Washtrays

K231144 · Dentsply Sirona · KCT · Jan 16, 2024 · General Hospital

Device Facts

• Record ID: K231144
• Device Name: Washtrays
• Applicant: Dentsply Sirona
• Product Code: KCT · General Hospital
• Decision Date: Jan 16, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Washtrays are intended for organizing, cleaning, sterilizing and storing of instruments. The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or a sterilization container.

Device Story

Washtrays are stainless-steel perforated trays used to organize, clean, sterilize, and store dental implant surgical instruments. The device includes baskets, a lid with a handle, and an anodized aluminum overlay with visual symbols to guide instrument positioning. Instruments are secured in PEEK holders with stainless steel springs. The base features silicone feet to prevent sliding. Used in clinical settings by dental staff, the trays hold instruments during automated cleaning and steam sterilization cycles. The device does not maintain sterility; it must be placed inside a validated sterilization pouch or container. The output is an organized, sterilized set of instruments ready for surgical use. Benefits include standardized instrument organization, efficient reprocessing, and secure instrument retention during transport and sterilization.

Clinical Evidence

No clinical data. Bench testing only. Validations included sterilization cycle (SAL ≤ 10^-6), drying time (≤ 3% weight gain), automated cleaning (protein < 6.4 µg/cm², hemoglobin < 2.2 µg/cm²), reprocessing durability (200 cycles), simulated use (500 repositioning cycles), transportation vibration/shock, and handle load capacity (40N). Biocompatibility confirmed via cytotoxicity testing (ISO 10993-5).

Technological Characteristics

Materials: Stainless steel (1.4301, 1.4303, 1.4310), silicone, PEEK, anodized aluminum. Dimensions: 10.83 x 6.93 x 2.32 inches. Sterilization: Pre-vacuum steam (132°C, 4 min exposure, 20 min dry). Connectivity: None. Software: None. Configuration: Perforated tray with baskets, lids, and instrument holders.

Indications for Use

Indicated for organizing, cleaning, sterilizing, and storing dental implant surgical instruments in healthcare facilities. Not intended to maintain sterility independently; must be used with a validated sterilization pouch or container.

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

• NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace SelectTM TC PureSet™ Tray (K212932)

Submission Summary (Full Text)

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January 16, 2024

Dentsply Sirona Rebecca Sporer Principle Regulatory Affairs Specialist 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401

Re: K231144

Trade/Device Name: Washtrays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT, Dated: December 11, 2023 Received: December 12, 2023

Dear Rebecca Sporer:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Colin O'neill -S Colin O'Neill, M.B.E.

Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K231144

Device Name

Washtrays

Indications for Use (Describe)

Washtrays are intended for organizing, cleaning, sterilizing and storing of instruments.

The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or a sterilization container.

#### Sterilization parameters

Pre-vacuum Steam at 132 ℃ (270 °F) for 4 minutes with a 20-minute dry time. Do not exceed the worst-case validated maximum load:

| Product name | Article<br>Number | Dimensions<br>Length x<br>Width x<br>Height (in) | Maximum Load<br>(g) | Vent to Volume Ratio<br>(in-1) |
|---------------------------------------------|-------------------|--------------------------------------------------|---------------------|--------------------------------|
| OmniTaper Washtray | 68015271 | | 1107.3 | 2.54 |
| OmniTaper Washtray GS | 68015354 | | 1107.3 | 2.54 |
| PrimeTaper Washtray | 68015323 | 10.83<br>x | 1107.3 | 2.54 |
| PrimeTaper Washtray GS | 68017267 | 6.93<br>x | 1107.3 | 2.54 |
| Washtray<br>Astra Tech Implant System EV | 31071000 | 2.32 | 1107.3 | 2.54 |
| Washtray<br>GS Astra Tech Implant System EV | 31071020 | | 1107.3 | 2.54 |
| Ankylos Washtray | 31036600 | | 1107.3 | 2.54 |

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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Dentsply Sirona Inc. 221 West Philadelphia Street, Suite 60W York, PA 17401

Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the text "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is aligned to the right of the leaf-like shape.

