The Esophagus Bougie Set was designed to treat cancer of the esophagus. The Esophagus Bougie Set is an applicator used to facilitate delivery of a radiation source to the esophagus when used with a Varian high dose rate afterloader.

Device Description

The Varian Medical Esophagus Bougie is an HDR applicator designed to facilitate delivery of radiation to the Esophagus and has been modified to work with Varian Medical afterloaders. The product can be steam sterilized up to 20 times and has a maximum implantation time of 24 hours. The device does not contain any electronics or software. A high activity radioactive source is placed within the applicator which has previously been placed for a specified clinical purpose in a patient. The radioactive source (enclosed within the wire/cable) is driven via coupling catheters (Transfer Guide Tubes) from the Afterloader into the applicator within the patient. The length of time and position that the High Dose Rate source spends within the applicator is controlled in accordance with an Irradiation Treatment Prescription.

AI/ML Overview

The provided document describes the Esophagus Bougie Set, a device used in brachytherapy to deliver radiation to the esophagus. The document focuses on the regulatory submission (510(k)) to the FDA, asserting substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific quantitative targets for "device performance" in the way one might expect for a diagnostic or AI-powered device. Instead, it describes bench testing to validate changes made to the device.

Acceptance Criteria Category	Reported Device Performance
Cleaning & Disinfection	Bench testing performed to evaluate the efficacy of the automatic manual cleaning and disinfection process. Test results: "Testing showed the test articles met the pre-defined acceptance criteria, thereby demonstrating the effectiveness of the cleaning and disinfection process plus the cleaning and disinfection agents according to DIN EN ISO 17664 (July 2004)."
Biocompatibility	Biocompatibility testing performed in accordance with ISO 10993-5 and 10993-10. Test results: "show the device is safe for bodily contact."
Material Reformulation	Evaluation of a reformulated PVC material (DEHP replaced with a safer alternative) through design verification and testing. Test results: "Non-clinical test articles met the predefined acceptance criteria, thereby demonstrating the reformulated material did not impact device performance or biocompatibility." (Specific acceptance criteria for "impact on device performance" are not detailed.)
Overall Conclusion	"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."

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data or AI model evaluation. The tests described are bench tests of the device's physical properties, cleaning efficacy, and biocompatibility. Therefore, descriptions of sample size and data provenance (country of origin, retrospective/prospective) are not applicable in the way they would be for a clinical study or AI model validation. The text mentions "test articles" for the bench testing, but not the number of these articles.

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 as the document describes bench tests for a medical device's physical properties and safety, not a study involving expert assessment of clinical data or AI output.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

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

This information is not applicable. The device described is an "Esophagus Bougie Set," which is a physical applicator for radiation delivery. It is not an AI-powered diagnostic or decision-support system that would involve human readers or AI assistance.

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

This information is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the tests performed was based on:

Established standards: DIN EN ISO 17664 (July 2004) for cleaning and disinfection efficacy.
International standards: ISO 10993-5 and 10993-10 for biocompatibility.
Pre-defined acceptance criteria: For the material reformulation, implying internal Varian specifications.

These are technical standards and internal specifications, not clinical "ground truth."

8. The sample size for the training set

This information is not applicable as the document describes a physical medical device, not an AI system that requires a "training set."

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

This information is not applicable for the same reason as point 8.

In summary:

The provided text details a 510(k) submission for a physical medical device. The "acceptance criteria" and "study" refer to engineering and materials testing, not clinical trials or AI validation studies. Therefore, many of the requested data points (related to clinical data, expert reviews, AI performance, training sets) are not present in this document. The document confirms that bench testing was performed and met predefined technical and safety standards.

Summary

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

October 2, 2016

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

Re: K161576

Trade/Device Name: Esophagus Bougie Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: September 7, 2016 Received: September 9, 2016

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.

Michael D'Hara

For

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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Indications for Use

510(k) Number (if known)

Device Name Esophagus Bougie Set

Indications for Use (Describe)

The Esophagus Bougie Set was designed to treat cancer of the Esophagus Bougie Set is an applicator used to facilitate delivery of a radiation source to the esophagus when used with a high dose rate afterloader.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com

Premarket Notification [510(k)] Summary

GM11008880 Esophagus Bougie Set

The following information is provided following the format of 21 CFR 807.92(c).

