(270 days)
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.
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.
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.
The device being described is a set of "Washtrays" intended for organizing, cleaning, sterilizing, and storing surgical instruments.
Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Cycle Validation | Sterility assurance level (SAL) of ≤ 10⁻⁶ | Pass |
| Drying Validation | No visible moisture; ≤ 3% weight gain of packaging and absorbable materials | Pass |
| Cleaning (Manual Pre-Cleaning and Automated Cleaning) | No visible soil; Protein < 6.4 µg/cm²; Hemoglobin < 2.2 µg/cm² | Pass |
| Reprocessing of Trays (cleaning and sterilization) | No signs of flush rust, rust corrosion, deformation, or damage | Pass |
| Simulated Use of Trays | No significant wear of the holders | Pass |
| Transportation Testing | No visible damages; Instruments fixed inside the Washtray and instrument holders | Pass |
| Load Test Handle | No permanent deformation of the handle or the lid with a load of 40N | Pass |
| Cytotoxicity | 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 explicitly state the exact sample sizes (number of trays or instruments) used for each specific test. However, it does indicate:
- Reprocessing of Trays: Trays were tested for "up to 200 reprocessing cycles."
- Simulated Use of Trays: "Five hundred (500) repeated positionings have been simulated for each holder."
The provenance of the data is non-clinical testing data, performed internally by Dentsply Sirona or their supplier Aesculap AG according to various international standards (e.g., ANSI/AAMI/ISO, AAMI TIR, ISO, ASTM, DIN EN ISO, ISTA) and internal test methods. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of clinical studies, as these are non-clinical (laboratory/bench) tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable as the provided document describes non-clinical performance data for physical medical devices (Washtrays), not diagnostic software or AI algorithms that require expert consensus for ground truth. Ground truth for these tests is established through objective measurements against scientific and regulatory standards (e.g., SAL of ≤ 10⁻⁶ for sterilization, specific µg/cm² limits for protein/hemoglobin, physical integrity assessments).
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
This section is not applicable for the same reason mentioned in point 3. Adjudication methods are typically used in clinical studies with human readers to resolve discrepancies in diagnoses or interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic accuracy or decision support systems involving human interpretation, which is not the nature of the "Washtrays" device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone (algorithm-only) performance study was not done. The "Washtrays" are physical devices, not software algorithms requiring standalone performance evaluation.
7. The Type of Ground Truth Used:
The ground truth used for these non-clinical tests is derived from established scientific and regulatory standards and objective measurements. Examples include:
- Sterilization: Sterility Assurance Level (SAL) of ≤ 10⁻⁶, a widely accepted microbiological standard.
- Cleaning: Measurable limits for residual protein and hemoglobin (e.g., Protein < 6.4 µg/cm², Hemoglobin < 2.2 µg/cm²).
- Drying: Absence of visible moisture and a specific weight gain percentage.
- Mechanical Integrity/Durability: Absence of deformation, damage, rust, or significant wear.
- Biocompatibility: Inhibition of cell proliferation compared to untreated cultures for cytotoxicity.
8. The Sample Size for the Training Set:
This section is not applicable as the "Washtrays" are physical devices undergoing performance testing, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reason mentioned in point 8.