## SECTION 5. 510(k) SUMMARY Washtravs K231144

#### 5.1 Submitter Information:

Dentsply Sirona Inc.

221 West Philadelphia Street Suite 60W York, PA 17401

Contact Person: Rebecca Sporer Telephone Number: 717-353-1150 Fax Number: 717-849-4343 Email: [e-mail]

Date Prepared: January 12, 2024

#### 5.2 Device Name:

| Proprietary Name: | Washtrays |
|----------------------|------------------------------------------------------------------------|
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other<br>Accessories |
| CFR Number: | 21 CFR 880.6850 |
| Device Class: | Class II |
| Product Code: | KCT |

#### 5.3 Predicate Device:

The predicate device identified is the following:

| Predicate Device Name | NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace<br>SelectTM TC PureSet™ Tray |
|-----------------------|-----------------------------------------------------------------------------------------------|
| 510(k) | K212932 |
| Company Name | Nobel Biocare AB |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| CFR Number: | 21 CFR 880.6850 |
| Device Class: | Class II |
| Product Code: | KCT |

## 5.4 Device Description:

The proposed Washtrays are used to store and organize dental implant surgical instruments needed during implant surgery, as well as hold instruments during cleaning and sterilization. The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or sterilization container.

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The proposed Washtrays consist of a stainless-steel perforated tray equipped with baskets and a lid with a handle. The large basket comprises instrument holders inserted in an anodized aluminum alloy Overlay printed with visual symbols for correct positioning of the designated instruments such as drills and taps.

The designated instruments are placed in the Overlay in the Instrument holders which are made with PEEK and have a stainless steel spring to hold the instruments in place. The Overlay guides the user through the surgical protocol for implant placement. The small basket with its own small lid and silicone mat inside is used to store the instruments which can be disassembled prior to cleaning. The metal grid base has silicone feet to prevent the Washtrays from slipping/sliding when placed on a surface.

The outer dimensions for all Washtrays is the same, 10.83 x 2.32 inches. The inner arrangement of the baskets varies between the Washtrays. Table 5.1 gives an overview of all Washtray configurations.

| Product name | Part number | Dimensions<br>Length x<br>Width x<br>Height (in) | Max load<br>(g) | Vent to<br>volume ratio<br>(in⁻¹) |
|-------------------------------------------|-------------|--------------------------------------------------|-----------------|-----------------------------------|
| OmniTaper Washtray | 68015271 | | 1107.3 | 2.54 |
| OmniTaper Washtray GS | 68015354 | 10.83 | 1107.3 | 2.54 |
| PrimeTaper Washtray | 68015323 | X | 1107.3 | 2.54 |
| PrimeTaper Washtray GS | 68017267 | 6.93 | 1107.3 | 2.54 |
| Washtray Astra Tech Implant System® EV | 31071000 | 2.32 | 1107.3 | 2.54 |
| Washtray GS Astra Tech Implant System® EV | 31071020 | | 1107.3 | 2.54 |
| Ankylos Washtray | 31036600 | | 1107.3 | 2.54 |

#### Table 5.1: Washtray configurations

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## 5.5 Indications for Use

The Washtrays are intended for organizing, cleaning, sterilizing and storing of instruments.

The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or a sterilization container.

#### Sterilization parameters

Pre-vacuum Steam at 132°C (270°F) for 4 minutes with a 20-minute dry time. Do not exceed the worst-case validated maximum load:

