Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes

• K Number: K201533
• Device Name: Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes
• Manufacturer: AVINENT Implant System S.L.U.
• Date Cleared: 2021-03-01 ( 266 days)
• Product Code: KCT
• Regulation Number: 880.6850

Intended Use

Avinent Sterilization Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for the following cycle: Prevaccum Steam - At 132° for 4 minutes with a 30 minute dry time. -The trays are intended for sterilization of non-porous loads. -The trays are recommended not to be stacked during sterilization. -The Biomimetic Coral Sterilization Cassette Guided Surgery represents the worst case validated load due to the number of components (32 instruments) and the weight of 599.6 grams. -Avinent Implant System SLU does not make any lumen claims for the Avinent Sterilization Cassettes.

Device Description

The Avinent Sterilization Cassettes are a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization. Each tray consists of three components – a base tray, a lid, and an internal individualized insert tray. All of the three components are perforated for steam penetration. The internal tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and torque wrench. The tray is available in one size, 207.5 x 157.5 x 71.7mm. The tray comes in two variations, Coral and Ocean. The trays in this submission are Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes. The rigid multi-piece tray holds dental device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows them to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared wrap must be used for sterilization purposes to maintain the sterility of contents. The trays are reusable and the tray material allows repeated sterilization cycles. The lid, base, and insert are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC and is identical to the Radel used in predicate device cleared under K191566. Radel R 5000 CL 301 is used for the lid, Radel R-5100 BK # 937 is used for the base and Radel R-5100 GY #1037 is used for the insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain drills and the tool holder with cradle on the base tray are made of medical grade silicone material which has been manufactured to meet FDA 21 CFR 177.2600. These brackets and holders are used to secure the instruments during transport, sterilization, and storage. Although these trays are reusable they will not be serviced or repaired. The instruments to be sterilized in the proposed trays are all non-porous devices and included dental surgical drills and tools. The tools and drills are all class I exempt.

Predicate Devices

K191566

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical sterilization cassette and its materials, with no mention of software, algorithms, or data processing.

Therapeutic

No.
The device is a sterilization cassette designed to hold and organize dental tools for sterilization, not to directly treat a medical condition.

Diagnostic

No

The Avinent Sterilization Cassettes are designed to hold and sterilize dental surgical instruments. They do not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical sterilization cassette made of polymer resin and silicone, designed to hold and organize dental instruments for steam sterilization. It is a hardware device.

IVD (In Vitro Diagnostic)

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 holding dental surgical drills and tools for organization, steam sterilization, and transport. This is a function related to the preparation and handling of medical devices, not for performing diagnostic tests on biological samples.
• Device Description: The device is described as a reusable rigid sterilization container or organizing tray. Its components and materials are designed for containing and protecting instruments during sterilization. There is no mention of any components or functions related to analyzing biological samples or providing diagnostic information.
• Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as:
  • Reagents or assays
  • Analysis of biological samples (blood, urine, tissue, etc.)
  • Measurement of biomarkers or analytes
  • Providing diagnostic information about a patient's health status

The device's purpose is to facilitate the sterilization and handling of dental instruments, which are used in medical procedures, but the device itself is not used to diagnose a condition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Avinent Sterilization Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for the following cycle:
Prevaccum Steam - At 132° for 4 minutes with a 30 minute dry time.
-The trays are intended for sterilization of non-porous loads.
-The trays are recommended not to be stacked during sterilization.
-The Biomimetic Coral Sterilization Cassette Guided Surgery represents the worst case validated load due to the number of components (32 instruments) and the weight of 599.6 grams.
-Avinent Implant System SLU does not make any lumen claims for the Avinent Sterilization Cassettes.

Product codes (comma separated list FDA assigned to the subject device)

KCT

Device Description

The Avinent Sterilization Cassettes are a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization. Each tray consists of three components – a base tray, a lid, and an internal individualized insert tray. All of the three components are perforated for steam penetration. The internal tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and torque wrench. The tray is available in one size, 207.5 x 157.5 x 71.7mm. The tray comes in two variations, Coral and Ocean. The trays in this submission are Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes.

The rigid multi-piece tray holds dental device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows them to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared wrap must be used for sterilization purposes to maintain the sterility of contents.

The trays are reusable and the tray material allows repeated sterilization cycles. The lid, base, and insert are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC and is identical to the Radel used in predicate device cleared under K191566. Radel R 5000 CL 301 is used for the lid, Radel R-5100 BK # 937 is used for the base and Radel R-5100 GY #1037 is used for the insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain drills and the tool holder with cradle on the base tray are made of medical grade silicone material which has been manufactured to meet FDA 21 CFR 177.2600. These brackets and holders are used to secure the instruments during transport, sterilization, and storage. Although these trays are reusable they will not be serviced or repaired.

