(127 days)
The Mini Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments 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 one of the following cycles:
Pre-vacuum Steam – At 132°C for 4 minutes with a 20 minutes dry time. Gravity Steam - At 132°C for 15 minutes with a 30 minutes dry time.
- The tray is intended for sterilization of non-porous loads.
- Do not stack trays during sterilization.
- The tested Tray represents the worst case validated load of 354.10 grams.
- Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Mini Sterilizable Tray.
The Mini Sterilizable Tray is a reusable perforated instrument cassette system to hold dental instruments in place during transport, steam sterilization, and storage. The tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses.
The Mini Sterilizable Tray is a container composed of three main components: a lid, a cassette base and a variable inner tray, all made of polyphenylsulfone (Radel R5000). The inner tray has silicone rubber that is co-molded in the plastic of the inner tray as well as silicone grommets. In addition, accessory stainless-steel components such as a pan and a bracket may be included in the tray.
The Mini Sterilizable Tray is available in one size with outer dimensions of 5.5 inch x 4.0 inch x 2.25 inch and offered in 5 inner tray configurations with varied instrument loads.
The provided document describes the FDA 510(k) clearance for a medical device called the "Mini Sterilizable Tray." This is a Class II device (Sterilization Wrap, Product Code: KCT). The document details the device's indications for use, its description, and a comparison to a predicate device, along with summary information on the non-clinical performance data used to demonstrate substantial equivalence.
However, the provided text does not contain information about an AI/ML powered device or a study involving human readers or expert consensus for ground truth establishment. Instead, it focuses on the physical and biological safety and effectiveness of a medical device used for organizing, steam sterilizing, and transporting dental instruments. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and biocompatibility testing required for medical devices, rather than the performance of an AI algorithm on a dataset.
Therefore, many of the requested fields related to AI/ML study design (such as sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types related to AI/ML) are not applicable to this document.
Below, I will extract the relevant information regarding the device's acceptance criteria and the studies performed, interpreting "acceptance criteria" as the performance standards the device must meet to be considered safe and effective for its intended use, and "study" as the non-clinical testing performed.
Acceptance Criteria and Study for the Mini Sterilizable Tray
This submission is for a physical medical device (sterilization tray), not an AI/ML-powered device. Therefore, the "acceptance criteria" relate to the physical and biological performance of the device, and the "study" refers to non-clinical laboratory testing. The concept of "ground truth" here is based on established scientific and regulatory standards for sterilization, biocompatibility, and physical integrity.
1. A table of acceptance criteria and the reported device performance
For a physical medical device like this, the acceptance criteria are typically defined by recognized standards (e.g., ISO, AAMI, ASTM) and internal specifications. The "reported device performance" is a statement that the device successfully met these standards.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and ISO 10993-5 (absence of cytotoxicity). | "The Mini Sterilizable Trays were successfully tested for biocompatibility testing in accordance with ISO 10993-1 and ISO 10993-5. The results of a cytotoxicity tests demonstrated that extracts of the device did not elicit a cytotoxic response in the test system." (Page 9) |
| Device Performance & Wear | Maintain functionality after simulated use cycles. | "Non-clinical performance and wear testing of the Mini Sterilizable Tray through simulated use testing. The Sterilizable Mini Tray and its co-packaged components were subjected to 120 simulated uses cycles. Simulated use testing demonstrated that the co-packaged components worked as designed after the simulated use." (Page 9) |
| Cleaning Validation | Effective cleaning; residuals within acceptable limits (TOC, protein). | "Cleaning efficiency was successfully conducted in accordance with AAMI TIR30 and AAMI TIR12. The study used a clinically-relevant, simulated soil, extended drying time between soiling and processing, and minimal processing parameters for the cleaning process. Extracts of proposed devices were analyzed for total organic carbon (TOC) and protein as residual soil markers." (Page 9) |
| Sterilization | Achieve a Sterility Assurance Level (SAL) of 10⁻⁶. | "Sterilization validation was successfully conducted in accordance with ISO 17665-1. The overkill approach as per ISO 17665-1 was used to demonstrate an SAL of 10⁻⁶." (Page 9) (Note: The document states "10°" which appears to be a typographical error, and given the context of SAL for sterilization, it should be 10⁻⁶ for medical devices to achieve terminal sterility). The specific sterilization cycles validated are: - Pre-vacuum Steam: 132°C for 4 minutes with a 20 minutes dry time. - Gravity Steam: 132°C for 15 minutes with a 30 minutes dry time. (Page 5) |
| Transportation Simulation | Maintain physical integrity and component retention during transit. | "Transportation simulation testing validates the packaging and distribution of the Mini Sterilizable Tray and co-packaged instruments. The tests performed included Handling, Stacking, Loose-Load Vibration, Vehicle Vibration, Concentrated Impact, and an additional Handling test per ASTM D4169-16 DC-13, Assurance Level I, Schedules: A, C, F, E, J, A. The transportation testing demonstrates that the Mini Sterilizable Trays and co-packed components were not damaged and remained in their designated location." (Page 9) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify exact numerical sample sizes for each test (e.g., how many trays were tested for biocompatibility or cleaning). It mentions "120 simulated uses cycles" for performance and wear testing (Page 9). Regulatory standards for these types of tests typically specify minimum sample sizes, but these are not enumerated in the summary.