| Product name | Article<br>Number | Dimensions<br>Length x Width<br>x Height (in) | Maximum<br>Load<br>(g) | Vent to<br>Volume Ratio<br>(in-1) | Element | Proposed Device<br>Washtrays<br>(K231144) | | | | | Predicate Device<br>NobelSpeedy® Groovy / Brånemark System® Mk III<br>TiUnite / Replace Select™ TC PureSet™ Tray<br>(K212932) | Discussion |
|-------------------------------------------|---------------------------|-----------------------------------------------|------------------------|-----------------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--------------------------------------------|---------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| OmniTaper Washtray | 68015271 | | 1107.3 | 2.54 | Indications for<br>Use | The Washtrays are intended for organizing, cleaning,<br>sterilizing and storing of instruments.<br><br>The Washtrays are not intended to maintain sterility and<br>are to be used in conjunction with a legally marketed,<br>validated sterilization pouch or a sterilization container.<br><br>Sterilization parameters<br>Pre-vacuum Steam at 132°C (270°F) for 4 minutes with<br>a 20 minute dry time.<br>Do not exceed the worst-case validated maximum load: | | | | | Nobel Biocare PureSet Trays are used in healthcare<br>facilities to store and organize Nobel Biocare<br>surgical/prosthetic instruments and components during<br>cleaning/sterilization and during implant/prosthetic<br>treatment.<br><br>Nobel Biocare PureSet Trays are not intended on their<br>own to maintain sterility; they are intended to be used in<br>conjunction with a legally marketed, validated, FDA<br>cleared sterilization container, sterilization pouch, or<br>sterilization wrap. | Same uses but the proposed<br>Washtrays are validated for<br>one sterilization parameter. |
| OmniTaper Washtray GS | 68015354 | | 1107.3 | 2.54 | | Product name | Article<br>Number | Dimensions<br>(Length x Width x<br>Height) | Maximum<br>Load (g) | Vent to<br>Volume<br>Ratio (in³) | Sterilization validations for the worst-case PureSet Tray<br>included surgical instruments such as torque wrenches,<br>implant drivers, direction indicators, drills, screw taps,<br>screwdrivers, and irrigation needles. The<br>PureSetTrayswere validated for a maximum load of<br>1635 grams<br>(Trefoil PureSet Tray), 1122 grams (NobelActive /<br>NobelParallel CC PureSet Tray), 1063 grams<br>(NobelReplace CC PureSet Tray), 454 grams (Nobel<br>Biocare N1™ PureSet Tray), 486 grams (Prosthetic<br>PureSet Tray), 1143 grams (NobelActive Guided<br>PureSet Tray), 1146 grams (NobelParallel CC Guided<br>PureSet Tray), 1176 grams (NobelReplace CC Guided<br>PureSet Tray), and 1035 grams (NobelSpeedy® Groovy<br>/ Brånemark System® Mk III TiUnite / Replace<br>Select™ TC PureSet™ Tray). | |
| PrimeTaper Washtray | 68015323 | 10.83<br>X | 1107.3 | 2.54 | | OmniTaper<br>Washtray | 68015271 | 10.83 in<br>x | 1107.3 | 2.54 | | |
| PrimeTaper Washtray GS | 68017267 | 6.93<br>X | 1107.3 | 2.54 | | OmniTaper<br>Washtray GS | 68015354 | 6.93 in<br>x | 1107.3 | 2.54 | | |
| Washtray Astra Tech Implant System® EV | 31071000 | | 1107.3 | 2.54 | | PrimeTaper<br>Washtray | 68015323 | 2.32 in | 1107.3 | 2.54 | | |
| Washtray GS Astra Tech Implant System® EV | 31071020 | 2.32 | 1107.3 | 2.54 | | PrimeTaper<br>Washtray GS | 68017267 | | 1107.3 | 2.54 | | |
| Ankylos Washtray | 31036600 | | 1107.3 | 2.54 | | Washtray<br>Astra Tech<br>Implant<br>System® EV | 31071000 | | 1107.3 | 2.54 | | |
| | Washtray GS<br>Astra Tech | 31071020 | | 1107.3 | 2.54 | | | | | | | |

## 5.6 Comparison of Technological Characteristics

An overview of the similarities and differences between the proposed and predicate device is given in Table 5.6.1.

