Surgical and Prosthetic Trays

K220791 · Dentsply Sirona · KCT · May 3, 2022 · General Hospital

Device Facts

• Record ID: K220791
• Device Name: Surgical and Prosthetic Trays
• Applicant: Dentsply Sirona
• Product Code: KCT · General Hospital
• Decision Date: May 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Surgical and Prosthetic Trays are intended for organizing, sterilizing and storing of instruments. The Surgical and Prosthetic Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.

Device Story

Reusable perforated containers (trays) for organizing, sterilizing, and storing surgical/prosthetic instruments. Composed of polyphenylsulfone (Radel R5000NT) lid, base, and overlay with co-molded silicone tooling supports and grommets. Available in medium and small sizes with custom printing for workflow guidance. Used in clinical settings; operated by healthcare staff. Instruments are placed in trays, then sterilized via pre-vacuum steam (132°C, 4 min, 20 min dry). Trays are not sterile barriers; must be used with validated sterilization pouches. Facilitates instrument organization and sterilization, ensuring readiness for implant/prosthetic procedures.

Clinical Evidence

Bench testing only. Validated sterilization (ANSI/AAMI/ISO 17665-1/2) achieving SAL ≤ 10^-6; drying validation (AAMI TIR12); cleaning validation (AAMI TIR30, ISO 15883-1); reprocessing durability (200 cycles); simulated use (1,500 cycles); packaging testing (ISTA 2A); and cytotoxicity (ISO 10993-5). All tests passed.

Technological Characteristics

Materials: Polyphenylsulfone (Radel R5000NT) base/lid/overlay, silicone tooling supports. Dimensions: Medium (7.3x5.5x2.4 in), Small (5.4x3.9x2.4 in). Sterilization: Pre-vacuum steam (132°C/4 min). Standards: ANSI/AAMI/ISO 17665-1/2, AAMI TIR12, AAMI TIR30, ISO 15883-1, ISO 10993-5, ISTA 2A. Connectivity: None. Software: None.

Indications for Use

Indicated for organizing, sterilizing, and storing surgical and prosthetic instruments. Used in conjunction with a validated sterilization pouch. No specific patient population or contraindications defined.

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

• Surgical Trays (K212281)

Submission Summary (Full Text)

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May 3, 2022

Image /page/0/Picture/1 description: The image shows 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Dentsply Sirona Courtney Clark Senior Director of Regulatory Affairs, Corporate 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401 USA

Re: K220791

Trade/Device Name: Surgical and Prosthetic Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap containers, Trays, Cassettes & Other Accessories Regulatory Class: Class II Product Code: KTC Dated: March 16, 2022 Received: March 18, 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

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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) 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 (OS) 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,

for

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)

## K220791

Device Name Surgical and Prosthetic Trays

Indications for Use (Describe)

The Surgical and Prosthetic Trays are intended for organizing, sterilizing and storing of instruments. The Surgical and Prosthetic 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 minute dry time Do not exceed the worst-case validated maximum load:

| Product name | Article Number | Maximum Load (g) | Vent to Volume Ratio (in -1) |
|------------------------------------|----------------|------------------|------------------------------|
| OmniTaper Surgical Tray | 68015282 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray | 68015321 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray GS Medium | 68017268 | 563.5 | 0.033 |
| OmniTaper Surgical Tray GS | 68017203 | 563.5 | 0.033 |
| Bone Reamer Tray | 68015280 | 271.9 | 0.046 |
| Prosthetic Tray | 68015288 | 271.9 | 0.046 |

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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Submitter Information:

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

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

Date Prepared: May 3, 2022

## Device Name:

| • Proprietary Name: | Surgical and Prosthetic Trays |
|------------------------|---------------------------------------------------------|
| • Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other |
| | Accessories |
| • CFR Number: | 21 CFR 880.6850 |
| • Device Class: | Class II |
| • Product Code: | KCT |

### Predicate Device:

The predicate device identified is the following:

| Predicate Device Name | 510(k) | Company Name |
|-----------------------|---------|-----------------|
| Surgical Trays | K212281 | Dentsply Sirona |

## Device Description:

The proposed Surgical and Prosthetic Trays are reusable perforated containers that are intended to store and organize the instruments needed before, during and after implant surgery and the prosthetic procedure as well as hold instruments during sterilization.

The Trays are containers composed of three main components: a lid, a base and an overlay, which are all made of polyphenylsulfone (Radel R5000NT). The trays have co-molded silicone tooling supports and silicone rubber grommets to hold instruments. The base and overlay are custom printed to indicate the guided surgery or prosthetic procedure workflow and the position of the instruments within the tray for the different product lines.

The proposed Surgical and Prosthetic Trays are available in two tray sizes. The Surgical trays are available in medium size with outer dimensions of 7.3 x 5.5 x 2.4 inches and the Prosthetic trays are available in small size with outer dimensions of 5.4 x 3.9 x 2.4. Each tray size is offered in 2 inner tray configurations with varied instrument loads, see Table 1.

