(267 days)
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. -The tray will be marketed in the variations found in the following table.
The Avinent Surgical Tray is 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 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 K142519. 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.
This document describes the non-clinical testing performed for the Avinent Surgical Tray (K191566) to demonstrate its safety and effectiveness. The information provided heavily focuses on the validation of the tray's ability to be cleaned and sterilized, along with its durability and biocompatibility, as opposed to an AI/ML device. Therefore, many of the requested criteria related to AI/ML device performance, such as MRMC studies, ground truth establishment for training sets, and expert qualifications for independent evaluation, are not applicable to this submission.
Here is the breakdown of the acceptance criteria and study results based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Testing | Purpose of Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 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. |
| 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. | 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 | Sterilized instruments were tested to demonstrate there were no residuals on them which would change their biocompatibility. | Pass is a score of no greater than 2 (based on ISO 10993-5 and -12 for cytotoxicity). | Pass with score of 0. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact "sample sizes" in terms of number of devices tested for each validation (e.g., how many trays were subjected to cleaning validation, sterilization, or 100 cycles). It refers to "the tray" being tested.
- Data Provenance: The studies were conducted by AVINENT Implant System, S.L.U. or a contracted lab to validate the device's performance. The origin of the data is implied to be from laboratory testing related to the device itself. It is inherently prospective as these are validation tests conducted specifically for this 510(k) submission. No information on country of origin for the data is explicitly stated, but the company is located in Spain.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the testing described is related to physical and biological performance of a medical device (sterilization tray), not an AI/ML algorithm. Ground truth here is established through objective laboratory measurements and standardized biological and physical tests (e.g., visible soil, specific chemical limits, microbial growth, visual inspection criteria for durability, cytotoxicity scores). No human experts are described as contributing to "ground truth" in terms of interpretation or consensus for these specific tests.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. The results are based on objective measurements and established pass/fail criteria for cleaning effectiveness, sterility, durability, and biocompatibility.
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
Not applicable. This device is a surgical tray for sterilization, not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The ground truth for these tests is based on:
- Objective Measurements: e.g., precise levels of hemoglobin and protein for cleaning validation, absence/presence of microbial growth for sterilization, visual inspection against pre-defined criteria, and quantitative scores for cytotoxicity.
- Standardized Criteria: Adherence to established scientific and regulatory standards (e.g., ISO 10993-5, and general sterility and cleaning validation principles).
- Pass/Fail Criteria: Predetermined thresholds for acceptable performance in each test.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.
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March 6, 2020
AVINENT Implant System, S.L.U. % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172
Re: K191566
Trade/Device Name: Avinent Surgical Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: January 28, 2020 Received: February 4, 2020
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 Sreekanth Gutala, 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)
K191566
Device Name Avinent Surgical Tray
Indications for Use (Describe)
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.
-A vinent Implant System SLU does not make any lumen claims for the Avinent Surgical Tray.
-The tray will be marketed in the variations found in the following table.
| DEVICE MODEL NAME | MAX no. ofINSTRUMENTS | WEIGHT of eachtray FULL (g) | WEIGHT of eachtray EMPTY (g) |
|---|---|---|---|
| Biomimetic Coral SterilizationCassette Guided Surgery | 32 | 599.6 | 510.0 |
| Biomimetic Ocean SterilizationCassette Guided Surgery | 26 | 592.8 | 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 Surgical Tray 510k Summary K191566
AVINENT Implant System S.L.U.
Pol. Ind. Santa Anna I - 08251 Santpedor Barcelona, Spain
+34 902 38 38 48
March 3, 2020
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
Regulation Number: 21 CFR 880.6850
Product Code: KCT
Class: II
Predicate Device: Implant Direct Interactive Complete Surgical Tray K142519
Device Description:
The Avinent Surgical Tray is 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 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.
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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 K142519. 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:
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.
-The tray will be marketed in the variations found in the following table.
| DEVICE MODEL NAME | MAX no. ofINSTRUMENTS | WEIGHT of eachtray FULL (g) | WEIGHT of eachtray EMPTY (g) |
|---|---|---|---|
| Biomimetic Coral SterilizationCassette Guided Surgery | 32 | 599.6 | 510.0 |
| Biomimetic Ocean SterilizationCassette Guided Surgery | 26 | 592.8 | 510.0 |
Technological Characteristics Comparison Table:
The table below provide a technological characteristics comparison of the Avinent Surgical Tray to the predicate device the InterActive Complete Surgical Tray.
| Device | Avinent Surgical Tray(K191566) | InterActive Complete SurgicalTray (K142519) |
|---|---|---|
| Product Code | KCT | KCT |
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| Indications for Use | 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 InterActive Complete Surgical Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. |
|---|---|---|
| Material Composition | Polymer Resin Radel-5000, biomedical grade silicone | Polymer Resin Radel-5000, biomedical grade silicone |
| Design | Plastic tray with locking lid and silicone containment brackets. | Plastic tray with locking lid and silicone containment brackets. |
| Sterilization by1 Gravity Steam | No | Yes |
| 2 Pre Vaccuum Steam | Yes | Yes |
| Air Permeance | Yes | Yes |
| Vent to Volume Ratio | $0.011 in²/in³$ | $.184 in²/in³$ |
| Locking System to hold lid in place | Yes | Yes |
| Reusable | Yes | Yes |
| Stackable | No | No |
| Material compatibility with sterilization process | Yes | Yes |
| Sterilant Penetration Studies | Yes | Yes |
| Biocompatibility | Cytotoxicity tests conducted according to ISO 10993-5 and – 12. | Cytotoxicity tests conducted according to ISO 10993-5 and – 12. |
| Cleaning Instructions for Reusable Devices Validated | Yes | Yes |
| Repeat Sterilization to show material compatibility over time | Yes | Yes |
| Drying Time | Yes | Yes |
| Method to Preserve Sterility of the Tray | FDA cleared wrap | FDA cleared wrap |
Summary of Non-Clinical Testing:
Provided below are the non-clinical testing performed with the subject device to demonstrate that the device met the acceptance criteria of the test method or the standard.
| 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. |
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| 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. | Pass 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 0 |
Cleaning validation using a manual method was done following simulated use according to the cleaning method in the instructions for use. Steam sterilization (half cycle) based on the cycle listed in the indications for use was completed. A second steam sterilization based on this cycle was done 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. Cytotoxicity (ISO 10993-5) of the instruments placed in the tray for sterilization was done after a sterilization cycle was completed to show there were no residuals from the tray on the instruments which would change their biocompatibility.
Conclusion: The conclusions drawn from the nonclinical test demonstrate that the Avinent Surgical Tray is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Interactive Complete Surgical Tray.
§ 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).