The proposed Washtrays and the predicate device NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace SelectTM TC PureSet™ Tray (K212932) have the same intended use, same sterilization method (Pre-Vacum) and parameters, and are made of the same materials (stainless steel, silicone and PEEK). The proposed Washtrays have the same configuration, with an evenly distributed hole pattern, similar to the predicate device.

The use of the Washtrays has been validated through performance, biocompatibility and sterilization testing. There are only minor differences between the proposed and the predicate device. The height of the proposed Washtrays is slightly different when compared to the predicate device. The proposed Washtrays are larger in height than the predicate device which results in a difference in the vent to volume ratio. When compared to the predicate device, the proposed Washtrays have a larger maximum sterilization load. The minor differences in dimension (height), vent to volume ratio, and weight do not impact the sterility, as substantial equivalence was demonstrated through sterilization testing which confirms a SAL level of 10-6.

To maintain sterility the proposed Washtrays are to be used in conjunction with a legally marketed, validated sterilization pouch or a sterilization container. In addition to this, the predicate device can also be used in conjunction with a legally marketed wrap. The proposed Washtrays sterilization validation confirms that the dry time is the same when using a sterilization container compared to the recommended wrap for the predicate device, and that a SAL level of 10-6 is achieved.

The proposed device is only validated for pre-vacuum steam sterilization. Unlike the predicate device, the proposed Washtrays are not intended to be sterilized via gravity displacement and therefore this method is not validated nor referenced in the Instructions for Use.

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Table 5.6.1: Technological Characteristics Comparison Table

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| Element | Proposed Device<br>Washtrays<br>(K231144) | | | | Predicate Device<br>NobelSpeedy® Groovy / Brånemark System® Mk III<br>TiUnite / Replace Select™ TC PureSet™ Tray<br>(K212932) | | | Discussion | | |
|------------------------|---------------------------------------------------------------------------------------------|----------|--|--------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | Implant<br>System® EV | | | | | Method<br><br>Cycle<br><br>Temparature<br><br>Exposure<br>time for the<br>single-use<br>pouched<br>device<br><br>Minimum<br>drying times | Dynamic-Air-<br>Removal<br>(fractionated<br>vacuum) | Steam Sterilization (Moist Heat<br>Sterilization<br>for Wrapped Instruments)<br><br>Gravity-<br>Displacement | | |
| | Ankylos<br>Washtray | 31036600 | | 1107.3 | 2.54 | | | | | |
| Intended Use | The Washtray are intended for organizing, cleaning, sterilizing and storing of instruments. | | | | | | | | The Nobel Biocare PureSet Tray is intended for use in healthcare facilities to store and organize Nobel Biocare surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The Nobel Biocare PureSet Trays are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization container, sterilization pouch, or sterilization wrap. Sterilization validations for the worst-case Nobel Biocare PureSet Tray (276.1 mm x 176 mm x 78 mm) included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, etc. | Similar<br>Predicate device shares the same device functionality of organizing, cleaning, sterilizing and storing instruments as proposed device. |
| | | | | | | | | 132°C<br>(270°F) | 132°C<br>(270°F) | |
| | | | | | | | | 4 minutes<br>(full-cycle) | 15 minutes<br>(full-cycle) | |
| | | | | | | | | 20 minutes | 30 minutes | |
| Manufacturer | Dentsply Sirona | | | | | Nobel Biocare AB | | | Different | |
| Product code | KCT | | | | | KCT | | | Same | |
| Device class | II | | | | | II | | | Same | |
| Classification<br>Name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | | | | | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | | | Same | |

