Surgical Trays

K212281 · Dentsply Sirona, Inc. · KCT · Mar 4, 2022 · General Hospital

Device Facts

• Record ID: K212281
• Device Name: Surgical Trays
• Applicant: Dentsply Sirona, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Mar 4, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Surgical Trays are intended for organizing, sterilizing and storing of instruments. The Surgical Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch. Sterilization parameters: Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time. The tested Surgical Tray represents the worst-case validated load of 513.7g. Do not exceed the following maximum load: Product name Article Number Max Load (g) Vent to Volume Ratio (in-1) OmniTaper Surgical Tray 68015282 513.7 0.033 PrimeTaper Surgical Tray 68015321 513.7 0.033

Device Story

Reusable perforated plastic container; organizes/stores instruments for implant surgery; facilitates sterilization. Components: lid, base, overlay (polyphenylsulfone); silicone tooling supports/grommets. Used in healthcare facilities; operated by clinical staff. Instruments placed in tray; tray placed in sterilization pouch; subjected to pre-vacuum steam sterilization (132°C, 4 min, 20 min dry). Tray design allows steam penetration. Supports workflow organization via custom printing. Benefits: safe instrument storage/transport; validated sterilization compatibility; durable for repeated reprocessing (up to 200 cycles).

Clinical Evidence

Bench testing only. Validated sterilization (ANSI/AAMI/ISO 17665-1/2) to SAL 10^-6; drying validation (AAMI TIR12); reprocessing durability (200 cycles); simulated use (1,500 repositioning cycles); biocompatibility (ISO 10993-5 cytotoxicity). All tests passed.

Technological Characteristics

Materials: Polyphenylsulfone (Radel R5000) base, lid, overlay; silicone tooling supports. Dimensions: 7.3 x 5.5 x 2.4 inches. Sterilization: Moist heat (steam) pre-vacuum. Vent-to-volume ratio: 0.033 in-1. Reusable. No software/electronics.

Indications for Use

Indicated for organizing, sterilizing, and storing instruments used in implant surgery. Intended for use in healthcare facilities. Not intended to maintain sterility; must be used with a validated sterilization pouch.

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

• Straumann BLX Surgical Cassette (K180791)

Submission Summary (Full Text)

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March 4, 2022

Dentsply Sirona Inc. Courtney Clark Sr. Director, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York. Pennsylvania 17401

Re: K212281

Trade/Device Name: Surgical Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 1, 2022 Received: February 2, 2022

# Dear Courtney Clark:

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. 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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K212281

Device Name Surgical Trays

Indications for Use (Describe)

The Surgical Trays are intended for organizing, sterilizing and storing of instruments.

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

Sterilization parameters:

Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time

The tested Surgical Tray represents the worst-case validated load of 513.7g. Do not exceed the following maximum load:

| Product name | Article<br>Number | Max Load (g) | Vent to Volume<br>Ratio (in-1) |
|--------------------------|-------------------|--------------|--------------------------------|
| OmniTaper Surgical Tray | 68015282 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray | 68015321 | 513.7 | 0.033 |

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.

# 510(k) SUMMARY Surgical Trays K212281

## 5.1 Submitter Information:

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

Courtney Clark Contact Person: Telephone Number: 248-895-4379 Fax Number: 717-849-4343 Email: [e-mail]

Date Prepared: March 4, 2022

## 5.2 Device Name:

| ● | Proprietary Name: | Surgical Trays |
|---|----------------------|------------------------------------------------------------------------|
| ● | 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 | 510(k) | Company Name |
|---------------------------------|---------|-----------------------|
| Straumann BLX Surgical Cassette | K180791 | Institut Straumann AG |

#### 5.4 Device Description:

The proposed Surgical Tray is a reusable perforated container that is intended to store and organize the instruments needed before, during and after implant surgery as well as holding instruments during sterilization.

The Surgical Tray is a container composed of three main components: a lid, a base and an overlay, all made of polyphenylsulfone (Radel R5000). The overlay has co-molded silicone tooling supports. The base has silicone rubber grommets to hold instruments. The base and overlay are custom printed to indicate the surgical workflow and the position of the instruments within the tray for the different product lines.

