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.

AI/ML Overview

The provided text is related to the FDA 510(k) premarket notification for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes. The document details the device description, indications for use, comparison to a predicate device, and a summary of non-clinical testing.

However, the questions you've asked are typically relevant to studies evaluating the performance of AI/ML-driven medical devices (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details).

Since the Avinent Sterilization Cassettes are a physical medical device (sterilization trays), and not an AI/ML software or diagnostic tool, many of the requested data points (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, ground truth types related to expert consensus or pathology, etc.) do not apply to this type of submission.

The "studies" described are validation tests for the physical properties and functionality of the sterilization cassettes themselves (e.g., cleaning validation, steam sterilization validation, cycle life, cytotoxicity).

Let's adapt the answer based on the information available and the nature of the device:

1. A table of acceptance criteria and the reported device performance

Name of Testing	Purpose of Testing	Acceptance Criteria	Reported Device Performance / 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 ($<6.4 µg/cm² protein and $< 2.2 µg/cm²$ hemoglobin). PASS
Steam Sterilization Validation	Validate the half-cycle of the cycle in the instructions for use	No growth on half cycles. No moisture on full drying cycle. Pass on Chemical Indicators half and full cycle.	$10^{-6}$ SAL (Sterility Assurance Level). Pass on chemical indicators half and full cycle. No moisture on full drying cycle. No growth on half cycle.
100 cycles sterilization	Show the tray will last at least 100 sterilization cycles	Pass visual inspection and test of functionality.	At all cycle counts, passed visual inspection and test of functionality.
Cytotoxicity	Demonstrate no residuals on sterilized instruments change their biocompatibility	Pass is a score of no greater than 2 (indicating non-cytotoxicity).	Pass with score of 0. No evidence of lysis - Non-Cytotoxic.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cleaning Validation: "Four articles were used." (These are physical test articles, not data samples in the context of AI/ML).
Steam Sterilization Validation: "Each test article was evaluated..." The number of test articles isn't explicitly stated beyond "each," but it would typically involve multiple units for validation.
100 cycles sterilization: "No changes were noted in the test articles after 100 cycles." The number of test articles is not specified.
Cytotoxicity: "instruments placed in the tray for sterilization was done after a sterilization cycle". It refers to the instruments exposed to the tray, not the tray itself being "tested" for cytotoxicity.
Data Provenance: The document does not specify the country of origin of the data for these non-clinical tests. These are typically laboratory-based validation studies rather than data collected from human subjects. They are prospective in the sense that the tests are designed and executed to validate the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. "Ground truth" in the context of expert consensus is specific to diagnostic AI/ML models. For a physical sterilization device, the "truth" is established by defined physical, chemical, and biological endpoints (e.g., quantitative residual levels, sterility assurance level, visual inspection).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable for a physical device validation. Adjudication methods are typically used to resolve conflicts in human expert interpretations, which is not relevant here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. An MRMC study evaluates human performance with and without AI assistance for diagnostic tasks. This device is a sterilization cassette, not a diagnostic tool or AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical product, not an algorithm. The "standalone" performance refers to the device's ability to sterilize instruments, which is what the Steam Sterilization Validation and Cleaning Validation tests assess.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the tests performed:
- Cleaning Validation: Quantifiable chemical residues (Hemoglobin, Protein, MEM reactivity) and visual inspection.
- Steam Sterilization Validation: Biological indicators (to determine Sterility Assurance Level, SAL) and chemical indicators, along with moisture checks.
- 100 cycles sterilization: Visual inspection and functional testing (physical integrity and operation).
- Cytotoxicity: Cell culture assays (scores quantify cellular response to extracts, with a score of 0 indicating no cytotoxicity).
These are objective, scientifically defined metrics and methods, not expert consensus or pathology in the human diagnostic sense.

8. The sample size for the training set

This question is not applicable. There is no concept of a "training set" for a physical medical device. The device itself is manufactured, and its performance is validated through specific tests, not "trained" on a dataset.

9. How the ground truth for the training set was established

This question is not applicable, as there is no training set for this type of device.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

+34 902 38 38 48

510k Summary – K201533

February 25, 2021

Submission Contact: Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704) 450-9934 angela@blackwelldevice.com

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 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

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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:

