(46 days)
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.
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.
The provided text describes the acceptance criteria and the studies that prove the device meets these criteria for "Surgical and Prosthetic Trays" (K220791).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization cycle validation | ANSI/AAMI/ISO 17665-1:2006/(R)2013, ISO 17665-2:2009 | Sterility assurance level (SAL) of ≤ 10-6 | Pass |
| Drying validation | AAMI TIR12:2020, ANSI/AAMI/ISO 17665-2:2009 | No visible moisture, ≤ 3% weight gain of packaging and absorbable materials | Pass |
| Cleaning (Manual Pre-Cleaning and automated Cleaning) | AAMI TIR 30:2011, ISO 15883-1:2014 | No visible soil.Protein and TOC content Limit < 5 [µg/cm²] Protein and TOC content Limit < 95 [µg/device] | Pass |
| Reprocessing of trays (cleaning and sterilization) | Internal Test Method | No signs of flush rust, rust corrosion, deformation or damage | Pass |
| Simulated use of trays | Internal Test Method | No significant wear of the holders | Pass |
| Packaging testing | ISTA 2A(2011) | No signs of cracks or ruptures on the surgical trays | Pass |
| Cytotoxicity | ISO 10993-5:2009 | Inhibition of cell proliferation must be at or below 30% compared to untreated cultures | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for individual tests (e.g., number of trays tested for sterilization, drying, or cleaning). It refers to the "Proposed device" for sterility and drying validation, and the "Predicate device" for cleaning, reprocessing, simulated use, packaging, and cytotoxicity.
The data provenance is from non-clinical performance data, meaning these are laboratory or bench tests, not involving human subjects. The country of origin of the data is not explicitly stated, but the submission is to the U.S. FDA, and the company is Dentsply Sirona Inc., with an address in York, Pennsylvania, USA. The testing methodologies are based on international standards (ANSI/AAMI/ISO, ISO, AAMI TIR) which are widely recognized.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For these types of non-clinical, performance-based tests (sterilization, drying, material properties), the "ground truth" is typically established by adhering to referenced international standards and specifications, rather than expert consensus on individual cases. The "experts" would be the personnel performing and analyzing these standardized tests, whose qualifications are usually governed by quality management systems within the testing facilities.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the tests, which are objective measurements against predefined criteria (e.g., SAL ≤ 10-6, ≤ 3% weight gain, specific chemical limits), an adjudication method in the sense of multiple expert reviews is not typically applicable. The results are usually a direct outcome of the test protocol.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging devices or algorithms where human readers interpret medical images. The device in question is a surgical tray for sterilization and storage, which does not involve human interpretation of data in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not applicable. The device is a physical sterile processing tray, not a software algorithm. Therefore, "standalone algorithm performance" is not a concept that applies to this device.
7. The Type of Ground Truth Used
The "ground truth" for these tests is based on objective criteria and methodologies defined by recognized international and national standards (e.g., ANSI/AAMI/ISO, ISO, AAMI TIR, ISTA). For example:
- Sterilization: Sterility Assurance Level (SAL) ≤ 10-6.
- Drying: No visible moisture, ≤ 3% weight gain.
- Cleaning: Absence of visible soil and specific limits for protein and TOC content.
- Material Biocompatibility (Cytotoxicity): Defined inhibition of cell proliferation percentage.
- Mechanical Performance (Reprocessing, Simulated Use): Absence of visible damage, deformation, significant wear.
8. The Sample Size for the Training Set
Not applicable. The device is a physical product (surgical tray), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as point 8.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: corporate-ra@dentsplysirona.com
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 | Partnumber | Tray size | Max no ofinstruments | Max load(g) | Vent to volumeratio(in⁻¹) |
|---|---|---|---|---|---|
| PrimeTaperSurgical Tray GSMedium | 68017268 | Medium | 55 | 563.5 | 0.033 |
| OmniTaperSurgical Tray GS | 68017203 | Medium | 56 | 563.5 | 0.033 |
| Bone ReamerTray | 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 | ArticleNumber | MaximumLoad (g) | Vent to VolumeRatio (in-1) |
|---|---|---|---|