- Data Provenance: Not explicitly stated regarding country of origin for the testing data. The testing is non-clinical (laboratory-based), not human clinical. All tests appear to be prospective as they are conducted specifically to demonstrate the performance of the new device for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This pertains to a physical medical device. "Ground truth" for biocompatibility, sterilization, and physical performance is established through adherence to international and national standards (e.g., ISO, AAMI, ASTM) and scientific principles, not through expert consensus on labeled image data.
4. Adjudication method for the test set
- Not applicable. This pertains to a physical medical device. Decisions about test success are based on whether the device meets pre-defined quantitative or qualitative acceptance criteria per the relevant standards, not on adjudication of subjective interpretations.
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 physical sterilization tray, not an AI/ML diagnostic or assistive tool. No human readers or AI assistance are involved in its primary function or testing for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for this device's performance is based on established scientific principles and consensus standards for medical device safety and effectiveness.
- For biocompatibility: Absence of cytotoxic response (measured in lab assays against scientific benchmarks).
- For sterilization: Achieving a defined Sterility Assurance Level (SAL), typically 10⁻⁶, based on validated microbiological methods.
- For cleaning: Residuals (TOC, protein) below recognized safe limits.
- For performance/wear: Functional integrity after simulated use cycles.
- For transportation: Physical integrity after simulated shipping stresses.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device relying on a training set of data.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device relying on a training set of data.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 6, 2020
Implant Direct Sybron Manufacturing, LLC Reina Choi Regulatory Affairs Manager 3050 East Hillcrest Drive Thousand Oaks, California 91362
Re: K200858
Trade/Device Name: Mini Sterilizable Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: July 2, 2020 Received: July 6, 2020
Dear Reina Choi:
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.
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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 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 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.
Ramesh Kapil Panguluri, 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) K200858
Device Name Mini Sterilizable Tray
Indications for Use (Describe)
The Mini Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared sterilizable wrap and sterilized in an FDA cleared sterilizer for one of the following cycles:
Pre-vacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time. Gravity Steam - At 132°C for 15 minutes with a 30 minutes dry time.
-The tray is intended for sterilization of non-porous loads.
- -Do not stack trays during sterilization.
-The tested Tray represents the worst case validated load of 354.10 grams.
-Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Mini Sterilizable Tray.
| Model Name | Model Number |
|---|---|
| Standard Surgical Kit Mini | CSSKM |
| Standard Surgical Kit Mini Empty | SSKM |
| InterActiveTM Surgical Kit Mini | CISKM |
| InterActiveTM Surgical Kit Mini Empty | ISKM |
| Drill Stop Kit - Long | CDSKL |
| Drill Stop Kit - Long Empty | DSKL |
| Drill Stop Kit - Short | CDSKS |
| Drill Stop Kit - Short Empty | DSKS |
| Prosthetic Kit | CPKM |
| Prosthetic Kit Empty | PKM |
| Drill Stop Kit Bracket Set - Long | DSK-BKTL |
| Drill Stop Kit Bracket Set - Short | DSK-BKTS |
| Replacement Kit Pan | PAN |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I. SUBMITTER
Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362
Contact Person: Reina Choi, Requlatory Affairs Manager E-mail: reina.choi@implantdirect.com Phone: (818) 444-3306
Date Prepared: August 3, 2020
II. DEVICE
Name of Device: Mini Sterilizable Tray Common or Usual Name: Sterilization Wrap Containers, Travs, Cassettes & Other Accessories Classification Name: Sterilization Wrap (21 CFR 880.6850) Regulatory Class: II Product Code: KCT
III.PREDICATE DEVICE
Predicate (primary) InterActive Complete Surgical Tray (K142519)
IV. DEVICE DESCRIPTION
The Mini Sterilizable Tray is a reusable perforated instrument cassette system to hold dental instruments in place during transport, steam sterilization, and storage. The tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses.
