(86 days)
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.
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.
The provided text describes a 510(k) premarket notification for "VariSource Transfer Guide Tube Sets." This document focuses on demonstrating substantial equivalence to a predicate device and details the modifications made. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is not a performance study for an AI/ML device.
The submission is for a physical medical device (transfer guide tubes for brachytherapy), not an AI/ML device. Therefore, the requested information regarding AI/ML performance, ground truth, expert consensus, sample sizes for training/test sets, MRMC studies, or standalone performance is not applicable to this document.
The document mainly includes:
- Device Description: What the VariSource Transfer Guide Tube Sets are and their function.
- Predicate Device: K952913 Applicators for Varian VariSource Remote HDR afterloader.
- Detailed Comparison Table: Highlighting features/specifications of the new/modified device versus the cleared predicate device. This table covers:
- Intended Use/Indications for Use
- Material
- Number of Uses
- Sterilization
- Fitting
- Closed or opened ended when not attached
- Other technical changes (manufacturing processes)
- Indications for Use: The specific medical purposes for which the device is intended.
The regulatory approval process for such a device largely relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and verification/validation testing of the physical components (which are not detailed in this specific snippet but would be part of a full submission).
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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
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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 OFNEW/MODIFIED DEVICE | CLEARED DEVICE FEATURE/SPECIFICATIONK952913 | DEVICE WITH CHANGE |
|---|---|---|
| Intended Use/Indications for Use | Covered by intended use ofcomplete afterloader system inoriginal submission. | The VariSource Reusable TransferGuide Tubes are intended toconnect between the VariSourceRemote HDR Afterloader systemand its range of applicators. Thisconnection creates a conduit forthe source wire to travel throughand allows radioisotopes to bepositioned within the patient'stumour site. |
| Material | Coupling Catheter:polytetrafluoroethylene (PTFE) orNickel Titanium (Information fromFeature Comparison Sheets for FSDcovered by K952913). | Fluorinated Ethylene Propylene(FEP). |
| Number of Uses. | Coupling Catheter-Single Use (PTFE)Multiple Use (Nickel Titanium)(From Data Sheets for applicatorscovered by K952913). | Multiple Use. |
| Sterilization | Coupling CatheterETO or Autoclave- Nickel TitaniumETO- PTFE(From Data Sheets for applicatorssubmitted for K952913). | None(No body contact) |
| Fitting | Screw thread | ClickFit/ClickFitNeedle/Catheter/Luer |
| FEATURE AND/OR SPECIFICATION OFNEW/MODIFIED DEVICE | CLEARED DEVICE FEATURE/SPECIFICATION | DEVICE WITH CHANGE |
| K952913 | ||
| Closed or opened ended when notattached | Open | Closed(ClickFit/Clickfit Needle) |
| Other technical changes -manufacturing | Wire channel screwed and bondedinto QuickConnect | Wire channel moulded directlyinto QuickConnect |
| Other technical changes -manufacturing | Original tolerance level for internaldiameter on Quick Connect toaccommodate thread insert for thetube. ( $\varnothing$ 5 ±0.1mm). | Changed tolerance level forinternal diameter on QuickConnect to accommodate threadinsert for the tube ( $\varnothing$ 5,2±0.05mm). Change made foreasier assembly duringmanufacture. |
. Technological Characteristics:
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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
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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 (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
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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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§ 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.