(127 days)
No
The device is a physical tray for organizing and sterilizing dental instruments and does not involve any computational or data processing functions.
No
The device is designed to organize, steam sterilize, and transport dental instruments, not to directly treat or diagnose a medical condition.
No
The device is a sterilizable tray designed to hold, organize, and transport dental instruments for sterilization, not for diagnostic purposes.
No
The device description clearly states it is a physical instrument cassette system made of polyphenylsulfone and silicone rubber, with accessory stainless-steel components. It is designed to hold and transport dental instruments for sterilization. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as holding, organizing, steam sterilizing, and transporting dental surgical and prosthetic instruments. This is a function related to the preparation and handling of medical devices, not the diagnosis of disease or other conditions.
- Device Description: The description details a physical container for instruments, made of specific materials and designed for sterilization. This aligns with a medical device used in a clinical setting, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue), detect markers of disease, or provide information for diagnosis.
- Performance Studies: The performance studies focus on biocompatibility, wear testing, cleaning validation, sterilization validation, and transportation simulation. These are all relevant to the safety and efficacy of a reusable medical device used for instrument handling and sterilization, not an IVD.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of disease or other conditions. This device does not fit that description.
N/A
Intended Use / 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 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.
Product codes
KCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Testing:
Biocompatibility: 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.
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.
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.
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 °.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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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3
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 |
4
| 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 |
5
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Technological
| characteristics | 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-molded | |||
| silicone and silicone grommet supports | ||||
| and stainless steel components | Plastic tray with locking lid and silicone | |||
| retaining supports | Subject device uses co- | |||
| molding for some silicone | ||||
| supports and includes a | ||||
| stainless steel pan and | ||||
| bracket | ||||
| 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 is | |
| smaller than the predicate | ||||
| Materials | Base – Radel 5000 | |||
| Lid – Radel 5000 | ||||
| Inner tray - Radel 5000 | ||||
| Tooling support - Silicone | ||||
| Pan - Stainless steel | ||||
| Bracket - Stainless steel | Base – Radel 5100 | |||
| Lid – Radel 5000 | ||||
| Inner tray - Radel 5100 | ||||
| Tooling support - Silicone | Base and Inner tray use | |||
| Radel 5100 rather than | ||||
| Radel 5000. Both Radel | ||||
| plastics have similar | ||||
| mechanical properties. | ||||
| Predicate does not include | ||||
| stainless steel | ||||
| Air permeance | Yes | Yes | Same | |
| Maximum | ||||
| number of | ||||
| instruments | CSSKM | |||
| 21 | ||||
| CISKM | ||||
| 20 | ||||
| CDSKL | ||||
| 36 | ||||
| CDSKS | ||||
| 32 | ||||
| CPKM | ||||
| 14 | 45 | Subject device has less | ||
| instruments | ||||
| Mass of | ||||
| maximum | ||||
| sterilization load | CSSKM | |||
| 278.50 g | ||||
| CISKM | ||||
| 276.60 g | ||||
| CDSKL | ||||
| 354.10 g | ||||
| CDSKS | ||||
| 209.01 g | ||||
| CPKM | ||||
| 262.55 g | 608.05 g | Subject device has a | ||
| smaller maximum | ||||
| sterilization load mass | ||||
| Technological | Subject Device | Predicate (primary) | Comparison | |
| characteristics | Mini Sterilizable Tray | InterActive Complete Surgical Tray | ||
| (K142519) | ||||
| Vent to volume | ||||
| ratio | CSSKM | |||
| 0.082 in-1 | ||||
| CISKM | ||||
| 0.082 in-1 | ||||
| CDSKL | ||||
| 0.087 in-1 | ||||
| CDSKS | ||||
| 0.087 in-1 | ||||
| CPKM | ||||
| 0.082 in-1 | 0.184 in-1 | Subject device has a lower | ||
| vent to volume ratio | ||||
| Sterility | Non-sterile | Non-sterile | Same | |
| Sterilization | ||||
| method | Moist heat gravity or pre vacuum | Moist heat gravity or pre vacuum | Same | |
| Reusable | Yes | Yes | Same | |
| Intended use | Perforated instrument cassette system to | |||
| hold dental instruments in place during | ||||
| transport, steam sterilization, and storage | Perforated instrument cassette system to | |||
| hold dental instruments in place during | ||||
| transport, steam sterilization, and storage | Same | |||
| Indication 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 | ||||
| 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 | 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. 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:
(1) Prevauum 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 trays are intended for sterilization of
non-porous loads. - The trays are recommended not to be
stacked during sterilization. | The Mini Sterilizable tray is
designed to hold
instruments necessary to
place prosthetics that the
predicate is not.
Both devices are indicated
to organize, steam
sterilize, and transport
instruments between uses.
Both devices require use
of sterilizable wrap when
autoclaving.
Both devices use the
same sterilization cycles. | |
| Technological
characteristics | Subject Device | Predicate (primary)
(K142519) | Comparison | |
| | Mini Sterilizable Tray | InterActive Complete Surgical Tray | | |
| | 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 Complete Surgical Tray represents
the worst case validated load due to the
number of components (45 instruments)
and the weight of 608.05 grams. - Implant Direct Sybron Manufacturing LLC
does not make any lumen claims for the
Interactive Complete Surgical Tray. - The tray will be marketed in following
variations. | The Mini Sterilizable tray
has a maximum validated
load of 354.10 g while the
predicate has a maximum
of 608.05 | |
| | Model Name
Standard Surgical Kit
Mini
Standard Surgical Kit
Mini Empty
InterActive™ Surgical
Kit Mini
InterActive™ Surgical
Kit Mini Empty
Drill Stop Kit - Long
Drill Stop Kit - Long
Empty
Drill Stop Kit - Short
Drill Stop Kit - Short
Empty
Prosthetic Kit
Prosthetic Kit Empty
Drill Stop Kit Bracket
Set - Long
Drill Stop Kit Bracket
Set - Short
Replacement Kit Pan | Device
Model
Name
CST
ICST
IBST
IST | | |
| | Model
Number
CSSKM
SSKM
CISKM
ISKM
CDSKL
DSKL
CDSKS
DSKS
CPKM
PKM
DSK - BKTL
DSK - BKTS
PAN | Max no. of
Instruments
45
34
18
0 | | |
| | | Weight of
each tray with
instruments
(gms.)
608.05
467.26
453.59
404.37 | | |
6
7
8
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
9
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).