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| Element | Proposed Device<br>Washtrays<br>(K231144) | Predicate Device<br>NobelSpeedy® Groovy / Brånemark System® Mk III<br>TiUnite / Replace SelectTM TC PureSet™ Tray<br>(K212932) | Discussion |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| CFR Number<br>and Name | 21 CFR 880.6850, Sterilization wrap | 21 CFR 880.6850, Sterilization wrap | Same |
| Dimensions | 10.83 in x 6.93 in x 2.32 in<br>(276.1mm in x 176mm in x 59 mm) | 276.1mm x 176mm x 47mm | Different |
| Tray<br>Perforation | Evenly distributed hole pattern | Evenly distributed hole pattern | Same |
| Configuration | Perforated metal grid base with baskets and lids,<br>instrument holders and outer lid with handle. | Perforated bases, lids and PEEK Luvocom grommets | Same |
| Materials | Washtray:<br>• Metal Grid Base-Stainless steel 1.4301<br>• Metal grid base feet-Silicone<br>• Large basket - Stainless steel 1.4303<br>• Small Basket - Stainless steel 1.4303<br>• Lid with Handle-Stainless Steel 1.4310<br>• Silicone mat (inside the small basket)-Silicone<br>• Instrument Holders – PEEK with stainless steel spring<br>• Overlay – Anodized aluminum | • PureSet Tray:<br>o Tray (including basket / lid / handle / sheet metal<br>parts): Stainless steel (1.4301, 1.4303, 1.4310)<br>o Grommets: PEEK, Stainless steel 1.4310<br>o Tray / Basket Closures: Stainless steel 1.4310, PEEK<br>o Feet: Silicone elastomer<br>• PureSet Tray Plate: Anodized aluminum | Same |
| Mass of<br>maximum<br>sterilization<br>load | 1107.3g | 1035g | Different |
| Volume to<br>Vent<br>Ratio | 2.54 in-1 (10.36 mm-1) | 29.4 | Different |
| Sterility | Non-sterile | Non-sterile | Same |
| Sterilization<br>Method | Moist heat (steam) | Moist heat (steam) | Same |
| Element | Proposed Device<br>Washtrays<br>(K231144) | Predicate Device<br>NobelSpeedy® Groovy / Brånemark System® Mk III<br>TiUnite / Replace SelectTM TC PureSet™ Tray<br>(K212932) | Discussion |
| Sterilization<br>Parameters | Pre vacuum,<br>At 132°C for 4 minutes with a 20 minute dry time | • Pre-Vacuum:<br>o Temp 132°C (270° F)<br>o Exposure Time 4 minutes<br>o Pre-vacuum: 4 times < 60 mbar<br>o Drying Time: 20 minutes<br>o Cooling Time: 30 minutes total<br>• Gravity Displacement:<br>o Temp 132°C (270° F)<br>o Exposure Time: 15 minutes<br>o Pre-vacuum: N/A<br>o Drying Time: 30 minutes<br>o Cooling Time: 30 minutes total | Same. |
| Sterile barrier | FDA cleared sterilization pouch/container | FDA cleared sterilization wrap/pouch | Different |
| Reusable | Yes | Yes | Same |
| Supplier | Aesculap AG | Aesculap AG | Same |

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## 5.7 Non-Clinical Performance Data

The proposed Washtrays are reusable devices provided non-sterile which need to be end user cleaned and sterilized. Sterilization of the proposed Washtrays was validated according to the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".

Non-clinical testing data submitted, referenced, or relied upon, including acceptance criteria and set specifications in test methodology and standards, are summarized in Table 5.7.1.

