K Number
K162499
Device Name
Best Instruminal Applicator
Date Cleared
2018-04-13

(583 days)

Product Code
Regulation Number
892.5700
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
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 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.
More Information

Not Found

No
The description focuses on the mechanical components and function of a brachytherapy applicator, with no mention of AI or ML technologies.

Yes
The device delivers intraluminal radiation (brachytherapy) to existing body lumens, which is a therapeutic intervention.

No

This device is designed for delivering radiation therapy (brachytherapy) and does not perform any diagnostic functions like detecting, identifying, or characterizing a disease or condition.

No

The device description clearly outlines a physical catheter with inflatable balloons and ports, designed for insertion into a body lumen and connection to a remote afterloader. This is a hardware device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to deliver brachytherapy (radiation treatment) directly to an existing body lumen. This is a therapeutic procedure, not a diagnostic test performed on samples outside the body.
  • Device Description: The device is a catheter with balloons designed for placement and centering within a body lumen to facilitate radiation delivery from a remote afterloader. This is a medical device used for treatment.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely therapeutic.

N/A

Intended Use / Indications for Use

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.

Product codes

JAO

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intralumenal, esophageal, endo-bronchial

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified physician
Brachytherapy treatment room

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

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, and the device will not be resterilzed.
No clinical performance data was collected in support of this premarket notification.

Key Metrics

Not Found

Predicate Device(s)

K082653

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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.

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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, PhD
Director, Research and Development
Phone: (703) 451-2378 Ext 151
Fax: (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 Applicator
21 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.

  1. 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 ® DevicePredicate Device
DeviceBest® Intraluminal Balloon
Applicator for Brachytherapy
K162499Varian® Intraluminal Applicator Set
GM 1000620 – K151022
DesignTreatment Catheter - 6 Fr (2.0 mm)
Extruded thermoplastic

Guide Tube - 4mm – 10 mm O.D.
Length - 70 cm – 150 cm
Extruded thermoplastic

Guide Wire – 0.9 mm O.D.
Length - 80 cm – 160 cm
Stainless steel

X-ray marker – Tungsten | Treatment Catheter - 5 FR (1.67 mm)
Extruded thermoplastic

Guide Tube – 3 mm O.D.
Length - 90 cm
Extruded thermoplastic

Guide Wire – 0.9 mm O.D.
Length - 260 cm
Stainless steel

X-ray marker - Tungsten |
| Packaging | Individual provided sterile | Individual provided sterile |
| Sterilization
Method | Ethylene Oxide | Gamma sterilization |
| Biocompatible | Fully biocompatible – single use | Fully biocompatible – single use |
| Anatomical
Sites | Intralumenal, esophageal, endo-
bronchial | Intralumenal, esophageal, endo-
bronchial, bile duct |
| Where used | Brachytherapy treatment room
Physician guidance | Brachytherapy treatment room
Physician 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.