The Mini Sterilizable Tray is a container composed of three main components: a lid, a cassette base and a variable inner tray, all made of polyphenylsulfone (Radel R5000). The inner tray has silicone rubber that is co-molded in the plastic of the inner tray as well as silicone grommets. In addition, accessory stainless-steel components such as a pan and a bracket may be included in the tray.
The Mini Sterilizable Tray is available in one size with outer dimensions of 5.5 inch x 4.0 inch x 2.25 inch and offered in 5 inner tray configurations with varied instrument loads.
| Model name | Model number | Max # of instruments | Max load mass(g) | Vent to volume ratio (in⁻¹) |
|---|---|---|---|---|
| Standard Surgical | CSSKM | 21 | 278.50 | 0.082 |
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| Kit Mini | ||||
|---|---|---|---|---|
| InterActive™Surgical Kit Mini | CISKM | 20 | 276.60 | 0.082 |
| Drill Stop Kit - Long | CDSKL | 36 | 354.10 | 0.087 |
| Drill Stop Kit - Short | CDSKS | 32 | 309.01 | 0.087 |
| Prosthetic Kit | CPKM | 14 | 262.55 | 0.082 |
The Mini Sterilizable Tray is available either empty or loaded with surgical and prosthetic instruments to support endosseous dental implants and abutments that are not subject devices to this submission. The empty tray, along with a complete load of instruments, weighs a maximum of 354.10 grams. The variable Inner Tray offers several configuration options to allow for the assembly of supporting surgical and prosthetic instruments.
V. INDICATIONS FOR USE
The Mini Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments 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 one of the following cycles:
Pre-vacuum Steam – At 132°C for 4 minutes with a 20 minutes dry time. Gravity Steam - At 132°C for 15 minutes with a 30 minutes dry time.
- The tray is intended for sterilization of non-porous loads.
- Do not stack trays during sterilization.
- The tested Tray represents the worst case validated load of 354.10 grams.
- Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Mini Sterilizable Tray.
| Model Name | Model Number |
|---|---|
| Standard Surgical Kit Mini | CSSKM |
| Standard Surgical Kit Mini Empty | SSKM |
| InterActive™ Surgical Kit Mini | CISKM |
| InterActive™ Surgical Kit Mini Empty | ISKM |
| Drill Stop Kit - Long | CDSKL |
| Drill Stop Kit – Long Empty | DSKL |
| Drill Stop Kit - Short | CDSKS |
| Drill Stop Kit – Short Empty | DSKS |
| Prosthetic Kit | CPKM |
| Prosthetic Kit Empty | PKM |
| Drill Stop Kit Bracket Set - Long | DSK - BKTL |
| Drill Stop Kit Bracket Set - Short | DSK - BKTS |
| Replacement Kit Pan | PAN |
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Technologicalcharacteristics | Subject Device | Predicate (primary) | Comparison | |
|---|---|---|---|---|
| Mini Sterilizable Tray | InterActive Complete Surgical Tray(K142519) | Comparison | ||
| Manufacturer | Implant Direct Sybron Manufacturing,LLC | Implant Direct Sybron Manufacturing, LLC | Same | |
| General design | Plastic tray with locking lid co-moldedsilicone and silicone grommet supportsand stainless steel components | Plastic tray with locking lid and siliconeretaining supports | Subject device uses co-molding for some siliconesupports and includes astainless steel pan andbracket | |
| Dimensions | 5.5 in x 4.0 in x 2.25 in | 7.2 in x 5.6 in 2.4 in | The subject device issmaller than the predicate | |
| Materials | Base – Radel 5000Lid – Radel 5000Inner tray - Radel 5000Tooling support - SiliconePan - Stainless steelBracket - Stainless steel | Base – Radel 5100Lid – Radel 5000Inner tray - Radel 5100Tooling support - Silicone | Base and Inner tray useRadel 5100 rather thanRadel 5000. Both Radelplastics have similarmechanical properties.Predicate does not includestainless steel | |
| Air permeance | Yes | Yes | Same | |
| Maximumnumber ofinstruments | CSSKM21CISKM20CDSKL36CDSKS32CPKM14 | 45 | Subject device has lessinstruments | |
| Mass ofmaximumsterilization load | CSSKM278.50 gCISKM276.60 gCDSKL354.10 gCDSKS209.01 gCPKM262.55 g | 608.05 g | Subject device has asmaller maximumsterilization load mass | |