| Table 5.7.1-Summary of Non-Clinical Testing of the Proposed Washtrays | | | | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------|
| Test Name | Test Methodology | Purpose | Acceptance Criteria | Results |
| Sterilization<br>Cycle<br>Validation | • ANSI/AAMI/ISO<br>17665-1:2006/(R)2013<br>• ISO 17665-2:2009 | To validate that the trays can be<br>sterilized via moist-heat<br>sterilization as specified on<br>labeling (132° C for 4 minutes) | Sterility assurance level<br>(SAL) of ≤ 10-6 | Pass |
| Drying<br>Validation | • AAMI TIR12: 2020<br>• ANSI/AAMI/ISO<br>17665-2:2009 | To validate that the trays can be<br>dried as specified on labeling<br>(drying time of 20 minutes) | No visible moisture<br>≤ 3% weight gain of<br>packaging and absorbable<br>materials | Pass |
| Cleaning<br>(Manual Pre-<br>Cleaning and<br>Automated<br>Cleaning) | • AAMI TIR12:2020<br>• AMI ST98:2022<br>• ISO 17664 | To validate that the trays can be<br>cleaned as specified on labeling | No visible soil.<br>Protein < 6.4 µg/cm²<br>Hemoglobin <2.2 µg/cm² | Pass |
| Reprocessing<br>of Trays<br>(cleaning and<br>sterilization) | Internal Test Method | To confirm that the trays can be<br>reprocessed as specified on<br>labeling (up to 200<br>reprocessing cycles without any<br>signs of abrasion) | No signs of flush rust, rust<br>corrosion, deformation or<br>damage | Pass |
| Simulated Use<br>of Trays | Internal Test Method | To confirm that the trays can<br>withstand simulated use of up<br>to 500 repeated reposition<br>cycles | No significant wear of the<br>holders | Pass |
| Transportation<br>Testing | • ASTM D 4728-06<br>• DIN EN ISO 60068-<br>2-27<br>• ISTA 3A (2010) | To confirm that the instrument<br>holder provides adequate fixing<br>of the instruments during<br>transportation | No visible damages<br>Instruments fixed inside the<br>Washtray and instrument<br>holders | Pass |
| Load Test<br>Handle | Internal Test Method | To confirm that no permanent<br>deformation of the handle or<br>the lid will occur | No permanent deformation<br>of the handle or the lid with<br>a load of 40N | Pass |
| Cytotoxicity | ISO 10993-5:2009 | To confirm that no cytotoxic<br>substances are released after<br>reprocessing of the trays | Inhibition of cell<br>proliferation must be at or<br>below 30% compared to<br>untreated cultures | Pass |

The non-clinical testing confirms that the proposed Washtrays can be sterilized via moist-heat sterilization as specified on the labeling (132° C for 4 minutes) to a sterility assurance level (SAL) of ≤ 10 %. In addition, the dry time as specified on the labeling (20 min) was validated to confirm that there is no visible moisture and that the weight gain of packaging and absorbable materials is ≤ 3%. Testing met the acceptance criteria.

A study for the evaluation of the automated cleaning procedure by determination of protein and hemoglobin residues was performed. Simulated use cycles were performed for the tested devices prior to the cleaning validation. The limit value for residual protein of 6.4 µg/cm² and hemoglobin content of 2.2 µg/ cm² was not exceeded.

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The in vitro cytotoxicity test conducted confirms that no cytotoxic substances are released after reprocessing of the trays. The result shows that the acceptance criteria were not exceeded. The proposed Washtrays are biocompatible for their intended use.

Product use and wear were evaluated through simulated use testing on the proposed Washtrays. After 200 cycles of cleaning and sterilization, the Washtrays did not show any signs of damage or alterations due to reprocessing. All relevant markings were still visible or readable with the naked eye. In addition, the reprocessed Washtrays have been used to simulate repeated repositioning of relevant instruments. Five hundred (500) repeated positionings have been simulated for each holder. The retention force of the holders was measured before and after the 500 repeated positionings were conducted. All tested Washtray instrument holders passed the repeated repositioning test and initial and final pull-off test to determine the retention force. There were no signs of damage or alterations after testing, and the instruments were safely seated in the holders.

The proposed Washtrays were evaluated for their ability to withstand vertical stresses during shortdistance transportation. Tests were performed with a loaded tray to evaluate if the instrument holders provide adequate fixing of the instruments. The Washtrays passed the vertical vibration and respective shock stresses.

The handle of the proposed Washtrays was tested for its suitability in terms of load capacity. The handle was pulled vertically and did not result in permanent deformation of the handle or the lid. The acceptance criterion was achieved. The handle is sufficiently resilient.

For all conducted test it can be shown that the acceptance criteria were met. The non-clinical test data support the conclusion that the proposed Washtrays are safe, effective and perform as intended.

## 5.8 Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device K212932.