Intraluminal Applicator Set

K151022 · Varian Medical Systems, Inc. · JAQ · Dec 17, 2015 · Radiology

Device Facts

• Record ID: K151022
• Device Name: Intraluminal Applicator Set
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Dec 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intraluminal Applicator Set is indicated for use for intraluminal brachytherapy treatments including endo-bronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy.

Device Story

Intraluminal Applicator Set facilitates HDR brachytherapy; used with Varian GammaMedplus afterloaders. Set includes catheters, guide tubes, and accessories (e.g., bite protectors, guide wires, markers). Operated by radiation oncologists, physicists, and technicians in hospital brachytherapy suites. Device guides radioactive source to target tissue; ensures positional accuracy for radiation delivery. Enables localized cancer treatment in endo-bronchial, esophageal, and bile duct sites. Bench testing confirms mechanical integrity, radiation resistance, and sterilization efficacy. Clinical benefit derived from precise, targeted radiation delivery to tumors.

Clinical Evidence

No clinical data. Bench testing only. Testing verified functional compatibility with afterloaders, mechanical durability over lifetime cycles, positional accuracy of the radioactive source, material radiation resistance, and sterilization effectiveness. Usability assessed per IEC 62366:2007.

Technological Characteristics

Materials: PA, FEP, Stainless Steel, PPSU. Components: Bronchial catheters, guide tubes, bite protectors, guide wires. Energy: HDR brachytherapy source (via afterloader). Connectivity: Mechanical interface with GammaMedplus. Sterilization: Gamma (single-use), Steam (single-use), or High-level disinfection (reusable). MR compatibility varies by component (MR Safe vs MR Unsafe).

Indications for Use

Indicated for patients requiring intraluminal HDR brachytherapy for endo-bronchial, esophageal, or bile duct treatments.

Regulatory Classification

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

• Gammamedplus High Dose Rate Remote Afterloading System (K983436)

Reference Devices

• Guide wire (K082094)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 17, 2015

Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304

Re: K151022

Trade/Device Name: Intraluminal Applicator Set GM11000620 Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: November 13, 2015 Received: November 16, 2015

Dear Mr. Coronado:

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Oals

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

#### 510(k) Number (if known) K151022

Device Name

Intraluminal Applicator Set GM11000620

Indications for Use (Describe)

The Intraluminal Applicator Set is indicated for use for intraluminal brachytherapy treatments including endo-bronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# PREMARKET NOTIFICATION

# 510(k) Summary

Intraluminal Applicator Set

# As required by 21 CFR 807.92

| Submitter's Name: | Varian Medical Systems<br>3100 Hansen Way, m/s E110<br>Palo Alto CA94304 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado<br>Phone: [phone]<br>Fax: [phone]<br>Date: 25 September 2015. |
| Proprietary Name: | GM11000620 Intraluminal Applicator Set |
| Classification Name: | Remote controlled radionuclide applicator system<br>21CFR892.5700<br>Class II |
| Common/Usual Name: | GM11000620 Intraluminal Applicator Set |
| Predicate Devices: | K983436.Gammamedplus High Dose Rate Remote Afterloading<br>System. |
| Device Description: | The Intraluminal Applicator Set is designed for intraluminal<br>brachytherapy treatments including endo-bronchial treatments<br>and treatments on body sites such as the esophagus and the bile<br>duct using HDR brachytherapy. It is compatible with Varian<br>GammaMedplus afterloaders and can be used in combination with<br>the appropriate accessories.<br>The devices are intended to be used by trained and qualified<br>personnel such as Radiation Oncologists, Physicians, Radiologists,<br>Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology<br>Technicians/Radiographers in a hospital environment. |
| Indications for Use: | The Intraluminal Applicator Set is indicated for use for intraluminal<br>brachytherapy treatments including endo-bronchial treatments<br>and treatments on body sites such as the esophagus and the bile<br>duct using HDR brachytherapy. |

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#### Technological Characteristics:

