SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS

K141336 · Varian Medical Systems, Inc. · JAQ · Aug 6, 2014 · Radiology

Device Facts

• Record ID: K141336
• Device Name: SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Aug 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GammaMedplus Source Guide Tubes are intended to connect between the GammaMedplus Remote Afterloader system and its range of applicators. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site

Device Story

GammaMedplus Source Guide Tubes serve as mechanical conduits in brachytherapy; they connect GammaMedplus Remote Afterloader systems to various applicators (probes, needles, interstitial tubes). The device provides a protected path for the radioactive source wire to travel from the afterloader to the patient's tumor site. Used in hospital brachytherapy treatment rooms by trained clinical staff (radiation oncologists, physicists, technicians). The device is a passive accessory; it does not process data or provide clinical outputs. It facilitates precise positioning of radioactive isotopes as defined by the treatment plan, enabling targeted radiotherapy while protecting the source wire and ensuring mechanical compatibility between the afterloader and the applicator.

Clinical Evidence

No clinical data included. Bench testing only. Testing confirmed functional compatibility with specified afterloaders/applicators, mechanical durability over the device lifetime, and material resistance to radiation exposure. Usability assessed per IEC 62366:2007.

Technological Characteristics

Non-sterile, passive mechanical accessory. Materials: FEP, stainless steel, PEEK, titanium, ABS/PP. Dimensions vary by applicator compatibility (113 mm to 500 mm). No energy source, software, or electronic components. Not in direct contact with body tissue.

Indications for Use

Indicated for use in brachytherapy procedures to connect remote afterloader systems to applicators for radioactive isotope delivery to tumor sites. No specific patient population limitations; usage restricted by maximal radiation dose to individual organs. Intended for use by trained radiation oncologists, physicians, radiologists, dosimetrists, medical physicists, and radiology technicians.

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

• VariSource Transfer Guide Tube sets (K113766)

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

August 6, 2014

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

Re: K141336

Trade/Device Name: GammaMedplus Source Guide Tubes Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: April 11, 2014 Received: May 23, 2014

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.

Michael D. O'Hara

For

Janine M. Morris 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)

K141336

Device Name GammaMedplus Source Guide Tubes

#### Indications for Use (Describe)

The GammaMedplus Source Guide Tubes are intended to connect between the GammaMedplus Remote Afterloader system and its range of applicators. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Michael D'Hara

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## PREMARKET NOTIFICATION

## 510(k) Summary

## GammaMedplus Source Guide Tubes

## As required by 21 CFR 807.92

| Submitter's Name: | Varian Medical Systems<br>3100 Hansen Way, m/s E-110<br>Palo Alto CA94304 | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|--|
| | Contact Name: Peter J. Coronado | |
| | Phone: [phone]<br>Fax: [phone] | |
| | e-mail: [e-mail] | |
| | Date: 15th May 2014 | |
| | | |
| Proprietary Name: | GammaMedplus Source Guide Tubes and PDR Quick Connectors | |
| Classification Name: | Remote controlled radionuclide applicator system<br>21CFR892.5700 | |
| | Class II | |
| Common/Usual Name: | Source Guide Tubes | |
| Product code: | JAQ | |
| Predicate Devices: | K113766 VariSource Transfer Guide Tube sets | |
| Device Description: | Source Guide Tubes are Brachytherapy applicator accessories. | |
| | Brachytherapy is a form of radiotherapy using Gamma rays from a | |
| | radioactive source placed at locations close to or within a tumor<br>or other treatment area to a predefined treatment plan. | |
| | They are designed to provide a path for the dummy and source | |
| | wire from the Afterloader to the Applicator. The applicator end of | |
| | a Source Guide Tube can vary in design to accommodate a range | |
| | of Applicators. | |
| | They are intended to be used by trained and qualified personnel | |
| | such as Radiation Oncologists, Physicians, Radiologists,<br>Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology | |
| | Technicians/Radiographers in a hospital environment. | |
| Indications for Use: | The GammaMedplus Source Guide Tubes are intended to connect | |
| | between the GammaMedplus Remote Afterloader system and its | |
| | range of applicators. This connection creates a conduit for the | |

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### source wire to travel through and allows the radioactive isotopes to be positioned within the patient´s tumor site.

Technological Characteristics:

| Predicate Device<br>Clearance Number: | K113766 | N/A |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible<br>Afterloader | VariSource Remote HDR Afterloader<br>system | GammaMed afterloaders |
| Compatible<br>Applicators | All applicators and needles that are<br>compatible with VariSource series<br>afterloaders | All applicators and needles that are<br>compatible with GammaMed series<br>afterloaders |
| Intended use | The VariSource Reusable transfer<br>Guide Tubes are intended to connect<br>between the VariSource Remote<br>HDR Afterloader system and its<br>range of applicators. This connection<br>creates a conduit for the source wire<br>to travel through and allows<br>radioisotopes to be positioned within<br>the patient's tumour site. | The GammaMedplus Source Guide<br>Tubes are intended to connect<br>between the GammaMedplus<br>Remote Afterloader system and its<br>range of applicators. This connection<br>creates a conduit for the source wire<br>to travel through and allows the<br>radioactive isotopes to be<br>positioned within the patient's<br>tumour site. |
| Indications for Use | Same as above | Same as above |
| Target population | There is no limitation to patient<br>population. Limitations are on the<br>maximal radiation dose applicable to<br>the individual organs. The equipment<br>is designed to be used by a trained<br>and qualified Radiation Oncologist,<br>Physician, Radiologist, Dosimetrist,<br>Medical Physicist, and Nurse / MTRA<br>/ Radiology Technician /<br>Radiographer | There is no limitation to patient<br>population. Limitations are on the<br>maximal radiation dose applicable to<br>the individual organs. The<br>equipment is designed to be used by<br>a trained and qualified Radiation<br>Oncologist, Physician, Radiologist,<br>Dosimetrist, Medical Physicist, and<br>Nurse / MTRA / Radiology<br>Technician / Radiographer. |
| Design | Transfer Guide Tubes are designed to<br>provide a secure connection<br>between the VariSource afterloader<br>and applicators, needles or catheters<br>along which the source wire travels<br>during Brachytherapy. | The Source Guide Tubes and PDR<br>Quick Connectors were developed<br>to connect between the<br>GammaMed Afterloader systems to<br>applicators with an internal length<br>of:<br>113 mm, 180 mm, 200 mm, 250 mm<br>257 mm, 320 mm, 500 mm,<br>285 mm (Third party applicators),<br>187 mm (Adjustable Luer) |
| Materials | ABS, FEP, PEEK, Titanium, stainless<br>steel, ABS/PP.<br>Not in direct contact with body<br>tissue. | FEP, Stainless Steel, PEEK, Titanium<br>and ABS/PP.<br>Not in direct contact with body<br>tissue. |
| Packing | Individual | Individual |
| Sterility | Non sterile | Non sterile |
| Sterilization method | N/A | N/A |
| Biocompatibility | No body contact | No body contact |
| Mechanical safety | Protection caps | Protection caps |
| Anatomical sites | NA | NA |
| Compatibility with<br>the environment and<br>other devices | Compatible with a range of<br>applicators, e.g. probes, needles,<br>interstitial tubes | Compatible with a range of<br>applicators, e.g. probes, needles,<br>interstitial tubes |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |

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#### Non Clinical Tests

Bench Testing has been performed to demonstrate that

- the device functions correctly with the specified afterloader and applicators
- . the device can withstand the number of cycles of use that it will experience in its lifetime;
- . 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;

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.