| Technological | Subject Device | Predicate (primary) | Comparison | |
| characteristics | Mini Sterilizable Tray | InterActive Complete Surgical Tray(K142519) | ||
| Vent to volumeratio | CSSKM0.082 in-1CISKM0.082 in-1CDSKL0.087 in-1CDSKS0.087 in-1CPKM0.082 in-1 | 0.184 in-1 | Subject device has a lowervent to volume ratio | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Sterilizationmethod | Moist heat gravity or pre vacuum | Moist heat gravity or pre vacuum | Same | |
| Reusable | Yes | Yes | Same | |
| Intended use | Perforated instrument cassette system tohold dental instruments in place duringtransport, steam sterilization, and storage | Perforated instrument cassette system tohold dental instruments in place duringtransport, steam sterilization, and storage | Same | |
| Indication for Use | The Mini Sterilizable Tray is designedto hold various dental surgical andprosthetic instruments in order toorganize, steam sterilize, and transportthe instruments between uses. Thetray is to be enclosed in an FDAcleared steam sterilizable wrap andsterilized in an FDA cleared sterilizerfor one of the following cycles:Pre-vacuum Steam - At 132°C for 4minutes with a 20 minutes dry time.Gravity Steam - At 132°C for 15minutes with a 30 minutes dry time.- The tray is intended for sterilizationof non-porous loads.- Do not stack trays during | The InterActive Complete Surgical Tray isdesigned to hold various dental surgicaldrills and tools in order to organize, steamsterilize, and transport the instrumentsbetween uses. The tray is to be enclosedin an FDA cleared steam sterilizable wrapand sterilized in an FDA cleared sterilizerfor one of the following cycles:(1) Prevauum Steam – At 132°C for 4minutes with a 20 minutes dry time.(2) Gravity Steam - At 132°C for 15minutes with a 30 minutes dry time.- The trays are intended for sterilization ofnon-porous loads.- The trays are recommended not to bestacked during sterilization. | The Mini Sterilizable tray isdesigned to holdinstruments necessary toplace prosthetics that thepredicate is not.Both devices are indicatedto organize, steamsterilize, and transportinstruments between uses.Both devices require useof sterilizable wrap whenautoclaving.Both devices use thesame sterilization cycles. | |
| Technologicalcharacteristics | Subject Device | Predicate (primary)(K142519) | Comparison | |
| Mini Sterilizable Tray | InterActive Complete Surgical Tray | |||
| sterilization.- The tested Tray represents theworst case validated load of 354.10grams.- Implant Direct SybronManufacturing LLC does not makeany lumen claims for the MiniSterilizable Tray. | - The Complete Surgical Tray representsthe worst case validated load due to thenumber of components (45 instruments)and the weight of 608.05 grams.- Implant Direct Sybron Manufacturing LLCdoes not make any lumen claims for theInteractive Complete Surgical Tray.- The tray will be marketed in followingvariations. | The Mini Sterilizable trayhas a maximum validatedload of 354.10 g while thepredicate has a maximumof 608.05 | ||
| Model NameStandard Surgical KitMiniStandard Surgical KitMini EmptyInterActive™ SurgicalKit MiniInterActive™ SurgicalKit Mini EmptyDrill Stop Kit - LongDrill Stop Kit - LongEmptyDrill Stop Kit - ShortDrill Stop Kit - ShortEmptyProsthetic KitProsthetic Kit EmptyDrill Stop Kit BracketSet - LongDrill Stop Kit BracketSet - ShortReplacement Kit Pan | DeviceModelNameCSTICSTIBSTIST | |||
| ModelNumberCSSKMSSKMCISKMISKMCDSKLDSKLCDSKSDSKSCPKMPKMDSK - BKTLDSK - BKTSPAN | Max no. ofInstruments4534180 | |||
| Weight ofeach tray withinstruments(gms.)608.05467.26453.59404.37 |
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Analysis of Differences Between Subject Device and Predicate
In addition to silicone supports, the Mini Sterilizable Tray uses co-molding to integrate the silicone used to hold tooling. The co-molding replaces the silicone orings used in the predicate. The use of co-molded silicone supports was validated though simulated use and wear testing.
