The Varian Sterilization boxes consist of an aluminium box with hinged lid and fasteners. There are arrays of holes in the top and bottom surfaces to allow evacuation during pre-vacuum processes. In the Universal Sterilization Box there is a perforated plastic inlay to allow placement of the components or devices to be sterilized. In the device-specific boxes there are supports to hold the components.

AI/ML Overview

This is a 510(k) premarket notification for the Varian Sterilization Boxes (K160021). The device is intended to securely store applicator parts during steam sterilization and subsequent storage.

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:

Acceptance Criteria / Performance Aspect	Reported Device Performance (Varian Sterilization Boxes)
Material Durability (Steam Sterilization Cycles)	Device can withstand up to 500 steam sterilization cycles.
Component Storage & Protection	Device enables components of applicators to be stored for easy access and does not damage them.
Sterilization Effectiveness	Sterilization validation performed on equivalent devices demonstrates that specified applicator components and accessories can be sterilized in the box.
Usability	Reviewed in comparison to similar devices to the requirements of IEC 62366:2007. Conforms to applicable requirements and specifications.
Biocompatibility/Toxicological Properties	N/A; non-invasive product, not intended for patient contact (per ISO 10993-1 / FDA G-95-1).
Microbial Barrier Properties (Packaging Integrity)	Device does not provide a sterile barrier. Sterilization wrap must be used. Hospital is responsible for wrapping materials, method, and shelf life validation.
Shelf Life	No sterile wrap supplied with the sterilization box.
Drying Time	25 minutes (validated for specific pre-vacuum autoclave cycles).
Aeration Time	N/A
Physical Properties	Dimensionally stable, no water absorption.
Chemical Properties	N/A, no polymeric composites used as packing materials.

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

The document primarily describes bench testing and sterilization validation. Specific sample sizes for each test are not explicitly stated in the provided text.

Data Provenance: The studies are "bench testing" and "sterilization validation". Given the nature of these tests for a sterilization container, they are most likely prospective data generated specifically for this submission. The country of origin of the data is not specified, but the submission is from Varian Medical Systems, Inc. in Palo Alto, CA, USA.

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

Not applicable for this device. The evaluation is based on objective bench testing and sterilization validation, not on expert interpretation of medical images or outcomes where human "ground truth" would be established.

4. Adjudication Method for the Test Set:

None specified or inferred. This type of device evaluation (bench testing) typically involves objective measurements and adherence to engineering specifications and international standards, rather than adjudicated expert reviews.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted clinical decision support tools. This device is a physical sterilization container, not a diagnostic or therapeutic medical AI large language model.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:

Not applicable. This device is not an algorithm and does not involve AI or human-in-the-loop performance. Its function is mechanical and relates to physical containment and steam sterilization.

7. The Type of Ground Truth Used:

For the bench testing related to durability, component storage, and physical properties, the "ground truth" is based on engineering specifications, material science principles, and observed functional performance against predefined criteria (e.g., "withstanding 500 cycles," "no damage to components").
For sterilization validation, the ground truth is established by microbiological testing (e.g., using biological indicators or test organisms) to confirm the complete inactivation of microbes under the specified sterilization parameters. This is a highly standardized and objective process.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring three profiles that resemble human faces, stacked on top of each other and connected by a flowing line.

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

April 13, 2016

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

Re: K160021

Trade/Device Name: Varian Sterilization Boxes Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: March 9, 2016 Received: March 11, 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) K160021

Device Name Varian Sterilization Boxes

Indications for Use (Describe)

The Varian Sterilization boxes are intended to securely store the applicator parts during steam sterilization process and subsequent storage.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with a stylized "I" that resembles a person. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font. The logo is simple and professional, and it conveys the company's focus on medical technology.

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

Varian Sterilization Boxes

The following information is provided following the format of 21 CFR 807.92

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: February 22, 2016
Proprietary Name:	Varian Sterilization Boxes
Classification Name:	Remote controlled radionuclide applicator system21 CFR 892.5700, JAQ, Class II
Common/Usual Name:	Remote controlled radionuclide applicator system
Predicate Devices:	[K980576] VariSource Endometrial Applicator for VariSource Remote High DoseRate Afterloader (predicate is the Sterilization Tray which is a component of theapplicator set).
Device Description:	The Varian Sterilization boxes consist of an aluminium box with hinged lid andfasteners. There are arrays of holes in the top and bottom surfaces to allowevacuation during pre-vacuum processes. In the Universal Sterilization Box there isa perforated plastic inlay to allow placement of the components or devices to besterilized. In the device-specific boxes there are supports to hold the components.
Intended Use Statement	The Varian Sterilization boxes are intended to securely store the applicator partsduring steam sterilization process and subsequent storage.
Indications for UseStatement	The Varian Sterilization boxes are indicated to securely store the applicator partsduring steam sterilization process and subsequent storage.

