The Intraluminal Applicator Set is indicated for use for intraluminal brachytherapy treatments including endo-bronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy.

Device Description

The Intraluminal Applicator Set is designed for intraluminal brachytherapy treatments including endo-bronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy. It is compatible with Varian GammaMedplus afterloaders and can be used in combination with the appropriate accessories. The devices 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.

AI/ML Overview

This document describes the premarket notification for the "Intraluminal Applicator Set GM11000620" by Varian Medical Systems, Inc. The submission is for a Class II medical device, specifically a remote-controlled radionuclide applicator system, used for intraluminal brachytherapy treatments.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of quantitative acceptance criteria with corresponding performance metrics for the device. Instead, it lists the types of non-clinical tests performed and states that the "Results of Bench Testing showed conformance to applicable requirements and specifications." The "Conclusions" section reiterates that "All the tests that were performed met the applied pass criteria."

However, based on the non-clinical tests described, we can infer the broad categories of acceptance criteria and the claimed performance:

Acceptance Criteria (Inferred from Non-Clinical Tests)	Reported Device Performance
Functional Compatibility: Device functions correctly with specified afterloaders.	Conforms to applicable requirements and specifications.
Durability/Lifetime: Device withstands the number of cycles of use over its lifetime.	Conforms to applicable requirements and specifications.
Positional Accuracy: Device enables the radioactive source to be located with required accuracy.	Positional accuracy of the source within the applicator is adequate; conforms to applicable requirements and specifications.
Material Radiation Resistance: Materials are not significantly affected by radiation exposure over the product's lifetime.	Conforms to applicable requirements and specifications.
Sterilization Efficacy: Device can be sterilized effectively.	Conforms to applicable requirements and specifications.
Reusability (Sterilization): Device can be used and sterilized for the specified number of times.	Conforms to applicable requirements and specifications.
Usability: Conformance to IEC 62366:2007.	Conforms to applicable requirements and specifications.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient data or clinical cases. The tests performed are described as "Bench Testing," implying laboratory or engineering tests on the device hardware itself. There is no indication of retrospective or prospective data use from human subjects in these tests.
Data Provenance: The data provenance is from bench testing conducted by Varian Medical Systems, Inc. This is not human patient data, therefore country of origin is not applicable in the context of clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This question is not applicable as the study involved non-clinical bench testing. There was no "ground truth" derived from expert interpretation of medical images or patient outcomes. The "ground truth" for these engineering tests would be derived from physical measurements (e.g., using calipers, gauges, radiation detectors) and engineering specifications, not expert medical opinion.

4. Adjudication Method for the Test Set

This question is not applicable as the study involved non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies among expert readers in clinical or imaging studies.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical applicator set for brachytherapy, not an AI-powered diagnostic or treatment planning software meant to improve human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable. The device is a physical intraluminal applicator set, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would have been derived from:

Engineering specifications and design documents: For functional compatibility, durability, material resistance, and physical dimensions.
Calibration standards/measurement devices: For positional accuracy of the radioactive source.
Sterilization efficacy testing protocols and standards: For sterilization effectiveness and reusability.
IEC 62366:2007 standard requirements: For usability assessment.

It is not expert consensus, pathology, or outcomes data, as these are clinical ground truths.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this device is not an AI/machine learning algorithm. The tests described are engineering verification and validation tests for a physical medical device.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no "training set."

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 17, 2015

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

Re: K151022

Trade/Device Name: Intraluminal Applicator Set GM11000620 Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: November 13, 2015 Received: November 16, 2015

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 (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,

Robert Oals

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K151022

Device Name

Intraluminal Applicator Set GM11000620

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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PREMARKET NOTIFICATION

510(k) Summary

Intraluminal Applicator Set

As required by 21 CFR 807.92

Submitter's Name:	Varian Medical Systems3100 Hansen Way, m/s E110Palo Alto CA94304
	Contact Name: Peter J. CoronadoPhone: 650/424.6320Fax: 650/646.9200Date: 25 September 2015.
Proprietary Name:	GM11000620 Intraluminal Applicator Set
Classification Name:	Remote controlled radionuclide applicator system21CFR892.5700Class II
Common/Usual Name:	GM11000620 Intraluminal Applicator Set
Predicate Devices:	K983436.Gammamedplus High Dose Rate Remote AfterloadingSystem.
Device Description:	The Intraluminal Applicator Set is designed for intraluminalbrachytherapy treatments including endo-bronchial treatmentsand treatments on body sites such as the esophagus and the bileduct using HDR brachytherapy. It is compatible with VarianGammaMedplus afterloaders and can be used in combination withthe appropriate accessories.The devices are intended to be used by trained and qualifiedpersonnel such as Radiation Oncologists, Physicians, Radiologists,Dosimetrists, Medical Physicists, and Nurses/MTRAs/RadiologyTechnicians/Radiographers in a hospital environment.
Indications for Use:	The Intraluminal Applicator Set is indicated for use for intraluminalbrachytherapy treatments including endo-bronchial treatmentsand treatments on body sites such as the esophagus and the bileduct using HDR brachytherapy.

