(99 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization capabilities of a sterilization box, with no mention of AI or ML.
No
The device is described as a sterilization box intended to store applicator parts during the steam sterilization process and subsequent storage, not for treating diseases or conditions.
No
The device is described as an aluminum box intended for storing applicator parts during steam sterilization and subsequent storage. Its function is to facilitate sterilization and storage, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is an aluminum box with a hinged lid and fasteners, indicating a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for securely storing applicator parts during steam sterilization and subsequent storage. This is a process related to the preparation and maintenance of medical devices, not for performing tests on biological samples to diagnose conditions.
- Device Description: The device is a physical box designed for holding and protecting items during sterilization. It does not contain reagents, controls, or components typically associated with in vitro diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is clearly intended for the reprocessing and storage of medical device components, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Varian Sterilization boxes are intended to securely store the applicator parts during steam sterilization process and subsequent storage.
Product codes (comma separated list FDA assigned to the subject device)
JAO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Reprocessing units
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
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)
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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-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 |
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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.