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 USAphone 703 451 2378 800 336 4970 fax 703 451 5228www.bestmedical.com

{1}------------------------------------------------

Best medical international

Attachment 5 (Page 2)

healthcare for everyone

Device Description :

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

{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 BalloonApplicator for Brachytherapy"	Contura® Multi-lumen BalloonSource Applicator forBrachytherapy -K081079
DeviceDescription	The Best® Multi-Lumen BalloonApplicator for Brachytherapyconsists of a multi-lumen catheterattached to an inflatable inner andouter spherical balloon. Lumens areprovided for attachment to acommercially available High DoseRate remote afterloader for passage ofthe radiation treatment delivery wireand source. Five treatment lumens areprovided, one central lumen locatedalong the long axis of the applicatorand four lumens which aresymmetrically offset from the centrallumen by inflation of an inner balloonwhich positions the treatment lumensat greater than or equal to 50% of theouter balloon diameter. A removablestiffening stylet is located in thecentral treatment lumen. Threeproximal ports are also provided withLuer-type connectors for inner andouter balloon inflation/deflation andfor application of intracavitaryvacuum.	The Contura® Multi-lumenBalloon Source Applicator forBrachytherapy consists of amulti-lumen catheter attached toan inflatable spherical balloon.Lumens are provided forattachment to a commerciallyavailable High Dose Rateremote afterloader for passageof the radiation treatmentdelivery wire. Five treatmentlumens are provided, onecentral lumen located along thelong axis of the applicator andfour curved lumenssymmetrically offset from thecentral lumen by approximately5 mm on a fixed plastic mount.A removable stiffening stylet islocated in the central treatmentlumen. Two proximal ports arealso provided with Luer-typeconnectors for ballooninflation/deflation and forapplication of intracavitaryvacuum.
IntendedUse	"Best® Multi-Lumen BalloonApplicator for Brachytherapy" isintended to provide brachytherapywhen the physician chooses to utilize aHigh Dose Rate remote afterloaderdevice to deliver intracavitaryradiation to the surgical marginsfollowing lumpectomy for breastcancer.	The Contura® Multi-LumenBalloon is intended to providebrachytherapy when thephysician chooses to utilize aHigh Dose Rate remoteafterloader device to deliverintracavitary radiation to thesurgical margins followinglumpectomy for breast cancer.

Indicationsfor Use:	"Best® Multi-Lumen BalloonApplicator for Brachytherapy" isintended to provide brachytherapywhen the physician chooses to deliverintracavitary radiation to the surgicalmargins following lumpectomy forbreast cancer. It is supplied as a single-use sterile device. The device isindicated for use under the directsupervision of a qualified physician.	The Contura® Multi-LumenBalloon Source Applicator forBrachytherapy is intended toprovide brachytherapy when thephysician chooses to deliverintracavitary radiation to thesurgical margins followinglumpectomy for breast cancer.
Conclusion: Performance tests were conducted to evaluate and characterize theperformance of the “Best® Multi-Lumen Balloon Applicator for Brachytherapy”. Thesetests 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 forBrachytherapy” performed as intended.
The proposed device is substantially equivalent to the approved Contura®Multi-lumenBalloon Source Applicator for Brachytherapy and is as safe and effective as theapproved device. Upon reviewing and comparing the proposed device and predicatedevice, the classification, the intended use, indication for use, method of use andtechnological characteristics, it can be concluded that the proposed device (The “Best®Multi-Lumen Balloon Applicator for Brachytherapy” is substantially equivalent to thePredicate 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)________________________________________________________________________________________________________________________________________________________________________

Page 1 of 1

Regulation Number and Section

§ 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.