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Technological Characteristics:

	GM11000620 Intraluminal ApplicatorSet(as part of GammaMed afterloader-K983436).	GM11000620 Intraluminal ApplicatorSet
CompatibleAfterloader	GammaMed plus	GammaMed plus
Intended use	Covered by intended use of completeafterloader system in originalsubmission:The intended use of the GammaMedPlus transportable high-dose-rateremotely controlled afterloadingbrachytherapy device is for thetreatment of cancer by intracavitary,interstitial, intraluminal andintraoperative irradiation.	The Intraluminal Applicator Set isintended for intraluminalbrachytherapy treatments includingendo-bronchial treatments andtreatments on body sites such as theesophagus and the bile duct usingHDR brachytherapy.
Indications for Use	Covered by indication for use ofcomplete afterloader system inoriginal submission:The intended use of the GammaMedPlus transportable high-dose-rateremotely controlledafterloading brachytherapy device isfor the treatment of cancer byintracavitary, interstitial, intraluminaland intraoperative irradiation.	The Intraluminal Applicator Set isindicated for use for intraluminalbrachytherapy treatments includingendo-bronchial treatments andtreatments on body sites such as theesophagus and the bile duct usingHDR brachytherapy.
Design	Set Components:	Set Components:
	Bronchial catheter 5 Fr.(Ø 1.67mm),PA[MR Safe]	Bronchial catheter 5 Fr. (Ø 1.67mm),PA[MR Safe]
	Clamping adapter for 5 Fr. Catheter,stainless steel[MR Unsafe]	Clamping adapter for 5 Fr. Catheter,stainless steel[MR Unsafe]
	Guide tube Ø 2.8mm, L=900mm(FEP)[MR Safe]	Guide tube Ø 2.8mm, L=900mm(FEP)[MR Safe]
	Bite protector for intraluminalapplicators,PBT[MR Safe]	Bite protector for intraluminalapplicators,PPSU[MR Safe]
	Guide wire 0.0032" x 2600 mm,sterile,Stainless steel, PTFE coated(K082094)[MR Unsafe]	Guide wire 0.0032" x 2600 mm,sterile,Stainless steel, PTFE coated(K082094)[MR Unsafe]
	----	Monofil, PA[MR Safe]
	Accessories:	Accessories:

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	GM11000620 Intraluminal ApplicatorSet(as part of GammaMed afterloader-K983436).	GM11000620 Intraluminal ApplicatorSet
Compatibility withthe environment andother devices	CT and MR compatible	CT compatible and MR Safe (WhenMR Safe components as listed inInstructions for Use are used).
Where used	Brachytherapy treatment room	Brachytherapy treatment room

Non Clinical Tests Bench Testing has been performed to demonstrate that

the device functions correctly with the specified afterloaders;
. the device can withstand the number of cycles of use that it will experience in its lifetime;
. the device enables the radioactive source to be located to the accuracy required,
. 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;
. the device may be sterilized effectively
the device can be used and sterilized for the specified number of times
. the positional accuracy of the source within the applicator is adequate.

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.

	GM11000620 Intraluminal ApplicatorSet(as part of GammaMed afterloader-K983436).	GM11000620 Intraluminal ApplicatorSet
	----	Tube catheter Ø 2.8mm (FEP)[MR Safe]
	----	Guide Tube Ø 4.5mm (FEP)[MR Safe]
	Length cutting gauge (stainless steel)[MR Unsafe]	Length cutting gauge (stainless steel)[MR Unsafe]
	X-ray marker(Nickel, Titanium, Aluminium,Tungsten, PEEK and PTFE coated)[MR Unsafe]	X-ray marker(Nickel, Titanium, Aluminium,Tungsten, PEEK and PTFE coated)[MR Unsafe]
	Length gauge (stainless steel)[MR Unsafe]	Length gauge (stainless steel)[MR Unsafe]
	Cleaning caps[MR Safe]	Cleaning caps[MR Safe]
	Tube Catheter, Ø 2.8mm(GammaMed plus)[MR Unsafe]	Tube Catheter, Ø 2.8mm(GammaMed plus)[MR Unsafe]
	Source guide tube support[MR Unsafe]	Source guide tube support[MR Unsafe]
Tube catheter	Tube catheter included as optionalaccessory	Tube catheter included as optionalaccessory
Materials	PA (Polyamide),FEP (Fluorinated EthylenePropylene),Stainless Steel	PA (Polyamide),FEP (Fluorinated EthylenePropylene),Stainless SteelPPSU (Polyphenylsulfone)
Packing	individual	individual
Sterility(Bronchial catheterand Monofil)	Supplied sterile - single use only	Supplied sterile - single use only
Sterilization method(Bronchial catheterand Monofil)	Gamma sterilization	Gamma sterilization
Sterilization method(Guide Tubes)	Steam sterilization - single use only	Steam sterilization - single use only
Sterilization method(Tube Catheter)	Steam sterilization up to 20 times	High level disinfection up to 20 times
Biocompatibility	Full biocompatibility	Full biocompatibility
Anatomical sites	Endo-bronchial treatments,esophagus (using a guide tube), andthe bile duct.	Endo-bronchial treatments,esophagus (using a guide tube), andthe bile duct.
Human factors	Controlled through Varianafterloaders	Controlled through Varianafterloaders