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| Product name | Part<br>number | Tray size | Max no of<br>instruments | Max load(g) | Vent to volume<br>ratio(in⁻¹) |
|------------------------------------------|----------------|-----------|--------------------------|-------------|-------------------------------|
| PrimeTaper<br>Surgical Tray GS<br>Medium | 68017268 | Medium | 55 | 563.5 | 0.033 |
| OmniTaper<br>Surgical Tray GS | 68017203 | Medium | 56 | 563.5 | 0.033 |
| Bone Reamer<br>Tray | 68015280 | Small | 24 | 271.9 | 0.046 |
| Prosthetic Tray | 68015288 | Small | 22 | 271.9 | 0.046 |

#### Table 1: Surgical and Prosthetic Trays configurations

#### Indications for Use

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

The Surgical and Prosthetic 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 minute dry time. Do not exceed the worst-case validated maximum load:

| Product name | Article<br>Number | Maximum<br>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 |
| PrimeTaper Surgical Tray GS<br>Medium | 68017268 | 563.5 | 0.033 |
| OmniTaper Surgical Tray GS | 68017203 | 563.5 | 0.033 |
| Bone Reamer Tray | 68015280 | 271.9 | 0.046 |
| Prosthetic Tray | 68015288 | 271.9 | 0.046 |

## Comparison of Technological Characteristics

An overview of the similarities and differences between the proposed and predicate device is given in Table 2. The proposed Surgical and Prosthetic Trays and the predicate device Surgical Trays (K212281), have the same intended use, same sterilization method and parameters, are materials, undergo the same manufacturing process, have a similar design, and have identical instrument holder material, design and spacing between the holders. The use of the proposed Surgical and Prosthetic Trays has been validated through performance, biocompatibility and sterilization testing or via analysis of existing data for inclusion.

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# Table 2: Similarities and Differences between the proposed and predicate devices

| Elements | Proposed Device<br>Surgical and Prosthetic Trays | Predicate Device<br>Surgical Trays (K212281) | Comparison | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|----------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|
| Manufacturer | Sirona Dental Systems GmbH | Sirona Dental Systems GmbH | Same Manufacturer | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Indications for use | The Surgical and Prosthetic Trays are intended for organizing,<br>sterilizing and storing of instruments.<br><br>The Surgical and Prosthetic Trays are not intended to maintain<br>sterility and are to be used in conjunction with a legally<br>marketed, validated sterilization pouch. | The Surgical Trays are intended for organizing,<br>sterilizing and storing of instruments.<br><br>The Surgical Trays are not intended to maintain<br>sterility and are to be used in conjunction with a<br>legally marketed, validated sterilization pouch. | Similar | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Sterilization parameters<br>Pre-vacuum Steam at 132°C (270°F) for 4 minutes with a 20<br>minute dry time. | Sterilization parameters:<br>Pre-vacuum Steam at 132°C (270°F) for 4 minutes<br>with a 20 minutes dry time.<br>The tested Surgical Tray represents the worst-case<br>validated load of 513.7g. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Do not exceed the<br>worst-case<br>validated<br>maximum<br>load:Product<br>name | Do not exceed the following maximum load:<br>Product name | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Article<br>Number Maximum<br>Load (g) Vent to<br>Volume Ratio<br>(in-1) 68015282 513.7 0.033 68015321 513.7 0.033 68017268 563.5 0.033 68017203 563.5 0.033 68015280 271.9 0.046 68015288 271.9 0.046 | | | | | | | | | | | | | | | | | | | | | | Article<br>Number Max<br>Load<br>(g) Vent to<br>Volume<br>Ratio (in-1) 68015282 513.7 0.033 68015321 513.7 0.033 | | | | | | | | | | |
| | OmniTaper<br>Surgical Tray<br>PrimeTaper<br>Surgical Tray<br>PrimeTaper<br>Surgical Tray GS<br>Medium<br>OmniTaper<br>Surgical Tray GS<br>Bone Reamer Tray<br>Prosthetic Tray | OmniTaper<br>Surgical Tray<br>PrimeTaper<br>Surgical Tray | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Product code | KCT | KCT | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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| Elements | Proposed Device<br>Surgical and Prosthetic Trays | Predicate Device<br>Surgical Trays (K212281) | Comparison | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------|-----------|
| General Design | Plastic trays with locking lid. Co-molded silicone and<br>silicone grommet supports | Plastic tray with locking lid. Co-molded silicone<br>and silicone grommet supports | Same | | |
| Dimensions | Medium Trays:<br>7.3 in x 5.5 in x 2.4 in<br>Small Trays:<br>5.4 in x 3.9 in x 2.4 in | 7.3 in x 5.5 in x 2.4 in | Same for the medium trays,<br>different for the small trays | | |
| Material | Base - Radel 5000<br>Lid - Radel 5000<br>Overlay - Radel 5000<br>Tooling support - Silicone | Base - Radel 5000<br>Lid - Radel 5000<br>Overlay - Radel 5000<br>Tooling support - Silicone | Same | | |
| Air permeance | Yes, allow moist heat (steam) penetration to achieve<br>sterilization | Yes, allow moist heat (steam) penetration to<br>achieve sterilization | Same | | |
| Mass of<br>maximum<br>sterilization load | OmniTaper Surgical Tray GS<br>PrimeTaper Surgical Tray GS<br>Medium<br>Prosthetic Tray<br>Bone Reamer Tray | $563.5g$<br>$563.5g$<br>$271.9g$<br>$271.9g$ | OmniTaper Surgical Tray<br>PrimeTaper Surgical Tray | $513.7 g$<br>$513.7 g$ | Different |
| Vent to volume<br>ratio | OmniTaper Surgical Tray GS<br>PrimeTaper Surgical Tray GS<br>Medium<br>Prosthetic Tray<br>Bone Reamer Tray | $0.033 in^{-1}$<br>$0.033 in^{-1}$<br>$0.046 in^{-1}$<br>$0.046 in^{-1}$ | OmniTaper Surgical Tray<br>PrimeTaper Surgical Tray | $0.033 in^{-1}$<br>$0.033 in^{-1}$ | Different |
| Sterility | Non-sterile | Non-sterile | Same | | |
| Sterilization<br>Method | Moist heat (steam) | Moist heat (steam) | Same | | |
| Sterilization<br>Parameters | Pre vacuum,<br>At 132°C for 4 minutes with a 20 minute dry time | Pre vacuum,<br>At 132°C for 4 minutes with a 20 minutes dry time | Same | | |
| Sterile barrier | FDA cleared sterilization pouch | FDA cleared sterilization pouch | Same | | |
| Reusable | Yes | Yes | Same | | |