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Image /page/0/Picture/0 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 | ArticleNumber | DimensionsLength xWidth xHeight (in) | Maximum Load(g) | Vent to Volume Ratio(in-1) |
|---|---|---|---|---|
| OmniTaper Washtray | 68015271 | 1107.3 | 2.54 | |
| OmniTaper Washtray GS | 68015354 | 1107.3 | 2.54 | |
| PrimeTaper Washtray | 68015323 | 10.83x | 1107.3 | 2.54 |
| PrimeTaper Washtray GS | 68017267 | 6.93x | 1107.3 | 2.54 |
| WashtrayAstra Tech Implant System EV | 31071000 | 2.32 | 1107.3 | 2.54 |
| WashtrayGS 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: corporate-ra@dentsplysirona.com
Date Prepared: January 12, 2024
5.2 Device Name:
| Proprietary Name: | Washtrays |
|---|---|
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & OtherAccessories |
| 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 / ReplaceSelectTM 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 | DimensionsLength xWidth xHeight (in) | Max load(g) | Vent tovolume ratio(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 | ArticleNumber | DimensionsLength x Widthx Height (in) | MaximumLoad(g) | Vent toVolume Ratio(in-1) | Element | Proposed DeviceWashtrays(K231144) | Predicate DeviceNobelSpeedy® Groovy / Brånemark System® Mk IIITiUnite / Replace Select™ TC PureSet™ Tray(K212932) | Discussion | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OmniTaper Washtray | 68015271 | 1107.3 | 2.54 | Indications forUse | The Washtrays are intended for organizing, cleaning,sterilizing and storing of instruments.The Washtrays are not intended to maintain sterility andare to be used in conjunction with a legally marketed,validated sterilization pouch or a sterilization container.Sterilization parametersPre-vacuum Steam at 132°C (270°F) for 4 minutes witha 20 minute dry time.Do not exceed the worst-case validated maximum load: | Nobel Biocare PureSet Trays are used in healthcarefacilities to store and organize Nobel Biocaresurgical/prosthetic instruments and components duringcleaning/sterilization and during implant/prosthetictreatment.Nobel Biocare PureSet Trays are not intended on theirown to maintain sterility; they are intended to be used inconjunction with a legally marketed, validated, FDAcleared sterilization container, sterilization pouch, orsterilization wrap. | Same uses but the proposedWashtrays are validated forone sterilization parameter. | |||||
| OmniTaper Washtray GS | 68015354 | 1107.3 | 2.54 | Product name | ArticleNumber | Dimensions(Length x Width xHeight) | MaximumLoad (g) | Vent toVolumeRatio (in³) | Sterilization validations for the worst-case PureSet Trayincluded surgical instruments such as torque wrenches,implant drivers, direction indicators, drills, screw taps,screwdrivers, and irrigation needles. ThePureSetTrayswere validated for a maximum load of1635 grams(Trefoil PureSet Tray), 1122 grams (NobelActive /NobelParallel CC PureSet Tray), 1063 grams(NobelReplace CC PureSet Tray), 454 grams (NobelBiocare N1™ PureSet Tray), 486 grams (ProstheticPureSet Tray), 1143 grams (NobelActive GuidedPureSet Tray), 1146 grams (NobelParallel CC GuidedPureSet Tray), 1176 grams (NobelReplace CC GuidedPureSet Tray), and 1035 grams (NobelSpeedy® Groovy/ Brånemark System® Mk III TiUnite / ReplaceSelect™ TC PureSet™ Tray). | |||
| PrimeTaper Washtray | 68015323 | 10.83X | 1107.3 | 2.54 | OmniTaperWashtray | 68015271 | 10.83 inx | 1107.3 | 2.54 | |||
| PrimeTaper Washtray GS | 68017267 | 6.93X | 1107.3 | 2.54 | OmniTaperWashtray GS | 68015354 | 6.93 inx | 1107.3 | 2.54 | |||
| Washtray Astra Tech Implant System® EV | 31071000 | 1107.3 | 2.54 | PrimeTaperWashtray | 68015323 | 2.32 in | 1107.3 | 2.54 | ||||
| Washtray GS Astra Tech Implant System® EV | 31071020 | 2.32 | 1107.3 | 2.54 | PrimeTaperWashtray GS | 68017267 | 1107.3 | 2.54 | ||||
| Ankylos Washtray | 31036600 | 1107.3 | 2.54 | WashtrayAstra TechImplantSystem® EV | 31071000 | 1107.3 | 2.54 | |||||
| Washtray GSAstra 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
{7}------------------------------------------------
| Element | Proposed DeviceWashtrays(K231144) | Predicate DeviceNobelSpeedy® Groovy / Brånemark System® Mk IIITiUnite / Replace Select™ TC PureSet™ Tray(K212932) | Discussion | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ImplantSystem® EV | MethodCycleTemparatureExposuretime for thesingle-usepoucheddeviceMinimumdrying times | Dynamic-Air-Removal(fractionatedvacuum) | Steam Sterilization (Moist HeatSterilizationfor Wrapped Instruments)Gravity-Displacement | |||||||
