K Number
K113766
Device Name
CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN
Date Cleared
2012-03-16

(86 days)

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

Not Found

No
The summary describes a mechanical device (transfer guide tubes) used in brachytherapy and makes no mention of AI or ML.

Yes
The device is described as forming a conduit for radioisotopes to be positioned within the patient's tumor site for Brachytherapy, which is a therapeutic treatment.

No
Explanation: The device is used to create a conduit for radioactive source wires to treat a patient's tumor, which is a therapeutic function, not a diagnostic one.

No

The device description clearly states it is a physical "Transfer Guide Tube" with connections, indicating it is a hardware component, not software.

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

Here's why:

  • Intended Use: The device is intended to connect a brachytherapy afterloader system to applicators to deliver radiation to a tumor site within the patient. This is a therapeutic procedure, not a diagnostic test performed in vitro (outside the body) on biological samples.
  • Device Description: The description reinforces its role in facilitating the delivery of radiation to the patient.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.

Therefore, the VariSource Reusable Transfer Guide Tubes are a component of a therapeutic medical device system used for brachytherapy, not an in vitro diagnostic device.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

JAQ

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's tumour site

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K952913

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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.

0

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: 650/424.5731 Fax:650/842.5040 vy.tran@varian.com 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

1

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

| FEATURE AND/OR SPECIFICATION OF
NEW/MODIFIED DEVICE | CLEARED DEVICE FEATURE/SPECIFICATION
K952913 | DEVICE WITH CHANGE |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indications for Use | Covered by intended use of
complete afterloader system in
original submission. | 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. |
| Material | Coupling Catheter:
polytetrafluoroethylene (PTFE) or
Nickel Titanium (Information from
Feature Comparison Sheets for FSD
covered by K952913). | Fluorinated Ethylene Propylene
(FEP). |
| Number of Uses. | Coupling Catheter
-Single Use (PTFE)
Multiple Use (Nickel Titanium)
(From Data Sheets for applicators
covered by K952913). | Multiple Use. |
| Sterilization | Coupling Catheter
ETO or Autoclave- Nickel Titanium
ETO- PTFE
(From Data Sheets for applicators
submitted for K952913). | None
(No body contact) |
| Fitting | Screw thread | ClickFit/ClickFit
Needle/Catheter/Luer |
| FEATURE AND/OR SPECIFICATION OF
NEW/MODIFIED DEVICE | CLEARED DEVICE FEATURE/SPECIFICATION | DEVICE WITH CHANGE |
| | K952913 | |
| Closed or opened ended when not
attached | Open | Closed(ClickFit/Clickfit Needle) |
| Other technical changes -
manufacturing | Wire channel screwed and bonded
into QuickConnect | Wire channel moulded directly
into QuickConnect |
| Other technical changes -
manufacturing | Original tolerance level for internal
diameter on Quick Connect to
accommodate thread insert for the
tube. ( $\varnothing$ 5 ±0.1mm). | Changed tolerance level for
internal diameter on Quick
Connect to accommodate thread
insert for the tube ( $\varnothing$ 5,2
±0.05mm). Change made for
easier assembly during
manufacture. |

. Technological Characteristics:

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

: :

3

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines beneath them. The profiles are arranged in a way that suggests unity and collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

4

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 (800) 638-2041 or (301) 796-7100 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

5

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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of In Vitro Diagnostic Device

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