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 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 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.

AI/ML Overview

This document describes the premarket notification for "GammaMedplus Source Guide Tubes." The provided text indicates that the device is an accessory for remote controlled radionuclide applicator systems used in brachytherapy. The submission is a 510(k) premarket notification, which means it seeks to demonstrate substantial equivalence to an existing legally marketed device, rather than proving novel safety and effectiveness. Therefore, the information provided focuses on comparative technological characteristics and non-clinical testing rather than extensive clinical studies or acceptance criteria for a novel device performance claim.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission for an accessory device, the "acceptance criteria" are predominantly related to functional compatibility and durability, benchmarked against the predicate device. There aren't specific quantitative clinical performance metrics like sensitivity, specificity, or AUC that would typically be associated with AI/diagnostic devices.

Acceptance Criterion (Implicit)	Reported Device Performance
Functional Compatibility: Correct operation with specified afterloader and applicators.	Bench testing demonstrated that "the device functions correctly with the specified afterloader and applicators."
Durability/Lifetime: Withstand the number of cycles of use over its lifetime.	Bench testing demonstrated that "the device can withstand the number of cycles of use that it will experience in its lifetime."
Material Integrity (Radiation Exposure): Materials not significantly affected by radiation over product lifetime.	Bench testing demonstrated that "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: Conformance to relevant usability standards.	Usability was assessed to the requirements of IEC 62366:2007, and "Results of Bench Testing showed conformance to applicable requirements and specifications."

2. Sample sized used for the test set and the data provenance:

Sample Size: Not specified quantitatively in the document. The testing described is "Bench Testing," implying a set of physical devices subjected to various tests. The number of individual guide tubes tested is not provided.
Data Provenance: The testing was "Bench Testing," which refers to laboratory or engineering tests. There is no mention of patient data (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this submission. The "ground truth" concept is typically relevant for AI/diagnostic devices where expert consensus or pathological findings are used to label data. For this accessory device, the "truth" is whether it functions correctly, is durable, and its materials are radiation-resistant, which is assessed through engineering and functional tests.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple experts in labeling data for AI/diagnostic studies. The testing described here involves technical performance evaluations without expert adjudication of results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. A MRMC comparative effectiveness study was not done. This device is a mechanical accessory (source guide tubes) for a brachytherapy system, not an AI or diagnostic tool that involves human readers or interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This device is a physical component, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The type of ground truth used:

As mentioned in point 3, the concept of "ground truth" as typically applied to clinical or diagnostic outcomes (e.g., expert consensus, pathology, outcomes data) is not applicable. For this device, the "ground truth" for acceptance criteria is its successful demonstration of functional compatibility, durability, material integrity under radiation, and usability validation through bench testing against engineering specifications and relevant standards.

8. The sample size for the training set:

This information is not applicable. This submission describes a physical medical device (guide tubes), not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable, as there is no AI algorithm or training set for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized representation of human figures.

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.

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K141336

Device Name GammaMedplus Source Guide Tubes

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

Michael D'Hara

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

PREMARKET NOTIFICATION

510(k) Summary

GammaMedplus Source Guide Tubes

As required by 21 CFR 807.92

Submitter's Name:	Varian Medical Systems3100 Hansen Way, m/s E-110Palo Alto CA94304
	Contact Name: Peter J. Coronado
	Phone: 650/424.6230Fax: 650/ 646.9200
	e-mail: submissions.support@varian.com
	Date: 15th May 2014

Proprietary Name:	GammaMedplus Source Guide Tubes and PDR Quick Connectors
Classification Name:	Remote controlled radionuclide applicator system21CFR892.5700
	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 tumoror 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,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

{4}------------------------------------------------

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

Technological Characteristics:

Predicate DeviceClearance Number:	K113766	N/A
CompatibleAfterloader	VariSource Remote HDR Afterloadersystem	GammaMed afterloaders
CompatibleApplicators	All applicators and needles that arecompatible with VariSource seriesafterloaders	All applicators and needles that arecompatible with GammaMed seriesafterloaders
Intended use	The VariSource Reusable transferGuide Tubes are intended to connectbetween the VariSource RemoteHDR Afterloader system and itsrange of applicators. This connectioncreates a conduit for the source wireto travel through and allowsradioisotopes to be positioned withinthe patient's tumour site.	The GammaMedplus Source GuideTubes are intended to connectbetween the GammaMedplusRemote Afterloader system and itsrange of applicators. This connectioncreates a conduit for the source wireto travel through and allows theradioactive isotopes to bepositioned within the patient'stumour site.
Indications for Use	Same as above	Same as above
Target population	There is no limitation to patientpopulation. Limitations are on themaximal radiation dose applicable tothe individual organs. The equipmentis designed to be used by a trainedand qualified Radiation Oncologist,Physician, Radiologist, Dosimetrist,Medical Physicist, and Nurse / MTRA/ Radiology Technician /Radiographer	There is no limitation to patientpopulation. Limitations are on themaximal radiation dose applicable tothe individual organs. Theequipment is designed to be used bya trained and qualified RadiationOncologist, Physician, Radiologist,Dosimetrist, Medical Physicist, andNurse / MTRA / RadiologyTechnician / Radiographer.
Design	Transfer Guide Tubes are designed toprovide a secure connectionbetween the VariSource afterloaderand applicators, needles or cathetersalong which the source wire travelsduring Brachytherapy.	The Source Guide Tubes and PDRQuick Connectors were developedto connect between theGammaMed Afterloader systems toapplicators with an internal lengthof:113 mm, 180 mm, 200 mm, 250 mm257 mm, 320 mm, 500 mm,285 mm (Third party applicators),187 mm (Adjustable Luer)
Materials	ABS, FEP, PEEK, Titanium, stainlesssteel, ABS/PP.Not in direct contact with bodytissue.	FEP, Stainless Steel, PEEK, Titaniumand ABS/PP.Not in direct contact with bodytissue.
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 withthe environment andother devices	Compatible with a range ofapplicators, e.g. probes, needles,interstitial tubes	Compatible with a range ofapplicators, e.g. probes, needles,interstitial tubes
Where used	Brachytherapy treatment room	Brachytherapy treatment room

{5}------------------------------------------------

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.

Regulation Number and Section

§ 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.