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Technological Characteristics:

	VARIAN ENDOMETRIAL APPLICATOR FORVARISOURCE REMOTE HIGH DOSE RATEAFTERLOADER K980576Predicate: Sterilization Tray GM11009940(Component of VariSource EndometrialApplicator Set K980576)	Varian Sterilization BoxesGM11010300, GM11010310GM11010320, GM11010340
Intended use	The Varian VariSource Remote High DoseRate Afterloader [system, includingapplicators and accessories] is a deviceinteded to be used by properly trainedand licensed medical personnel to provideradiation brachytherapy. The VariSourceEndometrial Applicator which is thesubject of this 510(k) is a component ofthe VariSource system.	The Varian Sterilization boxes are intendedto securely store the applicator parts duringsteam sterilization process and subsequentstorage.
	The sterilization tray is intended tosecurely store the applicator parts duringsteam sterilization process andsubsequent storage.[The intended use for the sterilization trayisn't specifically cleared however it is acomponent of the cleared applicator setK980576 and this is the intended use forthe component at that time.]

Indications for Use	The Varian VariSource Remote High DoseRate Afterloader [system, includingapplicators and accessories] is a deviceinteded to be used by properly trainedand licensed medical personnel to provideradiation brachytherapy. The VariSourceEndometrial Applicator which is thesubject of this 510(k) is a component ofthe VariSource system.
	The sterilization tray is intended tosecurely store the applicator parts duringsteam sterilization process andsubsequent storage.	The Varian Sterilization boxes are intendedto securely store the applicator parts duringsteam sterilization process and subsequentstorage.
	[The indications for use for thesterilization tray aren't specifically clearedhowever it is a component of the clearedapplicator set K980576 and this is theindications for use for the component atthat time.]
Design	The box has rectangular base with a latchable lid. The box has perforations on thelid and bottom to allow sterilantpenetration.	The box has rectangular base with a latchable lid. The box has perforations on the lidand bottom to allow sterilant penetration.
Materials	Aluminum alloy, silicone, stainless steel	Aluminum alloy, silicone, stainless steel
Physical Properties	Dimensionally stableNo water absorption	Dimensionally stableNo water absorption
Chemical Properties	N/A, no polymeric composites used aspacking materials.	N/A, no polymeric composites used aspacking materials.
Configuration/Dimension	L400mm x W260mm x H70mmVolume = 7280cm3	GM11010300:L399mm x W259mm x H75mmVolume = 7751 cm3GM11010310:L408mm x W262mm x H75mmVolume = 8017 cm3GM11010320:L399mm x W259mm x H75mmVolume = 7751 cm3GM11010340:L407mm x W262mm x H75mm.Volume = 7997 cm3
Air permeance	N/A, the box does not provide a sterilebarrier. Sterilization wrap has to be used.	N/A, the boxes does not provide a sterilebarrier. Sterilization wrap has to be used.
Percent of surface perforations	11%	GM11010300: 18%GM11010310: 17%GM11010320: 18%GM11010340: 19%
Method of holding applicators in place	Brackets	Silicone mat upon which items can be placed
Sterility	Provided non-sterile	Provided non-sterile
Sterilization method	Steam sterilization up to 500 timesPre-vacuum autoclave cycles have been validated for use in the health care facilities as follows:132°C (270°F) exposure temperature set-point, 4 minute exposure time, 25 minute drying time134°C (273°F) exposure temperature set-point, 3 minute exposure time, 25 minute drying time134°C (273°F) exposure temperature set-point, 5 minute exposure time, 25 minute drying time	Steam sterilization up to 500 timesPre-vacuum autoclave cycles have been validated for use in the health care facilities as follows:132°C (270°F) exposure temperature set-point, 4 minute exposure time, 25 minute drying time134°C (273°F) exposure temperature set-point, 3 minute exposure time, 25 minute drying time134°C (273°F) exposure temperature set-point, 5 minute exposure time, 25 minute drying time
Microbial Barrier Properties(Packaging Integrity)	The device does not provide a sterile barrier. Sterilization wrap has to be used. Hospital is responsible for wrapping materials, as well as method and shelf life validation.	The device does not provide a sterile barrier. Sterilization wrap has to be used. Hospital is responsible for wrapping materials, as well as method and shelf life validation.
Material Compatibility	Compatible to steam and can be used 500 times.	Compatible to steam and can be used 500 times.
Toxicological Properties(Biocompatibility, including Sterilant Residue Limits)	N/A, According to ISO 10993-1/FDA G-95-1 the Sterilization Box is a non-invasive product and is not intended to have any patient contact.	N/A, According to ISO 10993-1 / FDA G-95-1 the Sterilization Box is a non-invasive product and are not intended to have any patient contact.
Shelf Life	No sterile wrap is supplied with the sterilization box.	No sterile wrap is supplied with the sterilization box.
Drying time	25 minutes	25 minutes
Aeration time	N/A	N/A
Where used	Reprocessing units	Reprocessing units

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Non Clinical Tests Bench Testing has been performed to demonstrate that:

the device can withstand the number of steam autoclave cycles specified in the instructions for use. .
the device enables the components of the applicators to be stored to give easy access and does not damage them.
. Sterilization validation has been performed on equivalent devices to demonstrate that the specified applicator components and accessories can be sterilized in the sterilization box.

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Usability was reviewed in comparison to other similar devices 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 the device 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.