(149 days)
The Standard 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 (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles:
(1) Prevacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time.
-
(2) 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 667.52 grams.
-
Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.
The Standard 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 Standard Sterilizable Tray is a container composed of three main components: a lid, a trav base and a variable inner trav, 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 pan may be included in the tray.
The Standard Sterilizable Tray is available in one size with outer dimensions of 7.3 inch x 5.5 inch x 2.4 inch and offered in 2 inner tray configurations with varied instrument loads.
The provided document is a 510(k) Summary for a medical device called the "Standard Sterilizable Tray." It outlines the device's characteristics, indications for use, comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: The document describes non-clinical testing for a sterilization tray, which is a physical device, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study aspects for AI/ML device performance (like "human readers improve with AI," "standalone algorithm performance," "number of experts for ground truth," "adjudication method," and "training set details") are not applicable to this submission. The information provided focuses on the physical and functional performance of the sterilization tray.
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-5: Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | Observe the cytotoxicity potential of the device extract. | Morphological Grade 2 (mild) or better | Pass |
| ISO 17664: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices | Verify the continued performance of the device during its useful life. | No visual degradation, silicone retention performance | Pass |
| TIR30 & TIR 12: Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices; Designing, testing and labeling reusable medical devices for reprocessing in health care facilities | Verify the effectiveness of the recommended cleaning process. | < 12 µg/cm² of TOC recovered from devices; < 6.4 µg/cm² of protein recovered from devices. | Pass |
| ISO 17665-1: Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | Verify the ability of the sterilization process to adequately sterilize the load. | 6 log reduction at half-cycle | Pass |
| ASTM D4169-16: Standard Practice for Performance Testing of Shipping Containers and Systems | Verify the durability of the device during transportation. | No damage | Pass |
2. Sample size used for the test set and the data provenance
The document specifies the types of tests conducted (e.g., biocompatibility, cleaning validation, sterilization validation, transport simulation) but does not provide specific sample sizes (e.g., number of units tested) for each test.
- Data Provenance: The tests are described as non-clinical laboratory tests performed by the manufacturer (Implant Direct Sybron Manufacturing, LLC) to demonstrate the device's performance. The document does not specify the country of origin of the data beyond being associated with this manufacturer's testing, nor does it classify the data as "retrospective" or "prospective" in the typical sense for clinical studies; these are laboratory validation studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and study. The "ground truth" for a sterilization tray's performance is established by objective measurements and standardized test methods (e.g., chemical analysis for cleanliness, biological indicators for sterilization efficacy, visual inspection for degradation/damage, etc.), not by expert interpretation of images or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging, where multiple human experts interpret data to create a consensus ground truth. For the physical and functional testing of a sterilization tray, results are typically determined by objective measurements and adherence to pass/fail criteria.
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 is designed for evaluating the impact of AI on human reader performance in diagnostic tasks. This submission concerns a physical medical device (sterilization tray) and its non-clinical performance characteristics, not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This submission is for a physical medical device, not an AI/ML algorithm. There is no "algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by adherence to recognized international and industry standards (ISO, ASTM, TIR) and specific measurable criteria outlined within those standards for:
- Biocompatibility (cytotoxicity)
- Durability and continued performance over useful life (reprocessing cycles)
- Cleaning efficacy (residual protein and TOC)
- Sterilization efficacy (6-log reduction of biological indicators)
- Transportation durability (no damage)
These are objective, quantifiable measures derived from standardized laboratory tests, not subjective interpretations or clinical outcomes data.
8. The sample size for the training set
This question is not applicable. This is a submission for a physical medical device, not an AI/ML algorithm. There is no "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
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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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 28, 2021
Implant Direct Sybron Manufacturing, LLC Reina Choi Regulatory Affairs Manager 3050 East Hillcrest Drive Thousand Oaks, California 91362
Re: K202524
Trade/Device Name: Standard Sterilizable Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: December 21, 2020 Received: December 28, 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.
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 Clarence W. Murray, III, PhD 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) K202524
Device Name Standard Sterilizable Tray
Indications for Use (Describe)
The Standard 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 (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles:
(1) Prevacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time.
-
(2) 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 667.52 grams.
-
Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.
| Model Name | ModelNumber | Max # ofInstruments | Max Load (g) | Vent to volumeRatio (in⁻¹) |
|---|---|---|---|---|
| Standard Surgical Kit | CSSK | 46 | 667.52 | 0.021 |
| Standard Surgical Kit Empty | SSK | 385.2 | 0.021 | |
| InterActive™ Surgical Kit | CISK | 34 | 662.70 | 0.021 |
| InterActive™ Surgical Kit Empty | ISK | 384.2 | 0.021 |
Type of Use (Select one or both, as applicable)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
_ Prescription Use (Part 21 CFR 801 Subpart D)
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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) 307-3132
Date Prepared: January 27, 2021
II. DEVICE
Name of Device: Standard Sterilizable Tray Common or Usual Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Classification Name: Sterilization Wrap (21 CFR 880.6850) Requlatory Class: II Product Code: KCT
III.PREDICATE DEVICE
Primary Predicate: Mini Sterilizable Tray (K200858)
IV. DEVICE DESCRIPTION
The Standard 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 Standard Sterilizable Tray is a container composed of three main components: a lid, a trav base and a variable inner trav, 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 pan may be included in the tray.