In addition to the surgical tooling necessary to place a dental implant, the Mini Sterilizable Trav is designed to hold prosthetic tooling necessary to place a restoration. Prosthetic instruments are made of the same materials and are used during dental procedures like the surgical tooling. Therefore, this does not raise new questions of substantial equivalence.
The Mini Sterilizable Tray includes a stainless steel pan and bracket that are not included in the predicate device. The pan is used to hold drills and other tooling post-surgical use. The bracket aids in the placement of drill stops on the surgical drills. The use of these components has been validated through the use of biocompatibility and sterilization testing.
The Mini Sterilizable Tray uses Radel 5000 for all plastic components where the predicate device uses it only for the tray lid. Since the predicate uses the same plastic for the tray lid this does not pose a new question of substantial equivalence.
The vent to volume ratio for the Mini Sterilizable Tray is 0.087in1 while the predicate vent to volume ratio is 0.184 in-1. While the Mini Sterilizable Tray has a lower vent to volume ratio, this has been demonstrated to not be an issue through sterilization validation testing.
The Mini Sterilizable Tray is smaller and has a smaller maximum sterilization load. The maximum sterilization load for the Mini Sterilizable Tray is 354.10 g while the predicate maximum sterilization load is 608.05 g. The lower weight does not represent a new worst-case but has been validated to assure an SAL of 10-9.
The Mini Sterilizable Trays and predicate device have the same intended use. The indication for use is the same except for the ability to hold prosthetic tooling and the weight of the validated trays.
Summary:
The design differences between the subject and predicate device was evaluated through performance, biocompatibility, and sterilization testing. The documentation submitted in the premarket notification demonstrates that the Mini Sterilizable Tray is substantially equivalent to the predicate device.
VII. PERFORMANCE DATA
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Summary of Non-Clinical Testing:
Biocompatibilitv
The Mini Sterilizable Trays were successfully tested for biocompatibility testing in accordance with ISO 10993-1 and ISO 10993-5. The results of a cytotoxicity tests demonstrated that extracts of the device did not elicit a cytotoxic response in the test system. The results of the testing were used to address questions related to substantial equivalence based on differences in manufacturing processes (addition of DLC coating) between the subject and predicate device (K142519).
Performance testing
Non-clinical performance and wear testing of the Mini Sterilizable Tray through simulated use testing. The Sterilizable Mini Tray and its co-packaged components were subjected to 120 simulated uses cycles. Simulated use testing demonstrated that the co-packaged components worked as designed after the simulated use. The results of the testing were used to address questions related to substantial equivalence based on differences in device design between the subject and predicate device (K142519).
Cleaning Validation
Cleaning efficiency was successfully conducted in accordance with AAMI TIR30 and AAMI TIR12. The study used a clinically-relevant, simulated soil, extended drying time between soiling and processing, and minimal processing parameters for the cleaning process. Extracts of proposed devices were analyzed for total organic carbon (TOC) and protein as residual soil markers. The results of the testing were used to address questions related to substantial equivalence based on differences in product use between the subject and predicate device (K142519).
Sterilization
Sterilization validation was successfully conducted in accordance with ISO 17665-1. The overkill approach as per ISO 17665-1 was used to demonstrate an SAL of 10 °. The results of the testing were used to address questions related to substantial equivalence based on differences in product design between the subject and predicate device (K142519).
Transportation Simulation Testing
Transportation simulation testing validates the packaging and distribution of the Mini Sterilizable Tray and co-packaged instruments. The tests performed included Handling, Stacking, Loose-Load Vibration, Vehicle Vibration, Concentrated Impact, and an additional Handling test per ASTM D4169-16 DC-13, Assurance Level I, Schedules: A, C, F, E, J, A. The transportation testing demonstrates that the Mini Sterilizable Trays and co-packed components were not damaged and remained in their designated location. The results of the testing were used to address questions related to substantial equivalence based on differences in device design between the subject and predicate device (K142519).
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VIII. CONCLUSIONS
The Mini Sterilizable Tray was evaluated for substantial equivalence using standard and/or comparative testing. Based on technological characteristics and non-clinical test data included in this submission, the Mini Sterilizable Tray has been shown to be as safe, as effective and perform as well or better than the legally marketed predicate device, the InterActive Complete Surgical Tray (K142519).
§ 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).