(226 days)
Not Found
No
The device description and performance studies focus on the physical properties, sterilization, and usability of a surgical tray, with no mention of AI or ML.
No
The device is a surgical tray intended for organizing, sterilizing, and storing instruments, not for providing therapy.
No
The device is described as a "reusable perforated container that is intended to store and organize the instruments needed before, during and after implant surgery as well as holding instruments during sterilization." It does not perform any diagnostic function.
No
The device description clearly states it is a physical container made of polyphenylsulfone and silicone, intended for organizing, sterilizing, and storing instruments. It undergoes physical performance testing (sterilization, drying, reprocessing, simulated use, cytotoxicity). There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is clearly stated as "organizing, sterilizing and storing of instruments." This is a function related to the preparation and handling of surgical instruments, not the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical container for instruments, made of specific materials and designed for sterilization and organization. This aligns with the intended use and does not suggest any function related to in vitro testing.
- Performance Studies: The performance studies focus on sterilization effectiveness, drying, reprocessing, simulated use, and biocompatibility. These are all relevant to a reusable surgical instrument tray but are not typical performance metrics for an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components associated with in vitro diagnostic testing.
Therefore, the Surgical Tray described is a medical device used in the preparation and handling of surgical instruments, not an IVD.
N/A
Intended Use / Indications for Use
The Surgical Trays are intended for organizing, sterilizing and storing of instruments.
The Surgical Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.
Sterilization parameters:
Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time
The tested Surgical Tray represents the worst-case validated load of 513.7g. Do not exceed the following maximum load:
| Product name | Article Number | Max Load (g) | Vent to Volume Ratio (in-1) |
|---|---|---|---|
| OmniTaper Surgical Tray | 68015282 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray | 68015321 | 513.7 | 0.033 |
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The proposed Surgical Tray is a reusable perforated container that is intended to store and organize the instruments needed before, during and after implant surgery as well as holding instruments during sterilization.
The Surgical Tray is a container composed of three main components: a lid, a base and an overlay, all made of polyphenylsulfone (Radel R5000). The overlay has co-molded silicone tooling supports. The base has silicone rubber grommets to hold instruments. The base and overlay are custom printed to indicate the surgical workflow and the position of the instruments within the tray for the different product lines.
The proposed Surgical Tray is available in one size with outer dimensions of 7.3 x 5.5 x 2.4 inches and offered in 2 inner tray configurations with varied instrument loads, see Table 5.1.
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
Used in healthcare facilities
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data
Non-clinical testing data submitted, referenced, or relied upon, including acceptance criteria and set specifications in test methodology and standards, are summarized below:
| Test Name | Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| Sterilization cycle validation | • ANSI/AAMI/ISO 17665-1:2006/(R)2013 • ISO 17665-2:2009 | 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 |
§ 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
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March 4, 2022
Dentsply Sirona Inc. Courtney Clark Sr. Director, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York. Pennsylvania 17401
Re: K212281
Trade/Device Name: Surgical Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 1, 2022 Received: February 2, 2022
Dear Courtney Clark:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212281
Device Name Surgical Trays
Indications for Use (Describe)
The Surgical Trays are intended for organizing, sterilizing and storing of instruments.
The Surgical Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.
Sterilization parameters:
Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time
The tested Surgical Tray represents the worst-case validated load of 513.7g. Do not exceed the following maximum load:
| Product name | Article
Number | Max Load (g) | Vent to Volume
Ratio (in-1) |
|--------------------------|-------------------|--------------|--------------------------------|
| OmniTaper Surgical Tray | 68015282 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray | 68015321 | 513.7 | 0.033 |
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
Dentsply Sirona Inc. 221 West Philadelphia Street, Suite 60W York, PA 17401
Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the text "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is aligned to the right of the leaf-like shape.
510(k) SUMMARY Surgical Trays K212281
5.1 Submitter Information:
Dentsply Sirona Inc. 221 West Philadelphia Street Suite 60W York, PA 17401
Courtney Clark Contact Person: Telephone Number: 248-895-4379 Fax Number: 717-849-4343 Email: corporate-ra@dentsplysirona.com
Date Prepared: March 4, 2022
5.2 Device Name:
| ● | Proprietary Name: | Surgical Trays |
|---|---|---|
| ● | Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other |
| Accessories | ||
| ● | CFR Number: | 21 CFR 880.6850 |
| ● | Device Class: | Class II |
| ● | Product Code: | KCT |
5.3 Predicate Device:
The predicate device identified is the following:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| Straumann BLX Surgical Cassette | K180791 | Institut Straumann AG |
5.4 Device Description:
The proposed Surgical Tray is a reusable perforated container that is intended to store and organize the instruments needed before, during and after implant surgery as well as holding instruments during sterilization.
The Surgical Tray is a container composed of three main components: a lid, a base and an overlay, all made of polyphenylsulfone (Radel R5000). The overlay has co-molded silicone tooling supports. The base has silicone rubber grommets to hold instruments. The base and overlay are custom printed to indicate the surgical workflow and the position of the instruments within the tray for the different product lines.