| AnkylosWashtray | 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. | SimilarPredicate device shares the same device functionality of organizing, cleaning, sterilizing and storing instruments as proposed device. | |||||||
| 132°C(270°F) | 132°C(270°F) | |||||||||
| 4 minutes(full-cycle) | 15 minutes(full-cycle) | |||||||||
| 20 minutes | 30 minutes | |||||||||
| Manufacturer | Dentsply Sirona | Nobel Biocare AB | Different | |||||||
| Product code | KCT | KCT | Same | |||||||
| Device class | II | II | Same | |||||||
| ClassificationName | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Same |
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| Element | Proposed DeviceWashtrays(K231144) | Predicate DeviceNobelSpeedy® Groovy / Brånemark System® Mk IIITiUnite / Replace SelectTM TC PureSet™ Tray(K212932) | Discussion |
|---|---|---|---|
| CFR Numberand 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(276.1mm in x 176mm in x 59 mm) | 276.1mm x 176mm x 47mm | Different |
| TrayPerforation | Evenly distributed hole pattern | Evenly distributed hole pattern | Same |
| Configuration | Perforated metal grid base with baskets and lids,instrument holders and outer lid with handle. | Perforated bases, lids and PEEK Luvocom grommets | Same |
| Materials | Washtray:• Metal Grid Base-Stainless steel 1.4301• Metal grid base feet-Silicone• Large basket - Stainless steel 1.4303• Small Basket - Stainless steel 1.4303• Lid with Handle-Stainless Steel 1.4310• Silicone mat (inside the small basket)-Silicone• Instrument Holders – PEEK with stainless steel spring• Overlay – Anodized aluminum | • PureSet Tray:o Tray (including basket / lid / handle / sheet metalparts): Stainless steel (1.4301, 1.4303, 1.4310)o Grommets: PEEK, Stainless steel 1.4310o Tray / Basket Closures: Stainless steel 1.4310, PEEKo Feet: Silicone elastomer• PureSet Tray Plate: Anodized aluminum | Same |
| Mass ofmaximumsterilizationload | 1107.3g | 1035g | Different |
| Volume toVentRatio | 2.54 in-1 (10.36 mm-1) | 29.4 | Different |
| Sterility | Non-sterile | Non-sterile | Same |
| SterilizationMethod | Moist heat (steam) | Moist heat (steam) | Same |
| Element | Proposed DeviceWashtrays(K231144) | Predicate DeviceNobelSpeedy® Groovy / Brånemark System® Mk IIITiUnite / Replace SelectTM TC PureSet™ Tray(K212932) | Discussion |
| SterilizationParameters | Pre vacuum,At 132°C for 4 minutes with a 20 minute dry time | • Pre-Vacuum:o Temp 132°C (270° F)o Exposure Time 4 minuteso Pre-vacuum: 4 times < 60 mbaro Drying Time: 20 minuteso Cooling Time: 30 minutes total• Gravity Displacement:o Temp 132°C (270° F)o Exposure Time: 15 minuteso Pre-vacuum: N/Ao Drying Time: 30 minuteso 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 |
| SterilizationCycleValidation | • ANSI/AAMI/ISO17665-1:2006/(R)2013• ISO 17665-2:2009 | To validate that the trays can besterilized via moist-heatsterilization as specified onlabeling (132° C for 4 minutes) | Sterility assurance level(SAL) of ≤ 10-6 | Pass |
| DryingValidation | • AAMI TIR12: 2020• ANSI/AAMI/ISO17665-2:2009 | To validate that the trays can bedried as specified on labeling(drying time of 20 minutes) | No visible moisture≤ 3% weight gain ofpackaging and absorbablematerials | Pass |
| Cleaning(Manual Pre-Cleaning andAutomatedCleaning) | • AAMI TIR12:2020• AMI ST98:2022• ISO 17664 | To validate that the trays can becleaned as specified on labeling | No visible soil.Protein < 6.4 µg/cm²Hemoglobin <2.2 µg/cm² | Pass |
| Reprocessingof Trays(cleaning andsterilization) | Internal Test Method | To confirm that the trays can bereprocessed as specified onlabeling (up to 200reprocessing cycles without anysigns of abrasion) | No signs of flush rust, rustcorrosion, deformation ordamage | Pass |
| Simulated Useof Trays | Internal Test Method | To confirm that the trays canwithstand simulated use of upto 500 repeated repositioncycles | No significant wear of theholders | Pass |
| TransportationTesting | • ASTM D 4728-06• DIN EN ISO 60068-2-27• ISTA 3A (2010) | To confirm that the instrumentholder provides adequate fixingof the instruments duringtransportation | No visible damagesInstruments fixed inside theWashtray and instrumentholders | Pass |
| Load TestHandle | Internal Test Method | To confirm that no permanentdeformation of the handle orthe lid will occur | No permanent deformationof the handle or the lid witha load of 40N | Pass |
| Cytotoxicity | ISO 10993-5:2009 | To confirm that no cytotoxicsubstances are released afterreprocessing of the trays | Inhibition of cellproliferation must be at orbelow 30% compared tountreated 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.
§ 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).