| | GM11000620 Intraluminal Applicator<br>Set<br>(as part of GammaMed afterloader-<br>K983436). | GM11000620 Intraluminal Applicator<br>Set |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible<br>Afterloader | GammaMed plus | GammaMed plus |
| Intended use | Covered by intended use of complete<br>afterloader system in original<br>submission:<br>The intended use of the GammaMed<br>Plus transportable high-dose-rate<br>remotely controlled afterloading<br>brachytherapy device is for the<br>treatment of cancer by intracavitary,<br>interstitial, intraluminal and<br>intraoperative irradiation. | The Intraluminal Applicator Set is<br>intended for intraluminal<br>brachytherapy treatments including<br>endo-bronchial treatments and<br>treatments on body sites such as the<br>esophagus and the bile duct using<br>HDR brachytherapy. |
| Indications for Use | Covered by indication for use of<br>complete afterloader system in<br>original submission:<br>The intended use of the GammaMed<br>Plus transportable high-dose-rate<br>remotely controlled<br>afterloading brachytherapy device is<br>for the treatment of cancer by<br>intracavitary, interstitial, intraluminal<br>and intraoperative irradiation. | The Intraluminal Applicator Set is<br>indicated for use for intraluminal<br>brachytherapy treatments including<br>endo-bronchial treatments and<br>treatments on body sites such as the<br>esophagus and the bile duct using<br>HDR brachytherapy. |
| Design | Set Components: | Set Components: |
| | Bronchial catheter 5 Fr.(Ø 1.67mm),<br>PA<br>[MR Safe] | Bronchial catheter 5 Fr. (Ø 1.67mm),<br>PA<br>[MR Safe] |
| | Clamping adapter for 5 Fr. Catheter,<br>stainless steel<br>[MR Unsafe] | Clamping adapter for 5 Fr. Catheter,<br>stainless steel<br>[MR Unsafe] |
| | Guide tube Ø 2.8mm, L=900mm<br>(FEP)<br>[MR Safe] | Guide tube Ø 2.8mm, L=900mm<br>(FEP)<br>[MR Safe] |
| | Bite protector for intraluminal<br>applicators,<br>PBT<br>[MR Safe] | Bite protector for intraluminal<br>applicators,<br>PPSU<br>[MR Safe] |
| | Guide wire 0.0032" x 2600 mm,<br>sterile,<br>Stainless steel, PTFE coated<br>(K082094)<br>[MR Unsafe] | Guide wire 0.0032" x 2600 mm,<br>sterile,<br>Stainless steel, PTFE coated<br>(K082094)<br>[MR Unsafe] |
| | ---- | Monofil, PA<br>[MR Safe] |
| | Accessories: | Accessories: |

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| | GM11000620 Intraluminal Applicator<br>Set<br>(as part of GammaMed afterloader-<br>K983436). | GM11000620 Intraluminal Applicator<br>Set |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | ---- | Tube catheter Ø 2.8mm (FEP)<br>[MR Safe] |
| | ---- | Guide Tube Ø 4.5mm (FEP)<br>[MR Safe] |
| | Length cutting gauge (stainless steel)<br>[MR Unsafe] | Length cutting gauge (stainless steel)<br>[MR Unsafe] |
| | X-ray marker<br>(Nickel, Titanium, Aluminium,<br>Tungsten, PEEK and PTFE coated)<br>[MR Unsafe] | X-ray marker<br>(Nickel, Titanium, Aluminium,<br>Tungsten, PEEK and PTFE coated)<br>[MR Unsafe] |
| | Length gauge (stainless steel)<br>[MR Unsafe] | Length gauge (stainless steel)<br>[MR Unsafe] |
| | Cleaning caps<br>[MR Safe] | Cleaning caps<br>[MR Safe] |
| | Tube Catheter, Ø 2.8mm<br>(GammaMed plus)<br>[MR Unsafe] | Tube Catheter, Ø 2.8mm<br>(GammaMed plus)<br>[MR Unsafe] |
| | Source guide tube support<br>[MR Unsafe] | Source guide tube support<br>[MR Unsafe] |
| Tube catheter | Tube catheter included as optional<br>accessory | Tube catheter included as optional<br>accessory |
| Materials | PA (Polyamide),<br>FEP (Fluorinated Ethylene<br>Propylene),<br>Stainless Steel | PA (Polyamide),<br>FEP (Fluorinated Ethylene<br>Propylene),<br>Stainless Steel<br>PPSU (Polyphenylsulfone) |
| Packing | individual | individual |
| Sterility<br>(Bronchial catheter<br>and Monofil) | Supplied sterile - single use only | Supplied sterile - single use only |
| Sterilization method<br>(Bronchial catheter<br>and Monofil) | Gamma sterilization | Gamma sterilization |
| Sterilization method<br>(Guide Tubes) | Steam sterilization - single use only | Steam sterilization - single use only |
| Sterilization method<br>(Tube Catheter) | Steam sterilization up to 20 times | High level disinfection up to 20 times |
| Biocompatibility | Full biocompatibility | Full biocompatibility |
| Anatomical sites | Endo-bronchial treatments,<br>esophagus (using a guide tube), and<br>the bile duct. | Endo-bronchial treatments,<br>esophagus (using a guide tube), and<br>the bile duct. |
| Human factors | Controlled through Varian<br>afterloaders | Controlled through Varian<br>afterloaders |

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| | GM11000620 Intraluminal Applicator<br>Set<br>(as part of GammaMed afterloader-<br>K983436). | GM11000620 Intraluminal Applicator<br>Set |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Compatibility with<br>the environment and<br>other devices | CT and MR compatible | CT compatible and MR Safe (When<br>MR Safe components as listed in<br>Instructions for Use are used). |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |

Non Clinical Tests Bench Testing has been performed to demonstrate that

- the device functions correctly with the specified afterloaders;
- . the device can withstand the number of cycles of use that it will experience in its lifetime;
- . the device enables the radioactive source to be located to the accuracy required,
- . the device is constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
- . the device may be sterilized effectively
- the device can be used and sterilized for the specified number of times
- . the positional accuracy of the source within the applicator is adequate.

Usability was assessed to the requirements of IEC 62366:2007. Results of Bench Testing showed conformance to applicable requirements and specifications

Clinical Tests No clinical tests have been included in this pre-market submission.

Conclusions All the tests that were performed met the applied pass criteria. Varian considers to be safe and effective and to perform as well or better than the predicate