The Standard Sterilizable Tray is available in one size with outer dimensions of 7.3 inch x 5.5 inch x 2.4 inch and offered in 2 inner tray configurations with varied instrument loads.
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| Model name | Modelnumber | Max # ofInstruments | Max load(g) | Vent to volumeratio (in⁻¹) |
|---|---|---|---|---|
| Standard Surgical Kit | CSSK | 46 | 667.52 | 0.021 |
| InterActive™ SurgicalKit | CISK | 34 | 662.70 | 0.021 |
The Standard 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 667.52 grams. The variable Inner Tray offers two configuration options to allow for the assembly of supporting surgical and prosthetic instruments.
V. INDICATIONS FOR USE
The Standard 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 (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles:
(1) Prevacuum Steam - At 132°C for 4 minutes with a 20 minutes dry time.
- (2) 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 667.52 grams.
- Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.
| Model Name | ModelNumber | Max # ofInstruments | Mass(g) | Vent to volumeRatio (in⁻¹) |
|---|---|---|---|---|
| Standard Surgical Kit | CSSK | 46 | 667.52 | 0.021 |
| Standard Surgical Kit Empty | SSK | 385.2 | 0.021 | |
| InterActive™ Surgical Kit | CISK | 34 | 662.70 | 0.021 |
| InterActive™ Surgical Kit Empty | ISK | 384.2 | 0.021 |
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Technologicalcharacteristics | Subject Device(K202524) | Primary Predicate(K200858) | Comparison | |||
|---|---|---|---|---|---|---|
| Standard Sterilizable Tray | Mini Sterilizable Tray | |||||
| Manufacturer | Implant Direct Sybron Manufacturing, LLC | Implant Direct Sybron Manufacturing, LLC | Same | |||
| General design | Plastic tray with locking lid co-molded silicone andsilicone grommet supports and stainless steelcomponent | Plastic tray with locking lid co-moldedsilicone and silicone grommet supportsand stainless steel components | Same | |||
| Dimensions | 7.3 in x 5.5 in x 2.4 in | 5.5 in x 4.0 in 2.25 in | Different | |||
| Materials | Base - Radel 5000Lid - Radel 5000Inner tray - Radel 5000Tooling support - SiliconePan - Stainless steel | Base - Radel 5000Lid - Radel 5000Inner tray - Radel 5000Tooling support - SiliconePan - Stainless steelBracket - Stainless steel | Same | |||
| Air permeance | Yes | Yes | Same | |||
| Design Characteristic | Maximumnumber ofinstruments | CSSK | 46 | CSSKM | 21 | Different |
| CISK | 34 | CISKM | 20 | |||
| CDSKL | 36 | |||||
| CDSKS | 32 | |||||
| CPKM | 14 | |||||
| Mass ofmaximumsterilization load | CSSK | 667.52g | CSSKM | 278.50 g | Different | |
| CISK | 662.70g | CISKM | 276.60 g | |||
| CDSKL | 354.10 g | |||||
| CDSKS | 209.10 g | |||||
| CPKM | 262.55 g | |||||
| Vent to volumeratio | CSSK | 0.021 in-1 | CSSKM | 0.082 in-1 | Different | |
| CISK | 0.021 in-1 | CISKM | 0.082 in-1 | |||
| CDSKL | 0.087 in-1 | |||||
| CDSKS | 0.087 in-1 | |||||
| CPKM | 0.087 in-1 |
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| Technologicalcharacteristics | Subject Device(K202524)Standard Sterilizable Tray | Primary Predicate(K200858)Mini Sterilizable Tray | Comparison | |||||
|---|---|---|---|---|---|---|---|---|
| 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 to holddental instruments in place during transport, steamsterilization, and storage | Perforated instrument cassette systemto hold dental instruments in placeduring transport, steam sterilization, andstorage | Same | |||||
| Indication for Use | The Standard Sterilizable Tray is designed to holdvarious dental surgical and prosthetic instrumentsin order to organize, steam sterilize, and transportthe instruments between uses. The tray is to beenclosed in an FDA cleared steam sterilizablewrap (Maximum thickness KC300) and sterilizedin an FDA cleared sterilizer for one of thefollowing cycles:(1) Prevacuum Steam – At 132°C for 4 minuteswith a 20 minutes dry time.(2) Gravity Steam – At 132°C for 15 minutes witha 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 casevalidated load of 667.52 grams.- Implant Direct Sybron Manufacturing LLCdoes not make any lumen claims for theStandard Sterilizable Tray. | The Mini Sterilizable Tray is designed tohold various dental surgical andprosthetic instruments in order toorganize, steam sterilize, and transportthe instruments between uses. The trayis to be enclosed in an FDA clearedsteam sterilizable wrap and sterilized inan FDA cleared sterilizer for one of thefollowing cycles:(1) Prevacuum 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 sterilizationof non-porous loads.- Do not stack trays during sterilization.- The tested Tray represents the worstcase validated load of 354.10 grams.- Implant Direct Sybron ManufacturingLLC does not make any lumen claimsfor the Mini Sterilizable Tray. | Similar | |||||