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The proposed Surgical Tray is available in one size with outer dimensions of 7.3 x 5.5 x 2.4 inches and offered in 2 inner tray configurations with varied instrument loads, see Table 5.1.

| Table 5.1- Surgical Tray configurations | | | | |
|-----------------------------------------|--------------|-----------------------|--------------|-----------------------------|
| Product name | Model number | Max no of instruments | Max load (g) | Vent to volume ratio (in-1) |
| OmniTaper Surgical Tray | 68015282 | 51 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray | 68015321 | 45 | 513.7 | 0.033 |

## 5.5 Indications for Use

The Surgical Trays are intended for organizing, sterilizing and storing of instruments.

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

Sterilization parameters:

Pre-vacuum Steam at 132°C (270°F) for 4 minutes with a 20 minutes dry time. The tested Surgical Tray represents the worst case validated load of 513.7g.

| Product name | Article number | Max load (g) | Vent to volume<br>ratio (in-1) |
|--------------------------|----------------|--------------|--------------------------------|
| OmniTaper Surgical Tray | 68015282 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray | 68015321 | 513.7 | 0.033 |

#### 5.6 Comparison of Technological Characteristics

An overview of the similarities and differences between the proposed and predicate device is given in Table 5.2. The proposed Surgical Tray and the predicate device, Straumann BLX Surgical Cassette (K180791), have the same intended use, same sterilization method and parameters, are made of the same materials and have a similar design. The vent to volume ratio for the proposed Surgical Tray is 0.033 in- while the predicate vent to volume ratio is 0.054 in 1. The proposed Surgical Tray has a lower vent to volume ratio.

When compared to the predicate device, the proposed Surgical Tray can hold more instruments and has a larger maximum sterilization load. The maximum sterilization load for the proposed Surgical Tray is 513.7g, while the predicate's maximum sterilization load is 300g. Sterilization was performed to support the sterilization load of the proposed Surgical Tray and has been validated to SAL of 10°.

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| Table 5.2: Similarities and Differences between the proposed and predicate devices | | | | | | | | | | | | | | | |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Elements | Proposed Device<br>Surgical Tray | Predicate Device<br>Straumann BLX Surgical<br>Cassette (K180791) | Comparison | | | | | | | | | | | | |
| Manufacturer | Sirona Dental Systems GmbH | Institut Straumann AG | Different manufacturer | | | | | | | | | | | | |
| Indications for use | The Surgical Trays are intended for organizing, sterilizing and<br>storing of instruments.<br><br>The Surgical Tray is not intended to maintain sterility and are to be<br>used in conjunction with a legally marketed, validated sterilization<br>pouch.<br><br>Sterilization parameters:<br>Pre-vacuum Steam at 132°C (270°F) for 4 minutes with a 20<br>minutes dry time.<br><br>The tested Surgical Tray represents the worst case validated load of<br>513.7g.<br><br>Do not exceed the following maximum load:<br>Product name Article number Max load(g) Vent to volume ratio (in-1) OmniTaper<br>Surgical Tray 68015282 513.7 0.033 PrimeTaper<br>Surgical Tray 68015321 513.7 0.033 | | | | | | | | | | | | | The Straumann BLX Cassette<br>is used in healthcare facilities to<br>organize, enclose,<br>cleaning, sterilize, transport,<br>and store medical devices<br>between surgical uses. The<br>BLX Cassette is not intended to<br>maintain sterility; it is intended<br>to be used in conjunction with<br>a legally marketed, validated<br>sterilization wrap.<br><br>The BLX Cassette has been<br>validated for a maximum load<br>of 300 grams, including<br>cassette and instruments.<br>Sterilization parameters:<br>Pre-vacuum steam: 132°C<br>(270° F) for 4 minutes with 20<br>minutes drying time | Similar indications but the<br>proposed Surgical Tray is not<br>indicated for cleaning device.<br>The proposed device is intended<br>to be used with a validated<br>sterilization pouch. |
| Product code | KCT | KCT | Same | | | | | | | | | | | | |