The instruments to be sterilized in the proposed trays are all non-porous devices and included dental surgical drills and tools. The tools and drills are all class I exempt.

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

health care 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)

Cleaning Validation
Purpose: Validate the cleaning cycle in the instructions for use
Results: No visible soil. All acceptance criteria met. -6 SAL Pass on chemical indicators half and full cycle. No moisture on full drying cycle. No growth on half cycle.

100 cycles sterilization
Purpose: Show the tray will last at least 100 sterilization cycles
Results: At all cycle counts passed visual inspection and test of functionality.

Cytotoxicity
Purpose: Sterilized instruments were tested to demonstrate their were no residuals on them which would change their biocompatibility.
Results: Pass with score of 0 No evidence of lysis - Non-Cytotoxic

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K191566

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

March 1, 2021

AVINENT Implant System S.L.U. % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030

Re: K201533

Trade/Device Name: Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 01, 2021 Received: February 05, 2021

Dear Angela Blackwell:

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

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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 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray III, Ph.D. Acting 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

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Indications for Use

510(k) Number (if known) K201533

Device Name

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes

Indications for Use (Describe)

Avinent Sterilization Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The trav is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for the following cvcle:

Prevaccum Steam - At 1329 for 4 minutes with a 30 minute dry time.

-The trays are intended for sterilization of non-porous loads.

-The trays are recommended not to be stacked during sterilization.

-The Biomimetic Coral Sterilization Cassette Guided Surgery represents the worst case validated load due to the number of components (32 instruments) and the weight of 599.6 grams.

-Avinent Implant System SLU does not make any lumen claims for the Avinent Sterilization Cassettes.

• The tray will be marketed in the following variations,

Device Model Name Biomimetic Coral Sterilization Cassette	30	Weight of tray full (g) 593.4	Weight of tray empty (g) 510.0
Biomimetic Ocean-Iceberg Sterilization Cassette	26	567.8	510.0

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes

AVINENT Implant System S.L.U.

Pol. Ind. Santa Anna I - 08251 Santpedor Barcelona, Spain

[phone]

510k Summary – K201533

February 25, 2021

Submission Contact: Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 [phone] [e-mail]

Classification Name: Sterilization Wrap Containers, Trays, Cassettes, and other accessories

Common Name: Instrument Sterilization Tray

Device Trade Name: Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes

Regulation Number: 21 CFR 880.6850

Product Code: KCT

Class: Il

Predicate Device: Avinent Surgical Tray K191566 Coral and Ocean Guided Surgery Sterilization Cassettes

Device Description:

The Avinent Sterilization Cassettes are a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization. Each tray consists of three components – a base tray, a lid, and an internal individualized insert tray. All of the three components are perforated for steam penetration. The internal tray has the ability to hold individualized pieces and accessories which include dental tools, drills, and torque wrench. The tray is available in one size, 207.5 x 157.5 x 71.7mm. The tray comes in two variations, Coral and Ocean. The trays in this submission are Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes.

The rigid multi-piece tray holds dental device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows them to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are

4

perforated, an FDA cleared wrap must be used for sterilization purposes to maintain the sterility of contents.

The trays are reusable and the tray material allows repeated sterilization cycles. The lid, base, and insert are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC and is identical to the Radel used in predicate device cleared under K191566. Radel R 5000 CL 301 is used for the lid, Radel R-5100 BK # 937 is used for the base and Radel R-5100 GY #1037 is used for the insert tray where all the drills and tools are mounted. The small circular brackets (grommets) throughout the insert tray which are used to contain drills and the tool holder with cradle on the base tray are made of medical grade silicone material which has been manufactured to meet FDA 21 CFR 177.2600. These brackets and holders are used to secure the instruments during transport, sterilization, and storage. Although these trays are reusable they will not be serviced or repaired.

The instruments to be sterilized in the proposed trays are all non-porous devices and included dental surgical drills and tools. The tools and drills are all class I exempt.

Indications for Use:

Avinent Sterilization Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for the following cycle:

Prevaccum Steam - At 132° for 4 minutes with a 30 minute dry time.

-The trays are intended for sterilization of non-porous loads.

-The trays are recommended not to be stacked during sterilization.

-The Biomimetic Coral Sterilization Cassette Guided Surgery represents the worst case validated load due to the number of components (32 instruments) and the weight of 599.6 grams.

