(99 days)
No
The device is a sterilization tray, a passive accessory for storing and sterilizing other medical devices. The description focuses on its physical properties and sterilization validation, with no mention of AI/ML capabilities or data processing.
No.
The device is a sterilization tray intended to store other medical device components during sterilization, storage, and transportation, not to provide therapy directly to a patient.
No
This device is a sterilization tray used for storing and transporting other medical devices, not for diagnosing medical conditions.
No
The device is a physical sterilization tray, a hardware component, and the summary describes testing related to cleaning, sterilization, mechanical reliability, and human factors, all indicative of a physical 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 the storage, sterilization, and transportation of other medical devices (a generator and battery insertion guides) within a hospital environment. It's a container for other medical devices.
- Device Description: The description reinforces its function as a reusable accessory for enclosing other components during sterilization, storage, and transportation.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or treatment.
- Using reagents or assays.
The device's function is purely related to the handling and sterilization of other medical devices, not to performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Sonicision™ reusable sterilization tray is intended to provide storage for the Sonicision™ reusable generator and Sonicision™ reusable battery insertion guides during sterilization, storage, and transportation within the hospital environment. The Sonicision™ reusable sterilization tray is only intended to maintain sterility of the enclosed components during autoclave sterilization when used in conjunction with an FDA-cleared sterilization wrap or rigid container (validated with Aesculap™ rigid container model JN741/JK789). The sterilization tray has only been evaluated for a non-stacked configuration.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The Sonicision Sterilization Tray is a reusable, optional accessory to the Sonicision System (cleared through K180149). This device is specially made to enclose up to one Sonicision Reusable Generator and up to two Sonicision Reusable Battery Insertion Guides in order to provide storage during sterilization, storage, and transportation within the hospital environment. The tray does not provide a sterile barrier on its own: it can only maintain sterility using an FDA-cleared sterilization wrap or rigid container.
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
hospital environment
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)
Cleaning and Sterilization Testing was performed in accordance with ANSI/AAMI/ISO 17665-1, AAMI TIR30:2011, AAMI TIR12:2010, and FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff" published March 17, 2015.
Mechanical/Reliability Testing was carried out to verify that the proposed device performs as expected at initial use and after repeated cleaning and sterilization cycles.
Human Factors Validation Testing was performed in accordance with IEC 62366-1:2015 along with FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices" published February 3, 2016 to verify that intended users are able to safely and correctly use the device.
Key Results: The performance data support that the Sonicision Reusable Sterilization Tray is as safe, as effective, and performs as well or better than the legally marketed predicate device.
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.
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
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Covidien Candice Bautista-Biddle Associate Regulatory Affairs Specialist 5920 Longbow Drive Boulder, Colorado 80301
Re: K180915
Trade/Device Name: Sonicision Reusable Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 26, 2018 Received: June 27, 2018
Dear Candice Bautista-Biddle:
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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180915
Device Name Sonicision™ Reusable Sterilization Tray
Indications for Use (Describe)
The Sonicision™ reusable sterilization tray is intended to provide storage for the Sonicision™ reusable generator and Sonicision™ reusable battery insertion guides during sterilization, storage, and transportation within the hospital environment. The Sonicision™ reusable sterilization tray is only intended to maintain sterility of the enclosed components during autoclave sterilization when used in conjunction with an FDA-cleared sterilization wrap or rigid container (validated with Aesculap™ rigid container model JN741/JK789). The sterilization tray has only been evaluated for a non-stacked configuration.
The validated sterilization cycle parameters are as follows:
Steam Sterilization Cycles
| Cycle Type | Exposure
Temperature | Exposure Time
(minutes) | Minimum
Dry Time1
(minutes) | Compatible Sterile Barriers |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----------------------------|-----------------------------------|------------------------------|
| Pre-vacuum | 132 °C (270 °F) | 4 | 40 | Wrap(s) and rigid container2 |
| Pre-vacuum | 135 °C (275 °F) | 3 | 40 | Wrap(s) and rigid container2 |
| Gravity | 132 °C (270 °F) | 15 | 40 | Wrap(s) |
| Gravity | 135 °C (275 °F) | 10 | 30 | Wrap(s) |
| 1Due to variations in autoclave sterilization equipment, actual dry times may vary from the minimum
dry times validated for this product.