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| Table 5.2: Similarities and Differences between the proposed and predicate devices | | | |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Elements | Proposed Device<br>Surgical Tray | Predicate Device<br>Straumann BLX Surgical<br>Cassette (K180791) | Comparison |
| General Design | Plastic tray with locking lid. Co-molded silicone and<br>silicone grommet supports | Plastic tray and lid | Similar, both trays are designed<br>to hold instruments for implant<br>surgery and sterilization and<br>consist of a plastic box with an<br>insert adapted for the specific<br>surgical procedure. The inserts<br>have silicone holders for<br>instruments. |
| Dimensions | 7.3 in x 5.5 in x 2.4 in | 5.6 in x 3.9 in x 2.4 in | Similar |
| Material | Base – Radel 5000<br>Lid – Radel 5000<br>Overlay – Radel 5000<br>Tooling support - Silicone | Radel 5000<br>Silicone | Same |
| Air permeance | Yes, allow moist heat (steam) penetration to achieve sterilization | Yes, allow moist heat (steam)<br>penetration to achieve<br>sterilization | Same |
| Mass of<br>maximum<br>sterilization load | OmniTaper Surgical Tray<br>PrimeTaper Surgical Tray | 300g | Different |
| | 513.7g<br>513.7g | | |
| Vent to volume<br>ratio | OmniTaper Surgical Tray<br>PrimeTaper Surgical Tray | $0.054\ in^{-1}$ | Different |
| | $0.033\ in^{-1}$<br>$0.033\ in^{-1}$ | | |
| Sterility | Non-sterile | Non-sterile | Same |
| Sterilization Method | Moist heat (steam) | Moist heat (steam) | Same |
| Sterilization Parameters | Pre vacuum,<br>At 132°C for 4 minutes with a 20 minutes dry time | Pre vacuum<br>At 132°C for 4 minutes with a<br>20 minutes dry time | Same |
| Sterile barrier | FDA cleared sterilization pouch | FDA cleared sterilization pouch | Same |
| Reusable | Yes | Yes | Same |

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## 5.7 Non-Clinical Performance Data

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

| Test Name | Test Methodology | Purpose | Acceptance Criteria | Results |
|----------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------|
| Sterilization<br>cycle validation | • ANSI/AAMI/ISO<br>17665-1:2006/(R)2013<br>• ISO 17665-2:2009 | To validate that the trays<br>can be sterilized via<br>moist-heat sterilization as<br>specified on labeling<br>(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<br>can be dried as specified<br>on labeling (drying time<br>of 20 minutes) | No visible moisture<br>≤ 3% weight gain of<br>packaging and<br>absorbable materials | Pass |
| Reprocessing of<br>trays (cleaning<br>and sterilization) | Internal Test Method | To confirm that the trays<br>can be reprocessed as<br>specified on labeling (up<br>to 200 reprocessing cycles<br>without any signs of<br>abrasion) | No signs of flush rust,<br>rust corrosion,<br>deformation or damage | Pass |
| Simulated use of<br>trays | Internal Test Method | To confirm that the trays<br>can withstand simulated<br>use of up to 1,500<br>repeated reposition cycles | -No significant wear of<br>the holders<br>-The instruments must<br>have safe seating in the<br>holders after the shake<br>test | Pass |
| Cytotoxicity | ISO 10993-5:2009 | To confirm that no<br>cytotoxic substances are<br>released after<br>reprocessing of the trays | Inhibition of cell<br>proliferation must be at<br>or below 30% compared<br>to untreated cultures | Pass |

#### Sterilization validation

The subject device is a multiple-use device provided non-sterile which needs to be end user sterilized. The cleaning and sterilization procedures follow the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".

The sterilization parameters were validated to a sterility assurance level (SAL) of 10th using the biological indicator overkill method according to ANSI/AAMI/ISO 17665-1:2006/(R)2013 (Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices) and ISO 17665-2:2009 (Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1).

In addition to the SAL validation, dry times were validated to meet the requirements of the guidance outlined in AAMI TIR12:2020 (Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for manufacturers), as required, and ANSI/AAMI/ISO 17665-2:2009.

#### Usability wear study

Non-clinical performance and wear testing of the proposed Surgical Tray was performed through

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simulated use testing. The Surgical Tray was filled with instruments and subjected to 200 cleaning cycles and 200 sterilization rounds.

In addition, simulated use testing was performed to simulate 1,500 repeated repositioning of relevant instruments in the holder, after which the trays were subjected to a shake test.

There were no signs of damage or alter testing and the instruments were safely seated in the holders. The automated cleaning and sterilization method were validated and demonstrated the effectiveness of the recommended process as stated in the Instructions for Use.

#### Biocompatibility

Biocompatibility evaluation assessment for the Surgical Tray was performed according to ISO 10993-1:2018 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).

The biocompatibility studies conducted were in vitro cytotoxicity according to ISO 10993-5:2009 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity). The test results confirm that the Surgical Trays are biocompatible for their intended use.

#### 5.8 Conclusion

The conclusions drawn from the non-clinical test data support that the proposed Surgical Travs are as safe, as effective and perform as well as or better than the legally marketed predicate device Straumann BLX Surgical Cassette (K180791).