-Avinent Implant System SLU does not make any lument Sterilization Cassettes. -The tray will be marketed in the following variations.

| DEVICE MODEL NAME | MAX no. of
INSTRUMENTS | WEIGHT of each tray
FULL (g) | WEIGHT of each tray
EMPTY (g) |
|----------------------------------------------------|---------------------------|---------------------------------|----------------------------------|
| Biomimetic Coral Sterilization
Cassette | 30 | 593.4 | 510.0 |
| Biomimetic Ocean-Iceberg
Sterilization Cassette | 26 | 567.8 | 510.0 |

Comparison of Technological Characteristics:

The table below shows that the Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes compared to the predicate device the Avinent Surgical Tray (Coral and Ocean Guided Surgery Variations).

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| Device | Subject Device: Avinent
Biomimetic Coral and
Ocean-Iceberg
Sterilization Cassettes
(K201533) | Predicate Device:
Avinent Surgical Tray
Coral and Ocean Guided
Surgery Sterilization
Cassettes (K191566) | Comparison |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | KCT | KCT | Same |
| Indications for Use | Avinent Sterilization
Cassettes are designed
to hold various dental
surgical drills and tools
in order to organize,
steam sterilize, and
transport the
instruments between
uses. The tray is to be
enclosed in an FDA
cleared steam
sterilizable wrap and
sterilized in an FDA
cleared sterilizer for the
following cycle:
Prevaccum Steam - At
132° for 4 minutes with
a 30 minute dry time.
-The trays are intended
for sterilization of non-
porous loads.
-The trays are
recommended not to be
stacked during
sterilization.
-The Biomimetic Coral
Sterilization Cassette
Guided Surgery
represents the worst
case validated load due
to the number of
components (32
instruments) and the
weight of 599.6 grams.
-Avinent Implant System
SLU does not make any
lumen claims for the
Avinent Sterilization
Cassettes. | The Avinent Surgical
Tray is designed to hold
various dental surgical
drills and tools in order
to organize, steam
sterilize, and transport
the instruments
between uses. The tray
is to be enclosed in an
FDA cleared steam
sterilizable wrap and
sterilized in an FDA
cleared sterilizer for the
following cycle:
Prevaccum Steam - At
132° for 4 minutes with
a 30 minute dry time.
-The trays are intended
for sterilization of non-
porous loads.
-The trays are
recommended not to be
stacked during
sterilization.
-The Biomimetic Coral
Sterilization Cassette
Guided Surgery
represents the worst
case validated load due
to the number of
components (32
instruments) and the
weight of 599.6 grams.
-Avinent Implant System
SLU does not make any
lumen claims for the
Avinent Surgical Tray. | Same other than
the name of the
device. |
| Material Composition | Polymer Resin Radel-
5000, biomedical grade
silicone | Polymer Resin Radel-
5000, biomedical grade
silicone | Same |
| Design | Plastic tray with locking
lid and silicone
containment brackets. | Plastic tray with locking
lid and silicone
containment brackets. | Same |
| Dimensions | 207.5 x 157.5 x 71.7mm | 207.5 x 157.5 x 71.7mm | Same |
| Sterilization by
1 Gravity Steam | No | No | Same |
| 2 Pre Vaccuum Steam | Yes | Yes | Same |
| Air Permeance | Yes | Yes | Same |
| Vent to Volume Ratio | 0.011 in²/in³ | 0.011 in²/in³ | Same |
| Locking System to hold
lid in place | Yes | Yes | Same |
| Reusable | Yes | Yes | Same |
| Stackable | No | No | Same |
| Material compatibility
with sterilization process | Yes | Yes | Same |
| Sterilant Penetration
Studies | Yes | Yes | Same |
| Biocompatibility | Provided by material
suppliers.
Cytotoxicity tests
conducted according to
ISO 10993-5 and -12. | Provided by material
suppliers.
Cytotoxicity tests
conducted according to
ISO 10993-5 and -12. | Same |
| Cleaning Instructions for
Reusable Devices
Validated | Yes | Yes | Same |
| Repeat Sterilization to
show material
compatibility over time | Yes | Yes | Same |
| Drying Time | Yes | Yes | Same |
| Method to Preserve
Sterility of the Tray | FDA cleared wrap | FDA cleared wrap | Same |
| Reference Numbers
referring to tray contents | Coral 0376
Ocean-Iceberg 2725 | Coral G.S. 3003
Ocean G.S. 3005 | Different because
two reference
numbers were
cleared in
K191566 and two
additional ones
are the subject of
this 510k
(K201533) |

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Summary of Non-Clinical Testing:

Name of Testing	Purpose of Testing	Acceptance Criteria	Results
Cleaning Validation	Validate the cleaning
cycle in the instructions
for use	No visible soil.
Hemoglobin less than
$2.2µg/cm²$ . Protein
level $≤6.4 µg/cm²$ .
MEM reactivity grade
of 2 or less.	No visible soil. All
acceptance criteria
met.
$