| ModelName | ModelNumber | Max #of | Mass(g) | Vent tovolume | Model Name | ModelNumber | ||
| Technologicalcharacteristics | Subject Device(K202524)Standard Sterilizable Tray | Primary Predicate(K200858)Mini Sterilizable Tray | Comparison | |||||
| Instruments | Ratio(in-1) | |||||||
| StandardSurgical Kit | CSSK | 46 | 667.52 | 0.021 | Standard Surgical Kit MiniCSSKM | |||
| StandardSurgical KitEmpty | SSK | 385.2 | 0.021 | Standard Surgical Kit MiniEmptySSKM | ||||
| InterActiveTMSurgical Kit | CISK | 34 | 662.70 | 0.021 | InterActiveTM Surgical KitMiniCISKM | |||
| InterActiveTMSurgical KitEmpty | ISK | 384.2 | 0.021 | InterActiveTM Surgical KitMini EmptyISKM | ||||
| Drill Stop Kit – LongCDSKL | ||||||||
| Drill Stop Kit – LongEmptyDSKL | ||||||||
| Drill Stop Kit - ShortCDSKS | ||||||||
| Drill Stop Kit - ShortEmptyDSKS | ||||||||
| Prosthetic KitCPKM | ||||||||
| Prosthetic Kit EmptyPKM | ||||||||
| Drill Stop Kit Bracket Set -LongDSK-BKTL | ||||||||
| Drill Stop Kit Bracket Set -ShortDSK-BKTS | ||||||||
| Replacement Kit PanPAN |
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Comparison Between Subject Device and Predicate
The Standard Sterilizable Tray is larger in size than the predicate and made of same materials as the predicate. The use of Standard Sterilizable Tray has been validated through biocompatibility and sterilization testing. Therefore, this does not raise new questions of substantial equivalence.
The vent to volume ratio for the Standard Sterilizable Tray is 0.021 in 1 while the predicate vent to volume ratio is 0.087 in-1. While the Standard Sterilizable Tray has a lower vent to volume ratio, this has been demonstrated to not be an issue through sterilization validation testing.
The Standard Sterilizable Tray can hold more instruments and has a larger maximum sterilization load. The maximum sterilization load for the Standard Sterilizable Trav is 667,52g, while the predicate's maximum sterilization load is 354.10g. While the Standard Sterilizable Tray has a larger weight and more instruments, this has been demonstrated to not be an issue through sterilization testing and has been validated to assure a SAL of 10-6.
The Standard Sterilizable Trays and predicate device have the same intended use. The indication for use is the same except for and various versions of inner tray for the predicate and the weight of the validated trays.
| TestingMethodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5Biologicalevaluation ofmedical devices —Part 5: Tests for invitro cytotoxicity | The purpose ofthe testing is toobserve thecytoxicitypotential of thedevice extract. | Morphological Grade 2(mild) or better | Pass |
| ISO 17664Processing ofhealth careproducts —Information to beprovided by themedical devicemanufacturer forthe processing ofmedical devices | The purpose ofthis testing is toverify thecontinuedperformance ofthe deviceduring itsuseful life. | No visual degradation,silicone retentionperformance | Pass |
| TIR30- Acompendium ofprocesses,materials, testmethods, andacceptance criteriafor cleaningreusable medicaldevicesAnd TIR 12-Designing, testingand labelingreusable medicaldevices forreprocessing inhealth carefacilities: A guidefor medical devicemanufacturers | The purpose ofthis testing is toverify theeffectiveness oftherecommendedcleaningprocess. | < 12 µg/cm2 of TOC will berecovered from devicescleaned using therecommended minimumcleaningprocesses.< 6.4 µg/cm2 of protein willbe recovered from devicescleaned using therecommended minimumcleaningprocesses. | Pass |
| ISO 17665-1Sterilization ofhealth careproducts — Moistheat — Part 1:Requirements forthe development,validation androutine control of asterilizationprocess formedical devices | The purpose ofthis testing is toverify the abilityof thesterilizationprocess toadequatelysterilize theload. | 6 log reduction at half-cycle | Pass |
| ASTM D4169-16Standard Practicefor PerformanceTesting ofShippingContainers andSystems | The purpose ofthis testing is toverify thedurability of thedevice duringtransportation. | No damage | Pass |
VII. SUMMARY OF NON-CLINICAL TESTING
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VIII. CONCLUSIONS
The conclusions drawn from the non-clinical test data demonstrates that the Standard Sterilizable Tray is as safe, as effective, and performs as well as or better than the legally marketed predicate, Mini Sterilizable Tray (K200858).
§ 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).