Submitter's Name:	Varian Medical Systems, Inc.3100 Hansen Way E-110Palo Alto, CA 94304Contact Name: Peter J. CoronadoPhone: 650.424.6320Fax: 650.646.9200Date: June 6, 2016
Proprietary Name:	Esophagus Bougie Set - GM11008880
Classification Name:	Remote controlled radionuclide applicator system21 CFR 892.5700, Class IIProduct Code: JAQ
Common/Usual Name:	Remote controlled radionuclide applicator system
Predicate Devices:	K130251 Esophagus Bougie Set
Device Description:	The Varian Medical Esophagus Bougie is an HDR applicator designed to facilitatedelivery of radiation to the Esophagus and has been modified to work with VarianMedical afterloaders. The product can be steam sterilized up to 20 times and hasa maximum implantation time of 24 hours. The device does not contain anyelectronics or software. A high activity radioactive source is placed within theapplicator which has previously been placed for a specified clinical purpose in apatient. The radioactive source (enclosed within the wire/cable) is driven viacoupling catheters (Transfer Guide Tubes) from the Afterloader into the applicatorwithin the patient. The length of time and position that the High Dose Rate sourcespends within the applicator is controlled in accordance with an IrradiationTreatment Prescription.
Intended Use Statement	The Esophagus Bougie Set was designed to treat cancer of the esophagus. TheEsophagus Bougie Set is an applicator used to facilitate delivery of a radiationsource to the esophagus when used with a Varian high dose rate afterloader.
Indications for UseStatement	The Esophagus Bougie Set was designed to treat cancer of the esophagus. TheEsophagus Bougie Set is an applicator used to facilitate delivery of a radiationsource to the esophagus when used with a Varian high dose rate afterloader.

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Technological Characteristics:

	GM11008880 EsophagusBougie Set (K130251)	Modified Esophagus Bougie Set
Intended use	The Esophagus Bougie Set wasdesigned to treat cancer of theesophagus. The Esophagus Bougie Setis an applicator used to facilitatedelivery of a radiation source to theesophagus when used in conjunctionwith a high dose rate afterloader.	The Esophagus Bougie Set wasdesigned to treat cancer of theesophagus. The Esophagus Bougie Setis an applicator used to facilitatedelivery of a radiation source to theesophagus when used with a high doserate afterloader.
Indications for Use	The Esophagus Bougie Set wasdesigned to treat cancer of theesophagus. The Esophagus Bougie Setis an applicator used to facilitatedelivery of a radiation source to theesophagus when used in conjunctionwith a high dose rate afterloader.	The Esophagus Bougie Set wasdesigned to treat cancer of theesophagus. The Esophagus Bougie Setis an applicator used to facilitatedelivery of a radiation source to theesophagus when used with a high doserate afterloader.
Compatible Afterloaders	GammaMed plusGammaMed 12i(t)VariSource	GammaMed plusVariSource
Components and Dimensions:
Bougies	8, 10, 12 and 14 mm diameter	8, 10, 12 and 14 mm diameter
Tube catheter	3.2 mm diameter	3.2 mm diameter
Bite protector and fixation	For 8, 10, 12, and 14 mm bougiediameter	For 8, 10, 12, and 14 mm bougiediameter
Guidewire	0.032" x 2600mm (K082094)	0.032" x 2600mm (K082094)
Strap for bite protector bougie	(K955564)	(K955564)
Materials:
Bougies	PVC (Polyvinylchloride)	PVC (Polyvinylchloride) without DEHP
Tube catheter	FEP (Fluorinated ethylene propylene)	FEP (Fluorinated ethylene propylene)
Bite protector and fixation	PPSU (Polyphenylsulfone)	PPSU (Polyphenylsulfone)
Guidewire	Stainless Steel PTFE coated	Stainless Steel PTFE coated
Packaging	Individual	Individual
Sterility (Bougie, tube catheter, Bite protector, clamping screws, threaded ring)	Non sterile	Non sterile
Sterility(Guidewire)	sterile, single use	sterile, single use
Sterilization method:
Tube catheter	High Level disinfection up to 20 cycles	High Level disinfection up to 20 cycles
Bougie	Manual cleaning and high Leveldisinfection up to 20 cycles	Manual cleaning and high Leveldisinfection up to 20 cyclesMachine cleaning and thermaldisinfection up to 20 cycles
Bite protector, clamping screws,threaded ring	Steam sterilization up to 100 cycles	Steam sterilization up to 100 cyclesMachine cleaning
Biocompatibility	Full biocompatibilityPolymeric materials and stainless steelused.	Full biocompatibilityPolymeric materials and stainless steelused.
Anatomical sites	Esophagus	Esophagus
Compatibility with theenvironment and other devices	CT compatible	CT compatible
Where used	Brachytherapy treatment room	Brachytherapy treatment room

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Non Clinical Tests

Bench testing was performed to evaluate the efficacy of the automatic manual cleaning and disinfection process. Testing showed the test articles met the pre-defined acceptance criteria, thereby demonstrating the effectiveness of the cleaning and disinfection process plus the cleaning and disinfection agents according to DIN EN ISO 17664 (July 2004). Biocompatibility testing performed in accordance with ISO 10993-5 and 10993-10 show the device is safe for bodily contact.

Per the FDA's Guidance document Deciding When to Submit a 510(k) for a Change to an Existing Device, only the formulation of this non-implant PVC material was changed. This plasticizer DEHP is considered a potentially dangerous substance and has been replaced with a safer alternative. The reformulated material was evaluated through design verification and testing. Non-clinical test articles met the predefined acceptance criteria, thereby demonstrating the reformulated material did not impact device performance or biocompatibility.

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.