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#### Non-Clinical Performance Data

The proposed Surgical and Prosthetic Trays are reusable devices provided non-sterile which need to be end user sterilized. Sterilization of the proposed trays 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 below:

| Test Name | Test Methodology | Product<br>tested | Purpose | Acceptance<br>Criteria | Results |
|--------------------------------------------------------------------|-------------------------------------------------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------|
| Sterilization<br>cycle validation | • ANSI/AAMI/ISO<br>17665-1:2006/<br>(R)2013<br>• ISO 17665-2:2009 | Proposed<br>device | To validate that the trays<br>can be sterilized via<br>moist-heat sterilization<br>as specified on labeling<br>(132° C for 4 minutes) | Sterility<br>assurance level<br>(SAL) of ≤ 10-6 | Pass |
| Drying<br>validation | • AAMI TIR12:<br>2020<br>• ANSI/AAMI/ISO<br>17665-2:2009 | Proposed<br>device | To validate that the trays<br>can be dried as specified<br>on labeling (drying time<br>of 20 minutes) | No visible<br>moisture<br>≤ 3% weight<br>gain of<br>packaging and<br>absorbable<br>materials | Pass |
| Cleaning<br>(Manual Pre-<br>Cleaning and<br>automated<br>Cleaning) | • AAMI TIR<br>30:2011<br>• ISO 15883-1:2014 | Predicate<br>device | To validate that the trays<br>can be cleaned as<br>specified on labeling | No visible soil.<br>Protein and TOC<br>content Limit<br>$<5 [µg/cm²]$<br>$<95 [µg/device]$ | Pass |
| Reprocessing<br>of trays<br>(cleaning and<br>sterilization) | Internal Test Method | Predicate<br>device | To confirm that the trays<br>can be reprocessed as<br>specified on labeling (up<br>to 200 reprocessing<br>cycles without any signs<br>of abrasion) | No signs of flush<br>rust, rust<br>corrosion,<br>deformation or<br>damage | Pass |
| Simulated use<br>of trays | Internal Test Method | Predicate<br>device | To confirm that the trays<br>can withstand simulated<br>use of up to 1,500<br>repeated reposition<br>cycles | No significant<br>wear of the<br>holders | Pass |
| Packaging<br>stesting | ISTA 2A(2011) | Predicate<br>device | To confirm that the<br>packaging protects the<br>device during simulated<br>distribution | No signs of<br>cracks or<br>ruptures on the<br>surgical trays | Pass |
| Cytotoxicity | ISO 10993-5:2009 | Predicate<br>device | To confirm that no<br>cytotoxic substances are<br>released after<br>reprocessing of the trays | Inhibition of cell<br>proliferation<br>must be at or<br>below 30%<br>compared to<br>untreated<br>cultures | Pass |

### Conclusion

The conclusions drawn from the non-clinical test data and evaluation support that the proposed Surgical and Prosthetic Trays are as safe, as effective and perform as well as the legally marketed predicate device Dentsply Sirona Surgical Trays (K212281).