2Validated with Aesculap™* rigid container model JN741/JK789. | | | | |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: K180915
Date summary prepared: 7/16/2018
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Candice Bautista-Biddle Associate Regulatory Affairs Specialist Telephone: 303-530-6448 Fax: 303-530-6313 Email: candice.bautista-biddle@medtronic.com
Name of Device
| Trade Name: | Sonicision™ Reusable Sterilization Tray |
|---|---|
| Common Name: | Sterilization Tray |
| Catalog Numbers: | SCSTA |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes and Other Accessories (21 CFR 880.6850, Class II, KCT) |
Predicate Device
| Trade Name: | Signia™ Sterilization Tray |
|---|---|
| Catalog Numbers: | SIGTRAY |
| Common Name: | Sterilization Tray |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes and Other Accessories (21 CFR 880.6850, Class II, KCT) |
| 510(k) Number: | K161347 |
| Manufacturer: | Covidien |
Device Description
The Sonicision Sterilization Tray is a reusable, optional accessory to the Sonicision System (cleared through K180149). This device is specially made to enclose up to one Sonicision Reusable Generator and up to two Sonicision Reusable Battery Insertion Guides in order to provide storage during sterilization, storage, and transportation within the hospital environment. The tray does not provide a sterile barrier on its own: it can only maintain sterility using an FDA-cleared sterilization wrap or rigid container.
Indications for Use
The Sonicision™ reusable sterilization tray is intended to provide storage for the Sonicision™ reusable generator and Sonicision™ reusable battery insertion guides during sterilization, storage, and transportation within the hospital environment. The Sonicision™ reusable sterilization tray is only intended to maintain sterility of the enclosed components during autoclave sterilization when used in conjunction with an FDA-cleared sterilization wrap or rigid container (validated with Aesculan™M* Rigid Container model JN741/JK789). The sterilization tray has only been evaluated for a non-stacked configuration.
The validated sterilization cycle parameters are as follows:
4
Steam Sterilization Cycles
| Cycle Type | Exposure
Temperature | Exposure Time
(minutes) | Minimum Dry
Time1 (minutes) | Compatible Sterile
Barriers |
|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----------------------------|--------------------------------|---------------------------------|
| Pre-vacuum | 132 °C (270 °F) | 4 | 40 | Wrap(s) and rigid
container2 |
| Pre-vacuum | 135 °C (275 °F) | 3 | 40 | Wrap(s) and rigid
container2 |
| Gravity | 132 °C (270 °F) | 15 | 40 | Wrap(s) |
| Gravity | 135 °C (275 °F) | 10 | 30 | Wrap(s) |
| 1Due to variations in autoclave sterilization equipment, actual dry times may vary from the minimum dry times
validated for this product. | | | | |
| 2Validated with Aesculap Rigid Container model JN741/JK789 | | | | |
Comparison of Technological Characteristics with the Predicate Device
Both the proposed and predicate devices have the same intended use of providing storage for components of their respective systems during sterilization, storage, and transportation within the hospital environment. Additionally, both devices have the same basic design of tray and lid with perforations to allow for steam sterilization of the enclosed devices.
| | Subject Device
Sonicision Reusable Sterilization
Tray | Predicate Device K161347
Signia sterilization tray |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Enclosed devices
for sterilization | The tray can contain at a maximum:
One (1) Sonicision Reusable Generator,
Two (2) Sonicision Reusable Battery
Insertion Guides. | The tray can contain at a maximum:
One (1) Signia Adapter,
One (1) Signia Reusable Insertion
Guide and
One (1) Signia Manual Retraction Tool. |
| Dimensions | Approx. 8.5 x 11.0 x 3.0 (H) inches | Approx. 10.0 x 21.4 x 3.0 (H) inches |
| Sterilization
methods | Steam (Pre-vacuum and Gravity) | Steam (Pre-vacuum) |
| Steam sterilization
parameters | 132 °C Pre-vacuum Steam Cycle
Exposure temperature: 270 °F (132 °C)
Exposure time: 4 minutes
Minimum dry time: 40 minutes
135 °C Pre-vacuum Steam Cycle
Exposure temperature: 275 °F (135 °C)
Exposure time: 3 minutes
Minimum dry time: 40 minutes
132 °C Gravity Steam Cycle
Exposure temperature: 270 °F (132 °C)
Exposure time: 15 minutes
Minimum dry time: 40 minutes
135 °C Gravity Steam Cycle
Exposure temperature: 275 °F (135 °C)
Exposure time: 10 minutes
Minimum dry time: 30 minutes | 132 °C Pre-vacuum (Hi Vac) Steam
Cycle
Exposure temperature: 270 °F (132 °C)
Exposure time: 4 minutes
Vacuum dry time: 20-40 minutes
134 °C Pre-vacuum (Hi Vac) Steam
Cycle
Exposure temperature: 273 °F (134 °C)
Exposure time: 3 minutes
Vacuum dry time: 20-40 minutes
Not applicable |
5
| | Subject Device
Sonicision Reusable Sterilization
Tray | Predicate Device K161347
Signia sterilization tray |
|---------------------------|----------------------------------------------------------------|---------------------------------------------------------------|
| Base and Lid
Materials | Base: Polyphenylsulfone
Lid: Stainless Steel | Base and Lid: Stainless Steel |
| Stacking | Do not stack loaded/wrapped
sterilization trays in chamber. | Do not stack cases and trays in the
sterilization chamber. |
| Max. Load
Capacity |