Sonicision Reusable Sterilization Tray

K180915 · Covidien · KCT · Jul 17, 2018 · General Hospital

Device Facts

• Record ID: K180915
• Device Name: Sonicision Reusable Sterilization Tray
• Applicant: Covidien
• Product Code: KCT · General Hospital
• Decision Date: Jul 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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.

Device Story

Sonicision Reusable Sterilization Tray serves as storage accessory for Sonicision System components (reusable generator, battery insertion guides). Device facilitates steam sterilization (pre-vacuum/gravity) within hospital environments; requires external FDA-cleared sterilization wrap or rigid container to maintain sterility. Tray features perforated design for steam penetration; constructed from polyphenylsulfone base and stainless steel lid. Used by hospital staff to organize and protect components during reprocessing cycles. Benefits include standardized, validated storage and transport solution ensuring component integrity through repeated autoclave cycles.

Clinical Evidence

No clinical data. Evidence consists of bench testing: cleaning and sterilization validation per ANSI/AAMI/ISO 17665-1, AAMI TIR30:2011, and AAMI TIR12:2010; mechanical/reliability testing for repeated reprocessing; and human factors validation per IEC 62366-1.

Technological Characteristics

Materials: Polyphenylsulfone (base), stainless steel (lid). Design: Perforated tray/lid for steam sterilization. Dimensions: 8.5 x 11.0 x 3.0 inches. Sterilization: Steam (pre-vacuum and gravity). Standards: ANSI/AAMI/ISO 17665-1, AAMI TIR30:2011, AAMI TIR12:2010, IEC 62366-1.

Indications for Use

Indicated for storage of Sonicision reusable generator and battery insertion guides during sterilization, storage, and transport in hospital settings. Intended for use with FDA-cleared sterilization wraps or specific rigid containers (Aesculap JN741/JK789) in non-stacked autoclave configurations.

Regulatory Classification

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.

Predicate Devices

• Signia™ Sterilization Tray (K161347)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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<br>Temperature | Exposure Time<br>(minutes) | Minimum<br>Dry Time1<br>(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<br>dry times validated for this product.<br>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: [phone] Fax: [phone] Email: [e-mail]

#### 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:

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## Steam Sterilization Cycles

| Cycle Type | Exposure<br>Temperature | Exposure Time<br>(minutes) | Minimum Dry<br>Time1 (minutes) | Compatible Sterile<br>Barriers |
|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----------------------------|--------------------------------|---------------------------------|
| Pre-vacuum | 132 °C (270 °F) | 4 | 40 | Wrap(s) and rigid<br>container2 |
| Pre-vacuum | 135 °C (275 °F) | 3 | 40 | Wrap(s) and rigid<br>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<br>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<br>Sonicision Reusable Sterilization<br>Tray | Predicate Device K161347<br>Signia sterilization tray |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Enclosed devices<br>for sterilization | The tray can contain at a maximum:<br>One (1) Sonicision Reusable Generator,<br>Two (2) Sonicision Reusable Battery<br>Insertion Guides. | The tray can contain at a maximum:<br>One (1) Signia Adapter,<br>One (1) Signia Reusable Insertion<br>Guide and<br>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<br>methods | Steam (Pre-vacuum and Gravity) | Steam (Pre-vacuum) |
| Steam sterilization<br>parameters | <b>132 °C Pre-vacuum Steam Cycle</b><br>Exposure temperature: 270 °F (132 °C)<br>Exposure time: 4 minutes<br>Minimum dry time: 40 minutes<br><br><b>135 °C Pre-vacuum Steam Cycle</b><br>Exposure temperature: 275 °F (135 °C)<br>Exposure time: 3 minutes<br>Minimum dry time: 40 minutes<br><br><b>132 °C Gravity Steam Cycle</b><br>Exposure temperature: 270 °F (132 °C)<br>Exposure time: 15 minutes<br>Minimum dry time: 40 minutes<br><br><b>135 °C Gravity Steam Cycle</b><br>Exposure temperature: 275 °F (135 °C)<br>Exposure time: 10 minutes<br>Minimum dry time: 30 minutes | <b>132 °C Pre-vacuum (Hi Vac) Steam<br/>Cycle</b><br>Exposure temperature: 270 °F (132 °C)<br>Exposure time: 4 minutes<br>Vacuum dry time: 20-40 minutes<br><br><b>134 °C Pre-vacuum (Hi Vac) Steam<br/>Cycle</b><br>Exposure temperature: 273 °F (134 °C)<br>Exposure time: 3 minutes<br>Vacuum dry time: 20-40 minutes<br><br>Not applicable |

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| | Subject Device<br>Sonicision Reusable Sterilization<br>Tray | Predicate Device K161347<br>Signia sterilization tray |
|---------------------------|----------------------------------------------------------------|---------------------------------------------------------------|
| Base and Lid<br>Materials | Base: Polyphenylsulfone<br>Lid: Stainless Steel | Base and Lid: Stainless Steel |
| Stacking | Do not stack loaded/wrapped<br>sterilization trays in chamber. | Do not stack cases and trays in the<br>sterilization chamber. |
| Max. Load<br>Capacity | < 1800 grams (3.97 pounds, including<br>tray) | 10 pounds |

#### Performance Data

The following performance data were provided in support of the substantial equivalence determination.

#### Cleaning and Sterilization Testing

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

Mechanical and 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

Human factors 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.

#### Conclusion

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.