4
The proposed Surgical Tray is available in one size with outer dimensions of 7.3 x 5.5 x 2.4 inches and offered in 2 inner tray configurations with varied instrument loads, see Table 5.1.
| Table 5.1- Surgical Tray configurations | ||||
|---|---|---|---|---|
| Product name | Model number | Max no of instruments | Max load (g) | Vent to volume ratio (in-1) |
| OmniTaper Surgical Tray | 68015282 | 51 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray | 68015321 | 45 | 513.7 | 0.033 |
5.5 Indications for Use
The Surgical Trays are intended for organizing, sterilizing and storing of instruments.
The Surgical Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.
Sterilization parameters:
Pre-vacuum Steam at 132°C (270°F) for 4 minutes with a 20 minutes dry time. The tested Surgical Tray represents the worst case validated load of 513.7g.
| Product name | Article number | Max load (g) | Vent to volume
ratio (in-1) |
|--------------------------|----------------|--------------|--------------------------------|
| OmniTaper Surgical Tray | 68015282 | 513.7 | 0.033 |
| PrimeTaper Surgical Tray | 68015321 | 513.7 | 0.033 |
5.6 Comparison of Technological Characteristics
An overview of the similarities and differences between the proposed and predicate device is given in Table 5.2. The proposed Surgical Tray and the predicate device, Straumann BLX Surgical Cassette (K180791), have the same intended use, same sterilization method and parameters, are made of the same materials and have a similar design. The vent to volume ratio for the proposed Surgical Tray is 0.033 in- while the predicate vent to volume ratio is 0.054 in 1. The proposed Surgical Tray has a lower vent to volume ratio.
When compared to the predicate device, the proposed Surgical Tray can hold more instruments and has a larger maximum sterilization load. The maximum sterilization load for the proposed Surgical Tray is 513.7g, while the predicate's maximum sterilization load is 300g. Sterilization was performed to support the sterilization load of the proposed Surgical Tray and has been validated to SAL of 10°.
5
| Table 5.2: Similarities and Differences between the proposed and predicate devices | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Elements | Proposed Device | ||||||||||||||
| Surgical Tray | Predicate Device | ||||||||||||||
| Straumann BLX Surgical | |||||||||||||||
| Cassette (K180791) | Comparison | ||||||||||||||
| Manufacturer | Sirona Dental Systems GmbH | Institut Straumann AG | Different manufacturer | ||||||||||||
| Indications for use | The Surgical Trays are intended for organizing, sterilizing and | ||||||||||||||
| storing of instruments. |
The Surgical Tray is not intended to maintain sterility and are to be
used in conjunction with a legally marketed, validated sterilization
pouch.
Sterilization parameters:
Pre-vacuum Steam at 132°C (270°F) for 4 minutes with a 20
minutes dry time.
The tested Surgical Tray represents the worst case validated load of
513.7g.
Do not exceed the following maximum load:
Product name Article number Max load(g) Vent to volume ratio (in-1) OmniTaper
Surgical Tray 68015282 513.7 0.033 PrimeTaper
Surgical Tray 68015321 513.7 0.033 | | | | | | | | | | | | | The Straumann BLX Cassette
is used in healthcare facilities to
organize, enclose,
cleaning, sterilize, transport,
and store medical devices
between surgical uses. The
BLX Cassette is not intended to
maintain sterility; it is intended
to be used in conjunction with
a legally marketed, validated
sterilization wrap.
The BLX Cassette has been
validated for a maximum load
of 300 grams, including
cassette and instruments.
Sterilization parameters:
Pre-vacuum steam: 132°C
(270° F) for 4 minutes with 20
minutes drying time | Similar indications but the
proposed Surgical Tray is not
indicated for cleaning device.
The proposed device is intended
to be used with a validated
sterilization pouch. |
| Product code | KCT | KCT | Same | | | | | | | | | | | | |
6
| Table 5.2: Similarities and Differences between the proposed and predicate devices | |||
|---|---|---|---|
| Elements | Proposed Device | ||
| Surgical Tray | Predicate Device | ||
| Straumann BLX Surgical | |||
| Cassette (K180791) | Comparison | ||
| General Design | Plastic tray with locking lid. Co-molded silicone and | ||
| silicone grommet supports | Plastic tray and lid | Similar, both trays are designed | |
| to hold instruments for implant | |||
| surgery and sterilization and | |||
| consist of a plastic box with an | |||
| insert adapted for the specific | |||
| surgical procedure. The inserts | |||
| have silicone holders for | |||
| instruments. | |||
| Dimensions | 7.3 in x 5.5 in x 2.4 in | 5.6 in x 3.9 in x 2.4 in | Similar |
| Material | Base – Radel 5000 | ||
| Lid – Radel 5000 | |||
| Overlay – Radel 5000 | |||
| Tooling support - Silicone | Radel 5000 | ||
| 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 | ||
| PrimeTaper Surgical Tray | 300g | Different | |
| 513.7g | |||
| 513.7g | |||
| Vent to volume | |||
| ratio | OmniTaper Surgical Tray | ||
| PrimeTaper Surgical Tray | $0.054\ in^{-1}$ | Different | |
| $0.033\ in^{-1}$ | |||
| $0.033\ in^{-1}$ | |||
| 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 minutes 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
5.7 Non-Clinical Performance Data
Non-clinical testing data submitted, referenced, or relied upon, including acceptance criteria and set specifications in test methodology and standards, are summarized below:
| Test Name | Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| Sterilization | ||||
| cycle validation | • ANSI/AAMI/ISO | |||
| 17665-1:2006/(R)2013 | ||||
| • ISO 17665-2:2009 | 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 |