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. ofINSTRUMENTS	WEIGHT of each trayFULL (g)	WEIGHT of each trayEMPTY (g)
Biomimetic Coral SterilizationCassette	30	593.4	510.0
Biomimetic Ocean-IcebergSterilization 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: AvinentBiomimetic Coral andOcean-IcebergSterilization Cassettes(K201533)	Predicate Device:Avinent Surgical TrayCoral and Ocean GuidedSurgery SterilizationCassettes (K191566)	Comparison
Product Code	KCT	KCT	Same
Indications for Use	Avinent SterilizationCassettes are designedto hold various dentalsurgical drills and toolsin order to organize,steam sterilize, andtransport theinstruments betweenuses. The tray is to beenclosed in an FDAcleared steamsterilizable wrap andsterilized in an FDAcleared sterilizer for thefollowing cycle:Prevaccum Steam - At132° for 4 minutes witha 30 minute dry time.-The trays are intendedfor sterilization of non-porous loads.-The trays arerecommended not to bestacked duringsterilization.-The Biomimetic CoralSterilization CassetteGuided Surgeryrepresents the worstcase validated load dueto the number ofcomponents (32instruments) and theweight of 599.6 grams.-Avinent Implant SystemSLU does not make anylumen claims for theAvinent SterilizationCassettes.	The Avinent SurgicalTray is designed to holdvarious dental surgicaldrills and tools in orderto organize, steamsterilize, and transportthe instrumentsbetween uses. The trayis to be enclosed in anFDA cleared steamsterilizable wrap andsterilized in an FDAcleared sterilizer for thefollowing cycle:Prevaccum Steam - At132° for 4 minutes witha 30 minute dry time.-The trays are intendedfor sterilization of non-porous loads.-The trays arerecommended not to bestacked duringsterilization.-The Biomimetic CoralSterilization CassetteGuided Surgeryrepresents the worstcase validated load dueto the number ofcomponents (32instruments) and theweight of 599.6 grams.-Avinent Implant SystemSLU does not make anylumen claims for theAvinent Surgical Tray.	Same other thanthe name of thedevice.
Material Composition	Polymer Resin Radel-5000, biomedical gradesilicone	Polymer Resin Radel-5000, biomedical gradesilicone	Same
Design	Plastic tray with lockinglid and siliconecontainment brackets.	Plastic tray with lockinglid and siliconecontainment brackets.	Same
Dimensions	207.5 x 157.5 x 71.7mm	207.5 x 157.5 x 71.7mm	Same
Sterilization by1 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 holdlid in place	Yes	Yes	Same
Reusable	Yes	Yes	Same
Stackable	No	No	Same
Material compatibilitywith sterilization process	Yes	Yes	Same
Sterilant PenetrationStudies	Yes	Yes	Same
Biocompatibility	Provided by materialsuppliers.Cytotoxicity testsconducted according toISO 10993-5 and -12.	Provided by materialsuppliers.Cytotoxicity testsconducted according toISO 10993-5 and -12.	Same
Cleaning Instructions forReusable DevicesValidated	Yes	Yes	Same
Repeat Sterilization toshow materialcompatibility over time	Yes	Yes	Same
Drying Time	Yes	Yes	Same
Method to PreserveSterility of the Tray	FDA cleared wrap	FDA cleared wrap	Same
Reference Numbersreferring to tray contents	Coral 0376Ocean-Iceberg 2725	Coral G.S. 3003Ocean G.S. 3005	Different becausetwo referencenumbers werecleared inK191566 and twoadditional onesare the subject ofthis 510k(K201533)

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Summary of Non-Clinical Testing:

Name of Testing	Purpose of Testing	Acceptance Criteria	Results
Cleaning Validation	Validate the cleaningcycle in the instructionsfor use	No visible soil.Hemoglobin less than$2.2µg/cm²$ . Proteinlevel $≤6.4 µg/cm²$ .MEM reactivity gradeof 2 or less.	No visible soil. Allacceptance criteriamet.$<6.4 µg/cm²$ proteinand $< 2.2 µg/cm²$hemoglobin on deviceafter cleaningPASS
Steam SterilizationValidation	Validate the half-cycleof the cycle in theinstructions for use	No growth on halfcycles. No moisture onfull drying cycle. Passon Chemical Indicatorshalf and full cycle.	$10^{-6}$ SALPass on chemicalindicators half and fullcycle. No moisture onfull drying cycle. Nogrowth on half cycle.
100 cycles sterilization	Show the tray will lastat least 100sterilization cycles	Pass visual inspectionand test offunctionality.	At all cycle countspassed visualinspection and test offunctionality.
Cytotoxicity	Sterilized instrumentswere tested todemonstrate theirwere no residuals onthem which wouldchange theirbiocompatibility.	Pass is a score of nogreater than 2	Pass with score of 0No evidence of lysis -Non-Cytotoxic

Cleaning validation using a manual method was done following simulated use according to the cleaning method in the instructions for use. Six simulated use cycles contamination, cleaning, and sterilization were performed prior to validation. Four articles were used. The MEM article, negative article and negative device control were not simulated use articles. The positive was treated as a test article during the simulated use cycles. The test soil was defibrinated blood soil. The residuals tested were hemoglobin, protein, and minimal essential media.

Steam sterilization validation (half cycle) based on the cycle listed in the indications for use was completed. Each test article was evaluated to a sterility assurance level of ≤10° using the biological indicator overkill method. Dry times were validated using full cycle parameters. A second steam sterilization validation based on this cycle was done full cycle with thermal profiling.

Sterilization of the tray was done to verify the tray safely last for 100 cycles. No changes were noted in the test articles after 100 cycles. A visual inspection, photographs, and a test of functionality were done every 10 cycles. Test articles were rewrapped after every 10 cycles.

Biocompatibility information was provided on all the materials used in the cassettes. Cytotoxicity (ISO 10993-5) of the instruments placed in the tray for sterilization was done after a sterilization cycle was

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completed to show there were no residuals from the tray on the instruments which would change their biocompatibility.

Conclusion: The conclusions drawn from the non-clinical tests demonstrate the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.

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).