| OmniTaper Surgical Tray | 68015282 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray | 68015321 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray GSMedium | 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 DeviceSurgical and Prosthetic Trays | Predicate DeviceSurgical 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,sterilizing and storing of instruments.The Surgical and Prosthetic Trays are not intended to maintainsterility and are to be used in conjunction with a legallymarketed, validated sterilization pouch. | The Surgical Trays are intended for organizing,sterilizing and storing of instruments.The Surgical Trays are not intended to maintainsterility and are to be used in conjunction with alegally marketed, validated sterilization pouch. | Similar | ||||||||||||||||||||||||||||||
| Sterilization parametersPre-vacuum Steam at 132°C (270°F) for 4 minutes with a 20minute dry time. | Sterilization parameters:Pre-vacuum Steam at 132°C (270°F) for 4 minuteswith a 20 minutes dry time.The tested Surgical Tray represents the worst-casevalidated load of 513.7g. | ||||||||||||||||||||||||||||||||
| Do not exceed theworst-casevalidatedmaximumload:Productname | Do not exceed the following maximum load:Product name | ||||||||||||||||||||||||||||||||
| ArticleNumber MaximumLoad (g) Vent toVolume Ratio(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 | ArticleNumber MaxLoad(g) Vent toVolumeRatio (in-1) 68015282 513.7 0.033 68015321 513.7 0.033 | ||||||||||||||||||||||||||||||||
| OmniTaperSurgical TrayPrimeTaperSurgical TrayPrimeTaperSurgical Tray GSMediumOmniTaperSurgical Tray GSBone Reamer TrayProsthetic Tray | OmniTaperSurgical TrayPrimeTaperSurgical Tray | ||||||||||||||||||||||||||||||||
| Product code | KCT | KCT | Same |
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| Elements | Proposed DeviceSurgical and Prosthetic Trays | Predicate DeviceSurgical Trays (K212281) | Comparison | ||
|---|---|---|---|---|---|
| General Design | Plastic trays with locking lid. Co-molded silicone andsilicone grommet supports | Plastic tray with locking lid. Co-molded siliconeand silicone grommet supports | Same | ||
| Dimensions | Medium Trays:7.3 in x 5.5 in x 2.4 inSmall Trays: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,different for the small trays | ||
| Material | Base - Radel 5000Lid - Radel 5000Overlay - Radel 5000Tooling support - Silicone | Base - Radel 5000Lid - Radel 5000Overlay - Radel 5000Tooling support - Silicone | Same | ||
| Air permeance | Yes, allow moist heat (steam) penetration to achievesterilization | Yes, allow moist heat (steam) penetration toachieve sterilization | Same | ||
| Mass ofmaximumsterilization load | OmniTaper Surgical Tray GSPrimeTaper Surgical Tray GSMediumProsthetic TrayBone Reamer Tray | $563.5g$$563.5g$$271.9g$$271.9g$ | OmniTaper Surgical TrayPrimeTaper Surgical Tray | $513.7 g$$513.7 g$ | Different |
| Vent to volumeratio | OmniTaper Surgical Tray GSPrimeTaper Surgical Tray GSMediumProsthetic TrayBone Reamer Tray | $0.033 in^{-1}$$0.033 in^{-1}$$0.046 in^{-1}$$0.046 in^{-1}$ | OmniTaper Surgical TrayPrimeTaper Surgical Tray | $0.033 in^{-1}$$0.033 in^{-1}$ | Different |
| Sterility | Non-sterile | Non-sterile | Same | ||
| SterilizationMethod | Moist heat (steam) | Moist heat (steam) | Same | ||
| SterilizationParameters | Pre vacuum,At 132°C for 4 minutes with a 20 minute dry time | Pre vacuum,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 | Producttested | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|---|---|
| Sterilizationcycle validation | • ANSI/AAMI/ISO17665-1:2006/(R)2013• ISO 17665-2:2009 | Proposeddevice | To validate that the trayscan be sterilized viamoist-heat sterilizationas specified on labeling(132° C for 4 minutes) | Sterilityassurance level(SAL) of ≤ 10-6 | Pass |
| Dryingvalidation | • AAMI TIR12:2020• ANSI/AAMI/ISO17665-2:2009 | Proposeddevice | To validate that the trayscan be dried as specifiedon labeling (drying timeof 20 minutes) | No visiblemoisture≤ 3% weightgain ofpackaging andabsorbablematerials | Pass |
| Cleaning(Manual Pre-Cleaning andautomatedCleaning) | • AAMI TIR30:2011• ISO 15883-1:2014 | Predicatedevice | To validate that the trayscan be cleaned asspecified on labeling | No visible soil.Protein and TOCcontent Limit$<5 [µg/cm²]$$<95 [µg/device]$ | Pass |
| Reprocessingof trays(cleaning andsterilization) | Internal Test Method | Predicatedevice | To confirm that the trayscan be reprocessed asspecified on labeling (upto 200 reprocessingcycles without any signsof abrasion) | No signs of flushrust, rustcorrosion,deformation ordamage | Pass |
| Simulated useof trays | Internal Test Method | Predicatedevice | To confirm that the trayscan withstand simulateduse of up to 1,500repeated repositioncycles | No significantwear of theholders | Pass |
| Packagingstesting | ISTA 2A(2011) | Predicatedevice | To confirm that thepackaging protects thedevice during simulateddistribution | No signs ofcracks orruptures on thesurgical trays | Pass |
| Cytotoxicity | ISO 10993-5:2009 | Predicatedevice | To confirm that nocytotoxic substances arereleased afterreprocessing of the trays | Inhibition of cellproliferationmust be at orbelow 30%compared tountreatedcultures | 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).
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).