(46 days)
Not Found
No
The device is a physical tray for organizing and sterilizing instruments, with no mention of software, algorithms, or data processing that would involve AI/ML. The performance studies focus on physical properties and reprocessing capabilities.
No
The device is described as trays for organizing, sterilizing, and storing instruments, and for holding instruments during sterilization. It is not intended for treatment or diagnosis.
No.
The device is a surgical tray intended for organizing, sterilizing, and storing instruments. It does not perform any diagnostic function.
No
The device description clearly states the device is a physical container made of polyphenylsulfone with silicone components, intended for organizing and sterilizing instruments. It is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "organizing, sterilizing and storing of instruments." This relates to the handling and preparation of surgical instruments, not the analysis of biological samples or the diagnosis of diseases.
- Device Description: The description details a physical container for instruments, made of specific materials and designed for organization and sterilization. This aligns with a medical device used in surgical procedures, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information
- Reagents or assays
The device's function is purely related to the physical management and sterilization of surgical instruments.
N/A
Intended Use / 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 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 |
Product codes
KTC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
| Test Name | Test Methodology | Product tested | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| Sterilization cycle validation | • ANSI/AAMI/ISO 17665-1:2006/(R)2013 • ISO 17665-2:2009 | Proposed device | To validate that the trays can be sterilized via moist-heat sterilization as specified on labeling (132° C for 4 minutes) | Sterility assurance level (SAL) of ≤ 10-6 | Pass |
| Drying validation | • AAMI TIR12: 2020 • ANSI/AAMI/ISO 17665-2:2009 | Proposed device | To validate that the trays can be dried as specified on labeling (drying time of 20 minutes) | 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 | Predicate device | To validate that the trays can be cleaned as specified on labeling | No visible soil. Protein and TOC content Limit |
§ 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).
0
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
1
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
2
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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3
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.
4
| Product name | Part
number | Tray size | Max no of
instruments | Max load(g) | Vent to volume
ratio(in⁻¹) |
|------------------------------------------|----------------|-----------|--------------------------|-------------|-------------------------------|
| PrimeTaper
Surgical Tray GS
Medium | 68017268 | Medium | 55 | 563.5 | 0.033 |
| OmniTaper
Surgical Tray GS | 68017203 | Medium | 56 | 563.5 | 0.033 |
| Bone Reamer
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
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 |
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.
5
Table 2: Similarities and Differences between the proposed and predicate devices
| Elements | Proposed Device
Surgical and Prosthetic Trays | Predicate Device
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,
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 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. | Similar | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Sterilization parameters
Pre-vacuum Steam at 132°C (270°F) for 4 minutes with a 20
minute dry time. | 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. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Do not exceed the
worst-case
validated
maximum
load:Product
name | Do not exceed the following maximum load:
Product name | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Article
Number Maximum
Load (g) Vent to
Volume 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 | | | | | | | | | | | | | | | | | | | | | | Article
Number Max
Load
(g) Vent to
Volume
Ratio (in-1) 68015282 513.7 0.033 68015321 513.7 0.033 | | | | | | | | | | |
| | OmniTaper
Surgical Tray
PrimeTaper
Surgical Tray
PrimeTaper
Surgical Tray GS
Medium
OmniTaper
Surgical Tray GS
Bone Reamer Tray
Prosthetic Tray | OmniTaper
Surgical Tray
PrimeTaper
Surgical Tray | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Product code | KCT | KCT | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
6
| Elements | Proposed Device
Surgical and Prosthetic Trays | Predicate Device
Surgical Trays (K212281) | Comparison | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------|-----------|
| General Design | Plastic trays with locking lid. Co-molded silicone and
silicone grommet supports | Plastic tray with locking lid. Co-molded silicone
and silicone grommet supports | Same | | |
| Dimensions | Medium Trays:
7.3 in x 5.5 in x 2.4 in
Small 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 5000
Lid - Radel 5000
Overlay - Radel 5000
Tooling support - Silicone | Base - Radel 5000
Lid - Radel 5000
Overlay - Radel 5000
Tooling support - Silicone | Same | | |
| Air permeance | Yes, allow moist heat (steam) penetration to achieve
sterilization | Yes, allow moist heat (steam) penetration to
achieve sterilization | Same | | |
| Mass of
maximum
sterilization load | OmniTaper Surgical Tray GS
PrimeTaper Surgical Tray GS
Medium
Prosthetic Tray
Bone Reamer Tray | $563.5g$
$563.5g$
$271.9g$
$271.9g$ | OmniTaper Surgical Tray
PrimeTaper Surgical Tray | $513.7 g$
$513.7 g$ | Different |
| Vent to volume
ratio | OmniTaper Surgical Tray GS
PrimeTaper Surgical Tray GS
Medium
Prosthetic Tray
Bone Reamer Tray | $0.033 in^{-1}$
$0.033 in^{-1}$
$0.046 in^{-1}$
$0.046 in^{-1}$ | OmniTaper Surgical Tray
PrimeTaper Surgical Tray | $0.033 in^{-1}$
$0.033 in^{-1}$ | Different |
| Sterility | Non-sterile | Non-sterile | Same | | |
| Sterilization
Method | Moist heat (steam) | Moist heat (steam) | Same | | |
| Sterilization
Parameters | 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 | | |
7
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
tested | Purpose | Acceptance
Criteria | Results |
|--------------------------------------------------------------------|-------------------------------------------------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------|
| Sterilization
cycle validation | • ANSI/AAMI/ISO
17665-1:2006/
(R)2013
• ISO 17665-2:2009 | Proposed
device | To validate that the trays
can be sterilized via
moist-heat sterilization
as specified on labeling
(132° C for 4 minutes) | Sterility
assurance level
(SAL) of ≤ 10-6 | Pass |
| Drying
validation | • AAMI TIR12:
2020
• ANSI/AAMI/ISO
17665-2:2009 | Proposed
device | To validate that the trays
can be dried as specified
on labeling (drying time
of 20 minutes) | 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 | Predicate
device | To validate that the trays
can be cleaned as
specified on labeling | No visible soil.
Protein and TOC
content Limit
$