← Product Code [JAQ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ) · K160021 # Varian Sterilization Boxes (K160021) _Varian Medical Systems, Inc. · JAQ · Apr 13, 2016 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K160021 ## Device Facts - **Applicant:** Varian Medical Systems, Inc. - **Product Code:** [JAQ](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ.md) - **Decision Date:** Apr 13, 2016 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.5700 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The Varian Sterilization boxes are intended to securely store the applicator parts during steam sterilization process and subsequent storage. ## Device Story Varian Sterilization Boxes are aluminum containers with hinged lids and fasteners; designed for secure storage and steam sterilization of radiation brachytherapy applicator components. Boxes feature perforated top and bottom surfaces to facilitate steam penetration during pre-vacuum autoclave cycles; internal silicone mats or supports hold applicator parts in place. Used in hospital reprocessing units by sterile processing staff. Boxes do not provide a sterile barrier; must be used with sterilization wrap. Device is non-invasive, non-patient contacting, and reusable for up to 500 steam sterilization cycles. Benefits include organized, secure storage and protection of delicate applicator components during the sterilization process. ## Clinical Evidence No clinical data included. Bench testing only. Testing demonstrated device durability through 500 steam autoclave cycles, compatibility with specified sterilization parameters (132°C/4 min or 134°C/3-5 min), and ability to store/protect applicator components without damage. Usability evaluated per IEC 62366:2007. ## Technological Characteristics Materials: Aluminum alloy, silicone, stainless steel. Design: Rectangular box with hinged lid, latch, and perforated surfaces (17-19% perforation). Energy: Passive (steam autoclave). Connectivity: None. Sterilization: Steam (pre-vacuum autoclave). Non-sterile, reusable (500 cycles). Non-invasive, no patient contact. Dimensions: Various models (e.g., 399-408mm x 259-262mm x 75mm). ## Regulatory 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. ## Predicate Devices - VariSource Endometrial Applicator for VariSource Remote High Dose Rate Afterloader ([K980576](/device/K980576.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. {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.'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 {2}------------------------------------------------ # 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) ### 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 ## 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-110
Palo Alto, CA 94304

Contact Name: Peter J. Coronado
Phone: 650.424.6320
Fax: 650.646.9200

Date: February 22, 2016 | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Proprietary Name: | Varian Sterilization Boxes | | Classification Name: | Remote controlled radionuclide applicator system
21 CFR 892.5700, JAQ, Class II | | Common/Usual Name: | Remote controlled radionuclide applicator system | | Predicate Devices: | [K980576] VariSource Endometrial Applicator for VariSource Remote High Dose
Rate Afterloader (predicate is the Sterilization Tray which is a component of the
applicator set). | | Device Description: | 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. | | Intended Use Statement | The Varian Sterilization boxes are intended to securely store the applicator parts
during steam sterilization process and subsequent storage. | | Indications for Use
Statement | The Varian Sterilization boxes are indicated to securely store the applicator parts
during steam sterilization process and subsequent storage. | {4}------------------------------------------------ ## Technological Characteristics: | | VARIAN ENDOMETRIAL APPLICATOR FOR
VARISOURCE REMOTE HIGH DOSE RATE
AFTERLOADER K980576

Predicate: Sterilization Tray GM11009940
(Component of VariSource Endometrial
Applicator Set K980576) | Varian Sterilization Boxes
GM11010300, GM11010310
GM11010320, GM11010340 | |------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | The Varian VariSource Remote High Dose
Rate Afterloader [system, including
applicators and accessories] is a device
inteded to be used by properly trained
and licensed medical personnel to provide
radiation brachytherapy. The VariSource
Endometrial Applicator which is the
subject of this 510(k) is a component of
the VariSource system. | The Varian Sterilization boxes are intended
to securely store the applicator parts during
steam sterilization process and subsequent
storage. | | | The sterilization tray is intended to
securely store the applicator parts during
steam sterilization process and
subsequent storage.

[The intended use for the sterilization tray
isn't specifically cleared however it is a
component of the cleared applicator set
K980576 and this is the intended use for
the component at that time.] | | | | | | | Indications for Use | The Varian VariSource Remote High Dose
Rate Afterloader [system, including
applicators and accessories] is a device
inteded to be used by properly trained
and licensed medical personnel to provide
radiation brachytherapy. The VariSource
Endometrial Applicator which is the
subject of this 510(k) is a component of
the VariSource system. | | | | The sterilization tray is intended to
securely store the applicator parts during
steam sterilization process and
subsequent storage. | The Varian Sterilization boxes are intended
to securely store the applicator parts during
steam sterilization process and subsequent
storage. | | | [The indications for use for the
sterilization tray aren't specifically cleared
however it is a component of the cleared
applicator set K980576 and this is the
indications for use for the component at
that time.] | | | Design | The box has rectangular base with a latch
able lid. The box has perforations on the
lid and bottom to allow sterilant
penetration. | The box has rectangular base with a latch
able lid. The box has perforations on the lid
and bottom to allow sterilant penetration. | | Materials | Aluminum alloy, silicone, stainless steel | Aluminum alloy, silicone, stainless steel | | Physical Properties | Dimensionally stable
No water absorption | Dimensionally stable
No water absorption | | Chemical Properties | N/A, no polymeric composites used as
packing materials. | N/A, no polymeric composites used as
packing materials. | | Configuration/
Dimension | L400mm x W260mm x H70mm
Volume = 7280cm3 | GM11010300:
L399mm x W259mm x H75mm
Volume = 7751 cm3
GM11010310:
L408mm x W262mm x H75mm
Volume = 8017 cm3
GM11010320:
L399mm x W259mm x H75mm
Volume = 7751 cm3
GM11010340:
L407mm x W262mm x H75mm.
Volume = 7997 cm3 | | Air permeance | N/A, the box does not provide a sterile
barrier. Sterilization wrap has to be used. | N/A, the boxes does not provide a sterile
barrier. 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 times
Pre-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 time
134°C (273°F) exposure temperature set-point, 3 minute exposure time, 25 minute drying time
134°C (273°F) exposure temperature set-point, 5 minute exposure time, 25 minute drying time | Steam sterilization up to 500 times
Pre-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 time
134°C (273°F) exposure temperature set-point, 3 minute exposure time, 25 minute drying time
134°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 | {5}------------------------------------------------ {6}------------------------------------------------ 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. {7}------------------------------------------------ - 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. --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K160021](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/JAQ/K160021) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com