CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN

K113766 · Varian Medical Systems, Inc. · JAQ · Mar 16, 2012 · Radiology

Device Facts

• Record ID: K113766
• Device Name: CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Mar 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Varisource Reusable Transfer Guide Tubes are Intended to connect between the Varisource Remote HDR Afterloader system and its range of applicators. This connection creates a conduit for the source wire to travel through and allows radioisotopes to be positioned within the patient's tumour site.

Device Story

Transfer Guide Tubes serve as physical conduits for radioisotope source wires in brachytherapy; they connect the VariSource Remote HDR Afterloader to various applicators, needles, or catheters. The device facilitates the precise positioning of radioactive sources within a patient's tumor site. These tubes are reusable and feature ClickFit/Luer connections for secure attachment. They are intended for clinical use by healthcare professionals operating the afterloader system. The device does not have direct patient contact, thus requiring no sterilization. The design includes a wire channel molded into a QuickConnect fitting, ensuring smooth passage for the source wire during treatment delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Fluorinated Ethylene Propylene (FEP). Connection: ClickFit/Luer. Design: Wire channel molded directly into QuickConnect fitting. Sterilization: None (no body contact). Reusability: Multiple use.

Indications for Use

Indicated for connecting the VariSource Remote HDR Afterloader to applicators, needles, or catheters to create a conduit for radioisotope source wire delivery to a patient's tumor site.

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

• Applicators for Varian VariSource Remote HDR afterloader (K952913)

Submission Summary (Full Text)

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K113766

## PREMARKET NOTIFICATION

510(k) Summary

MAR 1 6 2012

## VariSource Transfer Guide Tube Sets

As required by 21 CFR 807.92

Submitter's Name:

Varian Medical Systems 3100 Hansen Way, m/s E110 Palo Alto CA94304

Contact Name: Ms Vy Tran, VP, QA/RA Phone: [phone] Fax:[phone] [e-mail] Date: 15 December 2011

Proprietry Name:

VariSource Transfer Guide Tube Sets.

Classification Name:

Common/Usual Name:

Predicate Devices:

Device Description:

Remote controlled radionuclide applicator system 21CFR892.5700 Class II •

Guide Tubes, Connecting Tubes, Transfer Guide Tubes, ConnectIng Catheters, Reusable Transfer Guide Tubes.

K952913 Applicators for Varian VariSource Remote HDR afterloader

Transfer Guide Tubes are designed to provide a secure connection between the VarlSource afterloader and applicators, needles or catheters along which the source wire travels during Brachytherapy.

Each Transfer Guide Tube has an appropriate connection at one end for the Varisource Afterloader and at the other end a connection for an applicator, needle or catheter.

Indications for Use:

The VariSource Reusable Transfer Guide tubes are intended to connect between the VariSource Remote HDR Afterloader system and its range of applicators. This connection creates a conduit for

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the source wire to travel through and allows radioisotopes to be positioned within the patient's turnour site.

| FEATURE AND/OR SPECIFICATION OF<br>NEW/MODIFIED DEVICE | CLEARED DEVICE FEATURE/SPECIFICATION<br>K952913 | DEVICE WITH CHANGE |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indications for Use | Covered by intended use of<br>complete afterloader system in<br>original submission. | The VariSource Reusable Transfer<br>Guide Tubes are intended to<br>connect between the VariSource<br>Remote HDR Afterloader system<br>and its range of applicators. This<br>connection creates a conduit for<br>the source wire to travel through<br>and allows radioisotopes to be<br>positioned within the patient's<br>tumour site. |
| Material | Coupling Catheter:<br>polytetrafluoroethylene (PTFE) or<br>Nickel Titanium (Information from<br>Feature Comparison Sheets for FSD<br>covered by K952913). | Fluorinated Ethylene Propylene<br>(FEP). |
| Number of Uses. | Coupling Catheter<br>-Single Use (PTFE)<br>Multiple Use (Nickel Titanium)<br>(From Data Sheets for applicators<br>covered by K952913). | Multiple Use. |
| Sterilization | Coupling Catheter<br>ETO or Autoclave- Nickel Titanium<br>ETO- PTFE<br>(From Data Sheets for applicators<br>submitted for K952913). | None<br>(No body contact) |
| Fitting | Screw thread | ClickFit/ClickFit<br>Needle/Catheter/Luer |
| FEATURE AND/OR SPECIFICATION OF<br>NEW/MODIFIED DEVICE | CLEARED DEVICE FEATURE/SPECIFICATION | DEVICE WITH CHANGE |
| | K952913 | |
| Closed or opened ended when not<br>attached | Open | Closed(ClickFit/Clickfit Needle) |
| Other technical changes -<br>manufacturing | Wire channel screwed and bonded<br>into QuickConnect | Wire channel moulded directly<br>into QuickConnect |
| Other technical changes -<br>manufacturing | Original tolerance level for internal<br>diameter on Quick Connect to<br>accommodate thread insert for the<br>tube. ( $\varnothing$ 5 ±0.1mm). | Changed tolerance level for<br>internal diameter on Quick<br>Connect to accommodate thread<br>insert for the tube ( $\varnothing$ 5,2<br>±0.05mm). Change made for<br>easier assembly during<br>manufacture. |

. Technological Characteristics:

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Ms. Vy Tran Vice President, Regulatory Affairs and Quality Systems Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304

MAY 1 7 2012

Re: K113766

Trade/Device Name: Transfer Guide Tubes Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: December 15, 2011 Received: December 21, 2011

Dear Ms. Tran:

This letter corrects our substantially equivalent letter of March 16, 2012.

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 (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.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely Yours,

Janine M. Morris

Janine M. Morris Acting Director

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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## Indications for Use Form

510(k) Number (if known): K113766

Device Name: Transfer Guide Tubes

Indications for Use:

The Varisource Reusable Transfer Guide Tubes are Intended to connect between the Varisource Remote HDR Afterloader system and its range of applicators. This connection creates a conduit for the source wire to travel through and allows radioisotopes to be positioned within the patient's tumour site.

Prescription Use _ × (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
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